Veltrim

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Veltrim

Clotrimazole

Clotrimazole is reported as an ingredient of Veltrim in the following countries:

• United States

International Drug Name Search

Sarilen plus

Sarilen plus may be available in the countries listed below.

Ingredient matches for Sarilen plus

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Sarilen plus in the following countries:

• Turkey

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Sarilen plus in the following countries:

• Turkey

International Drug Name Search

Cartix

Cartix may be available in the countries listed below.

Ingredient matches for Cartix

Glucosamine

Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Cartix in the following countries:

• Colombia

International Drug Name Search

Maxibone

Maxibone may be available in the countries listed below.

Ingredient matches for Maxibone

Alendronic Acid

Alendronic Acid is reported as an ingredient of Maxibone in the following countries:

• Israel

International Drug Name Search

Rosiced

Rosiced may be available in the countries listed below.

UK matches:

• Rosiced 7.5mg/g cream
• Rosiced 7.5mg/g cream (SPC)

Ingredient matches for Rosiced

Metronidazole

Metronidazole is reported as an ingredient of Rosiced in the following countries:

• France


• Germany


• Italy


• Netherlands


• Portugal


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Astawal

Astawal may be available in the countries listed below.

Ingredient matches for Astawal

Oxprenolol

Oxprenolol hydrochloride (a derivative of Oxprenolol) is reported as an ingredient of Astawal in the following countries:

• Japan

International Drug Name Search

Sulfasalazine Katwijk

Sulfasalazine Katwijk may be available in the countries listed below.

Ingredient matches for Sulfasalazine Katwijk

Sulfasalazine

Sulfasalazine is reported as an ingredient of Sulfasalazine Katwijk in the following countries:

• Netherlands

International Drug Name Search

Bufamoxy

Bufamoxy may be available in the countries listed below.

Ingredient matches for Bufamoxy

Amoxicillin

Amoxicillin is reported as an ingredient of Bufamoxy in the following countries:

• Indonesia

International Drug Name Search

Respolin

Respolin may be available in the countries listed below.

Ingredient matches for Respolin

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Respolin in the following countries:

• Bangladesh


• Chile

International Drug Name Search

Pravastatina Generis

Pravastatina Generis may be available in the countries listed below.

Ingredient matches for Pravastatina Generis

Pravastatin

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Pravastatina Generis in the following countries:

• Portugal

International Drug Name Search

Alpha-Lipon AL

Alpha-Lipon AL may be available in the countries listed below.

Ingredient matches for Alpha-Lipon AL

Thioctic Acid

Thioctic Acid is reported as an ingredient of Alpha-Lipon AL in the following countries:

• Germany

International Drug Name Search

Neo-Bronchol

Neo-Bronchol may be available in the countries listed below.

Ingredient matches for Neo-Bronchol

Ambroxol

Ambroxol is reported as an ingredient of Neo-Bronchol in the following countries:

• Lithuania

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Neo-Bronchol in the following countries:

• Croatia (Hrvatska)


• Czech Republic


• Latvia


• Slovakia

International Drug Name Search

Fixical

Fixical may be available in the countries listed below.

Ingredient matches for Fixical

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Fixical in the following countries:

• Tunisia

International Drug Name Search

Risperidon Spirig

Risperidon Spirig may be available in the countries listed below.

Ingredient matches for Risperidon Spirig

Risperidone

Risperidone is reported as an ingredient of Risperidon Spirig in the following countries:

• Switzerland

International Drug Name Search

One-Alpha Leo

One-Alpha Leo may be available in the countries listed below.

Ingredient matches for One-Alpha Leo

Alfacalcidol

Alfacalcidol is reported as an ingredient of One-Alpha Leo in the following countries:

• Greece

International Drug Name Search

Ketamine

In some countries, this medicine may only be approved for veterinary use.

In the US, Ketamine (ketamine systemic) is a member of the drug class general anesthetics and is used to treat Anesthesia.

US matches:

• Ketamine


• Ketamine Injection


• Ketamine Hydrochloride

Ingredient matches for Ketamine

Ketamine

Ketamine (BAN) is known as Ketamine in the US.

Ebastine

Ebastine is reported as an ingredient of Ketamine in the following countries:

• Greece

International Drug Name Search

Glossary

BAN	British Approved Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Clanohepar

Clanohepar may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Clanohepar

Clanobutin

Clanobutin is reported as an ingredient of Clanohepar in the following countries:

• Poland

International Drug Name Search

Epibrom

Epibrom may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Epibrom

Potassium Bromide

Potassium Bromide is reported as an ingredient of Epibrom in the following countries:

• Australia

International Drug Name Search

Biodiar

Biodiar may be available in the countries listed below.

Ingredient matches for Biodiar

Attapulgite

Attapulgite colloidal activated (a derivative of Attapulgite) is reported as an ingredient of Biodiar in the following countries:

• Indonesia

International Drug Name Search

Hostamox

Hostamox may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Hostamox

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Hostamox in the following countries:

• Germany


• Ireland


• Portugal

International Drug Name Search

belladonna alkaloids and phenobarbital

Generic Name: belladonna alkaloids and phenobarbital (BEL a DON a AL ka loids and FEEN oh BAR bi tal)

Brand names: Bellatal, D-Tal, Donnatal, ...show all 21 brand names.Chardonna-2, Hyosophen, Donnapine, Elixiral, Spasmolin, Haponal, Antispas, Barbidonna, Donnatal Extentabs, Antispasmodic, Bellalphen, Donnaphen, Spasquid, Alkabel-SR, Bellatal ER, Servira, PB-Hyos, Quadrapax

What is belladonna alkaloids and phenobarbital?

Phenobarbital is in a group of drugs called barbiturates (bar-BIT-chur-ates). Phenobarbital slows the activity of your brain and nervous system.

Belladonna alkaloids produce many effects in the body, including reduced muscle spasms in the digestive or urinary tract, and reduced fluid secretions from certain glands or organs.

The belladonna alkaloids included in this medication include atropine, hyoscyamine, and scopolamine.

The combination of belladonna alkaloids and phenobarbital is used to treat irritable bowel syndrome and ulcers in the intestine.

Belladonna alkaloids and phenobarbital may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about belladonna alkaloids and phenobarbital?

Phenobarbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take this medication together with a potassium supplement unless your doctor has told you to.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by belladonna alkaloids and phenobarbital. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while taking this medication or you could have increased dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Belladonna alkaloids and phenobarbital can decrease perspiration and you may be more prone to heat stroke.

Call your doctor if your symptoms do not improve, or if they get worse.

What should I discuss with my healthcare provider before taking belladonna alkaloids and phenobarbital?

You should not use this medication if you are allergic to atropine, hyoscyamine, scopolamine, or phenobarbital. You may not be able use this medication if you have:

• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  a blockage in your intestines or digestive tract;

  
  


• 
  

  a stomach condition called paralytic ileus;

  
  


• 
  

  active bleeding;

  
  


• 
  

  severe ulcerative colitis or toxic megacolon;

  
  


• 
  

  a muscle disorder called myasthenia gravis;

  
  


• 
  

  a hiatal hernia or reflux disease; or

  
  


• 
  

  porphyria.

  
  

Before taking this medication, tell your doctor if you are allergic to any drugs or if you have:

• 
  

  a colostomy or ileostomy;

  
  


• liver disease;


• kidney disease;


• 
  

  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  heart disease, high blood pressure, congestive heart failure;

  
  


• 
  

  a heart rhythm disorder; or

  
  


• 
  

  ulcerative colitis or stomach ulcer.

  
  

If you have any of these conditions, you may not be able to take belladonna alkaloids and phenobarbital, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. However, belladonna alkaloids and phenobarbital can slow breast milk production. Do not take this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without the advice of a doctor. Older adults may be more likely to have side effects such as constipation, dry mouth, problems with urination, agitation, confusion, or severe memory problems.

How should I take belladonna alkaloids and phenobarbital?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the medicine with a full glass of water.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, or if they get worse.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using belladonna alkaloids and phenobarbital.

Store belladonna alkaloids and phenobarbital at room temperature away from moisture and heat. Keep track of how much of this medicine has been used from each new bottle. Phenobarbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Belladonna alkaloids and phenobarbital dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, dizziness, nausea, vomiting, dry mouth, blurred vision, hot or dry skin, trouble swallowing, feeling excited or agitated,

What should I avoid while taking belladonna alkaloids and phenobarbital?

Do not take this medication together with a potassium supplement unless your doctor has told you to.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by belladonna alkaloids and phenobarbital. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while taking this medication or you could have increased dizziness and drowsiness.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Belladonna alkaloids and phenobarbital can decrease perspiration and you may be more prone to heat stroke.

Belladonna alkaloids and phenobarbital side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  diarrhea;

  
  


• 
  

  painful or difficult urination;

  
  


• 
  

  fast or pounding heartbeats;

  
  


• 
  

  blurred vision with eye pain, or seeing halos around lights;

  
  


• 
  

  feeling like you might pass out; or

  
  


• 
  

  mouth sores, red or bleeding gums, or tooth decay (with long-term use).

  
  

Less serious side effects may include:

• 
  

  drowsiness;

  
  


• 
  

  blurred vision, increased sensitivity to light;

  
  


• 
  

  dry mouth;

  
  


• 
  

  decreased taste sensation;

  
  


• 
  

  decreased sweating or urination;

  
  


• 
  

  headache, dizziness, weakness;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  nausea, vomiting, constipation, bloating;

  
  


• 
  

  feeling restless or excited; or

  
  


• 
  

  impotence, loss of interest in sex, or trouble having an orgasm.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Belladonna alkaloids and phenobarbital Dosing Information

Usual Adult Dose for Duodenal Ulcer:

Regular release tablets: 1 to 2 tablets orally 3 to 4 times a day according to condition and severity of symptoms
Elixir: 5 to 10 mL orally 3 to 4 times a day according to condition and severity of symptoms
Extended release tablets: 1 tablet orally every 12 hours; if necessary, 1 tablet orally every 8 hours may be given

Usual Adult Dose for Irritable Bowel Syndrome:

Regular release tablets: 1 to 2 tablets orally 3 to 4 times a day according to condition and severity of symptoms
Elixir: 5 to 10 mL orally 3 to 4 times a day according to condition and severity of symptoms
Extended release tablets: 1 tablet orally every 12 hours; if necessary, 1 tablet orally every 8 hours may be given

Usual Adult Dose for Enterocolitis:

Regular release tablets: 1 to 2 tablets orally 3 to 4 times a day according to condition and severity of symptoms
Elixir: 5 to 10 mL orally 3 to 4 times a day according to condition and severity of symptoms
Extended release tablets: 1 tablet orally every 12 hours; if necessary, 1 tablet orally every 8 hours may be given

Usual Pediatric Dose for Duodenal Ulcer:

Elixir:
Initial dose:
4.5 kg to less than 9.1 kg: 0.5 mL orally every 4 hours or 0.75 mL orally every 6 hours
9.1 kg to less than 13.6 kg: 1 mL orally every 4 hours or 1.5 mL orally every 6 hours
13.6 kg to less than 22.7 kg: 1.5 mL orally every 4 hours or 2 mL orally every 6 hours
22.7 kg to less than 34 kg: 2.5 mL orally every 4 hours or 3.75 mL orally every 6 hours
34 kg to less than 45.4 kg: 3.75 mL orally every 4 hours or 1 mL orally every 6 hours
45.4 kg or greater: 5 mL orally every 4 hours or 7.5 mL orally every 6 hours

Usual Pediatric Dose for Irritable Bowel Syndrome:

Elixir:
Initial dose:
4.5 kg to less than 9.1 kg: 0.5 mL orally every 4 hours or 0.75 mL orally every 6 hours
9.1 kg to less than 13.6 kg: 1 mL orally every 4 hours or 1.5 mL orally every 6 hours
13.6 kg to less than 22.7 kg: 1.5 mL orally every 4 hours or 2 mL orally every 6 hours
22.7 kg to less than 34 kg: 2.5 mL orally every 4 hours or 3.75 mL orally every 6 hours
34 kg to less than 45.4 kg: 3.75 mL orally every 4 hours or 1 mL orally every 6 hours
45.4 kg or greater: 5 mL orally every 4 hours or 7.5 mL orally every 6 hours

Usual Pediatric Dose for Enterocolitis:

Elixir:
Initial dose:
4.5 kg to less than 9.1 kg: 0.5 mL orally every 4 hours or 0.75 mL orally every 6 hours
9.1 kg to less than 13.6 kg: 1 mL orally every 4 hours or 1.5 mL orally every 6 hours
13.6 kg to less than 22.7 kg: 1.5 mL orally every 4 hours or 2 mL orally every 6 hours
22.7 kg to less than 34 kg: 2.5 mL orally every 4 hours or 3.75 mL orally every 6 hours
34 kg to less than 45.4 kg: 3.75 mL orally every 4 hours or 1 mL orally every 6 hours
45.4 kg or greater: 5 mL orally every 4 hours or 7.5 mL orally every 6 hours

What other drugs will affect belladonna alkaloids and phenobarbital?

The following drugs can interact with belladonna alkaloids and phenobarbital. Tell your doctor if you are using any of these:

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  ketoconazole (Nizoral);

  
  


• 
  

  an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  
  


• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bronchodilators such as ipratroprium (Atrovent) or tiotropium (Spiriva);

  
  


• 
  

  glycopyrrolate (Robinul);

  
  


• 
  

  mepenzolate (Cantil);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and there may be other drugs that can interact with belladonna alkaloids and phenobarbital. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More belladonna alkaloids and phenobarbital resources

• Belladonna alkaloids and phenobarbital Dosage
• Belladonna alkaloids and phenobarbital Use in Pregnancy & Breastfeeding
• Drug Images
• Belladonna alkaloids and phenobarbital Drug Interactions
• Belladonna alkaloids and phenobarbital Support Group
• 11 Reviews for Belladonna alkaloids and phenobarbital - Add your own review/rating

Compare belladonna alkaloids and phenobarbital with other medications

• Duodenal Ulcer
• Enterocolitis
• Irritable Bowel Syndrome

Where can I get more information?

• Your pharmacist can provide more information about belladonna alkaloids and phenobarbital.

Enper

Enper may be available in the countries listed below.

Ingredient matches for Enper

Zidovudine

Zidovudine is reported as an ingredient of Enper in the following countries:

• Argentina

International Drug Name Search

Calcivet

Calcivet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Calcivet

Calcium Gluconate

Calcium Gluconate monohydrate (a derivative of Calcium Gluconate) is reported as an ingredient of Calcivet in the following countries:

• Poland

Magnesium Chloride

Magnesium Chloride is reported as an ingredient of Calcivet in the following countries:

• Poland

International Drug Name Search

Combizard

Combizard may be available in the countries listed below.

Ingredient matches for Combizard

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Combizard in the following countries:

• Vietnam

Losartan

Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Combizard in the following countries:

• Vietnam

International Drug Name Search

Ranitidine Ranbaxy

Ranitidine Ranbaxy may be available in the countries listed below.

Ingredient matches for Ranitidine Ranbaxy

Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Ranitidine Ranbaxy in the following countries:

• Finland


• France


• Netherlands

International Drug Name Search

Ciproval Otico

Ciproval Otico may be available in the countries listed below.

Ingredient matches for Ciproval Otico

Ciprofloxacin

Ciprofloxacin is reported as an ingredient of Ciproval Otico in the following countries:

• Chile


• Peru

International Drug Name Search

Voldiamer B6

Voldiamer B6 may be available in the countries listed below.

Ingredient matches for Voldiamer B6

Pyridoxine

Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Voldiamer B6 in the following countries:

• Indonesia

International Drug Name Search

Metaoxedrin Ophtha

Metaoxedrin Ophtha may be available in the countries listed below.

Ingredient matches for Metaoxedrin Ophtha

Phenylephrine

Phenylephrine hydrochloride (a derivative of Phenylephrine) is reported as an ingredient of Metaoxedrin Ophtha in the following countries:

• Denmark

International Drug Name Search

Clorfenamina

Clorfenamina may be available in the countries listed below.

Ingredient matches for Clorfenamina

Chlorphenamine

Clorfenamina (DCIT) is also known as Chlorphenamine (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Pyridoxin

Pyridoxin may be available in the countries listed below.

Ingredient matches for Pyridoxin

Pyridoxine

Pyridoxine hydrochloride (a derivative of Pyridoxine) is reported as an ingredient of Pyridoxin in the following countries:

• Oman

International Drug Name Search

Eto

Eto may be available in the countries listed below.

Ingredient matches for Eto

Etoricoxib

Etoricoxib is reported as an ingredient of Eto in the following countries:

• Bangladesh

International Drug Name Search

Rotilen

Rotilen may be available in the countries listed below.

Ingredient matches for Rotilen

Metacycline

Metacycline hydrochloride (a derivative of Metacycline) is reported as an ingredient of Rotilen in the following countries:

• Italy

International Drug Name Search

Bayer Aspirin Sugar Free

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Aspirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about aspirin?

There are many brands and forms of aspirin available and not all brands are listed on this leaflet.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin, or if you have:

• 
  

  a recent history of stomach or intestinal bleeding;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:

• 
  

  asthma or seasonal allergies;

  
  


• 
  

  stomach ulcers;

  
  


• liver disease;


• kidney disease;


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  heart disease, high blood pressure, or congestive heart failure;

  
  


• 
  

  gout; or

  
  


• 
  

  nasal polyps.

  
  

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger or smaller amounts, or use it for longer than recommended.

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe nausea, vomiting, or stomach pain;

  
  


• 
  

  fever lasting longer than 3 days;

  
  


• 
  

  swelling, or pain lasting longer than 10 days; or

  
  


• 
  

  hearing problems, ringing in your ears.

  
  

Less serious side effects may include:

• 
  

  upset stomach, heartburn;

  
  


• 
  

  drowsiness; or

  
  


• 
  

  headache.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

Before taking aspirin, tell your doctor if you are using any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

  
  

This list is not complete and there may be other drugs that can interact with aspirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Bayer Aspirin Sugar Free resources

• Bayer Aspirin Sugar Free Side Effects (in more detail)
• Bayer Aspirin Sugar Free Use in Pregnancy & Breastfeeding
• Bayer Aspirin Sugar Free Drug Interactions
• Bayer Aspirin Sugar Free Support Group
• 2 Reviews for Bayer Aspirin Sugar Free - Add your own review/rating

• Aspirin Monograph (AHFS DI)


• Aspirin Prescribing Information (FDA)


• Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information


• ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Bayer Aspirin Sugar Free with other medications

• Angina
• Angina Pectoris Prophylaxis
• Ankylosing Spondylitis
• Antiphospholipid Syndrome
• Aseptic Necrosis
• Back Pain
• Fever
• Heart Attack
• Ischemic Stroke
• Ischemic Stroke, Prophylaxis
• Juvenile Rheumatoid Arthritis
• Kawasaki Disease
• Myocardial Infarction, Prophylaxis
• Niacin Flush
• Osteoarthritis
• Pain
• Prosthetic Heart Valves
• Prosthetic Heart Valves, Mechanical Valves
• Revascularization Procedures, Prophylaxis
• Rheumatic Fever
• Rheumatoid Arthritis
• Sciatica
• Systemic Lupus Erythematosus
• Thromboembolic Stroke Prophylaxis
• Transient Ischemic Attack

Where can I get more information?

• Your pharmacist can provide more information about aspirin.

See also: Bayer Aspirin Sugar Free side effects (in more detail)

Bleoloem

Bleoloem may be available in the countries listed below.

Ingredient matches for Bleoloem

Bleomycin

Bleomycin is reported as an ingredient of Bleoloem in the following countries:

• Sri Lanka

International Drug Name Search

Artenimol

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

P01BE05,P01BE06

CAS registry number (Chemical Abstracts Service)

0081496-81-3

Chemical Formula

C15-H24-O5

Molecular Weight

284

Therapeutic Categories

Antiprotozoal

Antiprotozoal agent: Antimalarial

Chemical Names

(3R,5aS,6R,8aS,9R,10S,12R,12aR)-3,6,9-Trimethyldecahydro-12H-3,12-epoxypyrano[4,3,-j]-1,2-benzodioxepin-10-ol (IUPAC)

(3R,5aS,6R,8aS,9R,10S,12R,12aR)-Decahydro-3,6,9-trimethyl-3,12-epoxy-12H-pyrano[4,3,-j]-1,2-benzodioxepin-10-ol (WHO)

3,12-Epoxy-12H-pyrano[4,3,-j]-1,2-benzodioxepin-10-ol, decahydro-3,6,9-trimethyl-, (3R,5aS,6R,8aS,9R,10S,12R,12aR)-

Foreign Names

• Artenimolum (Latin)
• Artenimol (German)
• Arténimol (French)
• Artenimol (Spanish)

Generic Names

• b-dihydroartemisinin (OS: Ph. Int.)
• Dihydroartemisinin (OS: Ph. Int.)
• DHA (IS)
• DHQS (IS)
• Dihydroginghaosu (IS)
• Artenimol (PH: Ph. Int. 4)
• Artenimolum (PH: Ph. Int. 4)

Brand Names

• Cotecxin
  Holley Pharm, China



• Duo-Cotecxin (Artenimol and Piperaquine)
  Holley Pharm, China

International Drug Name Search

Glossary

IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Ph. Int.	Pharmacopoea Internationalis
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Clopan

Clopan may be available in the countries listed below.

Ingredient matches for Clopan

Metoclopramide

Metoclopramide is reported as an ingredient of Clopan in the following countries:

• Ecuador

International Drug Name Search

Betamethasone MK

Betamethasone MK may be available in the countries listed below.

Ingredient matches for Betamethasone MK

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Betamethasone MK in the following countries:

• Aruba


• Belize


• Jamaica

International Drug Name Search

Cisplatin-GRY

Cisplatin-GRY may be available in the countries listed below.

Ingredient matches for Cisplatin-GRY

Cisplatin

Cisplatin is reported as an ingredient of Cisplatin-GRY in the following countries:

• Germany

International Drug Name Search

Celiprolol Mylan

Celiprolol Mylan may be available in the countries listed below.

Ingredient matches for Celiprolol Mylan

Celiprolol

Celiprolol hydrochloride (a derivative of Celiprolol) is reported as an ingredient of Celiprolol Mylan in the following countries:

• Belgium

International Drug Name Search

Veletri

Veletri is a brand name of epoprostenol, approved by the FDA in the following formulation(s):

VELETRI (epoprostenol sodium - injectable; injection)

• 
  Manufacturer: ACTELION
  
  Approval date: June 27, 2008
  
  Strength(s): EQ 1.5MG BASE/VIAL ^[RLD]

Has a generic version of Veletri been approved?

No. There is currently no therapeutically equivalent version of Veletri available.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Veletri. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Veletri.

See also...

• Veletri Consumer Information (Wolters Kluwer)
• Veletri Consumer Information (Cerner Multum)
• Veletri Advanced Consumer Information (Micromedex)
• Epoprostenol Consumer Information (Wolters Kluwer)
• Epoprostenol Consumer Information (Cerner Multum)
• Epoprostenol Intravenous Advanced Consumer Information (Micromedex)
• Epoprostenol Sodium AHFS DI Monographs (ASHP)

Loratadina Calox

Loratadina Calox may be available in the countries listed below.

Ingredient matches for Loratadina Calox

Loratadine

Loratadine is reported as an ingredient of Loratadina Calox in the following countries:

• Venezuela

International Drug Name Search

Humulina NPH

Humulina NPH may be available in the countries listed below.

Ingredient matches for Humulina NPH

Insulin, Isophane

Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Humulina NPH in the following countries:

• Spain

International Drug Name Search

Epi GRY

Epi GRY may be available in the countries listed below.

Ingredient matches for Epi GRY

Epirubicin

Epirubicin hydrochloride (a derivative of Epirubicin) is reported as an ingredient of Epi GRY in the following countries:

• Germany

International Drug Name Search

Panthenyl

Panthenyl may be available in the countries listed below.

Ingredient matches for Panthenyl

Dexpanthenol

Dexpanthenol is reported as an ingredient of Panthenyl in the following countries:

• Japan

International Drug Name Search

Reliv

Reliv may be available in the countries listed below.

Ingredient matches for Reliv

Paracetamol

Paracetamol is reported as an ingredient of Reliv in the following countries:

• Sweden

International Drug Name Search

Bécotide

Bécotide may be available in the countries listed below.

Ingredient matches for Bécotide

Beclometasone

Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Bécotide in the following countries:

• France

International Drug Name Search

Amitrox

Amitrox may be available in the countries listed below.

Ingredient matches for Amitrox

Acyclovir

Aciclovir is reported as an ingredient of Amitrox in the following countries:

• Greece

International Drug Name Search

Lunapon

Lunapon may be available in the countries listed below.

Ingredient matches for Lunapon

Fluorouracil

Fluorouracil is reported as an ingredient of Lunapon in the following countries:

• Japan

International Drug Name Search

ProHance Bracco

ProHance Bracco may be available in the countries listed below.

Ingredient matches for ProHance Bracco

Gadoteridol

Gadoteridol is reported as an ingredient of ProHance Bracco in the following countries:

• Finland

International Drug Name Search

Oxycodone Immediate-Release Capsules

Generic Name: oxycodone hydrochloride

Dosage Form: capsule
OXYCODONE HYDROCHLORIDE

IMMEDIATE-RELEASE ORAL CAPSULES, 5 mg

CII

Rx only

Oxycodone Immediate-Release Capsules Description

Oxycodone hydrochloride is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride, a white, odorless, crystalline powder which is derived from the opium alkaloid, thebaine, and may be represented by the structural formula:

Each Oxycodone Hydrochloride Immediate-Release Oral Capsule contains:

Oxycodone Hydrochloride USP .................5 mg


In addition, each capsule contains the following inactive ingredients: black iron oxide, gelatin, lactose, red iron oxide, silicon dioxide, stearic acid, titanium dioxide, yellow iron oxide.

ACTIONS

The analgesic ingredient, oxycodone, is a semisynthetic narcotic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of oxycodone are analgesia and sedation.

Oxycodone Immediate-Release Capsules - Clinical Pharmacology

Central Nervous System

Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia. Other therapeutic effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. Like all pure opioid agonists, there is no ceiling effect to analgesia, such as is seen with partial agonists or non-opioid analgesics.


The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.


Oxycodone produces respiratory depression by direct action on brain stem respiratory centers. The respiratory depression involves both a reduction in the responsiveness of the brain stem respiratory centers to increases in carbon dioxide tension and to electrical stimulation.


Oxycodone depresses the cough reflex by direct effect on the cough center in the medulla. Antitussive effects may occur with doses lower than those usually required for analgesia.


Oxycodone causes miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic. Marked mydriasis rather than miosis may be seen due to hypoxia in overdose situations.

Gastrointestinal Tract and Other Smooth Muscle

Oxycodone causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm resulting in constipation. Other opioid-induced effects may include a reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Cardiovascular System

Oxycodone may produce release of histamine with or without associated peripheral vasodilation. Manifestations of histamine release and/or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Concentration—Effect Relationships (Pharmacodynamics)

Studies in normal volunteers and patients reveal predictable relationships between oxycodone dosage and plasma oxycodone concentrations, as well as between concentration and certain expected opioid effects. In normal volunteers these include pupillary constriction, sedation and overall “drug effect” and in patients, analgesia and feelings of “relaxation.” In non-tolerant patients, analgesia is not usually seen at a plasma oxycodone concentration of less than 5 to 10 ng/mL.


As with all opioids, the minimum effective plasma concentration for analgesia will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients need to be treated with individualized titration of dosage to the desired effect. The minimum effective analgesic concentration of oxycodone for any individual patient may increase with repeated dosing due to an increase in pain and/or the development of tolerance.

Concentration—Adverse Experience Relationships

Oxycodone hydrochloride capsules are associated with typical opioid-related adverse experiences similar to those seen with all opioids. There is a general relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse experiences such as nausea, vomiting, CNS effects and respiratory depression. In opioid-tolerant patients, the situation is altered by the development of tolerance to opioid-related side effects, and the relationship is poorly understood.


As with all opioids, the dose must be individualized (see DOSAGE AND ADMINISTRATION), because the effective analgesic dose for some patients will be too high to be tolerated by other patients.

Indications and Usage for Oxycodone Immediate-Release Capsules

For the relief of moderate to moderately severe pain.

Contraindications

Oxycodone hydrochloride capsules are contraindicated in patients with known hypersensitivity to oxycodone, or in any situation where opioids are contraindicated. This includes patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone hydrochloride capsules are contraindicated in any patient who has or is suspected of having paralytic ileus.

Warnings

Respiratory Depression

Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration.


Oxycodone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

Hypotensive Effect

Oxycodone hydrochloride capsules, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Oxycodone hydrochloride capsules may produce orthostatic hypotension in ambulatory patients. Oxycodone hydrochloride capsules, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Drug Dependence

Oxycodone can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of this drug, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic containing medications. Like other narcotic containing medications, this drug is subject to the Federal Controlled Substances Act.

Usage in Ambulatory Patients

Oxycodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

Interaction with Other Central Nervous System Depressants

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with oxycodone hydrochloride may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Usage in Pregnancy

Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, this drug should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

Usage in Children

This drug should not be administered to children.

Precautions

General

Opioid analgesics given on a fixed-dosage schedule have a narrow therapeutic index in certain patient populations, especially when combined with other drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.


Use of oxycodone hydrochloride capsules is associated with increased potential risks and should be used only with caution in the following conditions: acute alcoholism; adrenocortical insufficiency (e.g., Addison’s disease); CNS depression or coma; delirium tremens; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.


The administration of oxycodone, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist and partial agonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.

Use in Pancreatic/Biliary Tract Disease

Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of this drug or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Information for Patients/Caregivers

If clinically advisable, patients receiving oxycodone hydrochloride capsules or their caregivers should be given the following information by the physician, nurse, pharmacist or caregiver:

1. Patients should be advised not to adjust the dose of this drug without consulting the prescribing professional.
   
   


2. Patients should be advised that this drug may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
   
   


3. Patients should not combine this drug with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
   
   


4. Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
   
   


5. Patients should be advised that this drug is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
   
   


6. Patients should be advised that if they have been receiving treatment with this drug for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper this drug dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

Laboratory Monitoring

Due to the broad range of plasma concentrations seen in clinical populations, the varying degrees of pain, and the development of tolerance, plasma oxycodone measurements are usually not helpful in clinical management. Plasma concentrations of the active drug substance may be of value in selected, unusual or complex cases.

Use in Drug and Alcohol Addiction

Oxycodone hydrochloride capsules are opioids with no approved use in the management of addictive disorders. Their proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of pain requiring opioid analgesia.

Drug-Drug Interactions

The CNS depressant effects of oxycodone hydrochloride may be additive with that of other CNS depressants (see WARNINGS).


Opioid analgesics, including oxycodone hydrochloride capsules, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.


Oxycodone is metabolized in part to oxymorphone via CYP2D6. While this pathway may be blocked by a variety of drugs (e.g., certain cardiovascular drugs and antidepressants), such blockade has not yet been shown to be of clinical significance with this agent. Clinicians should be aware of this possible interaction, however.

Mutagenicity/Carcinogenicity

Oxycodone was not mutagenic in the following assays: Ames Salmonella and E. Coli test with and without metabolic activation at doses of up to 5000 mcg, chromosomal aberration test in human lymphocytes in the absence of metabolic activation at doses of up to 1500 mcg/mL and with activation 48 hours after exposure at doses of up to 5000 mcg/mL, and in the in vivo bone marrow micronucleus test in mice (at plasma levels of up to 48 mcg/mL). Mutagenic results occurred in the presence of metabolic activation in the human chromosomal aberration test (at greater than or equal to 1250 mcg/mL) at 24 but not 48 hours of exposure and in the mouse lymphoma assay at doses of 50 mcg/mL or greater with metabolic activation and at 400 mcg/mL or greater without metabolic activation. The data from these tests indicate that the genotoxic risk to humans may be considered low.


Studies of oxycodone in animals to evaluate its carcinogenic potential have not been conducted owing to the length of clinical experience with the drug substance.

Pregnancy

Teratogenic Effects. Category B – Reproduction studies have been performed in rats and rabbits by oral administration at doses up to 8 mg/kg (48 mg/m2) and 125 mg/kg (1375 mg/m2), respectively. These doses are 3 and 47 times a human dose of 160 mg/day (90 mg/m2), based on mg/kg of a 60 kg adult (0.5 and 15 times this human dose based upon mg/m2). The results did not reveal evidence of harm to the fetus due to oxycodone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic Effects – Neonates whose mothers have been taking oxycodone chronically may exhibit respiratory depression and/or withdrawal symptoms, either at birth and/or in the nursery.

Labor and Delivery

Oxycodone hydrochloride capsules are not recommended for use in women during and immediately prior to labor and delivery because oral opioids may cause respiratory depression in the newborn.

Nursing Mothers

Low concentrations of oxycodone have been detected in breast milk. Withdrawal symptoms can occur in breast-feeding infants when maternal administration of an opioid analgesic is stopped. Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone hydrochloride capsules since oxycodone may be excreted in the milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Special Risk Patients

This drug should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease and prostatic hypertrophy or urethral stricture.

Adverse Reactions

The most frequently observed reactions include light-headedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Many of these adverse events will cease or decrease in intensity as oxycodone therapy is continued and some degree of tolerance is developed.


Other adverse reactions include euphoria, dysphoria, constipation, skin rash and pruritus.

DRUG ABUSE AND DEPENDENCE (Addiction)

Oxycodone products are common targets for both drug abusers and drug addicts.


Drug addiction (drug dependence, psychological dependence) is characterized by a preoccupation with the procurement, hoarding, and abuse of drugs for non-medicinal purposes. Drug dependence is treatable, utilizing a multi-disciplinary approach, but relapse is common. “Drug seeking” behavior is very common to addicts. Tolerance and physical dependence in pain patients are not signs of psychological dependence. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. Most chronic pain patients limit their intake of opioids to achieve a balance between the benefits of the drug and dose-limiting side effects. Physicians should be aware that psychological dependence may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true psychological dependence and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances.

MANAGEMENT OF OVERDOSAGE

Signs and Symptoms

Serious overdose of oxycodone hydrochloride is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment

Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including oxycodone. Therefore, an appropriate dose of naloxone (usual initial adult dose: 0.4 mg) should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.


Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.


Gastric emptying may be useful in removing unabsorbed drug.

Oxycodone Immediate-Release Capsules Dosage and Administration

Dosage should be adjusted to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effects of opioids. This drug is given orally. The usual adult dosage is 5 mg every 6 hours as needed for pain.

How is Oxycodone Immediate-Release Capsules Supplied

Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 mg are available as opaque brown cap, imprinted “0554”, and opaque light brown body imprinted

 

Bottles of 100.......................................NDC 0406-0554-01

Dispense in a tight, light-resistant container with a child-resistant closure.


Protect from moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

COVIDIEN™

Mallinckrodt

Mallinckrodt Inc.,

Hazelwood, MO 63042 USA.

Rev 020409

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 5 mg Bottle

NDC 0406-0554-01


100 CAPSULES


OXYCODONE HYDROCHLORIDE

IMMEDIATE-RELEASE CAPSULES


CII


5 mg


Each capsule contains:

Oxycodone Hydrochloride USP . . . . . . . 5 mg

Rx only


Mallinckrodt

OXYCODONE HYDROCHLORIDE   IMMEDIATE-RELEASE oxycodone hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0406-0554 Route of Administration ORAL DEA Schedule CII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg

Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE   GELATIN   LACTOSE   FERRIC OXIDE RED   SILICON DIOXIDE   STEARIC ACID   TITANIUM DIOXIDE   FERRIC OXIDE YELLOW

Product Characteristics Color brown (brown) , brown (light brown) Score no score Shape CAPSULE Size 14.3mm Flavor Imprint Code M;0554;5;mg Contains

Packaging # NDC Package Description Multilevel Packaging 1 0406-0554-01 100 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		06/18/2009

Labeler - Mallinckrodt Inc. (047021092)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Inc.		957414238	analysis, manufacture

Revised: 06/2009Mallinckrodt Inc.

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Ovranette

Ovranette may be available in the countries listed below.

UK matches:

• Ovranette 150/30 micrograms Coated Tablets

Ingredient matches for Ovranette

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Ovranette in the following countries:

• Austria


• United Kingdom

Levonorgestrel

Levonorgestrel is reported as an ingredient of Ovranette in the following countries:

• Austria


• United Kingdom

International Drug Name Search

Ogen Cream

Dosage Form: Vaginal Cream, USP

Warning

1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARClNOMA IN POSTMENOPAUSAL WOMEN.

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equi-estrogenic doses.

2. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.

There is no indication for estrogen therapy during pregnancy or during the immediate postpartum period. Estrogens are ineffective for the prevention or treatment of threatened, or habitual abortion. Estrogens are not indicated for the prevention of postpartum breast engorgement.

Estrogen therapy during pregnancy is associated with an increased risk of congenital defects in the reproductive organs of the fetus, and possibly other birth defects. Studies of women who received diethylstilbestrol (DES) during pregnancy have shown that female offspring have an increased risk of vaginal adenosis, squamous cell dysplasia of the uterine cervix, and clear cell vaginal cancer later in life; male offspring have an increased risk of urogenital abnormalities and possibly testicular cancer later in life. The 1985 DES Task Force concluded that use of DES during pregnancy is associated with a subsequent increased risk of breast cancer in the mothers, although a causal relationship remains unproven and the observed level of excess risk is similar to that for a number of other breast cancer risk factors.

Ogen Cream Description

OGEN (estropipate vaginal cream, USP), (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste. The amount of piperazine in OGEN is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)-trien-17-one,3-(sulfooxy)-, compound with piperazine (1:1). The structural formula may be represented as follows:

Each gram of OGEN Vaginal Cream contains 1.5 mg estropipate in a base composed of the following ingredients: glycerin, mineral oil, glyceryl monostearate, polyethylene glycol ether complex of higher fatty alcohols, cetyl alcohol, anhydrous lanolin, sodium biphosphate, cis-N-(3-chloroallyl) hexaminium chloride, propylparaben, methylparaben, piperazine hexahydrate, citric acid and water.

Ogen Cream - Clinical Pharmacology

Estrogen drug products act by regulating the transcription of a limited number of genes. Estrogens diffuse through cell membranes, distribute themselves throughout the cell, and bind to and activate the nuclear estrogen receptor, a DNA-binding protein which is found in estrogen-responsive tissues. The activated estrogen receptor binds to specific DNA sequences, or hormone-response elements, which enhance the transcription of adjacent genes and in turn lead to the observed effects. Estrogen receptors have been identified in tissues of the reproductive tract, breast, pituitary, hypothalamus, liver, and bone of women.

Estrogens are important in the development and maintenance of the female reproductive system and secondary sex characteristics. By a direct action, they cause growth and development of the uterus, fallopian tubes, and vagina. With other hormones, such as pituitary hormones and progesterone, they cause enlargement of the breasts through promotion of ductal growth, stromal development, and the accretion of fat. Estrogens are intricately involved with other hormones, especially progesterone, in the processes of the ovulatory menstrual cycle and pregnancy, and affect the release of pituitary gonadotropins. They also contribute to the shaping of the skeleton, maintenance of tone and elasticity of urogenital structures, changes in the epiphyses of the long bones that allow for the pubertal growth spurt and its termination, and pigmentation of the nipples and genitals.

Estrogens occur naturally in several forms. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 micrograms of estradiol daily, depending on the phase of the menstrual cycle. This is converted primarily to estrone, which circulates in roughly equal proportion to estradiol, and to small amounts of estriol. After menopause, most endogenous estrogen is produced by conversion of androstenedione, secreted by the adrenal cortex, to estrone by peripheral tissues. Thus, estrone – especially in its sulfate ester form – is the most abundant circulating estrogen in postmenopausal women. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than estrone or estriol at the receptor.

Estrogens used in therapy are well absorbed through the skin, mucous membranes, and gastrointestinal tract. When applied for a local action, absorption is usually sufficient to cause systemic effects. When conjugated with aryl and alkyl groups for parenteral administration, the rate of absorption of oily preparations is slowed with a prolonged duration of action, such that a single intramuscular injection of estradiol valerate or estradiol cypionate is absorbed over several weeks.

Administered estrogens and their esters are handled within the body essentially the same as the endogenous hormones. Metabolic conversion of estrogens occurs primarily in the liver (first pass effect), but also at local target tissue sites. Complex metabolic processes result in a dynamic equilibrium of circulating conjugated and unconjugated estrogenic forms which are continually interconverted, especially between estrone and estradiol and between esterified and unesterified forms. Although naturally-occurring estrogens circulate in the blood largely bound to sex hormone-binding globulin and albumin, only unbound estrogens enter target tissue cells. A significant proportion of the circulating estrogen exists as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogenic species. A certain proportion of the estrogen is excreted into the bile and then reabsorbed from the intestine. During this enterohepatic recirculation, estrogens are desulfated and resulfated and undergo degradation through conversion to less active estrogens (estriol and other estrogens), oxidation to nonestrogenic substances (catecholestrogens, which interact with catecholamine metabolism, especially in the central nervous system), and conjugation with glucuronic acids (which are then rapidly excreted in the urine).

When given orally, naturally-occurring estrogens and their esters are extensively metabolized (first pass effect) and circulate primarily as estrone sulfate, with smaller amounts of other conjugated and unconjugated estrogenic species. This results in limited oral potency. By contrast, synthetic estrogens, such as ethinyl estradiol and the nonsteroidal estrogens, are degraded very slowly in the liver and other tissues, which results in their high intrinsic potency. Estrogen drug products administered by non-oral routes are not subject to first-pass metabolism, but also undergo significant hepatic uptake, metabolism, and enterohepatic recycling.

Indications and Usage for Ogen Cream

OGEN Vaginal Cream is indicated for the treatment of vulval and vaginal atrophy.

Contraindications

Estrogens should not be used in individuals with any of the following conditions:

1. Known or suspected pregnancy (see boxed WARNING). Estrogens may cause fetal harm when administered to a pregnant woman.


2. Undiagnosed abnormal genital bleeding.


3. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease.


4. Known or suspected estrogen-dependent neoplasia.


5. Active thrombophlebitis or thromboembolic disorders.

OGEN Vaginal Cream (estropipate) is contraindicated in patients hypersensitive to its ingredients.

Warnings

1. Induction of malignant neoplasms

Endometrial cancer

The reported endometrial cancer risk among unopposed estrogen users is about 2 to 12 fold greater than in non-users, and appears dependent on duration of treatment and on estrogen dose. Most studies show no significant increased risk associated with use of estrogens for less than one year. The greatest risk appears associated with prolonged use – with increased risks of 15 to 24-fold for five to ten years or more. In three studies, persistence of risk was demonstrated for 8 to over 15 years after cessation of estrogen treatment. In one study a significant decrease in the incidence of endometrial cancer occurred six months after estrogen withdrawal. Concurrent progestin therapy may offset this risk but the overall health impact in postmenopausal women is not known (see PRECAUTIONS).

Breast Cancer

While the majority of studies have not shown an increased risk of breast cancer in women who have ever used estrogen replacement therapy, some have reported a moderately increased risk (relative risks of 1.3–2.0) in those taking higher doses or those taking lower doses for prolonged periods of time, especially in excess of 10 years. Other studies have not shown this relationship.

Congenital lesions with malignant potential

Estrogen therapy during pregnancy is associated with an increased risk of fetal congenital reproductive tract disorders, and possibly other birth defects. Studies of women who received DES during pregnancy have shown that female offspring have an increased risk of vaginal adenosis, squamous cell dysplasia of the uterine cervix, and clear cell vaginal cancer later in life; male offspring have an increased risk of urogenital abnormalities and possibly testicular cancer later in life. Although some of these changes are benign, others are precursors of malignancy.

2. Gallbladder disease

Two studies have reported a 2- to 4-fold increase in the risk of gallbladder disease requiring surgery in women receiving postmenopausal estrogens.

3. Cardiovascular disease

Large doses of estrogen (5 mg conjugated estrogens per day), comparable to those used to treat cancer of the prostate and breast, have been shown in a large prospective clinical trial in men to increase the risks of nonfatal myocardial infarction, pulmonary embolism, and thrombophlebitis. These risks cannot necessarily be extrapolated from men to women. However, to avoid the theoretical cardiovascular risk to women caused by high estrogen doses, the dose for estrogen replacement therapy should not exceed the lowest effective dose.

4. Elevated blood pressure

Occasional blood pressure increases during estrogen replacement therapy have been attributed to idiosyncratic reactions to estrogens. More often, blood pressure has remained the same or has dropped. One study showed that postmenopausal estrogen users have higher blood pressure than nonusers. Two other studies showed slightly lower blood pressure among estrogen users compared to nonusers. Postmenopausal estrogen use does not increase the risk of stroke. Nonetheless, blood pressure should be monitored at regular intervals with estrogen use.

5. Hypercalcemia

Administration of estrogens may lead to severe hypercalcemia in patients with breast cancer and bone metastases. If this occurs, the drug should be stopped and appropriate measures taken to reduce the serum calcium level.

Precautions

A. General

1. Addition of a progestin

Studies of the addition of a progestin for seven or more days of a cycle of estrogen administration have reported a lowered incidence of endometrial hyperplasia which would otherwise be induced by estrogen treatment. Morphological and biochemical studies of endometrium suggest that 10 to 14 days of progestin are needed to provide maximal maturation of the endometrium and to eliminate any hyperplastic changes. There are possible additional risks which may be associated with the inclusion of progestins in estrogen replacement regimens. These include: (1) adverse effects on lipoprotein metabolism (lowering HDL and raising LDL) which may diminish the possible cardioprotective effect of estrogen therapy (see PRECAUTIONS, D.4., below); (2) impairment of glucose tolerance; and (3) possible enhancement of mitotic activity in breast epithelial tissue (although few epidemiological data are available to address this point). The choice of progestin, its dose, and its regimen may be important in minimizing these adverse effects, but these issues remain to be clarified.

2. Physical examination

A complete medical and family history should be taken prior to the initiation of any estrogen therapy. The pretreatment and periodic physical examinations should include special reference to blood pressure, breasts, abdomen, and pelvic organs, and should include a Papanicolaou smear. As a general rule, estrogen should not be prescribed for longer than one year without reexamining the patient.

3. Hypercoagulability

Some studies have shown that women taking estrogen replacement therapy have hypercoagulability, primarily related to decreased antithrombin activity. This effect appears dose- and duration-dependent and is less pronounced than that associated with oral contraceptive use. Also, postmenopausal women tend to have increased coagulation parameters at baseline compared to premenopausal women. There is some suggestion that low dose postmenopausal mestranol may increase the risk of thromboembolism, although the majority of studies (of primarily conjugated estrogens users) report no such increase. There is insufficient information on hypercoagulability in women who have had previous thromboembolic disease.

4. Familial hyperlipoproteinemia

Estrogen therapy may be associated with massive elevations of plasma triglycerides leading to pancreatitis and other complications in patients with familial defects of lipoprotein metabolism.

5. Fluid retention

Because estrogens may cause some degree of fluid retention, conditions which might be exacerbated by this factor, such as asthma, epilepsy, migraine, and cardiac or renal dysfunction, require careful observation.

6. Uterine bleeding and mastodynia

Certain patients may develop undesirable manifestations of estrogenic stimulation, such as abnormal uterine bleeding and mastodynia.

7. Impaired liver function

Estrogen may be poorly metabolized in patients with impaired liver function and should be administered with caution.

B. Information for the Patient

See text of Patient Package Insert that appears after HOW SUPPLIED section.

C. Laboratory Tests

Estrogen administration should generally be guided by clinical response at the smallest dose, rather than laboratory monitoring, for relief of symptoms for those indications in which symptoms are observable.

D. Drug/Laboratory Test Interactions

1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII—X complex, II—VII—X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.


2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered.


3. Other binding proteins may be elevated in serum, i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroids respectively. Free or biologically active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-l-antitrypsin, ceruloplasmin).


4. Increased plasma HDL and HDL-2 subfraction concentrations, reduced LDL cholesterol concentration, increased triglycerides levels.


5. Impaired glucose tolerance.


6. Reduced response to metyrapone test.


7. Reduced serum folate concentration.

E. Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver. See CONTRAINDICATIONS and WARNINGS sections.

F. Pregnancy Category X

Estrogens should not be used during pregnancy. See CONTRAINDICATIONS and boxed WARNING.

G. Nursing Mothers

As a general principle, the administration of any drug to nursing mothers should be done only when clearly necessary since many drugs are excreted in human milk. In addition, estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk.

Adverse Reactions

Hypersensitivity reactions, systemic effects such as breast tenderness, and rarely, withdrawal bleeding, have occurred with the use of topical estrogens. Local irritation (especially when prior inflammation is present) has occurred at initiation of therapy.

The following additional adverse reactions have been reported with estrogen therapy (see WARNINGS regarding induction of neoplasia, adverse effects on the fetus, increased incidence of gallbladder disease, cardiovascular disease, elevated blood pressure, and hypercalcemia).

1. Genitourinary system.
   
   Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting.
   
   Increase in size of uterine leiomyomata.
   
   Vaginal candidiasis.
   
   Change in amount of cervical secretion.


2. Breasts.
   
   Tenderness, enlargement.


3. Gastrointestinal.
   
   Nausea, vomiting.
   
   Abdominal cramps, bloating.
   
   Cholestatic jaundice.
   
   Increased incidence of gallbladder disease.


4. Skin.
   
   Chloasma or melasma which may persist when drug is discontinued.
   
   Erythema multiforme.
   
   Erythema nodosum.
   
   Hemorrhagic eruption.
   
   Loss of scalp hair.
   
   Hirsutism.


5. Eyes.
   
   Steepening of corneal curvature.
   
   Intolerance to contact lenses.


6. Central Nervous System.
   
   Headache, migraine, dizziness.
   
   Mental depression.
   
   Chorea.


7. Miscellaneous.
   
   Increase or decrease in weight.
   
   Reduced carbohydrate tolerance.
   
   Aggravation of porphyria.
   
   Edema.
   
   Changes in libido.

Overdosage

Serious ill effects have not been reported following acute ingestion of large doses of estrogen-containing oral contraceptives by young children. Overdosage of estrogen may cause nausea and vomiting, and withdrawal bleeding may occur in females.

Ogen Cream Dosage and Administration

1. For treatment of vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.

Attempts to discontinue or taper medication should be made at 3-month to 6-month intervals.

Usual dosage range

Intravaginally, 2 to 4 grams of OGEN Vaginal Cream daily, depending upon the severity of the condition.

The following instructions for use are intended for the patient and are printed on the carton label for OGEN Vaginal Cream (estropipate):

1. Remove cap from tube.


2. Make sure plunger of applicator is all the way into the barrel.


3. Screw nozzle end of applicator onto the tube.


4. Squeeze tube to force sufficient cream into applicator so that number on plunger indicating prescribed dose is level with top of barrel.


5. Unscrew applicator from tube and replace cap on tube.


6. To deliver medication, insert end of applicator into vagina and push plunger all the way down.

Between uses, pull plunger out of barrel and wash applicator in warm, soapy water. DO NOT PUT APPLICATOR IN HOT OR BOILING WATER.

How is Ogen Cream Supplied

OGEN (estropipate vaginal cream, USP), 1.5 mg estropipate per gram, is available in packages containing a 1½ oz (42.5 g) tube with one plastic applicator calibrated at 1, 2, 3, and 4 g levels, (NDC 0009-3776-01).

RECOMMENDED STORAGE

Store below 86° F (30° C).

Rx only

INFORMATION FOR PATIENTS

Ogen®

estropipate vaginal cream, USP

INTRODUCTION

This leaflet describes when and how to use estrogens, and the risks and benefits of estrogen treatment.

Estrogens have important benefits but also some risks. You must decide, with your doctor, whether the risks to you of estrogen use are acceptable because of their benefits. If you use estrogens, check with your doctor to be sure you are using the lowest possible dose that works, and that you don't use them longer than necessary. How long you need to use estrogens will depend on the reason for use.

WARNINGS

ESTROGENS INCREASE THE RISK OF CANCER OF THE UTERUS IN WOMEN WHO HAVE HAD THEIR MENOPAUSE ("CHANGE OF LIFE").

If you use any estrogen-containing drug, it is important to visit your doctor regularly and report any unusual vaginal bleeding right away. Vaginal bleeding after menopause may be a warning sign of uterine cancer. Your doctor should evaluate any unusual vaginal bleeding to find out the cause.

ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.

Estrogens do not prevent miscarriage (spontaneous abortion) and are not needed in the days following childbirth. If you take estrogens during pregnancy, your unborn child has a greater than usual chance of having birth defects. The risk of developing these defects is small, but clearly larger than the risk in children whose mothers did not take estrogens during pregnancy. These birth defects may affect the baby's urinary system and sex organs. Daughters born to mothers who took DES (an estrogen drug) have a higher than usual chance of developing cancer of the vagina or cervix when they become teenagers or young adults. Sons may have a higher than usual chance of developing cancer of the testicles when they become teenagers or young adults.

USES OF ESTROGEN

(Not every estrogen drug is approved for every use listed in this section. If you want to know which of these possible uses are approved for the medicine prescribed for you, ask your doctor or pharmacist to show you the professional labeling. You can also look up the specific estrogen product in a book called the "Physicians' Desk Reference," which is available in many book stores and public libraries. Generic drugs carry virtually the same labeling information as their brand name versions.)

+ To reduce moderate or severe menopausal symptoms. Estrogens are hormones made by the ovaries of normal women. Between ages 45 and 55, the ovaries normally stop making estrogens. This leads to a drop in body estrogen levels which causes the "change of life" or menopause (the end of monthly menstrual periods). If both ovaries are removed during an operation before natural menopause takes place, the sudden drop in estrogen levels causes "surgical menopause."

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating ("hot flashes" or "hot flushes"). Using estrogen drugs can help the body adjust to lower estrogen levels and reduce these symptoms. Most women have only mild menopausal symptoms or none at all and do not need to use estrogen drugs for these symptoms. Others may need to take estrogens for a few months while their bodies adjust to lower estrogen levels. The majority of women do not need estrogen replacement for longer than six months for these symptoms.

+ To treat vulval and vaginal atrophy (itching, burning, dryness in or around the vagina, difficulty or burning on urination) associated with menopause.

+ To treat certain conditions in which a young woman's ovaries do not produce enough estrogen naturally.

+ To treat certain types of abnormal vaginal bleeding due to hormonal imbalance when your doctor has found no serious cause of the bleeding.

+ To treat certain cancers in special situations, in men and women.

+ To prevent thinning of bones. Osteoporosis is a thinning of the bones that makes them weaker and allows them to break more easily. The bones of the spine, wrists and hips break most often in osteoporosis. Both men and women start to lose bone mass after about age 40, but women lose bone mass faster after the menopause. Using estrogens after the menopause slows down bone thinning and may prevent bones from breaking. Lifelong adequate calcium intake, either in the diet (such as dairy products) or by calcium supplements (to reach a total daily intake of 1000 milligrams per day before menopause or 1500 milligrams per day after menopause), may help to prevent osteoporosis. Regular weight-bearing exercise (like walking and running for an hour, two or three times a week) may also help to prevent osteoporosis. Before you change your calcium intake or exercise habits, it is important to discuss these lifestyle changes with your doctor to find out if they are safe for you.

Since estrogen use has some risks, only women who are likely to develop osteoporosis should use estrogens for prevention. Women who are likely to develop osteoporosis often have the following characteristics: white or Asian race, slim, cigarette smokers, and a family history of osteoporosis in a mother, sister, or aunt. Women who have relatively early menopause, often because their ovaries were removed during an operation ("surgical menopause"), are more likely to develop osteoporosis than women whose menopause happens at the average age.

WHO SHOULD NOT USE ESTROGENS

Estrogens should not be used:

+ During pregnancy (see boxed WARNING). If you think you may be pregnant, do not use any form of estrogen-containing drug. Using estrogens while you are pregnant may cause your unborn child to have birth defects. Estrogens do not prevent miscarriage.

+ If you have unusual vaginal bleeding which has not been evaluated by your doctor (see boxed WARNING). Unusual vaginal bleeding can be a warning sign of cancer of the uterus, especially if it happens after menopause. Your doctor must find out the cause of the bleeding so that he or she can recommend the proper treatment. Taking estrogens without visiting your doctor can cause you serious harm if your vaginal bleeding is caused by cancer of the uterus.

+ If you have had cancer. Since estrogens increase the risk of certain types of cancer, you should not use estrogens if you have ever had cancer of the breast or uterus, unless your doctor recommends that the drug may help in the cancer treatment. (For certain patients with breast or prostate cancer, estrogens may help.)

+ If you have any circulation problems. Estrogen drugs should not be used except in unusually special situations in which your doctor judges that you need estrogen therapy so much that the risks are acceptable. Men and women with abnormal blood clotting conditions should avoid estrogen use (see DANGERS OF ESTROGENS, below).

+ When they do not work. During menopause, some women develop nervous symptoms or depression. Estrogens do not relieve these symptoms. You may have heard that taking estrogens for years after menopause will keep your skin soft and supple and keep you feeling young. There is no evidence for these claims and such long-term estrogen use may have serious risks.

+ After childbirth or when breastfeeding a baby. Estrogens should not be used to try to stop the breasts from filling with milk after a baby is born. Such treatment may increase the risk of developing blood clots (see DANGERS OF ESTROGENS, below).

If you are breastfeeding, you should avoid using any drugs because many drugs pass through to the baby in the milk. While nursing a baby, you should take drugs only on the advice of your health care provider.

DANGERS OF ESTROGENS

+ Cancer of the uterus. Your risk of developing cancer of the uterus gets higher the longer you use estrogens and the larger doses you use. One study showed that after women stop taking estrogens, this higher cancer risk quickly returns to the usual level of risk (as if you had never used estrogen therapy). Three other studies showed that the cancer risk stayed high for 8 to more than 15 years after stopping estrogen treatment. Because of this risk, IT IS IMPORTANT TO TAKE THE LOWEST DOSE THAT WORKS AND TO TAKE IT ONLY AS LONG AS YOU NEED IT.

Using progestin therapy together with estrogen therapy may reduce the higher risk of uterine cancer related to estrogen use (but see OTHER INFORMATION, below).

If you have had your uterus removed (total hysterectomy), there is no danger of developing cancer of the uterus.

+ Cancer of the breast. Most studies have not shown a higher risk of breast cancer in women who have ever used estrogens. However, some studies have reported that breast cancer developed more often (up to twice the usual rate) in women who used estrogens for long periods of time (especially more than 10 years), or who used higher doses for shorter time periods.

Regular breast examinations by a health professional and monthly self-examination are recommended for all women.

+ Gallbladder disease. Women who use estrogens after menopause are more likely to develop gallbladder disease needing surgery than women who do not use estrogens.

+ Abnormal blood clotting. Taking estrogens may cause changes in your blood clotting system. These changes allow the blood to clot more easily, possibly allowing clots to form in your bloodstream. If blood clots do form in your bloodstream, they can cut off the blood supply to vital organs, causing serious problems. These problems may include a stroke (by cutting off blood to the brain), a heart attack (by cutting off blood to the heart), a pulmonary embolus (by cutting off blood to the lungs), or other problems. Any of these conditions may cause death or serious long-term disability. However, most studies of low dose estrogen usage by women do not show an increased risk of these complications.

SIDE EFFECTS

In addition to the risks listed above, the following side effects have been reported with estrogen use:

  

Nausea and vomiting.

  

Breast tenderness or enlargement.

  

Enlargement of benign tumors ("fibroids") of the uterus.

  

Retention of excess fluid. This may make some conditions worsen, such as asthma, epilepsy, migraine, heart disease, or kidney disease.

  

A spotty darkening of the skin, particularly on the face.

REDUCING RISK OF ESTROGEN USE

If you use estrogens, you can reduce your risks by doing these things:

+ See your doctor regularly. While you are using estrogens, it is important to visit your doctor at least once a year for a check-up. If you develop vaginal bleeding while taking estrogens, you may need further evaluation. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast X-ray), you may need to have more frequent breast examinations.

+ Reassess your need for estrogens. You and your doctor should reevaluate whether or not you still need estrogens at least every six months.

+ Be alert for signs of trouble. If any of these warning signals (or any other unusual symptoms) happen while you are using estrogens, call your doctor immediately:

  

Abnormal bleeding from the vagina (possible uterine cancer).

  

Pains in the calves or chest, sudden shortness of breath, or coughing blood (possible clot in the legs, heart, or lungs).

  

Severe headache or vomiting, dizziness, faintness, changes in vision or speech, weakness or numbness of an arm or leg (possible clot in the brain or eye).

  

Breast lumps (possible breast cancer; ask your doctor or health professional to show you how to examine your breasts monthly).

  

Yellowing of the skin or eyes (possible liver problem).

  

Pain, swelling, or tenderness in the abdomen (possible gallbladder problem).

OTHER INFORMATION

Some doctors may choose to prescribe a progestin, a different hormonal drug, for you to take together with your estrogen treatment. Progestins lower your risk of developing endometrial hyperplasia (a possible pre-cancerous condition of the uterus) while using estrogens. Taking estrogens and progestins together may also protect you from the higher risk of uterine cancer, but this has not been clearly established. Combined use of progestin and estrogen treatment may have additional risks, however. The possible risks include unhealthy effects on blood fats (especially a lowering of HDL cholesterol, the "good" blood fat which protects against heart disease risk), unhealthy effects on blood sugar (which might worsen a diabetic condition), and a possible further increase in the breast cancer risk which may be associated with long-term estrogen use. The type of progestin drug used and its dosage schedule may be important in minimizing these effects.

Your doctor has prescribed this drug for you and you alone. Do not give the drug to anyone else.

If you will be taking calcium supplements as part of the treatment to help prevent osteoporosis, check with your doctor about how much to take.

Keep this and all drugs out of the reach of children. In case of overdose, call your doctor, hospital or poison control center immediately.

This leaflet provides a summary of the most important information about estrogens. If you want more information, ask your doctor or pharmacist to show you the professional labeling. The professional labeling is also published in a book called the "Physicians' Desk Reference," which is available in book stores and public libraries. Generic drugs carry virtually the same labeling information as their brand name versions.

HOW SUPPLIED

OGEN (estropipate vaginal cream, USP), 1.5 mg estropipate per gram, is available in packages containing a 1½ oz (42.5 g) tube with one plastic applicator calibrated at 1, 2, 3, and 4 g levels, (NDC 0009-3776-01).

RECOMMENDED STORAGE: Store below 86° F (30° C).

Rx only

Manufactured by

Abbott Laboratories,

North Chicago, IL 60064, USA

LAB-0092-2.0

July 2006

OGEN  estropipate  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0009-3776 Route of Administration VAGINAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength estropipate (estropipate) Active 1.5 MILLIGRAM  In 1 GRAM glycerin Inactive   mineral oil Inactive   glyceryl monostearate Inactive   polyethylene glycol ether complex of higher fatty alchohols Inactive   cetyl alcohol Inactive   anhydrous lanolin Inactive   sodium biphosphate Inactive   cis-N-(3-chloroallyl) hexaminium chloride Inactive   propylparaben Inactive   methylparaben Inactive   piperazine hexahydrat Inactive   citric acid Inactive   water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0009-3776-01 42.5 g (GRAM) In 1 TUBE, WITH APPLICATOR None

Revised: 07/2006Pharmacia and Upjohn Company

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