Omegamma

Omegamma may be available in the countries listed below.

Ingredient matches for Omegamma

Omeprazole

Omeprazole is reported as an ingredient of Omegamma in the following countries:

• Germany

International Drug Name Search

Sorcal

Sorcal may be available in the countries listed below.

Ingredient matches for Sorcal

Polystyrene Sulfonic Acid

Polystyrene Sulfonic Acid calcium salt (a derivative of Polystyrene Sulfonic Acid) is reported as an ingredient of Sorcal in the following countries:

• Brazil

International Drug Name Search

Fenobarbital Sodico Life

Fenobarbital Sodico Life may be available in the countries listed below.

Ingredient matches for Fenobarbital Sodico Life

Phenobarbital

Phenobarbital sodium salt (a derivative of Phenobarbital) is reported as an ingredient of Fenobarbital Sodico Life in the following countries:

• Ecuador

International Drug Name Search

Duro Tuss Cough Lozenges

Duro Tuss Cough Lozenges may be available in the countries listed below.

Ingredient matches for Duro Tuss Cough Lozenges

Cetylpyridinium

Cetylpyridinium chloride (a derivative of Cetylpyridinium) is reported as an ingredient of Duro Tuss Cough Lozenges in the following countries:

• New Zealand

Pholcodine

Pholcodine is reported as an ingredient of Duro Tuss Cough Lozenges in the following countries:

• New Zealand

International Drug Name Search

Diabetussic

Diabetussic may be available in the countries listed below.

Ingredient matches for Diabetussic

Sulfogaiacol

Sulfogaiacol is reported as an ingredient of Diabetussic in the following countries:

• Poland

International Drug Name Search

Secnizol ratio

Secnizol ratio may be available in the countries listed below.

Ingredient matches for Secnizol ratio

Secnidazole

Secnidazole is reported as an ingredient of Secnizol ratio in the following countries:

• Dominican Republic

International Drug Name Search

Dileva

Dileva may be available in the countries listed below.

Ingredient matches for Dileva

Drospirenone

Drospirenone is reported as an ingredient of Dileva in the following countries:

• Ecuador

Ethinylestradiol

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

• Ecuador

International Drug Name Search

Cloramfenicolo Succinato Sodico

Cloramfenicolo Succinato Sodico may be available in the countries listed below.

Ingredient matches for Cloramfenicolo Succinato Sodico

Chloramphenicol

Chloramphenicol succinate sodium (a derivative of Chloramphenicol) is reported as an ingredient of Cloramfenicolo Succinato Sodico in the following countries:

• Italy

International Drug Name Search

Calcar

Calcar may be available in the countries listed below.

Ingredient matches for Calcar

Calcium Carbonate

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

• Italy

International Drug Name Search

Cedoclor

Cedoclor may be available in the countries listed below.

Ingredient matches for Cedoclor

Cefaclor

Cefaclor is reported as an ingredient of Cedoclor in the following countries:

• Vietnam

International Drug Name Search

Dacogen

Pronunciation: dee-SYE-ta-been
Generic Name: Decitabine
Brand Name: Dacogen

Dacogen is used for:

Treating myelodysplastic syndromes (MDS) (eg, certain types of anemia or leukemia).

Dacogen is a nucleoside analog. It works by blocking cell growth.

Do NOT use Dacogen if:

• you are allergic to any ingredient in Dacogen

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dacogen:

Some medical conditions may interact with Dacogen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have liver or kidney problems

Some MEDICINES MAY INTERACT with Dacogen. However, no specific interactions with Dacogen are known at this time.

Ask your health care provider if Dacogen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dacogen:

Use Dacogen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Dacogen is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Dacogen at home, a health care provider will teach you how to use it. Be sure you understand how to use Dacogen. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Dacogen if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• If you miss a dose of Dacogen, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Dacogen.

Important safety information:

• Dacogen may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Dacogen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Dacogen may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Dacogen may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Men who take Dacogen should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Dacogen and for 2 months after you stop taking it.


• Dacogen may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Lab tests, including complete blood and platelet counts and liver and kidney function tests, may be performed while you use Dacogen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Dacogen should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Dacogen may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dacogen while you are pregnant. It is not known if Dacogen is found in breast milk. Do not breast-feed while using Dacogen.

Possible side effects of Dacogen:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; diarrhea; dizziness; hair loss; headache; joint or muscle pain; loss of appetite; nausea; stomach pain or upset; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine you produce; chest pain; confusion; depression; difficulty swallowing; fainting; fast or irregular heartbeat; fever, chills, or sore throat; numbness of an arm or leg; one-sided weakness; pain, swelling, or redness at the injection site; severe headache or dizziness; severe stomach pain or vomiting; shortness of breath; sores or white patches in the mouth; swelling; unusual bruising or bleeding; unusual tiredness or weakness; vision or speech changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dacogen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fever, chills, sore throat, or unusual bruising or bleeding.

Proper storage of Dacogen:

Dacogen is usually handled and stored by a health care provider. If you are using Dacogen at home, store Dacogen as directed by your pharmacist or health care provider. Keep Dacogen out of the reach of children and away from pets.

General information:

• If you have any questions about Dacogen, please talk with your doctor, pharmacist, or other health care provider.


• Dacogen is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dacogen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dacogen resources

• Dacogen Side Effects (in more detail)
• Dacogen Use in Pregnancy & Breastfeeding
• Dacogen Drug Interactions
• Dacogen Support Group
• 0 Reviews for Dacogen - Add your own review/rating

• Dacogen Prescribing Information (FDA)


• Dacogen Consumer Overview


• Dacogen Monograph (AHFS DI)


• Dacogen Advanced Consumer (Micromedex) - Includes Dosage Information


• Decitabine Professional Patient Advice (Wolters Kluwer)

Compare Dacogen with other medications

• Myelodysplastic Syndrome

Quinidine Sulfate

Ingredient matches for Quinidine Sulfate

Quinidine

Quinidine Sulfate (JAN) is known as Quinidine in the US.

International Drug Name Search

Glossary

JAN	Japanese Accepted Name

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

Bacacil

Bacacil may be available in the countries listed below.

Ingredient matches for Bacacil

Bacampicillin

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

• Italy

International Drug Name Search

Fortanest

Fortanest may be available in the countries listed below.

Ingredient matches for Fortanest

Midazolam

Midazolam is reported as an ingredient of Fortanest in the following countries:

• Indonesia

International Drug Name Search

Clonatril GMP

Clonatril GMP may be available in the countries listed below.

Ingredient matches for Clonatril GMP

Clonazepam

Clonazepam is reported as an ingredient of Clonatril GMP in the following countries:

• Venezuela

International Drug Name Search

Beta-Carotene Capsules

Pronunciation: BAY-tah KARE-oh-teen
Generic Name: Beta-Carotene
Brand Name: Generic only. No brands available.

Beta-Carotene Capsules is used for:

Treating vitamin A deficiency. It may also be used for other conditions as determined by your doctor.

Beta-Carotene Capsules is a precursor to vitamin A, a fat-soluble vitamin.

Do NOT use Beta-Carotene Capsules if:

• you are allergic to any ingredient in Beta-Carotene Capsules


• you are taking vitamin A supplements or any multivitamins that contain vitamin A


• you are taking acitretin

Contact your doctor or health care provider right away if any of these apply to you.

Before using Beta-Carotene Capsules:

Some medical conditions may interact with Beta-Carotene Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you take large doses of vitamins (megadoses or multivitamin therapy)

Some MEDICINES MAY INTERACT with Beta-Carotene Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acitretin because the risk of serious side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Beta-Carotene Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Beta-Carotene Capsules:

Use Beta-Carotene Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Beta-Carotene Capsules with food or milk.


• If you are unable to swallow a capsule, you may open it and mix the contents with orange juice or tomato juice. Drink the mixture immediately.


• Take Beta-Carotene Capsules regularly to receive the most benefit from it. Taking Beta-Carotene Capsules at the same time each day will help you remember to take it.


• If you miss a dose of Beta-Carotene Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Beta-Carotene Capsules.

Important safety information:

• Beta-Carotene Capsules may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Beta-Carotene Capsules. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Your skin may turn slightly yellow while you are taking Beta-Carotene Capsules. This is harmless and not a cause for concern.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while taking Beta-Carotene Capsules unless directed by your doctor.


• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Beta-Carotene Capsules during pregnancy. If you are or will be breast feeding while you are using Beta-Carotene Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Beta-Carotene Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Beta-Carotene side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Beta-Carotene Capsules:

Store Beta-Carotene Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Beta-Carotene Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Beta-Carotene Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Beta-Carotene Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Beta-Carotene Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Beta-Carotene resources

• Beta-Carotene Side Effects (in more detail)
• Beta-Carotene Use in Pregnancy & Breastfeeding
• Beta-Carotene Drug Interactions
• Beta-Carotene Support Group
• 0 Reviews for Beta-Carotene - Add your own review/rating

Compare Beta-Carotene with other medications

• Vitamin A Deficiency

Rosup

Rosup may be available in the countries listed below.

Ingredient matches for Rosup

Loxapine

Loxapine is reported as an ingredient of Rosup in the following countries:

• Taiwan

International Drug Name Search

Flecaïnideacetaat Disphar

Flecaïnideacetaat Disphar may be available in the countries listed below.

Ingredient matches for Flecaïnideacetaat Disphar

Flecainide

Flecainide acetate (a derivative of Flecainide) is reported as an ingredient of Flecaïnideacetaat Disphar in the following countries:

• Netherlands

International Drug Name Search

Topisolon

Topisolon may be available in the countries listed below.

Ingredient matches for Topisolon

Desoximetasone

Desoximetasone is reported as an ingredient of Topisolon in the following countries:

• Germany

International Drug Name Search

Megapress

Megapress may be available in the countries listed below.

Ingredient matches for Megapress

Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Megapress in the following countries:

• Greece


• Romania

International Drug Name Search

Aprepitant

In the US, Aprepitant (aprepitant systemic) is a member of the drug class miscellaneous antiemetics and is used to treat Nausea/Vomiting - Chemotherapy Induced and Nausea/Vomiting - Postoperative.

US matches:

• Aprepitant


• Aprepitant/Fosaprepitant Dimeglumine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A04AD12

CAS registry number (Chemical Abstracts Service)

0170729-80-3

Chemical Formula

C23-H21-F4-N4-O3

Molecular Weight

534

Therapeutic Category

Antiemetic

Chemical Name

3H-1,2,4-Triazol-3-one, 5[[(2R,3S)-2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl-4-morpholinyl]methyl]-1,2-dihydro-

Foreign Names

• Aprepitantum (Latin)
• Aprepitant (German)
• Aprepitant (French)
• Aprepitant (Spanish)

Generic Names

• Aprepitant (OS: USAN)
• L 754030 (IS)
• L-754939 (IS: Merck)
• MK 0869 (IS: Merck)

Brand Names

• Aprecap
  Glenmark, India



• Emend
  Merck, United States; Merck Frosst, Canada; Merck Sharp & Dohme, Netherlands Antilles; Merck Sharp & Dohme, Argentina; Merck Sharp & Dohme, Austria; Merck Sharp & Dohme, Australia; Merck Sharp & Dohme, Aruba; Merck Sharp & Dohme, Barbados; Merck Sharp & Dohme, Belgium; Merck Sharp & Dohme, Bulgaria; Merck Sharp & Dohme, Brazil; Merck Sharp & Dohme, Bahamas; Merck Sharp & Dohme, Belize; Merck Sharp & Dohme, Chile; Merck Sharp & Dohme, Czech Republic; Merck Sharp & Dohme, Germany; Merck Sharp & Dohme, Spain; Merck Sharp & Dohme, France; Merck Sharp & Dohme, United Kingdom; Merck Sharp & Dohme, Greece; Merck Sharp & Dohme, Hong Kong; Merck Sharp & Dohme, Croatia (Hrvatska); Merck Sharp & Dohme, Hungary; Merck Sharp & Dohme, Ireland; Merck Sharp & Dohme, Iceland; Merck Sharp & Dohme, Italy; Merck Sharp & Dohme, Jamaica; Merck Sharp & Dohme, Cayman Islands; Merck Sharp & Dohme, Luxembourg; Merck Sharp & Dohme, Mexico; Merck Sharp & Dohme, Malaysia; Merck Sharp & Dohme, Netherlands; Merck Sharp & Dohme, New Zealand; Merck Sharp & Dohme, Peru; Merck Sharp & Dohme, Portugal; Merck Sharp & Dohme, Russian Federation; Merck Sharp & Dohme, Sweden; Merck Sharp & Dohme, Singapore; Merck Sharp & Dohme, Slovenia; Merck Sharp & Dohme, Thailand; Merck Sharp & Dohme, Turkey; Merck Sharp & Dohme, Trinidad & Tobago; Merck Sharp & Dohme, Taiwan; Merck Sharp & Dohme, Venezuela; Merck Sharp & Dohme, South Africa; Merck Sharp & Dome, Dominican Republic; MSD, Switzerland; MSD, Denmark; MSD, Finland; MSD, Georgia; MSD, Norway; Vianex / BIANEΞ, Greece

International Drug Name Search

Glossary

IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Nix

In the US, Nix (permethrin topical) is a member of the drug class topical anti-infectives and is used to treat Head Lice.

US matches:

• Nix Cream Rinse


• Nix Complete Lice Treatment System


• Nix Lice Control


• Nix Creme Rinse Topical


• Nix Dermal Cream Topical


• Nix Topical


• Nix Shampoo

Ingredient matches for Nix

Permethrin

Permethrin is reported as an ingredient of Nix in the following countries:

• Belgium


• Canada


• Denmark


• Estonia


• Finland


• Greece


• Iceland


• Italy


• Latvia


• Norway


• Portugal


• Romania


• Russian Federation


• Slovenia


• Sweden


• United States

International Drug Name Search

Lercanidipine Winthrop

Lercanidipine Winthrop may be available in the countries listed below.

Ingredient matches for Lercanidipine Winthrop

Lercanidipine

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

• France

International Drug Name Search

Nevrorestol

Nevrorestol may be available in the countries listed below.

Ingredient matches for Nevrorestol

Buspirone

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

• Greece

International Drug Name Search

Dilasig

Dilasig may be available in the countries listed below.

Ingredient matches for Dilasig

Carvedilol

Carvedilol is reported as an ingredient of Dilasig in the following countries:

• Australia

International Drug Name Search

Alquen

Alquen may be available in the countries listed below.

Ingredient matches for Alquen

Ranitidine

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

• Spain

International Drug Name Search

Losartan Sumol

Losartan Sumol may be available in the countries listed below.

Ingredient matches for Losartan Sumol

Losartan

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

• Spain

International Drug Name Search

Stiglyn

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

Ingredient matches for Stiglyn

Neostigmine

Neostigmine metilsulfate (a derivative of Neostigmine) is reported as an ingredient of Stiglyn in the following countries:

• United States

International Drug Name Search

Clon

Clon may be available in the countries listed below.

Ingredient matches for Clon

Clonazepam

Clonazepam is reported as an ingredient of Clon in the following countries:

• Bangladesh

International Drug Name Search

Thrombate III

In the US, Thrombate III (antithrombin iii systemic) is a member of the drug class miscellaneous coagulation modifiers and is used to treat Antithrombin III Deficiency.

US matches:

• Thrombate III

Ingredient matches for Thrombate III

Antithrombin Iii

Antithrombin III is reported as an ingredient of Thrombate III in the following countries:

• United States

International Drug Name Search

Peptic Ulcer with Obstruction Medications

There are currently no drugs listed for "Peptic Ulcer with Obstruction".

Learn more about Peptic Ulcer with Obstruction

Micromedex Care Notes:

• Peptic Ulcer

Medical Encyclopedia:

• Erosion
• Gastric ulcer
• Peptic ulcer

Drug List:

Diapec

Diapec may be available in the countries listed below.

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

Ingredient matches for Diapec

Ivermectin

Ivermectin is reported as an ingredient of Diapec in the following countries:

• Germany

International Drug Name Search

Clasifel

Clasifel may be available in the countries listed below.

Ingredient matches for Clasifel

Hydroquinone

Hydroquinone is reported as an ingredient of Clasifel in the following countries:

• Chile


• Peru

International Drug Name Search

Patentex Oval

Patentex Oval may be available in the countries listed below.

Ingredient matches for Patentex Oval

Nonoxinol

Nonoxinol is reported as an ingredient of Patentex Oval in the following countries:

• Estonia


• Georgia


• Hong Kong


• Lithuania


• Luxembourg


• Poland


• Russian Federation


• Serbia


• Slovenia

Nonoxinol 9 (a derivative of Nonoxinol) is reported as an ingredient of Patentex Oval in the following countries:

• Austria


• Croatia (Hrvatska)

International Drug Name Search

Rhinathiol Tusso

Rhinathiol Tusso may be available in the countries listed below.

Ingredient matches for Rhinathiol Tusso

Prenoxdiazine

Prenoxdiazine hydrochloride (a derivative of Prenoxdiazine) is reported as an ingredient of Rhinathiol Tusso in the following countries:

• Hungary

International Drug Name Search

Zolpidem Almus

Zolpidem Almus may be available in the countries listed below.

Ingredient matches for Zolpidem Almus

Zolpidem

Zolpidem tartrate (a derivative of Zolpidem) is reported as an ingredient of Zolpidem Almus in the following countries:

• France

International Drug Name Search

Topiramato Cinfa

Topiramato Cinfa may be available in the countries listed below.

Ingredient matches for Topiramato Cinfa

Topiramate

Topiramate is reported as an ingredient of Topiramato Cinfa in the following countries:

• Spain

International Drug Name Search

Sofix

Sofix may be available in the countries listed below.

Ingredient matches for Sofix

Cefixime

Cefixime is reported as an ingredient of Sofix in the following countries:

• Indonesia

International Drug Name Search

UriHexal

UriHexal may be available in the countries listed below.

Ingredient matches for UriHexal

Oxybutynin

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

• South Africa

International Drug Name Search

Trilostane

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

Scheme

Prop.INN

ATC (Anatomical Therapeutic Chemical Classification)

H02CA01

CAS registry number (Chemical Abstracts Service)

0013647-35-3

Chemical Formula

C20-H27-N-O3

Molecular Weight

329

Therapeutic Categories

Inhibitor of 3β-hydroxysteroid dehydrogenase

Inhibitor of the adrenocortical corticosteroid synthesis

Chemical Name

Androst-2-ene-2-carbonitrile, 4,5-epoxy-3,17-dihydroxy-, (4α,5α,17ß)-

Foreign Names

• Trilostanum (Latin)
• Trilostan (German)
• Trilostane (French)
• Trilostano (Spanish)

Generic Names

• Trilostane (OS: DCF, USAN, BAN)
• Win 24540 (IS: Winthrop)

Brand Names

• Desopan
  Mochida, Japan



• Modrenal
  Bioenvision, United Kingdom



• Vetoryl (veterinary use)
  Arnolds, Austria; Arnolds, United Kingdom; Arnolds, Netherlands; Arnolds Veterinary Products, Norway; Intervet, Italy; Janssen Animal Health, Belgium; Janssen Animal Health, Germany; Janssen Santé Animale, France; Orion, Finland; Orion, Sweden; Veterinaria, Switzerland

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
IS	Inofficial Synonym
OS	Official Synonym
Prop.INN	Proposed International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Ciprofel

Ciprofel may be available in the countries listed below.

Ingredient matches for Ciprofel

Ciprofloxacin

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

• Dominican Republic

International Drug Name Search

Defendog

Defendog may be available in the countries listed below.

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

Ingredient matches for Defendog

Permethrin

Permethrin is reported as an ingredient of Defendog in the following countries:

• Belgium


• France


• Italy


• Netherlands


• Portugal


• Switzerland

International Drug Name Search

Dacarin

Dacarin may be available in the countries listed below.

Ingredient matches for Dacarin

Dacarbazine

Dacarbazine is reported as an ingredient of Dacarin in the following countries:

• India

International Drug Name Search

Loremex

Loremex may be available in the countries listed below.

Ingredient matches for Loremex

Loratadine

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

• Argentina

International Drug Name Search

Pravastatine Na Stada

Pravastatine Na Stada may be available in the countries listed below.

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Pravastatin

Pravastatin sodium salt (a derivative of Pravastatin) is reported as an ingredient of Pravastatine Na Stada in the following countries:

• Netherlands

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Dectomax-S

Dectomax-S may be available in the countries listed below.

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

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Doramectin

Doramectin is reported as an ingredient of Dectomax-S in the following countries:

• Germany

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Sergel

Sergel may be available in the countries listed below.

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Esomeprazole

Esomeprazole is reported as an ingredient of Sergel in the following countries:

• Bangladesh

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Omepradex

Omepradex may be available in the countries listed below.

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Omeprazole

Omeprazole is reported as an ingredient of Omepradex in the following countries:

• Israel

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Ethics Aspirin

Ethics Aspirin may be available in the countries listed below.

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Aspirin

Acetylsalicylic Acid is reported as an ingredient of Ethics Aspirin in the following countries:

• New Zealand

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Reandron

Reandron may be available in the countries listed below.

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Testosterone

Testosterone undecanoate (a derivative of Testosterone) is reported as an ingredient of Reandron in the following countries:

• Australia


• New Zealand


• Spain

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Nifedipine Merck

Nifedipine Merck may be available in the countries listed below.

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Nifedipine

Nifedipine is reported as an ingredient of Nifedipine Merck in the following countries:

• Netherlands

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Heartgard

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

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Ivermectin

Ivermectin is reported as an ingredient of Heartgard in the following countries:

• Australia


• Portugal


• United States

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Darby Topical Fluoride Foam

Generic Name: sodium fluoride

Dosage Form: aerosol, foam
DARBY 2.72 % Topical Sodium Fluoride Foam Mint

Darby 2.72 % Topical Sodium Fluoride Foam

(1.23 % Fluoride Ions)

Mint

4.4 oz / 125 g

NDC 66467-3760-1

A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

130 applications

Medicinal ingredients:

Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)

Non-Medicinal ingredients: cocamidopropyl betaine, sodium phosphate, poloxamer 407, sucralose, xylitol, purified water, mint flavour

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx only Made in USA

Distributed by:

Darby Dental Supply, LLC

Jericho, Ny11753

UPC 952-9102

Rev 01

DARBY   TOPICAL SODIUM FLUORIDE MINT sodium fluoride  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66467-3760 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength sodium fluoride (fluoride ion) fluoride ion .0272 g  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66467-3760-1 125 g In 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/31/2012

Labeler - Darby Dental Supply Co (825137818)

Revised: 11/2011Darby Dental Supply Co

Neufan

Neufan may be available in the countries listed below.

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Allopurinol

Allopurinol is reported as an ingredient of Neufan in the following countries:

• Japan

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Gamanil

Gamanil may be available in the countries listed below.

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Lofepramine

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

• Ireland

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Diltenk

Diltenk may be available in the countries listed below.

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Diltiazem

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

• Argentina

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Dafor

Dafor may be available in the countries listed below.

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Amlodipine

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Dafor in the following countries:

• Greece

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Budeprion XL

bupropion hydrochloride

Dosage Form: tablet, extended release
Budeprion XL®

(buPROPion Hydrochloride Extended-Release Tablets)

PRESCRIBING INFORMATION

Rx only

WARNING

Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of bupropion hydrochloride extended-release tablets (XL) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Bupropion hydrochloride extended-release tablets (XL) are not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use).

Use in Smoking Cessation Treatment

WELLBUTRIN® (bupropion hydrochloride tablets), WELLBUTRIN SR® [bupropion hydrochloride extended-release tablets (SR)] and bupropion hydrochloride extended-release tablets (XL) are not approved for smoking cessation treatment, but bupropion under the name ZYBAN® is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.

All patients treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking ZYBAN® in the post-marketing experience. When symptoms were reported, most were during treatment with ZYBAN®, but some were following discontinuation of treatment with ZYBAN®. These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of ZYBAN®.

Advise patients and caregivers that the patient using bupropion for smoking cessation should contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of ZYBAN® was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN® has been demonstrated to increase the likelihood of abstinence from smoking for as long as 6 months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial (see WARNINGS: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment and PRECAUTIONS: Information for Patients).

Budeprion XL Description

Bupropion hydrochloride extended-release tablets (XL) (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is:

Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 300-mg, yellow extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and microcrystalline cellulose. The film-coating material contains FD&C Red No. 40, FD&C Yellow No. 5, hypromellose, macrogol, polydextrose, titanium dioxide and triacetin. Bupropion hydrochloride extended-release tablets (XL) meet USP Dissolution Test 6.

The insoluble shell of the extended-release tablet may remain intact during gastrointestinal transit and is eliminated in the feces.

Budeprion XL - Clinical Pharmacology

Pharmacodynamics

Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine, and does not inhibit monoamine oxidase or the re-uptake of serotonin. While the mechanism of action of bupropion, as with other antidepressants, is unknown, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms.

Pharmacokinetics

Bupropion is a racemic mixture. The pharmacologic activity and pharmacokinetics of the individual enantiomers have not been studied. The mean elimination half-life (±SD) of bupropion after chronic dosing is 21 (±9) hours, and steady-state plasma concentrations of bupropion are reached within 8 days.

In a study comparing 14-day dosing with a bupropion hydrochloride extended-release tablet (XL) 300 mg once daily to the immediate-release formulation of bupropion at 100 mg 3 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites (hydroxybupropion, threohydrobupropion, and erythrohydrobupropion). Additionally, in a study comparing 14-day dosing with a bupropion hydrochloride extended-release tablet (XL) 300 mg once daily to the sustained-release formulation of bupropion at 150 mg 2 times daily, equivalence was demonstrated for peak plasma concentration and area under the curve for bupropion and the 3 metabolites.

Absorption

Following oral administration of bupropion hydrochloride extended-release tablets (XL) to healthy volunteers, time to peak plasma concentrations for bupropion was approximately 5 hours and food did not affect the Cmax or AUC of bupropion.

Distribution

In vitro tests show that bupropion is 84% bound to human plasma proteins at concentrations up to 200 mcg/mL. The extent of protein binding of the hydroxybupropion metabolite is similar to that for bupropion, whereas the extent of protein binding of the threohydrobupropion metabolite is about half that seen with bupropion.

Metabolism

Bupropion is extensively metabolized in humans. Three metabolites have been shown to be active: hydroxybupropion, which is formed via hydroxylation of the tert-butyl group of bupropion, and the amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, which are formed via reduction of the carbonyl group. In vitro findings suggest that cytochrome P450IIB6 (CYP2B6) is the principal isoenzyme involved in the formation of hydroxybupropion, while cytochrome P450 isoenzymes are not involved in the formation of threohydrobupropion. Oxidation of the bupropion side chain results in the formation of a glycine conjugate of meta-chlorobenzoic acid, which is then excreted as the major urinary metabolite. The potency and toxicity of the metabolites relative to bupropion have not been fully characterized. However, it has been demonstrated in an antidepressant screening test in mice that hydroxybupropion is one half as potent as bupropion, while threohydrobupropion and erythrohydrobupropion are 5-fold less potent than bupropion. This may be of clinical importance because the plasma concentrations of the metabolites are as high or higher than those of bupropion.

Because bupropion is extensively metabolized, there is the potential for drug-drug interactions, particularly with those agents that are metabolized by or which inhibit/induce the cytochrome P450IIB6 (CYP2B6) isoenzyme, such as ritonavir. In a healthy volunteer study, ritonavir at a dose of 100 mg twice daily reduced the AUC and Cmax of bupropion by 22% and 21%, respectively. The exposure of the hydroxybupropion metabolite was decreased by 23%, the threohydrobupropion decreased by 38% and the erythrohydrobupropion decreased by 48%.

In a second healthy volunteer study, ritonavir at a dose of 600 mg twice daily decreased the AUC and Cmax of bupropion by 66% and 62%, respectively. The exposure of the hydroxybupropion metabolite was decreased by 78%, the threohydrobupropion decreased by 50% and the erythrohydrobupropion decreased by 68%.

In another healthy volunteer study, KALETRA® (lopinavir 400 mg/ritonavir 100 mg twice daily) decreased bupropion AUC and Cmax by 57%. The AUC and Cmax of hydroxybupropion were decreased by 50% and 31%, respectively, (see PRECAUTIONS: Drug Interactions).

Although bupropion is not metabolized by cytochrome P450IID6 (CYP2D6), there is the potential for drug-drug interactions when bupropion is co-administered with drugs metabolized by this isoenzyme (see PRECAUTIONS: Drug Interactions).

In humans, peak plasma concentrations of hydroxybupropion occur approximately 7 hours after administration of bupropion hydrochloride extended-release tablets (XL). Following administration of bupropion hydrochloride extended-release tablets (XL), peak plasma concentrations of hydroxybupropion are approximately 7 times the peak level of the parent drug at steady state. The elimination half-life of hydroxybupropion is approximately 20 (±5) hours, and its AUC at steady state is about 13 times that of bupropion. The times to peak concentrations for the erythrohydrobupropion and threohydrobupropion metabolites are similar to that of the hydroxybupropion metabolite. However, their elimination half-lives are longer, approximately 33 (±10) and 37 (±13) hours, respectively, and steady-state AUCs are 1.4 and 7 times that of bupropion, respectively.

Bupropion and its metabolites exhibit linear kinetics following chronic administration of 300 to 450 mg/day.

Elimination

Following oral administration of 200 mg of 14C-bupropion in humans, 87% and 10% of the radioactive dose were recovered in the urine and feces, respectively. However, the fraction of the oral dose of bupropion excreted unchanged was only 0.5%, a finding consistent with the extensive metabolism of bupropion.

Population Subgroups

Factors or conditions altering metabolic capacity (e.g., liver disease, congestive heart failure [CHF], age, concomitant medications, etc.) or elimination may be expected to influence the degree and extent of accumulation of the active metabolites of bupropion. The elimination of the major metabolites of bupropion may be affected by reduced renal or hepatic function because they are moderately polar compounds and are likely to undergo further metabolism or conjugation in the liver prior to urinary excretion.

Hepatic

The effect of hepatic impairment on the pharmacokinetics of bupropion was characterized in 2 single-dose studies, one in patients with alcoholic liver disease and one in patients with mild-to-severe cirrhosis. The first study showed that the half-life of hydroxybupropion was significantly longer in 8 patients with alcoholic liver disease than in 8 healthy volunteers (32±14 hours versus 21±5 hours, respectively). Although not statistically significant, the AUCs for bupropion and hydroxybupropion were more variable and tended to be greater (by 53% to 57%) in patients with alcoholic liver disease. The differences in half-life for bupropion and the other metabolites in the 2 patient groups were minimal.

The second study showed no statistically significant differences in the pharmacokinetics of bupropion and its active metabolites in 9 patients with mild to moderate hepatic cirrhosis compared to 8 healthy volunteers. However, more variability was observed in some of the pharmacokinetic parameters for bupropion (AUC, Cmax, and Tmax) and its active metabolites (t1/2) in patients with mild to moderate hepatic cirrhosis. In addition, in patients with severe hepatic cirrhosis, the bupropion Cmax and AUC were substantially increased (mean difference: by approximately 70% and 3-fold, respectively) and more variable when compared to values in healthy volunteers; the mean bupropion half-life was also longer (29 hours in patients with severe hepatic cirrhosis vs. 19 hours in healthy subjects). For the metabolite hydroxybupropion, the mean Cmax was approximately 69% lower. For the combined amino-alcohol isomers threohydrobupropion and erythrohydrobupropion, the mean Cmax was approximately 31% lower. The mean AUC increased by about 1½-fold for hydroxybupropion and about 2½-fold for threo/erythrohydrobupropion. The median Tmax was observed 19 hours later for hydroxybupropion and 31 hours later for threo/erythrohydrobupropion. The mean half-lives for hydroxybupropion and threo/erythrohydrobupropion were increased 5- and 2-fold, respectively, in patients with severe hepatic cirrhosis compared to healthy volunteers (see WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).

Renal

There is limited information on the pharmacokinetics of bupropion in patients with renal impairment. An inter-study comparison between normal subjects and patients with end-stage renal failure demonstrated that the parent drug Cmax and AUC values were comparable in the 2 groups, whereas the hydroxybupropion and threohydrobupropion metabolites had a 2.3- and 2.8-fold increase, respectively, in AUC for patients with end-stage renal failure. A second study comparing normal subjects and patients with moderate-to-severe renal impairment (GFR 30.9 ± 10.8 mL/min) showed that exposure to a single 150-mg dose of sustained-release bupropion was approximately 2-fold higher in patients with impaired renal function while levels of the hydroxybupropion and threo/erythrohydrobupropion (combined) metabolites were similar in the 2 groups. The elimination of bupropion and/or the major metabolites of bupropion may be reduced by impaired renal function (see PRECAUTIONS: Renal Impairment).

Left Ventricular Dysfunction

During a chronic dosing study with bupropion in 14 depressed patients with left ventricular dysfunction (history of CHF or an enlarged heart on x-ray), no apparent effect on the pharmacokinetics of bupropion or its metabolites was revealed, compared to healthy volunteers.

Age

The effects of age on the pharmacokinetics of bupropion and its metabolites have not been fully characterized, but an exploration of steady-state bupropion concentrations from several depression efficacy studies involving patients dosed in a range of 300 to 750 mg/day, on a 3 times daily schedule, revealed no relationship between age (18 to 83 years) and plasma concentration of bupropion. A single-dose pharmacokinetic study demonstrated that the disposition of bupropion and its metabolites in elderly subjects was similar to that of younger subjects. These data suggest there is no prominent effect of age on bupropion concentration; however, another pharmacokinetic study, single and multiple dose, has suggested that the elderly are at increased risk for accumulation of bupropion and its metabolites (see PRECAUTIONS: Geriatric Use).

Gender

A single-dose study involving 12 healthy male and 12 healthy female volunteers revealed no sex-related differences in the pharmacokinetic parameters of bupropion.

Smokers

The effects of cigarette smoking on the pharmacokinetics of bupropion were studied in 34 healthy male and female volunteers; 17 were chronic cigarette smokers and 17 were nonsmokers. Following oral administration of a single 150-mg dose of bupropion, there was no statistically significant difference in Cmax, half-life, Tmax, AUC, or clearance of bupropion or its active metabolites between smokers and nonsmokers.

Clinical Trials

Major Depressive Disorder

The efficacy of bupropion as a treatment for major depressive disorder was established with the immediate-release formulation of bupropion in two 4-week, placebo-controlled trials in adult inpatients and in one 6-week, placebo-controlled trial in adult outpatients. In the first study, patients were titrated in a bupropion dose range of 300 to 600 mg/day of the immediate-release formulation on a 3 times daily schedule; 78% of patients received maximum doses of 450-mg/day or less. This trial demonstrated the effectiveness of bupropion on the Hamilton Depression Rating Scale (HDRS) total score, the depressed mood item (item 1) from that scale, and the Clinical Global Impressions (CGI) severity score. A second study included 2 fixed doses of the immediate-release formulation of bupropion (300 and 450 mg/day) and placebo. This trial demonstrated the effectiveness of bupropion, but only at the 450-mg/day dose of the immediate-release formulation; the results were positive for the HDRS total score and the CGI severity score, but not for HDRS item 1. In the third study, outpatients received 300 mg/day of the immediate-release formulation of bupropion. This study demonstrated the effectiveness of bupropion on the HDRS total score, HDRS item 1, the Montgomery-Asberg Depression Rating Scale, the CGI severity score, and the CGI improvement score.

In a longer-term study, outpatients meeting DSM-IV criteria for major depressive disorder, recurrent type, who had responded during an 8-week open trial on bupropion (150 mg twice daily of the sustained-release formulation) were randomized to continuation of their same dose of bupropion or placebo, for up to 44 weeks of observation for relapse. Response during the open phase was defined as CGI Improvement score of 1 (very much improved) or 2 (much improved) for each of the final 3 weeks. Relapse during the double-blind phase was defined as the investigator's judgment that drug treatment was needed for worsening depressive symptoms. Patients receiving continued bupropion treatment experienced significantly lower relapse rates over the subsequent 44 weeks compared to those receiving placebo.

Although there are no independent trials demonstrating the antidepressant effectiveness of bupropion hydrochloride extended-release tablets (XL), studies have demonstrated similar bioavailability of bupropion hydrochloride extended-release tablets (XL) to both the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion under steady-state conditions, i.e., bupropion hydrochloride extended-release tablets (XL) 300 mg once daily was shown to have bioavailability that was similar to that of 100 mg 3 times daily of the immediate-release formulation of bupropion and to that of 150 mg 2 times daily of the sustained-release formulation of bupropion, with regard to both peak plasma concentration and extent of absorption, for parent drug and metabolites.

Seasonal Affective Disorder

The efficacy of bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes associated with seasonal affective disorder was established in 3 double-blind, placebo-controlled trials in adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern (as defined by DSM-IV criteria). Treatment was initiated prior to the onset of symptoms in the autumn (September to November) and was discontinued following a 2 week taper that began the first week of spring (fourth week of March), resulting in a treatment duration of approximately 4 to 6 months for the majority of patients. At the start of the study, patients were randomized to receive placebo or bupropion hydrochloride extended-release tablets (XL) 150 mg once daily for 1 week, followed by up-titration to 300 mg once daily. Patients who were deemed by the investigator to be unlikely or unable to tolerate 300 mg once daily were allowed to remain on, or had their dose reduced to, 150 mg once daily. The mean bupropion hydrochloride extended-release tablets (XL) doses in the 3 studies ranged from 257 to 280 mg/day.

In these 3 trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for bupropion hydrochloride extended-release tablets (XL) than for placebo; 81.4% vs. 69.7%, 87.2% vs. 78.7%, and 84.0% vs. 69.0% for Study 1, 2 and 3, respectively; with a depression-free rate for the 3 studies combined of 84.3% vs. 72.0%.

Indications and Usage for Budeprion XL

Major Depressive Disorder

Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder.

The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL TRIALS).

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.

The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Seasonal Affective Disorder

Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.

The efficacy of bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see CLINICAL TRIALS).

Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.

Contraindications

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a seizure disorder.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients treated with ZYBAN® [bupropion hydrochloride extended release tablets (SR)], WELLBUTRIN® (bupropion hydrochloride tablets) the immediate-release formulation; WELLBUTRIN SR® [bupropion hydrochloride extended-release tablets (SR)] the sustained-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

The concurrent administration of bupropion hydrochloride extended-release tablets (XL) and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride extended-release tablets (XL).

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up bupropion hydrochloride extended-release tablets (XL).

Warnings

Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.

Table 1

Age Range	Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated
Increases Compared to Placebo
< 18	14 additional cases
18 to 24	5 additional cases
Decreases Compared to Placebo
25 to 64	1 fewer case
≥ 65	6 fewer cases

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for bupropion hydrochloride extended-release tablets (XL) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment

WELLBUTRIN® (bupropion hydrochloride tablets), WELLBUTRIN SR® [bupropion hydrochloride extended-release tablets (SR)], and bupropion hydrochloride extended-release tablets (XL) are not approved for smoking cessation treatment, but bupropion under the name ZYBAN® [bupropion hydrochloride extended release tablets (SR)] is approved for this use. Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation (see BOXED WARNING, ADVERSE REACTIONS). These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke. When symptoms were reported, most were during bupropion treatment, but some were following discontinuation of bupropion therapy.

These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses. All patients being treated with bupropion as part of smoking cessation treatment should be observed for neuropsychiatric symptoms or worsening of pre-existing psychiatric illness.

Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of ZYBAN®.

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of ZYBAN® [bupropion hydrochloride extended release tablets (SR)] was reported, although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN® [bupropion hydrochloride extended release tablets (SR)] has been demonstrated to increase the likelihood of abstinence from smoking for as long as six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial.

Screening Patients for Bipolar Disorder

A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that bupropion hydrochloride extended-release tablets (XL) are not approved for use in treating bipolar depression.

Bupropion-Containing Products

Patients should be made aware that bupropion hydrochloride extended-release tablets (XL) contain the same active ingredient found in ZYBAN® [bupropion hydrochloride extended release tablets (SR)], used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (XL) should not be used in combination with ZYBAN® [bupropion hydrochloride extended release tablets (SR)], or any other medications that contain bupropion, such as WELLBUTRIN SR® [bupropion hydrochloride extended-release tablets (SR)], the sustained-release formulation or WELLBUTRIN® (bupropion hydrochloride tablets), the immediate-release formulation.

Seizures

Bupropion is associated with a dose-related risk of seizures. The risk of seizures is also related to patient factors, clinical situations, and concomitant medications, which must be considered in selection of patients for therapy with bupropion hydrochloride extended-release tablets (XL).

Bupropion hydrochloride extended-release tablets (XL) should be discontinued and not restarted in patients who experience a seizure while on treatment.

As bupropion hydrochloride extended-release tablets (XL) are bioequivalent to both the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion, the seizure incidence with bupropion hydrochloride extended-release tablets (XL), while not formally evaluated in clinical trials, may be similar to that presented below for the immediate-release and sustained-release formulations of bupropion.

• Dose: At doses up to 300 mg/day of the sustained-release formulation of bupropion (WELLBUTRIN SR®), the incidence of seizure is approximately 0.1% (1/1,000).
  

  
  
  Data for the immediate-release formulation of bupropion revealed a seizure incidence of approximately 0.4% (i.e., 13 of 3,200 patients followed prospectively) in patients treated at doses in a range of 300 to 450 mg/day. This seizure incidence (0.4%) may exceed that of some other marketed antidepressants.

  
  

  
  
  Additional data accumulated for the immediate-release formulation of bupropion suggested that the estimated seizure incidence increases almost tenfold between 450 and 600 mg/day. The 600 mg dose is twice the usual adult dose and one and one-third the maximum recommended daily dose (450 mg) of bupropion hydrochloride extended-release tablets (XL). This disproportionate increase in seizure incidence with dose incrementation calls for caution in dosing.
  
   

  
  


• Patient factors: Predisposing factors that may increase the risk of seizure with bupropion use include history of head trauma or prior seizure, central nervous system (CNS) tumor, the presence of severe hepatic cirrhosis, and concomitant medications that lower seizure threshold.


• Clinical situations: Circumstances associated with an increased seizure risk include, among others, excessive use of alcohol or sedatives (including benzodiazepines); addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and anorectics; and diabetes treated with oral hypoglycemics or insulin.


• Concomitant medications: Many medications (e.g., antipsychotics, antidepressants, theophylline, systemic steroids) are known to lower seizure threshold.

Recommendations for Reducing the Risk of Seizure

Retrospective analysis of clinical experience gained during the development of bupropion suggests that the risk of seizure may be minimized if

• the total daily dose of bupropion hydrochloride extended-release tablets (XL) does not exceed 450 mg,


• the rate of incrementation of dose is gradual.

Bupropion hydrochloride extended-release tablets (XL) should be administered with extreme caution to patients with a history of seizure, cranial trauma, or other predisposition(s) toward seizure, or patients treated with other agents (e.g., antipsychotics, other antidepressants, theophylline, systemic steroids, etc.) that lower seizure threshold.

Hepatic Impairment

Bupropion hydrochloride extended-release tablets (XL) should be used with extreme caution in patients with severe hepatic cirrhosis. In these patients a reduced frequency and/or dose is required, as peak bupropion, as well as AUC, levels are substantially increased and accumulation is likely to occur in such patients to a greater extent than usual. The dose should not exceed 150 mg every other day in these patients (see CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE AND ADMINISTRATION).

Potential for Hepatotoxicity

In rats receiving large doses of bupropion chronically, there was an increase in incidence of hepatic hyperplastic nodules and hepatocellular hypertrophy. In dogs receiving large doses of bupropion chronically, various histologic changes were seen in the liver, and laboratory tests suggesting mild hepatocellular injury were noted.

Precautions

General

Agitation and Insomnia

Increased restlessness, agitation, anxiety, and insomnia, especially shortly after initiation of treatment, have been associated with treatment with bupropion. In 3 placebo-controlled clinical trials of seasonal affective disorder with bupropion hydrochloride extended-release tablets (XL), the incidence of agitation, anxiety, and insomnia are shown in Table 2.

Table 2. Incidence of Agitation, Anxiety, and Insomnia in Placebo-Controlled Trials of Bupropion Hydrochloride Extended-Release Tablets (XL) for Seasonal Affective Disorder

Adverse Event Term	Bupropion Hydrochloride Extended-Release Tablets (XL) 150 to 300 mg/day (n=537)	Placebo (n=511)
Agitation	2%	<1%
Anxiety	7%	5%
Insomnia	20%	13%

Patients in placebo-controlled trials of major depressive disorder with WELLBUTRIN SR® (bupropion extended-release tablets (SR)), the sustained-release formulation of bupropion, experienced agitation, anxiety, and insomnia as shown in Table 3.

Table 3. Incidence of Agitation, Anxiety, and Insomnia in Placebo-Controlled Trials of WELLBUTRIN SR® for Major Depressive Disorder

Adverse Event Term	WELLBUTRIN SR® 300 mg/day (n=376)	WELLBUTRIN SR® 400 mg/day (n=114)	Placebo (n=385)
Agitation	3%	9%	2%
Anxiety	5%	6%	3%
Insomnia	11%	16%	6%

In clinical studies of major depressive disorder, these symptoms were sometimes of sufficient magnitude to require treatment with sedative/hypnotic drugs.

Symptoms in these studies were sufficiently severe to require discontinuation of treatment in 1% and 2.6% of patients treated with 300 and 400 mg/day, respectively, of bupropion sustained-release tablets and 0.8% of patients treated with placebo.

Psychosis, Confusion, and Other Neuropsychiatric Phenomena

Depressed patients treated with bupropion have been reported to show a variety of neuropsychiatric signs and symptoms, including delusions, hallucinations, psychosis, concentration disturbance, paranoia, and confusion. In some cases, these symptoms abated upon dose reduction and/or withdrawal of treatment.

Activation of Psychosis and/or Mania

Antidepressants can precipitate manic episodes in bipolar disorder patients during the depressed phase of their illness and may activate latent psychosis in other susceptible patients. Bupropion hydrochloride extended-release tablets (XL) are expected to pose similar risks.

Altered Appetite and Weight

In 3 placebo-controlled clinical trials of seasonal affective disorder with bupropion hydrochloride extended-release tablets (XL), the percentage of patients with weight gain or weight loss are shown in Table 4.

Table 4. Incidence of Weight Gain and Weight Loss in Placebo-Controlled Trials of Bupropion Hydrochloride Extended-Release Tablets (XL) for Seasonal Affective Disorder

Weight Change	Bupropion Hydrochloride Extended-Release Tablets (XL) 150 mg to 300 mg/day (n=537)	Placebo (n=511)
Gained > 5 lbs	11%	21%
Lost > 5 lbs	23%	11%

In placebo-controlled studies of major depressive disorder using WELLBUTRIN SR®, the sustained-release formulation of bupropion, patients experienced weight gain or weight loss as shown in Table 5.

Table 5. Incidence of Weight Gain and Weight Loss in Placebo-Controlled Trials of WELLBUTRIN SR® for Major Depressive Disorder

Weight Change	WELLBUTRIN SR® 300 mg/day (n=339)	WELLBUTRIN SR® 400 mg/day (n=112)	Placebo (n=347)
Gained > 5 lbs	3%	2%	4%
Lost > 5 lbs	14%	19%	6%