Omedoc

Omedoc may be available in the countries listed below.

Ingredient matches for Omedoc

Omeprazole

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

• Germany

International Drug Name Search

Pilocarpina

Pilocarpina may be available in the countries listed below.

Ingredient matches for Pilocarpina

Pilocarpine

Pilocarpine is reported as an ingredient of Pilocarpina in the following countries:

• Chile

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

• Brazil


• Italy


• Peru

International Drug Name Search

Apovent

Apovent may be available in the countries listed below.

Ingredient matches for Apovent

Ipratropium

Ipratropium Bromide is reported as an ingredient of Apovent in the following countries:

• Israel

International Drug Name Search

Golimumab

In the US, Golimumab (golimumab systemic) is a member of the drug class TNF alfa inhibitors and is used to treat Ankylosing Spondylitis, Psoriatic Arthritis and Rheumatoid Arthritis.

US matches:

• Golimumab


• Golimumab Subcutaneous

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

L04AB06

CAS registry number (Chemical Abstracts Service)

0476181-74-5

Chemical Formula

C6530-H10068-N1752-O2026-S44

Therapeutic Categories

Anti-inflammatory agent

Disease-modifying antirheumatic drug, DMARD

Immunomodulator

Foreign Names

• Golimumabum (Latin)
• Golimumab (German)
• Golimumab (French)
• Golimumab (Spanish)

Generic Names

• Golimumab (OS: USAN)
• CNTO 148 (IS)

Brand Names

• Simponi
  Centocor, United States; Essex, Germany; Schering-Plough, Australia; Schering-Plough, Canada; Schering-Plough, Sweden

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.

Tinacef

Tinacef may be available in the countries listed below.

Ingredient matches for Tinacef

Ceftazidime

Ceftazidime pentahydrate (a derivative of Ceftazidime) is reported as an ingredient of Tinacef in the following countries:

• Argentina


• Peru

International Drug Name Search

Neostigmin-Rotexmedica

Neostigmin-Rotexmedica may be available in the countries listed below.

Ingredient matches for Neostigmin-Rotexmedica

Neostigmine

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

• Germany

International Drug Name Search

Ocu-Mycin

Generic Name: gentamicin ophthalmic (JEN ta MYE sin off THAL mik)

Brand Names: Garamycin Ophthalmic, Gentak, Gentasol, Ocu-Mycin

What is Ocu-Mycin (gentamicin ophthalmic)?

Gentamicin ophthalmic is an antibiotic.

Gentamicin ophthalmic is used to treat bacterial infections of the eyes.

Gentamicin ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ocu-Mycin (gentamicin ophthalmic)?

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear ducts.

Who should not use Ocu-Mycin (gentamicin ophthalmic)?

Do not use gentamicin ophthalmic if you have a viral or fungal infection in your eye. It is used to treat infections caused by bacteria only. It is not known whether gentamicin ophthalmic will harm an unborn baby. Do not use gentamicin ophthalmic without first talking to your doctor if you are pregnant. It is also not known whether gentamicin ophthalmic passes into breast milk. Do not use gentamicin ophthalmic without first talking to your doctor if you are breast-feeding a baby.

How should I use Ocu-Mycin (gentamicin ophthalmic)?

Use gentamicin ophthalmic eyedrops or ointment exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before using the eyedrops or ointment.

To apply the eyedrops:

• 
  

  Shake the drops gently to be sure the medicine is well mixed. Tilt your head back slightly and pull down on your lower eyelid. Position the dropper above your eye. Look up and away from the dropper. Squeeze out a drop and close your eye. Apply gentle pressure to the inside corner of your eye (near your nose) for about 1 minute to prevent the liquid from draining down your tear duct. If you are using more than one drop in the same eye or drops in both eyes, repeat the process with about 5 minutes between drops.

  
  

To apply the ointment:

• 
  

  Hold the tube in your hand for a few minutes to warm it up so that the ointment comes out easily. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around in all directions for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before the next application.

  
  

Do not touch the dropper or tube opening to any surface, including your eyes or hands. The dropper or tube opening is sterile. If it becomes contaminated, it could cause an infection in your eye. Do not use any eyedrop that is discolored or has particles in it. Store gentamicin ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube properly capped.

What happens if I miss a dose?

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

What happens if I overdose?

An overdose of this medication is unlikely to occur. If you do suspect an overdose, wash the eye with water and call an emergency room or poison control center near you. If the drops or ointment have been ingested, drink plenty of fluid and call an emergency center for advice.

What should I avoid while using Ocu-Mycin (gentamicin ophthalmic)?

Use caution when driving, operating machinery, or performing other hazardous activities. Gentamicin ophthalmic may cause blurred vision. If you experience blurred vision, avoid these activities.

If you wear contact lenses, ask your doctor if you should wear them during treatment. After applying this medication, wait at least 15 minutes before inserting contact lenses, unless otherwise directed by your doctor.

Do not use other eye drops or medications during treatment with gentamicin ophthalmic unless otherwise directed by your doctor.

Ocu-Mycin (gentamicin ophthalmic) side effects

Serious side effects are not expected to occur during treatment with this medication.

Commonly, some eye burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

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 Ocu-Mycin (gentamicin ophthalmic)?

Do not use other eye drops or medications during treatment with gentamicin ophthalmic unless otherwise directed by your doctor.

Drugs other than those listed here may also interact with gentamicin ophthalmic. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Ocu-Mycin resources

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

• Ocu-Mycin Advanced Consumer (Micromedex) - Includes Dosage Information


• Genoptic Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Gentak Prescribing Information (FDA)


• Gentak eent Monograph (AHFS DI)


• Gentak Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ocu-Mycin with other medications

• Conjunctivitis, Bacterial

Where can I get more information?

• Your pharmacist has additional information about gentamicin ophthalmic written for health professionals that you may read.

See also: Ocu-Mycin side effects (in more detail)

Lomflox

Lomflox may be available in the countries listed below.

Ingredient matches for Lomflox

Lomefloxacin

Lomefloxacin is reported as an ingredient of Lomflox in the following countries:

• Russian Federation

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

• India


• Singapore

International Drug Name Search

Band-Ex

Band-Ex may be available in the countries listed below.

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

Ingredient matches for Band-Ex

Praziquantel

Praziquantel is reported as an ingredient of Band-Ex in the following countries:

• Germany

International Drug Name Search

Patalon

Patalon may be available in the countries listed below.

Ingredient matches for Patalon

Olopatadine

Olopatadine is reported as an ingredient of Patalon in the following countries:

• Bangladesh

International Drug Name Search

Oestrone

Oestrone may be available in the countries listed below.

Ingredient matches for Oestrone

Estrone

Oestrone (BAN) is known as Estrone in the US.

International Drug Name Search

Glossary

BAN	British Approved Name

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

Lebensart

Lebensart may be available in the countries listed below.

Ingredient matches for Lebensart

Fluoxetine

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

• Mexico

International Drug Name Search

Mosapride

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0112885-41-3

Chemical Formula

C21-H25-Cl-F-N3-O3

Molecular Weight

421

Therapeutic Category

Peristaltic stimulant

Chemical Name

(±)-4-Amino-5-chloro-2-ethoxy-N-[[4-(p-fluorobenzyl)-2-morpholinyl]methyl]-benzamide (WHO)

Foreign Names

• Mosapridum (Latin)
• Mosaprid (German)
• Mosapride (French)
• Mosaprida (Spanish)

Generic Names

• Mosapiride citrate (OS: JAN)
• AS 4370 (IS)
• Rimopride citrate (IS)

Brand Names

• Biotonus
  Farmindustria, Peru



• Gastride
  Legrand, Colombia



• Kinetix
  Lupin, India



• Mopride
  Micro Nova, India



• Mosad OD/Mosad MT
  Torrent, Vietnam



• Mosafe
  Glenmark, India



• Mosart
  Cadila, Sri Lanka



• Mosid
  Torrent, India



• Moten Instab
  Ranbaxy, India



• Moza MPS (Mosapride and Methylpolysiloxane)
  Intas, India



• Moza Plus (Mosapride and Pantoprazole)
  Intas, India



• Moza
  Intas, India



• Mozasef
  Sun, India



• Mozax-MPS (Mosapride and Methylpolysiloxane)
  Sun, India



• M-Pride
  Centaur, India



• Musapro
  Emcure, India



• Muzic
  Alkem, India



• Normagut
  Wockhardt, India



• Reflucil
  Tecnofarma, Peru



• Safepride
  Glenmark, Vietnam



• Dosier
  Medicamenta, Ecuador



• Galopran
  Laboratorios, Argentina



• Gasmotin
  Dainippon, China; Dainippon Sumitomo, Japan



• Intesul
  Beta, Argentina



• Lostapride
  Temis-Lostalo, Argentina



• Mosar
  Phoenix, Argentina



• Mosid
  Torrent, Myanmar



• Mosid-MPS (Mosapride and Dimethicone)
  Torrent, India



• Motigest
  Rodim, Belize; Rodim, Guatemala; Rodim, Honduras; Rodim, El Salvador



• Moxar
  Bussié, Colombia



• Moza
  Intas, Myanmar



• Mozax
  Sun, Myanmar



• Vagantyl
  Sidus, Argentina

International Drug Name Search

Glossary

IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
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.

Baby Shield

Baby Shield may be available in the countries listed below.

Ingredient matches for Baby Shield

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Baby Shield in the following countries:

• Singapore

International Drug Name Search

Pharex Paracetamol

Pharex Paracetamol may be available in the countries listed below.

Ingredient matches for Pharex Paracetamol

Paracetamol

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

• Philippines

International Drug Name Search

Mésulfène

Mésulfène may be available in the countries listed below.

Ingredient matches for Mésulfène

Mesulfen

Mésulfène (DCF) is also known as Mesulfen (Prop.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Prop.INN	Proposed International Nonproprietary Name (World Health Organization)

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

Fluxene

Fluxene may be available in the countries listed below.

Ingredient matches for Fluxene

Fluoxetine

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

• Brazil

International Drug Name Search

Chlopolidine

Chlopolidine may be available in the countries listed below.

Ingredient matches for Chlopolidine

Trichlormethiazide

Trichlormethiazide is reported as an ingredient of Chlopolidine in the following countries:

• Japan

International Drug Name Search

Cocaïne

Cocaïne may be available in the countries listed below.

Ingredient matches for Cocaïne

Cocaine

Cocaïne (DCF) is known as Cocaine in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

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

Tinidazole

In the US, Tinidazole (tinidazole systemic) is a member of the drug class amebicides and is used to treat Amebiasis, Bacterial Vaginitis, Giardiasis and Trichomoniasis.

US matches:

• Tinidazole

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

J01XD02,P01AB02

CAS registry number (Chemical Abstracts Service)

0019387-91-8

Chemical Formula

C8-H13-N3-O4-S

Molecular Weight

247

Therapeutic Category

Antiprotozoal agent: Trichomonacidal

Chemical Name

1H-Imidazole, 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-

Foreign Names

• Tinidazolum (Latin)
• Tinidazol (German)
• Tinidazole (French)
• Tinidazol (Spanish)

Generic Names

• Tinidazole (OS: BAN, DCF, JAN, USAN)
• Tinidazolo (OS: DCIT)
• CP 12574 (IS)
• Tinidazol (PH: Ph. Eur. 6)
• Tinidazole (PH: BP 2010, JP XIV, USP 32, Ph. Eur. 6)
• Tinidazolum (PH: Ph. Eur. 6)

Brand Names

• Afumix (Tinidazole and Fluconazole)
  Senosiain, Peru



• Alcip-TZ (Tinidazole and Ciprofloxacin)
  Allenge, India



• Amebamagma
  Wyeth, India



• Amibiol
  Etyc, Colombia



• Amplium
  Farmasa, Brazil



• Amtiba
  Cadila Health Care, Ethiopia



• Enidazol
  East India, India



• Estovyn-T
  Grossman, Mexico



• Famidal (Tinidazole and Miconazole)
  ABL, Peru



• Fasigin-N (Tinidazole and Nystatin)
  Pfizer, Italy



• Fasigyn
  Pfizer, United Arab Emirates; Pfizer, Argentina; Pfizer, Australia; Pfizer, Belgium; Pfizer, Bahrain; Pfizer, Belize; Pfizer, Chile; Pfizer, Colombia; Pfizer, Costa Rica; Pfizer, Cyprus; Pfizer, Dominican Republic; Pfizer, Ecuador; Pfizer, Egypt; Pfizer, Egypt; Pfizer, United Kingdom; Pfizer, Georgia; Pfizer, Greece; Pfizer, Guatemala; Pfizer, Guyana; Pfizer, Hong Kong; Pfizer, Honduras; Pfizer, Israel; Pfizer, India; Pfizer, Jordan; Pfizer, Kenya; Pfizer, Kuwait; Pfizer, Lebanon; Pfizer, Sri Lanka; Pfizer, Luxembourg; Pfizer, Malawi; Pfizer, Mexico; Pfizer, Nigeria; Pfizer, Nicaragua; Pfizer, Oman; Pfizer, Panama; Pfizer, Peru; Pfizer, Portugal; Pfizer, Romania; Pfizer, Saudi Arabia; Pfizer, Sudan; Pfizer, Sweden; Pfizer, Singapore; Pfizer, El Salvador; Pfizer, Thailand; Pfizer, Uganda; Pfizer, Venezuela; Pfizer, South Africa; Pfizer Pharma, Ethiopia



• Fasigyne
  Pfizer, Burkina Faso; Pfizer, Benin; Pfizer, Central African Republic; Pfizer, Congo; Pfizer, Cote D'ivoire; Pfizer, Cameroon; Pfizer, Gabon; Pfizer, Guinea; Pfizer, Madagascar; Pfizer, Mali; Pfizer, Mauritania; Pfizer, Mauritius; Pfizer, Niger; Pfizer, Senegal; Pfizer, Chad; Pfizer, Togo; Pfizer, Tunisia; Pfizer, Vietnam; Pfizer, Zaire; Teofarma, France



• Ginedazol (Tinidazole and Miconazole)
  Medco, Peru



• Gynormal
  Andromaco, Argentina



• Gynoval (Tinidazole and Miconazole)
  Markos, Peru



• Gynozol (Tinidazole and Ketoconazole)
  Medifarma, Peru



• Haisigyn
  Fuji Yakuhin, Japan



• Ladylen
  Mertens, Argentina



• Medivel (Tinidazole and Miconazole)
  Medifarma, Peru



• Midazole
  Micro Labs, Myanmar



• Pangamil
  Biotech, Venezuela



• Pletil
  Pfizer, Brazil



• Protocide
  Unipharm, Israel



• Protogyn
  Hayat, United Arab Emirates; Hayat, Bahrain; Hayat, Iraq; Hayat, Jordan; Hayat, Lebanon; Hayat, Libya; Hayat, Qatar; Hayat, Saudi Arabia; Hayat, Sudan; Hayat, Yemen; Renata, Bangladesh



• Protozole
  Medical Union Pharmaceuticals, Ethiopia



• Simplotan
  Pfizer, Australia



• Sporinex
  Medochemie, Oman



• Timerol
  Remedica, Cyprus



• Tindamax
  Mission, United States; Presutti, United States



• Tiniba
  Cadila, Ghana; Cadila, Kenya; Cadila, Malawi; Cadila, Nigeria; Cadila, Sudan; Cadila, Tanzania; Cadila, Uganda; Cadila, Zambia; Cadila Health Care, Ethiopia; Zydus, Latvia; Zydus, Russian Federation; Zydus Cadila, India; Zydus Cadila, Myanmar



• Tinidafyl
  Jagson Pal, India



• Tinidal
  Farmacoop, Colombia



• Tinidan
  ECU, Ecuador



• Tinidazol Actavis
  Balkanpharma, Bulgaria



• Tinidazol Best
  Best, Colombia



• Tinidazol Domesco
  Domesco, Vietnam



• Tinidazol Ecar
  Ecar, Colombia



• Tinidazol Genfar
  Genfar, Colombia; Genfar, Ecuador; Genfar, Peru



• Tinidazol L.CH.
  Chile, Chile



• Tinidazol La Santé
  La Santé, Colombia



• Tinidazol Lch
  Ivax, Peru



• Tinidazol MK
  Bonima, Costa Rica; Bonima, Dominican Republic; Bonima, Guatemala; Bonima, Honduras; Bonima, Nicaragua; Bonima, Panama; Bonima, El Salvador; McKesson, Ecuador; MK, Colombia



• Tinidazol Polpharma
  Polpharma, Latvia; Polpharma, Poland



• Tinidazol
  Actavis, Georgia; Actavis, Lithuania; AZ Pharma, Colombia; Blaskov, Colombia; Ecuaquímica, Ecuador; Elter - Medicamentos Genéricos, Venezuela; Ivax, Peru; La Sante, Peru; Medicalex, Colombia; Mintlab, Chile; Pentacoop, Colombia; Pentacoop, Peru; PlusAndex, Venezuela; Polpharma, Georgia; Polpharma, Lithuania; Sicomed, Georgia; Synthesis, Colombia



• Tinidazole
  Flamingo Pharmacueticals, Ethiopia; Limasole Industrial Estate, Ethiopia; Polpharma, Hungary; Remedica, Ethiopia; Unique, Russian Federation; Yung Shin, Taiwan



• Tinidazole-Akri
  Akrihin, Russian Federation



• Tinidazolum
  Polpharma, Poland



• Tinidral
  Infaca, Dominican Republic



• Tinigen
  Genamerica, Ecuador



• Tinizol
  Infomed, Romania; Zentiva, Romania



• Tiprogyn
  Helcor, Romania



• Tizol
  Farqui, Dominican Republic



• Triagil
  Galenika, Serbia



• Triamil
  Remo, Colombia



• Tricolam
  Farmasierra, Spain



• Triconidazol
  ABL, Peru



• Trimonase
  Mipharm, Italy



• Trinigyn
  Grünenthal, Mexico



• Troxxil
  Chile, Chile; Ivax, Peru

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
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.

Fensik

Fensik may be available in the countries listed below.

Ingredient matches for Fensik

Mefenamic Acid

Mefenamic Acid is reported as an ingredient of Fensik in the following countries:

• Indonesia

International Drug Name Search

Comprid

Comprid may be available in the countries listed below.

Ingredient matches for Comprid

Gliclazide

Gliclazide is reported as an ingredient of Comprid in the following countries:

• Bangladesh

International Drug Name Search

Inca Oxy B

Inca Oxy B may be available in the countries listed below.

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

Ingredient matches for Inca Oxy B

Oxytetracycline

Oxytetracycline hydrochloride (a derivative of Oxytetracycline) is reported as an ingredient of Inca Oxy B in the following countries:

• Australia

International Drug Name Search

Vomiof

Vomiof may be available in the countries listed below.

Ingredient matches for Vomiof

Ondansetron

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

• India

International Drug Name Search

Gentamicina Germed

Gentamicina Germed may be available in the countries listed below.

Ingredient matches for Gentamicina Germed

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentamicina Germed in the following countries:

• Italy

International Drug Name Search

Insulatard FlexPen

Insulatard FlexPen may be available in the countries listed below.

Ingredient matches for Insulatard FlexPen

Insulin, Isophane

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

• Spain


• Sweden

International Drug Name Search

Lamilea

Lamilea may be available in the countries listed below.

Ingredient matches for Lamilea

Lamivudine

Lamivudine is reported as an ingredient of Lamilea in the following countries:

• Argentina

International Drug Name Search

Gemcitabin Haemato

Gemcitabin Haemato may be available in the countries listed below.

Ingredient matches for Gemcitabin Haemato

Gemcitabine

Gemcitabine hydrochloride (a derivative of Gemcitabine) is reported as an ingredient of Gemcitabin Haemato in the following countries:

• Germany

International Drug Name Search

Cetralon

Cetralon may be available in the countries listed below.

Ingredient matches for Cetralon

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetralon in the following countries:

• Bahrain


• Oman

International Drug Name Search

Baxter Sevoflurane

Baxter Sevoflurane may be available in the countries listed below.

Ingredient matches for Baxter Sevoflurane

Sevoflurane

Sevoflurane is reported as an ingredient of Baxter Sevoflurane in the following countries:

• Australia

International Drug Name Search

Antix

Antix may be available in the countries listed below.

Ingredient matches for Antix

Acyclovir

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

• Finland


• Norway

International Drug Name Search

Corhydron

Corhydron may be available in the countries listed below.

Ingredient matches for Corhydron

Hydrocortisone

Hydrocortisone 21-(sodium succinate) (a derivative of Hydrocortisone) is reported as an ingredient of Corhydron in the following countries:

• Poland

International Drug Name Search

Amoxicilina Clav Acost

Amoxicilina Clav Acost may be available in the countries listed below.

Ingredient matches for Amoxicilina Clav Acost

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicilina Clav Acost in the following countries:

• Spain

International Drug Name Search

Hexedine

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

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A01AB12

CAS registry number (Chemical Abstracts Service)

0005980-31-4

Chemical Formula

C22-H45-N3

Molecular Weight

351

Therapeutic Categories

Antiseptic

Disinfectant

Chemical Name

1H-Imidazo[1,5-c]imidazole, 2,6-bis(2-ethylhexyl)hexahydro-7a-methyl-

Foreign Names

• Hexedinum (Latin)
• Hexedin (German)
• Hexédine (French)
• Hexedina (Spanish)

Generic Names

• Hexedine (OS: USAN)
• W 4701 (IS)

Brand Name

• Hexil (veterinary use)
  Virbac, New Zealand

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.

Maibastan

Maibastan may be available in the countries listed below.

Ingredient matches for Maibastan

Pravastatin

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

• Japan

International Drug Name Search

Taharsept

Taharsept may be available in the countries listed below.

Ingredient matches for Taharsept

Troclosene

Troclosene is reported as an ingredient of Taharsept in the following countries:

• Israel

International Drug Name Search

Miniphase

Miniphase may be available in the countries listed below.

Ingredient matches for Miniphase

Ethinylestradiol

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

• France

Norethisterone

Norethisterone 17ß-acetate (a derivative of Norethisterone) is reported as an ingredient of Miniphase in the following countries:

• France

International Drug Name Search

Dopamina Biologici

Dopamina Biologici may be available in the countries listed below.

Ingredient matches for Dopamina Biologici

Dopamine

Dopamine hydrochloride (a derivative of Dopamine) is reported as an ingredient of Dopamina Biologici in the following countries:

• Italy

International Drug Name Search

Amoxon

Amoxon may be available in the countries listed below.

Ingredient matches for Amoxon

Amoxicillin

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

• Bangladesh

International Drug Name Search

Clormadinone

Clormadinone may be available in the countries listed below.

Ingredient matches for Clormadinone

Chlormadinone

Clormadinone (DCIT) is also known as Chlormadinone (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.

Donatussin MAX

Generic Name: carbinoxamine, hydrocodone, and phenylephrine (kar bi NOX a meen, hy dro KOE done, fen il EFF rin)

Brand Names: Donatussin MAX, Excof, Excof-SF

What is Donatussin MAX (carbinoxamine, hydrocodone, and phenylephrine)?

Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Carbinoxamine, hydrocodone, and phenylephrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

This medication may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Donatussin MAX (carbinoxamine, hydrocodone, and phenylephrine)?

Always ask a doctor before giving a cough or cold medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Do not use carbinoxamine, hydrocodone, and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body. Carbinoxamine, hydrocodone, and phenylephrine 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. It can increase some of the side effects of this medication.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Do not take this product for cough caused by smoking, asthma, or emphysema. Do not take this medicine if your cough produces a lot of mucus, unless your doctor has told you to.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be given to 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.

What should I discuss with my health care provider before taking Donatussin MAX (carbinoxamine, hydrocodone, and phenylephrine)?

Do not give this medication to a child younger than 2 years old, even if the medicine label provides dosing intructions for children in this age group. Deaths have been reported in children under 2 years old who had received carbinoxamine, although it has not been determined that carbinoxamine was the cause of these deaths. Talk with your doctor about other FDA-approved products available for use in young children with cold or allergy symptoms. Do not use carbinoxamine, hydrocodone, and phenylephrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine, hydrocodone, and phenylephrine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to carbinoxamine, hydrocodone, or phenylephrine, or if you have:

• 
  

  a history of drug or alcohol addiction;

  
  


• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  coronary artery disease;

  
  


• 
  

  a stomach ulcer or an obstruction in your stomach or intestines;

  
  


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  head injury, brain injury, or brain tumor;

  
  


• 
  

  Addison's disease;

  
  


• 
  

  thyroid problems;

  
  


• 
  

  emphysema or chronic bronchitis;

  
  


• 
  

  asthma.

  
  

If you have any of these conditions, you may not be able to take this medication, or you may require a dosage adjustment or special monitoring 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. Carbinoxamine, hydrocodone, and phenylephrine 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. Older adults may be more likely to have side effects from this medicine.

How should I take Donatussin MAX (carbinoxamine, hydrocodone, and phenylephrine)?

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

You may take this medication with or without food.

If the medication upsets your stomach, you may take it with food or milk.

Measure the 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 where you can get one.

Hydrocodone may cause constipation. Drink 6 to 8 full glasses of water each day while you are taking this medicine. Increasing the amount of fiber in your diet may also help relieve constipation.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. This medicine should never be given to 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. Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Symptoms of an overdose may include dizziness, ringing in the ears, blurred vision, large pupils, dry mouth, a weak heartbeat, extreme drowsiness, sweating, shaking, pale skin, blue lips and fingernails, hallucinations, confusion, seizures, shallow breathing, coma, and death.

What should I avoid while taking Donatussin MAX (carbinoxamine, hydrocodone, and phenylephrine)?

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. It can increase some of the side effects of this medication. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Avoid using other medicines that make you sleepy (such as cold medicine, other narcotics, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by carbinoxamine, hydrocodone, and phenylephrine.

Donatussin MAX (carbinoxamine, hydrocodone, and phenylephrine) 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:

• 
  

  seizure (convulsions);

  
  


• 
  

  unusual behavior or hallucinations;

  
  


• 
  

  an irregular or fast heartbeat;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  wheezing, tightness in your chest;

  
  


• 
  

  fast or pounding heartbeat;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  pale skin, easy bruising or bleeding;

  
  


• 
  

  slow or weak breathing; or

  
  


• 
  

  swelling, rapid weight gain.

  
  

Continue taking this medication and talk to your doctor if you have any of these less serious side effects:

• 
  

  drowsiness, dizziness;

  
  


• 
  

  lack of coordination;

  
  


• 
  

  upset stomach, nausea, stomach cramps, or constipation;

  
  


• 
  

  stuffy nose, chest congestion;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  itchy skin rash;

  
  


• 
  

  decreased hearing or ringing in the ears;

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  dry mouth or nose; or

  
  


• 
  

  blurred vision.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

The hydrocodone in this medication may cause constipation. Drink plenty of water (six to eight full glasses a day) to lessen this side effect. Increasing the amount of fiber in your diet may also help to alleviate constipation.

What other drugs will affect Donatussin MAX (carbinoxamine, hydrocodone, and phenylephrine)?

Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), or selegiline (Eldepryl) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking carbinoxamine, hydrocodone, and phenylephrine, tell your doctor if you are taking any of the following medicines:

• 
  

  medicine to treat high blood pressure or a heart condition;

  
  


• 
  

  medicine to treat diabetes;

  
  


• 
  

  weight loss medication;

  
  


• 
  

  another decongestant (cold or allergy product); or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

  
  

If you are using any of these drugs, you may not be able to use carbinoxamine, hydrocodone, and phenylephrine or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect carbinoxamine, hydrocodone, and phenylephrine. 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 Donatussin MAX resources

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

• Carbinoxamine/Hydrocodone/Phenylephrine Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Donatussin MAX with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist has additional information about carbinoxamine, hydrocodone, and phenylephrine written for health professionals that you may read.

What does my medication look like?

Carbinoxamine, hydrocodone, and phenylephrine is available with a prescription under the brand names Donatussin and Excof. Other brand and generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

See also: Donatussin MAX side effects (in more detail)

Xavin

Xavin may be available in the countries listed below.

Ingredient matches for Xavin

Budesonide

Budesonide is reported as an ingredient of Xavin in the following countries:

• Italy

Xantinol Nicotinate

Xantinol Nicotinate is reported as an ingredient of Xavin in the following countries:

• Hungary

International Drug Name Search

Panadia

Panadia may be available in the countries listed below.

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

Ingredient matches for Panadia

Tetracycline

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

• France

International Drug Name Search

Niramine

Niramine may be available in the countries listed below.

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

Ingredient matches for Niramine

Chlorphenamine

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

• Australia


• Taiwan

International Drug Name Search

Tricidine

Tricidine may be available in the countries listed below.

Ingredient matches for Tricidine

Fusidic Acid

Fusidic Acid is reported as an ingredient of Tricidine in the following countries:

• Tunisia

International Drug Name Search

Klavux

Klavux may be available in the countries listed below.

Ingredient matches for Klavux

Amoxicillin

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

• Italy

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Klavux in the following countries:

• Italy

International Drug Name Search

Rohist

Rohist may be available in the countries listed below.

Ingredient matches for Rohist

Loratadine

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

• South Africa

International Drug Name Search

Paramethasone

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

H02AB05

CAS registry number (Chemical Abstracts Service)

0000053-33-8

Chemical Formula

C22-H29-F-O5

Molecular Weight

392

Therapeutic Category

Adrenal cortex hormone, glucocorticoid

Chemical Name

Pregna-1,4-diene-3,20-dione, 6-fluoro-11,17,21-trihydroxy-16-methyl-, (6α,11ß,16α)-

Foreign Names

• Paramethasonum (Latin)
• Paramethason (German)
• Paraméthasone (French)
• Parametasona (Spanish)

Generic Names

• Parametasone (OS: DCIT)
• Paramethasone (OS: BAN)
• Paraméthasone (OS: DCF)
• CS 1483 (IS)
• Paramethasone Acetate (OS: USAN, JAN, BANM)
• Paraméthasone (acétate de) (IS: DCF vieille)
• Paramethasone Acetate (PH: USP 32)

Brand Names

• Depo-Dilar
  Abdi Ibrahim, Turkey



• Dilar
  Syntex, Mexico



• Paramesone
  Tanabe Mitsubishi, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
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.

Doxazosine Disphar

Doxazosine Disphar may be available in the countries listed below.

Ingredient matches for Doxazosine Disphar

Doxazosin

Doxazosin mesilate (a derivative of Doxazosin) is reported as an ingredient of Doxazosine Disphar in the following countries:

• Netherlands

International Drug Name Search

Sentix

Sentix may be available in the countries listed below.

Ingredient matches for Sentix

Flupentixol

Flupentixol dihydrochloride (a derivative of Flupentixol) is reported as an ingredient of Sentix in the following countries:

• Bangladesh

International Drug Name Search

Miconazolnitraat Ratiopharm

Miconazolnitraat Ratiopharm may be available in the countries listed below.

Ingredient matches for Miconazolnitraat Ratiopharm

Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Miconazolnitraat Ratiopharm in the following countries:

• Netherlands

International Drug Name Search

Otilax

Otilax may be available in the countries listed below.

Ingredient matches for Otilax

Otilonium Bromide

Otilonium Bromide is reported as an ingredient of Otilax in the following countries:

• Greece

International Drug Name Search

Benoson

Benoson may be available in the countries listed below.

Ingredient matches for Benoson

Betamethasone

Betamethasone is reported as an ingredient of Benoson in the following countries:

• Indonesia

International Drug Name Search

Oxytrol

In the US, Oxytrol (oxybutynin systemic) is a member of the drug class urinary antispasmodics and is used to treat Dysuria, Hyperhidrosis, Overactive Bladder, Prostatitis and Urinary Incontinence.

US matches:

• Oxytrol


• Oxytrol System


• Oxytrol transdermal

Ingredient matches for Oxytrol

Oxybutynin

Oxybutynin is reported as an ingredient of Oxytrol in the following countries:

• Australia


• Canada


• New Zealand


• United States

International Drug Name Search

Felodipin AL

Felodipin AL may be available in the countries listed below.

Ingredient matches for Felodipin AL

Felodipine

Felodipine is reported as an ingredient of Felodipin AL in the following countries:

• Czech Republic


• Germany


• Romania

International Drug Name Search

Lipoclin

Lipoclin may be available in the countries listed below.

Ingredient matches for Lipoclin

Clinofibrate

Clinofibrate is reported as an ingredient of Lipoclin in the following countries:

• Japan

International Drug Name Search

Atropin Dispersa

Atropin Dispersa may be available in the countries listed below.

Ingredient matches for Atropin Dispersa

Atropine

Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Atropin Dispersa in the following countries:

• Luxembourg

International Drug Name Search

Era

Era may be available in the countries listed below.

Ingredient matches for Era

Erythromycin

Erythromycin stearate (a derivative of Erythromycin) is reported as an ingredient of Era in the following countries:

• New Zealand

International Drug Name Search

Sulfarinol

Sulfarinol may be available in the countries listed below.

Ingredient matches for Sulfarinol

Naphazoline

Naphazoline nitrate (a derivative of Naphazoline) is reported as an ingredient of Sulfarinol in the following countries:

• Poland

Sulfathiazole

Sulfathiazole is reported as an ingredient of Sulfarinol in the following countries:

• Poland

International Drug Name Search

Clenil Jet

Clenil Jet may be available in the countries listed below.

Ingredient matches for Clenil Jet

Beclometasone

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

• Italy

International Drug Name Search

Vermequine

Vermequine may be available in the countries listed below.

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

Ingredient matches for Vermequine

Oxibendazole

Oxibendazole is reported as an ingredient of Vermequine in the following countries:

• France

International Drug Name Search

Adobiol

Adobiol may be available in the countries listed below.

Ingredient matches for Adobiol

Bufetolol

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

• Japan

International Drug Name Search

Amiodarone Labatec

Amiodarone Labatec may be available in the countries listed below.

Ingredient matches for Amiodarone Labatec

Amiodarone

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

• Switzerland

International Drug Name Search

Citrihexal

Citrihexal may be available in the countries listed below.

Ingredient matches for Citrihexal

Calcitriol

Calcitriol is reported as an ingredient of Citrihexal in the following countries:

• Australia

International Drug Name Search

Fusiver

Fusiver may be available in the countries listed below.

Ingredient matches for Fusiver

Fusidic Acid

Fusidic Acid sodium (a derivative of Fusidic Acid) is reported as an ingredient of Fusiver in the following countries:

• Bahrain

International Drug Name Search

Streptothenat

Streptothenat may be available in the countries listed below.

Ingredient matches for Streptothenat

Streptomycin

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

• Ethiopia

International Drug Name Search

Melgar

Melgar may be available in the countries listed below.

Ingredient matches for Melgar

Naproxen

Naproxen is reported as an ingredient of Melgar in the following countries:

• Argentina

International Drug Name Search

Sedakter

Sedakter may be available in the countries listed below.

Ingredient matches for Sedakter

Terbutaline

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

• Indonesia

International Drug Name Search

Axit

Axit may be available in the countries listed below.

Ingredient matches for Axit

Mirtazapine

Mirtazapine is reported as an ingredient of Axit in the following countries:

• Australia

International Drug Name Search

Osyrol Lasix

Osyrol Lasix may be available in the countries listed below.

Ingredient matches for Osyrol Lasix

Furosemide

Furosemide is reported as an ingredient of Osyrol Lasix in the following countries:

• Germany

Spironolactone

Spironolactone is reported as an ingredient of Osyrol Lasix in the following countries:

• Germany

International Drug Name Search

Amenox

Amenox may be available in the countries listed below.

Ingredient matches for Amenox

Quinfamide

Quinfamide is reported as an ingredient of Amenox in the following countries:

• Mexico

International Drug Name Search

Cilpier

Cilpier may be available in the countries listed below.

Ingredient matches for Cilpier

Piperacillin

Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Cilpier in the following countries:

• Italy

International Drug Name Search

Suxin

Suxin may be available in the countries listed below.

Ingredient matches for Suxin

Buspirone

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

• China

International Drug Name Search

Sterilon

Sterilon may be available in the countries listed below.

Ingredient matches for Sterilon

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Sterilon in the following countries:

• Belgium


• Luxembourg


• Netherlands

International Drug Name Search

Chemicetina

Chemicetina may be available in the countries listed below.

Ingredient matches for Chemicetina

Chloramphenicol

Chloramphenicol is reported as an ingredient of Chemicetina in the following countries:

• Italy

International Drug Name Search

Gonococcal Infection, Uncomplicated Medications

Drugs associated with Gonococcal Infection, Uncomplicated

The following drugs and medications are in some way related to, or used in the treatment of Gonococcal Infection, Uncomplicated. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Gonococcal Infection, Uncomplicated

Harvard Health Guide:

• Symptoms and treatment for Gonorrhea

Drug List:

Ala-Tet

Azithromycin-3-Day-Dose-Pack

Cefizox

Ceftin

Cipro

Cipro-I-V

Cipro-Xr-Extended-Release-Tablets

Claforan

Floxin

Levaquin

Levaquin-Leva-Pak

Mefoxin

Noroxin

Penetrex

Pipracil

Rocephin

Spectrobid

Sumycin

Suprax

Tequin

Tequin-Teqpaq

Trobicin

Vantin

Zinacef

Zithromax

Zmax-Extended-Release-Oral-Suspension

Cefaclor-ratiopharm

Cefaclor-ratiopharm may be available in the countries listed below.

Ingredient matches for Cefaclor-ratiopharm

Cefaclor

Cefaclor monohydrate (a derivative of Cefaclor) is reported as an ingredient of Cefaclor-ratiopharm in the following countries:

• Germany


• Italy

International Drug Name Search

Penicillin V acis

Penicillin V acis may be available in the countries listed below.

Ingredient matches for Penicillin V acis

Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Penicillin V acis in the following countries:

• Germany

International Drug Name Search

Otarex

Otarex may be available in the countries listed below.

Ingredient matches for Otarex

Hydroxyzine

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

• Israel

International Drug Name Search

Carniprol

Carniprol may be available in the countries listed below.

Ingredient matches for Carniprol

Levocarnitine

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

• Greece

International Drug Name Search

Galcodine

Galcodine may be available in the countries listed below.

Ingredient matches for Galcodine

Codeine

Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Galcodine in the following countries:

• Ireland

International Drug Name Search

Doxil

Dosage Form: injection, suspension, liposomal
FULL PRESCRIBING INFORMATION

WARNING: INFUSION REACTIONS, MYELOSUPPRESSION, CARDIOTOXICITY, LIVER IMPAIRMENT, ACCIDENTAL SUBSTITUTION

1.

The use of Doxil (doxorubicin HCl liposome injection) may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550 mg/m2. In a clinical study in patients with advanced breast cancer, 250 patients received Doxil at a starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450–500 mg/m2 or between 500–550 mg/m2, the risk of cardiac toxicity for patients treated with Doxil was 11%. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dosage. Cardiac toxicity may also occur at lower cumulative doses in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy [see Warnings and Precautions (5.1)].

2.

Acute infusion-related reactions including, but not limited to, flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness in the chest or throat, and/or hypotension have occurred in up to 10% of patients treated with Doxil. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction has resolved with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use. Doxil should be administered at an initial rate of 1 mg/min to minimize the risk of infusion reactions [see Warnings and Precautions (5.2)].

3.

Severe myelosuppression may occur [see Warnings and Precautions (5.3)].

4.

Dosage should be reduced in patients with impaired hepatic function [see Dosage and Administration (2.6) and Use in Specific Populations (8.6)].

5.

Accidental substitution of Doxil for doxorubicin HCl has resulted in severe side effects. Doxil should not be substituted for doxorubicin HCl on a mg per mg basis [see Dosage and Administration (2.1)].

Indications and Usage for Doxil

Ovarian Cancer

Doxil (doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

AIDS-Related Kaposi's Sarcoma

Doxil is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.

Multiple Myeloma

Doxil in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

Doxil Dosage and Administration

Usage and Administration Precautions

Liposomal encapsulation can substantially affect a drug's functional properties relative to those of the unencapsulated drug. Therefore DO NOT SUBSTITUTE one drug for the other.

Do not administer as a bolus injection or an undiluted solution. Rapid infusion may increase the risk of infusion-related reactions [see Warnings and Precautions (5.2)]. Doxil must not be given by the intramuscular or subcutaneous route.

Until specific compatibility data are available, it is not recommended that Doxil be mixed with other drugs.

Doxil should be considered an irritant and precautions should be taken to avoid extravasation. With intravenous administration of Doxil, extravasation may occur with or without an accompanying stinging or burning sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the infusion should be immediately terminated and restarted in another vein. The application of ice over the site of extravasation for approximately 30 minutes may be helpful in alleviating the local reaction.

Patients With Ovarian Cancer

Doxil (doxorubicin HCl liposome injection) should be administered intravenously at a dose of 50 mg/m2 (doxorubicin HCl equivalent) at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion-related adverse reactions are observed, the rate of infusion can be increased to complete administration of the drug over one hour. The patient should be dosed once every 4 weeks, for as long as the patient does not progress, shows no evidence of cardiotoxicity [see Warnings and Precautions (5.1)], and continues to tolerate treatment. A minimum of 4 courses is recommended because median time to response in clinical trials was 4 months. To manage adverse reactions such as hand-foot syndrome (HFS), stomatitis, or hematologic toxicity the doses may be delayed or reduced [see Dosage and Administration (2.5)]. Pretreatment with or concomitant use of antiemetics should be considered.

Patients With AIDS-Related Kaposi's Sarcoma

Doxil (doxorubicin HCl liposome injection) should be administered intravenously at a dose of 20 mg/m2 (doxorubicin HCl equivalent). An initial rate of 1 mg/min should be used to minimize the risk of infusion-related reactions. If no infusion-related adverse reactions are observed, the infusion rate should be increased to complete the administration of the drug over one hour. The dose should be repeated once every three weeks, for as long as patients respond satisfactorily and tolerate treatment.

Patients With Multiple Myeloma

Bortezomib is administered at a dose of 1.3 mg/m2 as intravenous bolus on days 1, 4 , 8 and 11, every three weeks. Doxil 30 mg/m2 should be administered as a 1-hr intravenous infusion on day 4 following bortezomib. With the first Doxil dose, an initial rate of 1 mg/min should be used to minimize the risk of infusion-related reactions. If no infusion-related adverse reactions are observed, the infusion rate should be increased to complete the administration of the drug over one hour. Patients may be treated for up to 8 cycles until disease progression or the occurrence of unacceptable toxicity.

Dose Modification Guidelines

Doxil exhibits nonlinear pharmacokinetics at 50 mg/m2; therefore, dose adjustments may result in a non-proportional greater change in plasma concentration and exposure to the drug [see Clinical Pharmacology (12.3)].

Patients should be carefully monitored for toxicity. Adverse reactions, such as HFS, hematologic toxicities, and stomatitis may be managed by dose delays and adjustments. Following the first appearance of a Grade 2 or higher adverse reactions, the dosing should be adjusted or delayed as described in the following tables. Once the dose has been reduced, it should not be increased at a later time.

Recommended Dose Modification Guidelines

Table 1: Hand-Foot Syndrome (HFS)

Toxicity Grade	Dose Adjustment
1 (mild erythema, swelling, or desquamation not interfering with daily activities)	Redose unless patient has experienced previous Grade 3 or 4 HFS. If so, delay up to 2 weeks and decrease dose by 25%. Return to original dose interval.
2 (erythema, desquamation, or swelling interfering with, but not precluding normal physical activities; small blisters or ulcerations less than 2 cm in diameter)	Delay dosing up to 2 weeks or until resolved to Grade 0–1. If after 2 weeks there is no resolution, Doxil should be discontinued. If resolved to Grade 0–1 within 2 weeks, and there are no prior Grade 3–4 HFS, continue treatment at previous dose and return to original dose interval. If patient experienced previous Grade 3–4 toxicity, continue treatment with a 25% dose reduction and return to original dose interval.
3 (blistering, ulceration, or swelling interfering with walking or normal daily activities; cannot wear regular clothing)	Delay dosing up to 2 weeks or until resolved to Grade 0–1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, Doxil should be discontinued.
4 (diffuse or local process causing infectious complications, or a bed ridden state or hospitalization)	Delay dosing up to 2 weeks or until resolved to Grade 0–1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, Doxil should be discontinued.

Table 2: Hematological Toxicity

Grade	ANC	Platelets	Modification
1	1,500 – 1,900	75,000 – 150,000	Resume treatment with no dose reduction
2	1,000 – <1,500	50,000 – <75,000	Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose with no dose reduction
3	500 – 999	25,000 – <50,000	Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose with no dose reduction
4	<500	<25,000	Wait until ANC ≥ 1,500 and platelets ≥ 75,000; redose at 25% dose reduction or continue full dose with cytokine support

Table 3: Stomatitis

Toxicity Grade	Dose Adjustment
1 (painless ulcers, erythema, or mild soreness)	Redose unless patient has experienced previous Grade 3 or 4 toxicity. If so, delay up to 2 weeks and decrease dose by 25%. Return to original dose interval.
2 (painful erythema, edema, or ulcers, but can eat)	Delay dosing up to 2 weeks or until resolved to Grade 0–1. If after 2 weeks there is no resolution, Doxil should be discontinued. If resolved to Grade 0–1 within 2 weeks and there was no prior Grade 3–4 stomatitis, continue treatment at previous dose and return to original dose interval. If patient experienced previous Grade 3–4 toxicity, continue treatment with a 25% dose reduction and return to original dose interval.
3 (painful erythema, edema, or ulcers, and cannot eat)	Delay dosing up to 2 weeks or until resolved to Grade 0–1. Decrease dose by 25% and return to original dose interval. If after 2 weeks there is no resolution, Doxil should be discontinued.
4 (requires parenteral or enteral support)	Delay dosing up to 2 weeks or until resolved to Grade 0–1. Decrease dose by 25% and return to Doxil original dose interval. If after 2 weeks there is no resolution, Doxil should be discontinued.

Multiple Myeloma

For patients treated with Doxil in combination with bortezomib who experience hand-foot syndrome or stomatitis, the Doxil dose should be modified as described in Tables 1 and 3 above. Table 4 describes dosage adjustments for Doxil and bortezomib combination therapy. For bortezomib dosing and dosage adjustments, see manufacturer's prescribing information.

Table 4: Dosage adjustments for Doxil + bortezomib combination therapy

Patient status	Doxil	bortezomib
Fever ≥38°C and ANC <1,000/mm3	Do not dose this cycle if before Day 4; if after Day 4, reduce next dose by 25%.	Reduce next dose by 25%
On any day of drug administration after Day 1 of each cycle: Platelet count <25,000/mm3 Hemoglobin <8g/dL ANC <500/mm3	Do not dose this cycle if before Day 4; if after Day 4 reduce next dose by 25% in the following cycles if bortezomib is reduced for hematologic toxicity.	Do not dose; if 2 or more doses are not given in a cycle, reduce dose by 25% in following cycles.
Grade 3 or 4 non-hematologic drug related toxicity	Do not dose until recovered to Grade <2 and reduce dose by 25% for all subsequent doses.	Do not dose until recovered to Grade <2 and reduce dose by 25% for all subsequent doses.
Neuropathic pain or peripheral neuropathy	No dosage adjustments.	See bortezomib manufacturer's prescribing information for dosage adjustments in patients with neuropathic pain.

Patients With Impaired Hepatic Function

Limited clinical experience exists in treating patients with hepatic impairment with Doxil. Based on experience with doxorubicin HCl, it is recommended that the Doxil dosage be reduced if the bilirubin is elevated as follows: serum bilirubin 1.2 to 3.0 mg/dL - give ½ normal dose; serum bilirubin > 3 mg/dL - give ¼ normal dose.

No information, including dosage adjustments, is available for patients with multiple myeloma with hepatic impairment.

Preparation for Intravenous Administration

Each 10-mL vial contains 20 mg doxorubicin HCl at a concentration of 2 mg/mL.

Each 30-mL vial contains 50 mg doxorubicin HCl at a concentration of 2 mg/mL.

Doxil doses up to 90 mg must be diluted in 250 mL of 5% Dextrose Injection, USP prior to administration. Doses exceeding 90 mg should be diluted in 500 mL of 5% Dextrose Injection, USP prior to administration. Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Doxil. Diluted Doxil should be refrigerated at 2°C to 8°C (36°F to 46°F) and administered within 24 hours.

Do not use with in-line filters.

Do not mix with other drugs.

Do not use with any diluent other than 5% Dextrose Injection.

Do not use any bacteriostatic agent, such as benzyl alcohol.

Doxil is not a clear solution but a translucent, red liposomal dispersion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.

Rapid flushing of the infusion line should be avoided.

Procedure for Proper Handling and Disposal

Caution should be exercised in the handling and preparation of Doxil.

The use of gloves is required.

If Doxil comes into contact with skin or mucosa, immediately wash thoroughly with soap and water.

Doxil should be considered an irritant and precautions should be taken to avoid extravasation. With intravenous administration of Doxil, extravasation may occur with or without an accompanying stinging or burning sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the infusion should be immediately terminated and restarted in another vein. Doxil must not be given by the intramuscular or subcutaneous route.

Doxil should be handled and disposed of in a manner consistent with other anticancer drugs. Several guidelines on this subject exist [see References (15)].

Dosage Forms and Strengths

• 20 mg/10 mL single use vial


• 50 mg/30 mL single use vial

Contraindications

Doxil (doxorubicin HCl liposome injection) is contraindicated in patients who have a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of Doxil [see Warnings and Precautions (5.2)].

Doxil is contraindicated in nursing mothers [see Use in Specific Populations (8.3)].

Warnings and Precautions

Cardiac Toxicity

Special attention must be given to the risk of myocardial damage from cumulative doses of doxorubicin HCl. Acute left ventricular failure may occur with doxorubicin, particularly in patients who have received a total cumulative dosage of doxorubicin exceeding the currently recommended limit of 550 mg/m2. Lower (400 mg/m2) doses appear to cause heart failure in patients who have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents such as cyclophosphamide.

Prior use of other anthracyclines or anthracenodiones should be included in calculations of total cumulative dosage. Congestive heart failure or cardiomyopathy may be encountered after discontinuation of anthracycline therapy. Patients with a history of cardiovascular disease should be administered Doxil only when the potential benefit of treatment outweighs the risk.

Cardiac function should be carefully monitored in patients treated with Doxil. The most definitive test for anthracycline myocardial injury is endomyocardial biopsy. Other methods, such as echocardiography or multigated radionuclide scans, have been used to monitor cardiac function during anthracycline therapy. Any of these methods should be employed to monitor potential cardiac toxicity in patients treated with Doxil. If these test results indicate possible cardiac injury associated with Doxil therapy, the benefit of continued therapy must be carefully weighed against the risk of myocardial injury.

In a clinical study in patients with advanced breast cancer, 250 patients received Doxil at starting dose of 50 mg/m2 every 4 weeks. At all cumulative anthracycline doses between 450–500 mg/m2, or between 500–550 mg/m2, the risk of cardiac toxicity for patients treated with Doxil was 11%. In this study, cardiotoxicity was defined as a decrease of >20% from baseline if the resting left ventricular ejection fraction (LVEF) remained in the normal range, or a decrease of >10% if the resting LVEF became abnormal (less than the institutional lower limit of normal). The data on left ventricular ejection fraction (LVEF) defined cardiotoxicity and congestive heart failure (CHF) are in the table below.

Table 5: Number of Patients With Advanced Breast Cancer

	Doxil (n=250)
Patients who Developed Cardiotoxicity (LVEF Defined)	10
Cardiotoxicity (With Signs & Symptoms of CHF)	0
Cardiotoxicity (no Signs & Symptoms of CHF)	10
Patients With Signs and Symptoms of CHF Only	2

In the randomized multiple myeloma study, the incidence of heart failure events (ventricular dysfunction, cardiac failure, right ventricular failure, congestive cardiac failure, chronic cardiac failure, acute pulmonary edema and pulmonary edema) was similar in the Doxil+bortezomib group and the bortezomib monotherapy group, 3% in each group. LVEF decrease was defined as an absolute decrease of ≥15% over baseline or a ≥5% decrease below the institutional lower limit of normal. Based on this definition, 25 patients in the bortezomib arm (8%) and 42 patients in the Doxil + bortezomib arm (13%) experienced a reduction in LVEF.

Infusion Reactions

Acute infusion-related reactions were reported in 7.1% of patients treated with Doxil in the randomized ovarian cancer study. These reactions were characterized by one or more of the following symptoms: flushing, shortness of breath, facial swelling, headache, chills, chest pain, back pain, tightness in the chest and throat, fever, tachycardia, pruritus, rash, cyanosis, syncope, bronchospasm, asthma, apnea, and hypotension. In most patients, these reactions resolve over the course of several hours to a day once the infusion is terminated. In some patients, the reaction resolved when the rate of infusion was slowed. In this study, two patients treated with Doxil (0.8%) discontinued due to infusion-related reactions. In clinical studies, six patients with AIDS-related Kaposi's sarcoma (0.9%) and 13 (1.7%) solid tumor patients discontinued Doxil therapy because of infusion-related reactions.

Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have been reported. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use.

The majority of infusion-related events occurred during the first infusion. Similar reactions have not been reported with conventional doxorubicin and they presumably represent a reaction to the Doxil liposomes or one of its surface components.

The initial rate of infusion should be 1 mg/min to help minimize the risk of infusion reactions [see Dosage and Administration (2)].

Myelosuppression

Because of the potential for bone marrow suppression, careful hematologic monitoring is required during use of Doxil, including white blood cell, neutrophil, platelet counts, and Hgb/Hct. With the recommended dosage schedule, leukopenia is usually transient. Hematologic toxicity may require dose reduction or delay or suspension of Doxil therapy. Persistent severe myelosuppression may result in superinfection, neutropenic fever, or hemorrhage. Development of sepsis in the setting of neutropenia has resulted in discontinuation of treatment and, in rare cases, death.

Doxil may potentiate the toxicity of other anticancer therapies. In particular, hematologic toxicity may be more severe when Doxil is administered in combination with other agents that cause bone marrow suppression.

In patients with relapsed ovarian cancer, myelosuppression was generally moderate and reversible. In the three single-arm studies, anemia was the most common hematologic adverse reaction (52.6%), followed by leukopenia (WBC< 4,000 mm3; 42.2%), thrombocytopenia (24.2%), and neutropenia (ANC <1,000; 19.0%). In the randomized study, anemia was the most common hematologic adverse reaction (40.2%), followed by leukopenia (WBC <4,000 mm3; 36.8%), neutropenia (ANC <1,000; 35.1%), and thrombocytopenia (13.0%) [see Adverse Reactions (6.2)].

In patients with relapsed ovarian cancer, 4.6% received G-CSF (or GM-CSF) to support their blood counts [see Dosage and Administrations (2.5)].

For patients with AIDS-related Kaposi's sarcoma who often present with baseline myelosuppression due to such factors as their HIV disease or concomitant medications, myelosuppression appears to be the dose-limiting adverse reaction at the recommended dose of 20 mg/m2 [see Adverse Reactions (6.2)]. Leukopenia is the most common adverse reaction experienced in this population; anemia and thrombocytopenia can also be expected. Sepsis occurred in 5% of patients; for 0.7% of patients the event was considered possibly or probably related to Doxil. Eleven patients (1.6%) discontinued study because of bone marrow suppression or neutropenia.

Table 10 presents data on myelosuppression in patients with multiple myeloma receiving Doxil and bortezomib in combination [see Adverse Reactions (6.2)].

Hand-Foot Syndrome (HFS)

In the randomized ovarian cancer study, 50.6% of patients treated with Doxil at 50 mg/m2 every 4 weeks experienced HFS (developed palmar-plantar skin eruptions characterized by swelling, pain, erythema and, for some patients, desquamation of the skin on the hands and the feet), with 23.8% of the patients reporting HFS Grade 3 or 4 events. Ten subjects (4.2%) discontinued treatment due to HFS or other skin toxicity. HFS toxicity grades are described above [see definitions of HFS grades in Dosage and Administration (2.5)].

Among 705 patients with AIDS-related Kaposi's sarcoma treated with Doxil at 20 mg/m2 every 2 weeks, 24 (3.4%) developed HFS, with 3 (0.9%) discontinuing.

In the randomized multiple myeloma study, 19% of patients treated with Doxil at 30 mg/m2 every three weeks experienced HFS.

HFS was generally observed after 2 or 3 cycles of treatment but may occur earlier. In most patients the reaction is mild and resolves in one to two weeks so that prolonged delay of therapy need not occur. However, dose modification may be required to manage HFS [see Dosage and Administration (2.5)]. The reaction can be severe and debilitating in some patients and may require discontinuation of treatment.

Radiation Recall Reaction

Recall reaction has occurred with Doxil administration after radiotherapy.

Fetal Mortality

Pregnancy Category D

Doxil can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If Doxil is to be used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus. If pregnancy occurs in the first few months following treatment with Doxil, the prolonged half-life of the drug must be considered. Women of childbearing potential should be advised to avoid pregnancy during treatment with Doxil. [see Use in Specific Populations (8.1)].

Toxicity Potentiation

The doxorubicin in Doxil may potentiate the toxicity of other anticancer therapies. Exacerbation of cyclophosphamide-induced hemorrhagic cystitis and enhancement of the hepatotoxicity of 6-mercaptopurine have been reported with the conventional formulation of doxorubicin HCl. Radiation-induced toxicity to the myocardium, mucosae, skin, and liver have been reported to be increased by the administration of doxorubicin HCl.

Monitoring: Laboratory Tests

Complete blood counts, including platelet counts, should be obtained frequently and at a minimum prior to each dose of Doxil [see Warnings and Precautions (5.3)].

Adverse Reactions

Overall Adverse Reactions Profile

The following adverse reactions are discussed in more detail in other sections of the labeling.

• Cardiac Toxicity [see Warnings and Precautions (5.1)]


• Infusion reactions [see Warnings and Precautions (5.2)]


• Myelosuppression [see Warnings and Precautions (5.3)]


• Hand-Foot syndrome [see Warnings and Precautions (5.4)]

The most common adverse reactions observed with Doxil are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia and anemia.

The most common serious adverse reactions observed with Doxil are described in Section 6.2.

The safety data described below reflect exposure to Doxil in 1310 patients including: 239 patients with ovarian cancer, 753 patients with AIDS-related Kaposi's sarcoma and 318 patients with multiple myeloma [see Adverse Reactions in Clinical Trials (6.2)].

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates on other clinical trials and may not reflect the rates observed in clinical practice.

The following tables present adverse reactions from clinical trials of Doxil in ovarian cancer and AIDS-Related Kaposi's sarcoma.

Patients With Ovarian Cancer

The safety data described below are from 239 patients with ovarian cancer treated with Doxil (doxorubicin HCl liposome injection) at 50 mg/m2 once every 4 weeks for a minimum of 4 courses in a randomized, multicenter, open-label study. In this study, patients received Doxil for a median number of 98.0 days (range 1–785 days). The population studied was 27–87 years of age, 91% Caucasian, 6% Black and 3% Hispanic and other.

Table 6 presents the hematologic adverse reactions from the randomized study of Doxil compared to topotecan.

Table 6: Ovarian Cancer Randomized Study Hematology Data Reported in Patients With Ovarian Cancer

	Doxil Patients (n = 239)	Topotecan Patients (n = 235)
Neutropenia
500 – <1000/mm3	19 (7.9%)	33 (14.0%)
<500/mm3	10 (4.2%)	146 (62.1%)
Anemia
6.5 – <8 g/dL	13 (5.4%)	59 (25.1%)
< 6.5 g/dL	1 (0.4%)	10 (4.3%)
Thrombocytopenia
10,000 – <50,000/mm3	3 (1.3%)	40 (17.0%)
<10,000/mm3	0 (0.0%)	40 (17.0%)

Table 7 presents a comparative profile of the non-hematologic adverse reactions from the randomized study of Doxil compared to topotecan.

Table 7: Ovarian Cancer Randomized Study

Non-Hematologic Adverse Reaction 10% or Greater	Doxil (%) treated (n = 239)		Topotecan (%) treated (n =235)
	All grades	Grades 3–4	All grades	Grades 3–4
Body as a Whole
Asthenia	40.2	7.1	51.5	8.1
Fever	21.3	0.8	30.6	5.5
Mucous Membrane Disorder	14.2	3.8	3.4	0
Back Pain	11.7	1.7	10.2	0.9
Infection	11.7	2.1	6.4	0.9
Headache	10.5	0.8	14.9	0
Digestive
Nausea	46.0	5.4	63.0	8.1
Stomatitis	41.4	8.3	15.3	0.4
Vomiting	32.6	7.9	43.8	9.8
Diarrhea	20.9	2.5	34.9	4.2
Anorexia	20.1	2.5	21.7	1.3
Dyspepsia	12.1	0.8	14.0	0
Nervous
Dizziness	4.2	0	10.2	0
Respiratory
Pharyngitis	15.9	0	17.9	0.4
Dyspnea	15.1	4.1	23.4	4.3
Cough increased	9.6	0	11.5	0
Skin and Appendages
Hand-foot syndrome	50.6	23.8	0.9	0
Rash	28.5	4.2	12.3	0.4
Alopecia	19.2	N/A	52.3	N/A

The following additional adverse reactions (not in table) were observed in patients with ovarian cancer with doses administered every four weeks.

Incidence 1% to 10%

Cardiovascular: vasodilation, tachycardia, deep thrombophlebitis, hypotension, cardiac arrest.

Digestive: oral moniliasis, mouth ulceration, esophagitis, dysphagia, rectal bleeding, ileus.

Hemic and Lymphatic: ecchymosis.

Metabolic and Nutritional: dehydration, weight loss, hyperbilirubinemia, hypokalemia, hypercalcemia, hyponatremia.

Nervous: somnolence, dizziness, depression.

Respiratory: rhinitis, pneumonia, sinusitis, epistaxis.

Skin and Appendages: pruritus, skin discoloration, vesiculobullous rash, maculopapular rash, exfoliative dermatitis, herpes zoster, dry skin, herpes simplex, fungal dermatitis, furunculosis, acne.

Special Senses: conjunctivitis, taste perversion, dry eyes.

Urinary: urinary tract infection, hematuria, vaginal moniliasis.

Patients With AIDS-Related Kaposi's Sarcoma

The safety data below is based on the experience reported in 753 patients with AIDS-related Kaposi's sarcoma enrolled in four studies. The median age of the population was 38.7 years (range 24–70 years), which was 99% male, 1% female, 88% Caucasian, 6% Hispanic, 4% Black, and 2% Asian/other/unknown. The majority of patients were treated with 20 mg/m2 of Doxil every two to three weeks. The median time on study was 127 days and ranged from 1 to 811 days. The median cumulative dose was 120 mg/m2 and ranged from 3.3 to 798.6 mg/m2. Twenty-six patients (3.0%) received cumulative doses of greater than 450 mg/m2.

Of these 753 patients, 61.2% were considered poor risk for KS tumor burden, 91.5% poor for immune system, and 46.9% for systemic illness; 36.2% were poor risk for all three categories. Patients' median CD4 count was 21.0 cells/mm3, with 50.8% of patients having less than 50 cells/mm3. The mean absolute neutrophil count at study entry was approximately 3,000 cells/mm3.

Patients received a variety of potentially myelotoxic drugs in combination with Doxil. Of the 693 patients with concomitant medication information, 58.7% were on one or more antiretroviral medications; 34.9% patients were on zidovudine (AZT), 20.8% on didanosine (ddI), 16.5% on zalcitabine (ddC), and 9.5% on stavudine (D4T). A total of 85.1% patients were on PCP prophylaxis, most (54.4%) on sulfamethoxazole/trimethoprim. Eighty-five percent of patients were receiving antifungal medications, primarily fluconazole (75.8%). Seventy-two percent of patients were receiving antivirals, 56.3% acyclovir, 29% ganciclovir, and 16% foscarnet. In addition, 47.8% patients received colony-stimulating factors (sargramostim/filgrastim) sometime during their course of treatment.

Adverse reactions led to discontinuation of treatment in 5% of patients with AIDS related Kaposi's sarcoma. Those that did so included bone marrow suppression, cardiac adverse reactions, infusion-related reactions, toxoplasmosis, HFS, pneumonia, cough/dyspnea, fatigue, optic neuritis, progression of a non-KS tumor, allergy to penicillin, and unspecified reasons.

Table 8: Hematology Data Reported in Patients With AIDS-Related Kaposi's Sarcoma

		Patients With Refractory or Intolerant AIDS-Related Kaposi's Sarcoma (n = 74)		Total Patients With AIDS-Related Kaposi's Sarcoma (n = 720)
Neutropenia
	< 1000/mm3	34	(45.9%)	352	(48.9%)
	< 500/mm3	8	(10.8%)	96	(13.3%)
Anemia
	< 10 g/dL	43	(58.1%)	399	(55.4%)
	< 8 g/dL	12	(16.2%)	131	(18.2%)
Thrombocytopenia
	< 150,000/mm3	45	(60.8%)	439	(60.9%)
	< 25,000/mm3	1	(1.4%)	30	(4.2%)

Table 9: Probably and Possibly Drug-Related Non-Hematologic Adverse Reactions Reported in ≥ 5% of Patients With AIDS-Related Kaposi's Sarcoma

Adverse Reactions	Patients With Refractory or Intolerant AIDS-Related Kaposi's Sarcoma (n = 77)		Total Patients With AIDS-Related Kaposi's Sarcoma (n = 705)
Nausea	14	(18.2%)	119	(16.9%)
Asthenia	5	(6.5%)	70	(9.9%)
Fever	6	(7.8%)	64	(9.1%)
Alopecia	7	(9.1%)	63