Lentrin

Lentrin may be available in the countries listed below.

Ingredient matches for Lentrin

Pentoxifylline

Pentoxifylline is reported as an ingredient of Lentrin in the following countries:

• Indonesia

International Drug Name Search

Efatec

Efatec may be available in the countries listed below.

Ingredient matches for Efatec

Efavirenz

Efavirenz is reported as an ingredient of Efatec in the following countries:

• Myanmar

International Drug Name Search

Colirio Llorens Hemidexa Antihistaminico

Colirio Llorens Hemidexa Antihistaminico may be available in the countries listed below.

Ingredient matches for Colirio Llorens Hemidexa Antihistaminico

Chlorphenamine

Chlorphenamine maleate (a derivative of Chlorphenamine) is reported as an ingredient of Colirio Llorens Hemidexa Antihistaminico in the following countries:

• Spain

Dexamethasone

Dexamethasone phosphate (a derivative of Dexamethasone) is reported as an ingredient of Colirio Llorens Hemidexa Antihistaminico in the following countries:

• Spain

International Drug Name Search

Ciplactin

Ciplactin may be available in the countries listed below.

Ingredient matches for Ciplactin

Cyproheptadine

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

• India


• Vietnam

International Drug Name Search

Lariam

In the US, Lariam (mefloquine systemic) is a member of the drug class antimalarial quinolines and is used to treat Malaria and Malaria Prevention.

US matches:

• Lariam

UK matches:

• Lariam (SPC)

Ingredient matches for Lariam

Mefloquine

Mefloquine is reported as an ingredient of Lariam in the following countries:

• Chile


• Luxembourg


• Peru

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

• Argentina


• Australia


• Austria


• Bangladesh


• Belgium


• Botswana


• Canada


• Czech Republic


• Denmark


• Estonia


• Finland


• France


• Germany


• Ghana


• Greece


• Hong Kong


• Hungary


• Iceland


• Ireland


• Israel


• Italy


• Kenya


• Luxembourg


• Malaysia


• Mauritius


• Namibia


• Netherlands


• New Zealand


• Norway


• Philippines


• Russian Federation


• Saudi Arabia


• Singapore


• Slovakia


• South Africa


• South Korea


• Sweden


• Switzerland


• Taiwan


• United Kingdom


• United States


• Uruguay

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Norofulvin

Norofulvin may be available in the countries listed below.

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

Ingredient matches for Norofulvin

Griseofulvin

Griseofulvin is reported as an ingredient of Norofulvin in the following countries:

• Ireland


• United Kingdom

International Drug Name Search

Preventef

Preventef may be available in the countries listed below.

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

Ingredient matches for Preventef

Dimpylate

Dimpylate is reported as an ingredient of Preventef in the following countries:

• Belgium


• Portugal


• Switzerland


• United Kingdom

International Drug Name Search

Quinapril ratiopharm

Quinapril ratiopharm may be available in the countries listed below.

Ingredient matches for Quinapril ratiopharm

Quinapril

Quinapril is reported as an ingredient of Quinapril ratiopharm in the following countries:

• Luxembourg

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

• Netherlands

International Drug Name Search

Succinilcolina Fabra

Succinilcolina Fabra may be available in the countries listed below.

Ingredient matches for Succinilcolina Fabra

Suxamethonium Chloride

Suxamethonium Chloride is reported as an ingredient of Succinilcolina Fabra in the following countries:

• Argentina

International Drug Name Search

Chlorosol

Chlorosol may be available in the countries listed below.

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

Ingredient matches for Chlorosol

Chlortetracycline

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

• United Kingdom

International Drug Name Search

Dimenhydrinat

Dimenhydrinat may be available in the countries listed below.

Ingredient matches for Dimenhydrinat

Dimenhydrinate

Dimenhydrinate is reported as an ingredient of Dimenhydrinat in the following countries:

• Georgia

International Drug Name Search

Medichol

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

Ingredient matches for Medichol

Chloramphenicol

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

• United States

International Drug Name Search

Dopamin Carino

Dopamin Carino may be available in the countries listed below.

Ingredient matches for Dopamin Carino

Dopamine

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

• Germany

International Drug Name Search

CotrimHefa

CotrimHefa may be available in the countries listed below.

Ingredient matches for CotrimHefa

Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of CotrimHefa in the following countries:

• Germany

Trimethoprim

Trimethoprim is reported as an ingredient of CotrimHefa in the following countries:

• Germany

International Drug Name Search

Coopers Spot On

Coopers Spot On may be available in the countries listed below.

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

Ingredient matches for Coopers Spot On

Deltamethrin

Deltamethrin is reported as an ingredient of Coopers Spot On in the following countries:

• Poland

International Drug Name Search

Mexylin

Mexylin may be available in the countries listed below.

Ingredient matches for Mexylin

Amoxicillin

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

• Indonesia

International Drug Name Search

Megacilina

Megacilina may be available in the countries listed below.

Ingredient matches for Megacilina

Clemizole Penicillin

Clemizole Penicillin is reported as an ingredient of Megacilina in the following countries:

• Peru

International Drug Name Search

Animec

Animec may be available in the countries listed below.

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

Ingredient matches for Animec

Ivermectin

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

• Finland


• Ireland


• Netherlands


• United Kingdom

International Drug Name Search

Carvedilol AbZ

Carvedilol AbZ may be available in the countries listed below.

Ingredient matches for Carvedilol AbZ

Carvedilol

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

• Germany

International Drug Name Search

Flixonase

Flixonase may be available in the countries listed below.

UK matches:

• Flixonase Aqueous Nasal Spray
• Flixonase Allergy Nasal Spray (SPC)
• Flixonase Aqueous Nasal Spray (SPC)

Ingredient matches for Flixonase

Fluticasone

Fluticasone is reported as an ingredient of Flixonase in the following countries:

• Tunisia

Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Flixonase in the following countries:

• Argentina


• Australia


• Austria


• Bahrain


• Bangladesh


• Belgium


• Bosnia & Herzegowina


• Brazil


• Bulgaria


• Chile


• Colombia


• Costa Rica


• Croatia (Hrvatska)


• Czech Republic


• Denmark


• Dominican Republic


• Ecuador


• Estonia


• Finland


• France


• Georgia


• Guatemala


• Honduras


• Hong Kong


• Hungary


• Iceland


• Indonesia


• Iran


• Ireland


• Israel


• Italy


• Jamaica


• Kuwait


• Latvia


• Lithuania


• Malaysia


• Malta


• Mexico


• Myanmar


• Netherlands


• New Zealand


• Nicaragua


• Oman


• Panama


• Peru


• Poland


• Qatar


• Romania


• Russian Federation


• Serbia


• Singapore


• Slovakia


• Slovenia


• South Africa


• Sri Lanka


• Taiwan


• Thailand


• Trinidad & Tobago


• Turkey


• United Arab Emirates


• United Kingdom


• Venezuela


• Vietnam

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Vincristine-Mayne

Vincristine-Mayne may be available in the countries listed below.

Ingredient matches for Vincristine-Mayne

Vincristine

Vincristine sulfate (a derivative of Vincristine) is reported as an ingredient of Vincristine-Mayne in the following countries:

• Denmark


• France


• Iceland


• Luxembourg


• Norway

International Drug Name Search

Rudduck's Antiseptiv Intra-uterine Pessary

Rudduck's Antiseptiv Intra-uterine Pessary may be available in the countries listed below.

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

Ingredient matches for Rudduck's Antiseptiv Intra-uterine Pessary

Chlorhexidine

Chlorhexidine dihydrochloride (a derivative of Chlorhexidine) is reported as an ingredient of Rudduck's Antiseptiv Intra-uterine Pessary in the following countries:

• Australia

International Drug Name Search

Nitren-acis

Nitren-acis may be available in the countries listed below.

Ingredient matches for Nitren-acis

Nitrendipine

Nitrendipine is reported as an ingredient of Nitren-acis in the following countries:

• Germany

International Drug Name Search

Glucomol

Glucomol may be available in the countries listed below.

Ingredient matches for Glucomol

Timolol

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

• India

International Drug Name Search

Norditropin

See also: Generic Norditropin FlexPro, Generic Norditropin Nordiflex

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

NORDITROPIN (somatropin recombinant - injectable; injection)

• 
  Manufacturer: NOVO NORDISK INC
  
  Approval date: June 20, 2000
  
  Strength(s): 15MG/1.5ML ^[RLD]

Has a generic version of Norditropin been approved?

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

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

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

• 
  Biosynthetic human growth hormone
  Patent 5,633,352
  Issued: May 27, 1997
  Inventor(s): Dalb.o slashed.ge; Henrik & Pedersen; John & Christensen; Thorkild & Ringsted; J.o slashed.rli W. & Jessen; Torben E.
  Assignee(s): Novo Nordisk A/S
  A desired protein having the formula: EQU A-B-C-P wherein a) A is Lys or Arg, and B and C are arbitrary amino acids, or b) A is an arbitrary amino acid different from Pro, Lys and Arg, and B and/or C is Pro, is produced from a biosynthetically formed amino acid extended protein having the formula: EQU X-A-B-C-P wherein A, B, C and P are as defined above, and X is an amino acid sequence with an even number of amino acids, of which the first one, seen from the N-terminal end, is different from Lys and Arg, all other uneven amino acids are different from Pro, Lys and Arg, and all even amino acids are different from Pro, by reaction with the enzyme dipeptidyl aminopeptidase (DAP I). The desired protein is obtained in a pure state. Thus, e.g. hGH without content of Met-hGH may be produced by the process.
  
  Patent expiration dates:
  
  
  • May 27, 2014
    
  
  



• 
  Pharmaceutical formulation
  Patent 5,849,700
  Issued: December 15, 1998
  Inventor(s): S.o slashed.rensen; Hans Holmegaard & Skriver; Lars & Hoelgaard; Annie Rassing
  Assignee(s): Novo Nordisk A/S
  A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
  
  Patent expiration dates:
  
  
  • December 15, 2015
    
    ✓ 
    Patent use: THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS GROWTH HORMONE SECRETION IN CHILDREN
  
  



• 
  Pharmaceutical formulation
  Patent 5,849,704
  Issued: December 15, 1998
  Inventor(s): S.o slashed.rensen; Hans Holmegaard & Skriver; Lars & Hoelgaard; Annie Rassing
  Assignee(s): Novo Nordisk A/S
  A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
  
  Patent expiration dates:
  
  
  • December 15, 2015
    
  
  

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

• Exclusivity expiration dates:
  • September 20, 2010 - TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME
  
  
  • October 31, 2011 - TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH NO CATCH-UP BY AGE 2-4 YRS.
  
  
  • May 31, 2014 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Norditropin Consumer Information (Wolters Kluwer)
• Norditropin Consumer Information (Cerner Multum)
• Norditropin Cartridge Consumer Information (Cerner Multum)
• Norditropin Advanced Consumer Information (Micromedex)
• Somatropin (rDNA origin - Nonrefrigerated) Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Cartridge Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Vial Consumer Information (Wolters Kluwer)
• Somatropin (rDNA origin - Refrigerated) Vials Consumer Information (Wolters Kluwer)
• Somatropin Consumer Information (Cerner Multum)
• Somatropin, e-coli derived Subcutaneous, Injection Advanced Consumer Information (Micromedex)
• Somatropin, mammalian derived Subcutaneous, Injection Advanced Consumer Information (Micromedex)

Hes Grifols

Hes Grifols may be available in the countries listed below.

Ingredient matches for Hes Grifols

Hetastarch

Hetastarch is reported as an ingredient of Hes Grifols in the following countries:

• Spain

International Drug Name Search

Deoxyribonuclease I

ATC (Anatomical Therapeutic Chemical Classification)

B06AA02,B06AA10

CAS registry number (Chemical Abstracts Service)

0009003-98-9

Therapeutic Categories

Mucolytic agent

Enzyme

Debriding agent

Foreign Names

• Deoxyribonuclease I (German)
• Desoxyribonuclease I (French)
• Desoxirribonucleasa I (Spanish)

Generic Names

• Desoxyribonuclease I (IS)
• DNase I (IS)
• Pancreatic deoxyribonuclease (IS)
• Pancreatic DNase (IS)
• Pancreatic Dornase (IS)
• Thymonuclease (IS)
• Desoxyribonuclease, Rind (IS)
• DNase I, bovine (IS)
• Pancreatic deoxyribonuclease, bovine (IS)
• Pancreatic DNase, bovine (IS)
• Pancreatic Dornase, bovine (IS)
• Thymonuclease, bovine (IS)
• Dornase Alfa (OS: BAN, USAN, Rec.INN)
• Deoxyribonuclease, human, recombinant (IS)
• Desoxyribonuclease, human, rekombinant (IS)
• DNase I, recombinant human (IS)
• rhDNase (IS)

Brand Names

• Elase (Deoxyribonuclease I and Fibrinolysin)
  Pfizer, France



• Fibrolan (Deoxyribonuclease I and Fibrinolysin)
  Pfizer, Austria; Pfizer, Switzerland; Pfizer, Slovenia



• Elase (Deoxyribonuclease I and Fibrinolysin)
  Daiichi Sankyo, Japan



• Pulmozyme
  Dr. Fisher, Netherlands; EU-Pharma, Netherlands; Eureco, Netherlands; Euro, Netherlands; Genentech, United States; Roche, Argentina; Roche, Austria; Roche, Australia; Roche, Bosnia & Herzegowina; Roche, Belgium; Roche, Brazil; Roche, Canada; Roche, Switzerland; Roche, Chile; Roche, Colombia; Roche, Cyprus; Roche, Czech Republic; Roche, Germany; Roche, Denmark; Roche, Estonia; Roche, Spain; Roche, Finland; Roche, France; Roche, United Kingdom; Roche, Greece; Roche, Croatia (Hrvatska); Roche, Hungary; Roche, Ireland; Roche, Israel; Roche, Iceland; Roche, Italy; Roche, Lebanon; Roche, Lithuania; Roche, Luxembourg; Roche, Latvia; Roche, Malta; Roche, Mexico; Roche, Netherlands; Roche, Norway; Roche, New Zealand; Roche, Oman; Roche, Peru; Roche, Poland; Roche, Portugal; Roche, Romania; Roche, Serbia; Roche, Russian Federation; Roche, Saudi Arabia; Roche, Sweden; Roche, Slovenia; Roche, Slovakia; Roche, Turkey; Roche, Uruguay; Roche, South Africa



• Viscozyme
  Roche, Chile

International Drug Name Search

Glossary

BAN	British Approved Name
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.

Levodopa / Carbidopa CF

Levodopa/Carbidopa CF may be available in the countries listed below.

Ingredient matches for Levodopa/Carbidopa CF

Carbidopa

Carbidopa is reported as an ingredient of Levodopa/Carbidopa CF in the following countries:

• Netherlands

Carbidopa monohydrate (a derivative of Carbidopa) is reported as an ingredient of Levodopa/Carbidopa CF in the following countries:

• Netherlands

Levodopa

Levodopa is reported as an ingredient of Levodopa/Carbidopa CF in the following countries:

• Netherlands

International Drug Name Search

Isotretinoin Sandoz

Isotretinoin Sandoz may be available in the countries listed below.

Ingredient matches for Isotretinoin Sandoz

Isotretinoin

Isotretinoin is reported as an ingredient of Isotretinoin Sandoz in the following countries:

• Estonia


• Finland


• Latvia


• Switzerland

International Drug Name Search

Caldil

Caldil may be available in the countries listed below.

Ingredient matches for Caldil

Calcium Carbonate

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

• Bangladesh

International Drug Name Search

Célestamine

Célestamine may be available in the countries listed below.

Ingredient matches for Célestamine

Betamethasone

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

• France

Dexchlorpheniramine

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

• France

International Drug Name Search

Tedipulmo

Tedipulmo may be available in the countries listed below.

Ingredient matches for Tedipulmo

Terbutaline

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

• Spain

International Drug Name Search

Coricide Verrucide Liquid

Coricide Verrucide Liquid may be available in the countries listed below.

Ingredient matches for Coricide Verrucide Liquid

Salicylic Acid

Salicylic Acid is reported as an ingredient of Coricide Verrucide Liquid in the following countries:

• Tunisia

International Drug Name Search

Besivance Drops

Pronunciation: BE-si-FLOX-a-sin
Generic Name: Besifloxacin
Brand Name: Besivance

Besivance Drops are used for:

Treating eye infections caused by certain bacteria.

Besivance Drops are a quinolone antibiotic. It works by killing sensitive bacteria by stopping the production of essential proteins needed by the bacteria to survive.

Do NOT use Besivance Drops if:

• you are allergic to any ingredient in Besivance Drops or any other fluoroquinolone antibiotic (eg, levofloxacin)

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

Before using Besivance Drops:

Some medical conditions may interact with Besivance Drops. 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 wear contact lenses

Some MEDICINES MAY INTERACT with Besivance Drops. Because little, if any, of Besivance Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Besivance Drops 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 Besivance Drops:

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

• To use Besivance Drops in the eye, first, wash your hands. Turn the closed bottle of medicine upside down and shake once before each use. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• Do not wear contact lenses while you are using Besivance Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.


• To clear up your infection completely, use Besivance Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Besivance Drops, use 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 use 2 doses at once.

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

Important safety information:

• Besivance Drops may cause blurred vision. Use Besivance Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not use leftover medicine for treating other infections or conditions without checking with your doctor.


• Be sure to use Besivance Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Besivance Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Besivance Drops should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Besivance Drops while you are pregnant. It is not known if Besivance Drops are found in breast milk after topical use. If you are or will be breast-feeding while you use Besivance Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Besivance Drops:

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:

Mild eye redness, irritation, itching, or pain.

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); new or worsening eye redness, irritation, itching, pain, or blurred vision.

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: Besivance 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 Besivance Drops:

Store Besivance Drops at 59 to 77 degrees F (15 to 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Besivance Drops out of the reach of children and away from pets.

General information:

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


• Besivance Drops are 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 Besivance Drops. 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 Besivance resources

• Besivance Side Effects (in more detail)
• Besivance Use in Pregnancy & Breastfeeding
• Besivance Support Group
• 1 Review for Besivance - Add your own review/rating

Compare Besivance with other medications

• Conjunctivitis, Bacterial
• Ophthalmic Surgery

Medicoat

Medicoat may be available in the countries listed below.

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

Ingredient matches for Medicoat

Miconazole

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

• Australia

Triclosan

Triclosan is reported as an ingredient of Medicoat in the following countries:

• Australia

International Drug Name Search

Bosentan

Class: Vasodilating Agents, Miscellaneous
VA Class: CV900
Chemical Name: 4 - (1,1 - Dimethylethyl) - N - [6 - (2 - hydroxyethoxy) - 5 - (2 - methoxyphenoxy)[2,2′ - bipyrimidin] - 4 - yl] - benzenesulfonamide monohydrate
Molecular Formula: C₂₇H₂₉N₅O₆S•H₂O
CAS Number: 157212-55-0
Brands: Tracleer

• Hepatotoxicity


• 
  

  Risk of developing serious hepatic injury.^{1 b} With close monitoring, unexplained hepatic cirrhosis and liver failure reported rarely after prolonged bosentan therapy (>12 months) during postmarketing surveillance.^{a c}

  
  


• 
  

  Serum aminotransferase (AST/ALT) concentrations must be measured prior to initiation of therapy and monthly thereafter.^{1 b c} (See Hepatic Effects under Cautions.)

  
  


• 
  

  In patients with adverse hepatic effects, dosage reduction or discontinuance of the drug may be necessary.^{1 c} (See Patients with Adverse Hepatic Effects under Dosage and Administration.)

  
  


• 
  

  Bosentan generally should be avoided in patients with elevated aminotransferases (>3 × ULN) at baseline (because monitoring for liver injury may be more difficult) and in those with preexisting moderate to severe hepatic impairment.^{1 b}

  
  

• Fetotoxicity


• 
  

  May cause fetal harm; contraindicated in pregnant women.^{1 b} Pregnancy must be excluded before start of treatment and prevented thereafter by use of reliable contraception.^{1 b} (See Fetal/Neonatal Morbidity and Mortality under Cautions.) Oral, injectable, transdermal, and implantable hormonal contraceptives may not be reliable when used concomitantly with bosentan and should not be used as the sole contraceptive method; additional forms of nonhormonal contraception should be used.^{1 b} (See Specific Drugs under Interactions.)

  
  

REMS:

FDA approved a REMS for bosentan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of bosentan and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Vasodilator; an endothelin receptor antagonist.¹

Uses for Bosentan

Pulmonary Arterial Hypertension

Adjunctive therapy for the treatment of pulmonary arterial hypertension (PAH) (WHO group I), in patients with WHO class III or IV symptoms to improve exercise capacity and to slow clinical worsening.^{1 2 3 6}

Additional studies needed to clarify the role of oral bosentan with or without concomitant IV epoprostenol in the treatment of PAH, particularly in patients with WHO class IV symptoms.^{4 7}

CHF

Not effective in treatment of CHF with left ventricular dysfunction†.^a

Bosentan Dosage and Administration

General

• 
  

  Restricted distribution program (see Boxed Warning); not available through community pharmacies.^{1 5 6 9 b c} Contact manufacturer at 866-228-3546 for specific information.^{1 5}

  
  


• 
  

  Medication guide must be distributed each time bosentan is dispensed.^{6 b}

  
  


• 
  

  Avoid abrupt discontinuance.^{1 9 b} To minimize the risk for clinical deterioration, consider gradual dosage reduction (e.g., 62.5 mg twice daily for 3–7 days).^{1 9}

  
  

Administration

Oral Administration

Administer orally twice daily (morning and evening) without regard to meals.^{1 b}

Dosage

Adults

Pulmonary Arterial Hypertension

Oral

Initially, 62.5 mg twice daily for 4 weeks, followed by maintenance dosage of 125 mg twice daily.¹

Special Populations

Patients with Adverse Hepatic Effects

If elevations in AST and ALT concentrations are accompanied by manifestations of hepatic disease (e.g., nausea, vomiting, fever, abdominal pain, jaundice, lethargy, fatigue) or bilirubin concentrations are ≥2 × ULN, discontinue bosentan by gradually reducing dosage (e.g., 62.5 mg twice daily for 3–7 days).^{1 9}

If confirmed (i.e., upon a repeat test) AST or ALT elevations of >3 but ≤5 × ULN develop during bosentan therapy, reduce dosage or interrupt therapy.^{1 9 c}

If confirmed AST or ALT concentrations of >5 but ≤8 × ULN, discontinue bosentan by gradually reducing dosage.^{1 9 c}

Monitor serum AST/ALT concentrations at least every 2 weeks following dosage reduction or discontinuance.^{1 c}

May consider reinitiation of bosentan therapy at starting dosage of 62.5 mg twice daily following return of AST/ALT concentrations to pretreatment levels if AST/ALT elevations did not exceed 8 × ULN; check serum AST/ALT concentrations within 3 days of reinitiating therapy and every 2 weeks thereafter.^{1 9 c}

Manufacturer states that reinitiation of bosentan therapy should not be considered if AST/ALT concentrations exceeded 8 × ULN.^{1 c} Clinical experience with reinitiation of bosentan therapy is lacking in such patients, as well as in those with AST/ALT elevations accompanied by manifestations of hepatic disease or by increases in bilirubin concentrations of ≥2 × ULN.^{1 c}

Patients with Low Body Weight

In patients >12 years of age who weigh <40 kg, recommended dosage for both initial and maintenance therapy is 62.5 mg twice daily.¹

Cautions for Bosentan

Contraindications

• 
  

  Known or suspected pregnancy.^{1 b}

  
  


• 
  

  Concomitant therapy with cyclosporine or glyburide.^{1 b}

  
  


• 
  

  Known hypersensitivity to bosentan or any ingredient in the formulation.^{1 b}

  
  

Warnings/Precautions

Warnings

Hepatic Effects

With close monitoring, unexplained hepatic cirrhosis and liver failure reported rarely after prolonged bosentan therapy (i.e., >12 months) during postmarketing surveillance.^{a c} (See Boxed Warning.)

In at least 1 patient, marked elevations in liver function test results developed (after >20 months of bosentan therapy) accompanied by nonspecific symptoms.^{a c} Following discontinuance, AST/ALT concentrations remained elevated and bilirubin concentrations continued to increase; liver failure and biopsy-confirmed cirrhosis developed.^{a c} Causality to the drug could not be excluded.^{a c} Liver failure later abated and liver function tests slowly resolved (7 months after discontinuance).^c (See Boxed Warning.)

The manufacturer reinforces the importance of strict adherence to the monthly monitoring schedule for the duration of bosentan therapy and to dosage adjustment and monitoring guidelines.^{a c} (See Patients with Adverse Hepatic Effects under Dosage and Administration.)

Dose-dependent elevations in AST or ALT concentrations of >3 × ULN were observed in 11% of patients receiving bosentan (up to 2 g daily) in clinical trials; occasionally accompanied by elevations in bilirubin concentrations,^{1 9} indicating potential serious hepatic injury.¹ (See Boxed Warning.)

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.^{1 b}

Prior to initiating therapy in women of childbearing potential, ascertain that patient is not sexually active or is not pregnant (i.e., by obtaining negative results from a urine or serum pregnancy test performed during the first 5 days of a normal menstrual period and ≥11 days after the last unprotected act of sexual intercourse).^{1 5 6 b}

Must prevent pregnancy by means of reliable contraceptive methods.^{1 b} (See Specific Drugs under Interactions.) Perform serum pregnancy tests monthly.^{1 9 b c}

Sensitivity Reactions

Hypersensitivity Reactions

Angioedema (occurring 8 hours to 21 days after initiating therapy) reported during postmarketing surveillance.^a

General Precautions

Hematologic Effects

Possible dose-related decreases in hemoglobin and hematocrit.^{1 9 b} Monitor hemoglobin 1 and 3 months after initiation of therapy and every 3 months thereafter.¹

Cardiovascular Effects

Increased hospitalization for CHF associated with weight gain and increased leg edema reported in patients with severe CHF during first 4–8 weeks of therapy.^a

Fluid retention requiring diuretics, fluid management, or hospitalization for decompensating heart failure within weeks of initiating therapy reported in patients with PAH during postmarketing surveillance.^a

Pulmonary Effects

Consider possibility of associated pulmonary veno-occlusive disease (PVOD) and discontinue bosentan if manifestations of pulmonary edema occur during therapy.^a

Specific Populations

Pregnancy

Category X.¹ (See Fetal/Neonatal Morbidity and Mortality and also see Contraindications under Cautions.)

Lactation

Not known whether bosentan is distributed into milk.^{1 b} Use is not recommended.^{1 b}

Pediatric Use

Safety and efficacy not established in children <12 years of age.⁵

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹

Hepatic Impairment

Use not recommended in patients with preexisting moderate to severe hepatic impairment or AST/ALT concentrations of >3 × ULN.^{1 9} Use with caution in patients with mild hepatic impairment.¹

Common Adverse Effects

Headache,^{1 b} nasopharyngitis,^{1 b} flushing,^{1 b} abnormal hepatic function,¹ lower limb edema,^{1 b} hypotension,^{1 b} palpitations,^{1 b} dyspepsia,^{1 b} edema,¹ fatigue,^{1 b} pruritus,^{1 b} rash,^b anemia.^{1 b}

Interactions for Bosentan

Induces and is metabolized by CYP2C9 and CYP3A4; may possibly induce CYP2C19.¹

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2C9 and CYP3A4: potential pharmacokinetic interaction (increased plasma bosentan concentrations).¹ Concomitant administration of both a potent inhibitor of CYP2C9 and an inhibitor of CYP3A4 with bosentan is not recommended.^a

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP2C9 and CYP3A4 and possibly CYP2C19: potential pharmacokinetic interaction (decreased plasma substrate concentrations).^{1 9}

Specific Drugs

Drug	Interaction	Comments
Antidiabetic agents, oral	Decreased plasma concentrations of antidiabetic agents metabolized by CYP2C9 or CYP3A41 9
Amiodarone	Increased plasma bosentan concentrations, particularly if combined with an inhibitor of CYP3A4a	Do not use concomitantly with both an inhibitor of CYP3A4 and bosentana
Atorvastatin	Decreased plasma atorvastatin concentrations1 9
Cyclosporine	Increased plasma bosentan concentrations, decreased plasma cyclosporine concentrations1	Concomitant use contraindicated1
Digoxin	Pharmacokinetic interaction unlikely1
Fluconazole	Increased plasma bosentan concentrations, particularly if combined with an inhibitor of CYP3A4a	Do not use concomitantly with both an inhibitor of CYP3A4 and bosentana
Glyburide	Increased risk of elevated serum aminotransferase concentrations; decreased plasma glyburide concentrations; decreased plasma bosentan concentrations1	Concomitant use contraindicated1
Hormonal contraceptives	Decreased plasma norethindrone and ethinyl estradiol concentrations;a possible contraceptive failure secondary to induction of contraceptive hormone metabolism1	Use concomitant nonhormonal contraceptive method;1 do not use hormonal contraceptives as the sole contraceptive methoda
Itraconazole	Increased plasma bosentan concentrations, particularly if combined with an inhibitor of CYP2C9a	Do not use concomitantly with both a potent inhibitor of CYP2C9 and bosentana
Ketoconazole	Increased plasma bosentan concentrations, especially if combined with an inhibitor of CYP2C91	Bosentan dosage adjustment not necessary, but consider potential for increased effects1 Do not use concomitantly with both a potent inhibitor of CYP2C9 and bosentana
Losartan	Pharmacokinetic interaction unlikely1
Lovastatin	Decreased plasma lovastatin concentrations1 9
Nimodipine	Pharmacokinetic interaction unlikely1
Ritonavir	Increased plasma bosentan concentrations, particularly if combined with an inhibitor of CYP2C9a	Do not use concomitantly with both a potent inhibitor of CYP2C9 and bosentana
Sildenafil	Decreased plasma sildenafil concentrationsa Increased plasma bosentan concentrationsa	Bosentan or sildenafil dosage adjustment not necessary, whether sildenafil is being used in the treatment of PAH or erectile dysfunctiona
Simvastatin	Decreased plasma simvastatin concentrations1 9
Tacrolimus	Increased plasma bosentan concentrations in animalsa	Use concomitantly with cautiona
Warfarin	Decreased plasma warfarin concentrations1 9

Bosentan Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability in healthy individuals is about 50%.¹

Food

Food does not affect bioavailability.¹

Plasma Concentrations

Maximum plasma concentrations attained within 3–5 hours; steady state reached within 3–5 days.¹

Special Populations

Increased exposure (twofold) to bosentan following oral or IV administration in patients with PAH compared with healthy individuals.¹

Distribution

Extent

Does not penetrate into erythrocytes.¹

Plasma Protein Binding

>98% (mainly albumin).¹

Elimination

Metabolism

Metabolized by CYP2C9 and CYP3A4; appears to induce its own metabolism following multiple-dose administration.¹

Elimination Route

Biliary excretion following metabolism in the liver.¹

Half-life

Terminal elimination half-life is about 5 hours.¹

Special Populations

Because of extensive hepatic metabolism, hepatic impairment may increase exposure to the drug.¹

Pharmacokinetics of the drug not affected in patients with mild hepatic impairment; not evaluated in those with moderate or severe hepatic impairment.^a

Stability

Storage

Oral

Tablets

20–25°C (may be exposed to 15–30°C).¹

Actions

• 
  

  Exhibits specific and competitive antagonism of endothelin type A and type B receptors in the endothelium and vascular smooth muscle.¹

  
  


• 
  

  Improves exercise capacity and hemodynamics in patients with PAH by inhibiting vasoconstricting effects of endothelin-1.¹

  
  

Advice to Patients

• 
  

  Importance of patients taking medication as prescribed.^b Importance of not taking a double dose to make up for a missed dose but instead taking the next scheduled dose.^b

  
  


• 
  

  Risk of liver injury.^{1 b} Importance of patients promptly informing clinicians of any nausea, vomiting, fever, unusual tiredness, abdominal pain, or yellowing of the skin or white of the eyes.^{a b}

  
  


• 
  

  Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 b}

  
  


• 
  

  Importance of avoidance of pregnancy; importance of using reliable nonhormonal methods of contraception.^{1 b}

  
  


• 
  

  Importance of monthly monitoring of serum aminotransferases and monthly pregnancy testing.^{1 b c}

  
  


• 
  

  Importance of carefully reading the patient information (medication guide) provided by the manufacturer before initiating therapy and each time the prescription is refilled.^{1 b}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as concomitant illnesses.^{1 b}

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Distribution of bosentan is restricted.^{1 5 6 b c} (See General under Dosage and Administration.)

Bosentan

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	62.5 mg (of anhydrous bosentan)	Tracleer (with povidone)	Actelion
		125 mg (of anhydrous bosentan)	Tracleer (with povidone)	Actelion

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Actelion Pharmaceuticals US. Tracleer (bosentan) tablets prescribing information. South San Francisco, CA: 2001 Nov.

2. Rubin LJ, Badesch DB, Barst RJ et al. Bosentan therapy for pulmonary arterial hypertension. N Engl J Med. 2002; 346:896-903. [IDIS 478525] [PubMed 11907289]

3. Channick RN, Simonneau G, Sitbon O et al. Effects of the dual endothelin-receptor antagonist bosentan in patients with pulmonary hypertension: a randomised placebo-controlled study. Lancet. 2001; 358:1119-23. [IDIS 471290] [PubMed 11597664]

4. Dupuis J. Endothelin-receptor antagonists in pulmonary hypertension. Lancet. 2001; 358:1113-4. [IDIS 471289] [PubMed 11597660]

5. Giaid A, Yanagisawa M, Langleben D et al. Expression of endothelin-1 in the lungs of patients with pulmonary hypersion. N Engl J Med. 1993; 328:1732-9 [PubMed 8497283]

6. FDA approves first oral medication for pulmonary arterial hypertension. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2001 Nov 20.

7. Newman JH. Treatment of primary pulmonary hypertension—the next generation. N Engl J Med. 2002; 346:933-5. [IDIS 478527] [PubMed 11907295]

8. Stewart DJ, Levy RD, Cernacek P et al. Increased plasma endothelin-1 in pulmonary hypertension: Marker or mediator of disease. Ann Intern Med. 1991; 114:464-9. [PubMed 1994793]

9. Actelion, South San Francisco, CA: Personal communication.

a. Actelion Pharmaceuticals US. Tracleer (bosentan) tablets prescribing information. South San Francisco, CA: 2006 Jan.

b. Actelion Pharmaceuticals US. Tracleer (bosentan) tablets medication guide. South San Francisco, CA: 2005 Nov 14.

c. Segal ES. Dear healthcare professional letter regarding important prescribing information for Tracleer (bosentan). South San Francisco, CA: Actelion Pharmaceuticals US; 2006 Mar 1.

More Bosentan resources

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

• Bosentan Professional Patient Advice (Wolters Kluwer)


• Bosentan MedFacts Consumer Leaflet (Wolters Kluwer)


• bosentan Concise Consumer Information (Cerner Multum)


• bosentan Advanced Consumer (Micromedex) - Includes Dosage Information


• Tracleer Prescribing Information (FDA)

Compare Bosentan with other medications

• Pulmonary Arterial Hypertension

Piol

Piol may be available in the countries listed below.

Ingredient matches for Piol

Pioglitazone

Pioglitazone is reported as an ingredient of Piol in the following countries:

• Bangladesh

International Drug Name Search

Amerge

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

AMERGE (naratriptan hydrochloride - tablet; oral)

• 
  Manufacturer: GLAXOSMITHKLINE
  
  Approval date: February 10, 1998
  
  Strength(s): EQ 1MG BASE ^[AB], EQ 2.5MG BASE ^[RLD][AB]

Has a generic version of Amerge been approved?

Yes. The following products are equivalent to Amerge:

NARATRIPTAN (naratriptan hydrochloride tablet; oral)

• 
  Manufacturer: HERITAGE PHARMS INC
  
  Approval date: February 28, 2011
  
  Strength(s): EQ 1MG BASE ^[AB], EQ 2.5MG BASE ^[AB]


• 
  Manufacturer: PADDOCK LLC
  
  Approval date: July 8, 2010
  
  Strength(s): EQ 1MG BASE ^[AB], EQ 2.5MG BASE ^[AB]


• 
  Manufacturer: ROXANE
  
  Approval date: July 7, 2010
  
  Strength(s): EQ 1MG BASE ^[AB], EQ 2.5MG BASE ^[AB]


• 
  Manufacturer: SANDOZ
  
  Approval date: July 7, 2010
  
  Strength(s): EQ 1MG BASE ^[AB], EQ 2.5MG BASE ^[AB]


• 
  Manufacturer: TEVA PHARMS
  
  Approval date: July 7, 2010
  
  Strength(s): EQ 1MG BASE ^[AB], EQ 2.5MG BASE ^[AB]

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

See also: About generic drugs.

Related Patents

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

See also...

• Amerge Consumer Information (Wolters Kluwer)
• Amerge Consumer Information (Cerner Multum)
• Amerge Advanced Consumer Information (Micromedex)
• Amerge AHFS DI Monographs (ASHP)
• Naratriptan Consumer Information (Wolters Kluwer)
• Naratriptan Consumer Information (Cerner Multum)
• Naratriptan Advanced Consumer Information (Micromedex)
• Naratriptan Hydrochloride AHFS DI Monographs (ASHP)

Meclomen

In the US, Meclomen (meclofenamate systemic) is a member of the drug class nonsteroidal anti-inflammatory agents and is used to treat Premenstrual Dysphoric Disorder and Rheumatoid Arthritis.

US matches:

• Meclomen

Ingredient matches for Meclomen

Meclofenamic Acid

Meclofenamic Acid is reported as an ingredient of Meclomen in the following countries:

• Chile

Meclofenamic Acid sodium salt (a derivative of Meclofenamic Acid) is reported as an ingredient of Meclomen in the following countries:

• Greece

International Drug Name Search

Ficlox

Ficlox may be available in the countries listed below.

Ingredient matches for Ficlox

Cloxacillin

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

• Bangladesh

International Drug Name Search

Betoptic S

Generic Name: betaxolol (Ophthalmic route)

be-TAX-oh-lol

Commonly used brand name(s)

In the U.S.

• Betoptic S

Available Dosage Forms:

• Solution


• Suspension

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Beta-Adrenergic Blocker, Cardioselective

Uses For Betoptic S

Betaxolol is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called ocular (eye) hypertension. This medicine is a beta-blocker .

This medicine is available only with your doctor's prescription .

Before Using Betoptic S

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of betaxolol in children .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of betaxolol in the elderly .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol


• Amiodarone


• Arformoterol


• Bambuterol


• Bitolterol


• Broxaterol


• Clenbuterol


• Clonidine


• Colterol


• Diltiazem


• Disopyramide


• Dronedarone


• Fenoldopam


• Fenoterol


• Formoterol


• Hexoprenaline


• Indacaterol


• Isoetharine


• Levalbuterol


• Metaproterenol


• Pirbuterol


• Procaterol


• Reproterol


• Rimiterol


• Ritodrine


• Salmeterol


• Terbutaline


• Tretoquinol


• Tulobuterol


• Verapamil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Aceclofenac


• Acemetacin


• Acetohexamide


• Alclofenac


• Alfuzosin


• Amlodipine


• Apazone


• Arbutamine


• Benfluorex


• Benoxaprofen


• Bromfenac


• Bufexamac


• Bunazosin


• Carprofen


• Chlorpropamide


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Digoxin


• Dipyrone


• Doxazosin


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Guar Gum


• Ibuprofen


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Lornoxicam


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Mibefradil


• Miglitol


• Moxisylyte


• Nabumetone


• Naproxen


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propyphenazone


• Proquazone


• Repaglinide


• St John's Wort


• Sulindac


• Suprofen


• Tamsulosin


• Tenidap


• Tenoxicam


• Terazosin


• Tiaprofenic Acid


• Tolazamide


• Tolbutamide


• Tolmetin


• Trimazosin


• Troglitazone


• Urapidil


• Zomepirac

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease (especially blood vessels in the brain) or


• Stroke, history of—Use with caution. This medicine may worsen these conditions .

• Bradycardia (slow heartbeat) or


• Heart block or


• Heart failure—Should not use in patients with these conditions .

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Lung disease (e.g., asthma, bronchitis, emphysema)—Use with caution. May cause difficulty with breathing in patients with this condition .

• Myasthenia gravis—May worsen symptoms of this condition, such as muscle weakness .

Proper Use of Betoptic S

Shake the medicine well just before each use .

To use the eye drops (solution):

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the medicine, wash your hands to remove any medicine that may be on them.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines .

If your doctor ordered two different eye medicines to be used together, wait at least 10 minutes before using the second medicine. This will help prevent the second medicine from “washing out” the first one .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution dosage form (eye drops):
  
  • For glaucoma or ocular hypertension:
    
    • Adults and children—One drop in the affected eye(s) two times a day .
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Betoptic S

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, stop using this medicine and check with your doctor. These signs may mean that you are allergic to this medicine .

Betaxolol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery .

Betoptic S Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Pain in the eye

Rare

• Blistering, peeling, or loosening of skin


• blue lips, fingernails, or skin


• blurred vision


• change in color vision


• chest pain or discomfort


• chills


• cough


• crusting of eyelashes


• decreased urine output


• decreased vision


• diarrhea


• different size pupils of the eyes


• difficulty in breathing, chewing, swallowing, or talking


• difficulty seeing at night


• dilated neck veins


• double vision


• drainage from eyes


• drooping eyelids


• extreme fatigue


• fast, slow, or irregular heartbeat


• feeling of having something in the eye


• hives


• increased sensitivity of eyes to sunlight


• irregular, fast or slow, or shallow breathing


• irritation or inflammation of eye


• itching, dryness of eyes


• itching skin


• joint or muscle pain


• lightheadedness, dizziness, or fainting


• muscle weakness


• noisy breathing


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• severe tiredness


• shortness of breath


• skin rash


• sore throat


• sores, ulcers, or white spots in mouth or on lips


• sweating


• swelling of eyelids


• swelling of face, fingers, feet, or lower legs


• tearing


• thickened mucous from lungs


• tightness in chest


• troubled breathing


• unusual tiredness or weakness


• weight gain


• wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Bad, unusual, or unpleasant (after) taste


• change in sense of smell


• change in taste


• discouragement


• feeling of constant movement of self or surroundings


• feeling sad or empty


• hair loss


• headaches


• irritability


• lack of appetite


• loss of interest or pleasure


• redness, swelling, or soreness of tongue


• sensation of spinning


• sleeplessness


• tiredness


• trouble concentrating


• trouble sleeping


• unable to sleep


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Betoptic S side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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• Betoptic S Side Effects (in more detail)
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