Sunday 25 December 2011

Liaderyl




Liaderyl may be available in the countries listed below.


Ingredient matches for Liaderyl



Tenoxicam

Tenoxicam is reported as an ingredient of Liaderyl in the following countries:


  • Greece

International Drug Name Search

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Dercin




Dercin may be available in the countries listed below.


Ingredient matches for Dercin



Gemcitabine

Gemcitabine is reported as an ingredient of Dercin in the following countries:


  • Bulgaria

  • Poland

International Drug Name Search

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Thursday 22 December 2011

Cromolind




Cromolind may be available in the countries listed below.


Ingredient matches for Cromolind



Cromoglicic Acid

Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Cromolind in the following countries:


  • Germany

International Drug Name Search

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Tuesday 20 December 2011

Algiderma




Algiderma may be available in the countries listed below.


Ingredient matches for Algiderma



Diethylamine Salicylate

Diethylamine Salicylate is reported as an ingredient of Algiderma in the following countries:


  • Portugal

International Drug Name Search

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Wednesday 14 December 2011

Acarsan




Acarsan may be available in the countries listed below.


Ingredient matches for Acarsan



Benzyl Benzoate

Benzyl Benzoate is reported as an ingredient of Acarsan in the following countries:


  • Brazil

International Drug Name Search

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Friday 9 December 2011

Pravamate




Pravamate may be available in the countries listed below.


Ingredient matches for Pravamate



Pravastatin

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


  • Japan

International Drug Name Search

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Monday 5 December 2011

Lanfast




Lanfast may be available in the countries listed below.


Ingredient matches for Lanfast



Lansoprazole

Lansoprazole is reported as an ingredient of Lanfast in the following countries:


  • Bahrain

  • Oman

International Drug Name Search

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Sunday 4 December 2011

Fludroxicortide




Fludroxicortide may be available in the countries listed below.


Ingredient matches for Fludroxicortide



Fludroxycortide

Fludroxicortide (DCIT) is also known as Fludroxycortide (Rec.INN)

International Drug Name Search

Glossary

DCITDenominazione Comune Italiana
Rec.INNRecommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.
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Saturday 26 November 2011

Fentul




Fentul may be available in the countries listed below.


Ingredient matches for Fentul



Ifosfamide

Ifosfamide is reported as an ingredient of Fentul in the following countries:


  • Argentina

International Drug Name Search

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Friday 25 November 2011

Fluvoxamin Stada




Fluvoxamin Stada may be available in the countries listed below.


Ingredient matches for Fluvoxamin Stada



Fluvoxamine

Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Fluvoxamin Stada in the following countries:


  • Germany

International Drug Name Search

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Thursday 24 November 2011

Inspra


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


INSPRA (eplerenone - tablet; oral)



  • Manufacturer: GD SEARLE LLC

    Approval date: September 27, 2002

    Strength(s): 25MG [AB], 50MG [RLD][AB]

Has a generic version of Inspra been approved?


A generic version of Inspra has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Inspra and have been approved by the FDA:


eplerenone tablet; oral



  • Manufacturer: APOTEX

    Approval date: July 30, 2008

    Strength(s): 25MG [AB], 50MG [AB]


  • Manufacturer: SANDOZ

    Approval date: August 1, 2008

    Strength(s): 25MG [AB], 50MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Inspra. 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.




  • Immediate release eplerenone compositions
    Patent 6,410,054
    Issued: June 25, 2002
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G. D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION


    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Combination therapy of angiotensin converting enzyme inhibitor and aldosterone antagonist for reducing morbidity and mortality from cardiovascular disease
    Patent 6,410,524
    Issued: June 25, 2002
    Inventor(s): Alfonzo T.; Perez & Debra J.; Asner & Richard J.; LaChapelle & John C.; Alexander & Barbara; Roniker
    Assignee(s): G. D. Searle & Co.
    Combinations of an ACE inhibitor, an aldosterone antagonist, and a loop diuretic are described for use in treatment of circulatory disorders. Of particular interest are therapies using captopril, enalapril or lisinopril co-administered with spironolactone. This co-therapy would be particularly useful to reduce the death rate or the number of non-fatal hospitalizations or prevent the progression of congestive heart failure in patients with cardiovascular disease.
    Patent expiration dates:

    • November 5, 2019
      ✓ 
      Patent use: USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR FOR TREATING HYPERTENSION


    • May 5, 2020
      ✓ 
      Pediatric exclusivity




  • Eplerenone compositions having improved bioavailability
    Patent 6,495,165
    Issued: December 17, 2002
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G.D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION


    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Immediate release eplerenone compositions
    Patent 6,534,093
    Issued: March 18, 2003
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G.D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF HYPERTENSION


    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Immediate release eplerenone compositions
    Patent 6,558,707
    Issued: May 6, 2003
    Inventor(s): Shilpa S.; Thosar & Rajeev D.; Gokhale & Dwain S.; Tolbert
    Assignee(s): G. D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND CARDIAC INSUFFICIENCY, WITH EPLERENONE
      ✓ 
      Drug product


    • June 8, 2020
      ✓ 
      Pediatric exclusivity




  • Methods of treating heart failure and hypertension using combinations of eplerenone and an angiotensin converting enzyme inhibitor
    Patent 6,747,020
    Issued: June 8, 2004
    Inventor(s): Alfonzo T.; Perez & Debra J.; Asner & Richard J.; LaChapelle & John C.; Alexander & Barbara; Roniker
    Assignee(s): Pharmacia Corporation
    Methods of using eplerenone, an angiotensin converting enzyme inhibitor and optionally a diuretic are described for treatment of heart failure and hypertension.
    Patent expiration dates:

    • November 5, 2019
      ✓ 
      Patent use: USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE) INHIBITOR (AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND HYPERTENSION


    • May 5, 2020
      ✓ 
      Pediatric exclusivity




  • Immediate release eplerenone compositions
    Patent 6,863,902
    Issued: March 8, 2005
    Inventor(s): Thosar; Shilpa S. & Gokhale; Rajeev D. & Tolbert; Dwain S.
    Assignee(s): G. D. Searle & Co.
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • April 10, 2020
      ✓ 
      Patent use: TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED, SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
      ✓ 
      Drug product


    • October 10, 2020
      ✓ 
      Pediatric exclusivity




  • Micronized eplerenone compositions
    Patent 7,157,101
    Issued: January 2, 2007
    Inventor(s): Thosar; Shilpa S. & Gokhale; Rajeev D. & Tolbert; Dwain S.
    Assignee(s): G.D. Searle, LLC
    The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.
    Patent expiration dates:

    • December 8, 2019
      ✓ 
      Patent use: TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED, SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
      ✓ 
      Drug product


    • June 8, 2020
      ✓ 
      Pediatric exclusivity



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:
    • January 31, 2011 - INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC PATIENTS

    • July 31, 2011 - PEDIATRIC EXCLUSIVITY

See also...

  • Inspra Consumer Information (Wolters Kluwer)
  • Inspra Consumer Information (Cerner Multum)
  • Inspra Advanced Consumer Information (Micromedex)
  • Inspra AHFS DI Monographs (ASHP)
  • Eplerenone Consumer Information (Wolters Kluwer)
  • Eplerenone Consumer Information (Cerner Multum)
  • Eplerenone Advanced Consumer Information (Micromedex)
  • Eplerenone AHFS DI Monographs (ASHP)
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Wednesday 23 November 2011

Fénofibrate Zydus




Fénofibrate Zydus may be available in the countries listed below.


Ingredient matches for Fénofibrate Zydus



Fenofibrate

Fenofibrate is reported as an ingredient of Fénofibrate Zydus in the following countries:


  • France

International Drug Name Search

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Monday 21 November 2011

Esomed




Esomed may be available in the countries listed below.


Ingredient matches for Esomed



Hydroquinone

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


  • Israel

International Drug Name Search

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Saturday 19 November 2011

Estriol-Ovulum Jenapharm




Estriol-Ovulum Jenapharm may be available in the countries listed below.


Ingredient matches for Estriol-Ovulum Jenapharm



Estriol

Estriol is reported as an ingredient of Estriol-Ovulum Jenapharm in the following countries:


  • Germany

International Drug Name Search

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Wednesday 16 November 2011

Idedex




Idedex may be available in the countries listed below.


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

Ingredient matches for Idedex



Glycerol

Glycerol is reported as an ingredient of Idedex in the following countries:


  • Australia

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Idedex in the following countries:


  • Australia

International Drug Name Search

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Tuesday 15 November 2011

Doctor




Doctor may be available in the countries listed below.


Ingredient matches for Doctor



Miconazole

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


  • Argentina

International Drug Name Search

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Friday 11 November 2011

Aluminium Hydroxide




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

Scheme

Ph. Int.

ATC (Anatomical Therapeutic Chemical Classification)

A02AB01

CAS registry number (Chemical Abstracts Service)

0021645-51-2

Chemical Formula

Al-(OH)3

Molecular Weight

78

Therapeutic Categories

Pharmaceutic aid

Antacid

Chemical Names

Aluminium Hydroxide (Ph. Int.)

Aluminium trihydrate

Hydrated alumina

Foreign Names

  • Aluminii hydroxidum (Latin)
  • Aluminium hydroxid (German)

Generic Names

  • UNII-5QB0T2IUN0 (IS)
  • Aluminium Hydroxide (PH: Ph. Int. 4)
  • Aluminium Hydroxide Dried (PH: BP 2010)
  • Aluminum Hydroxide Gel (PH: USP 32)
  • Dried Aluminum Hydroxide Gel (PH: USP 32)
  • Dried Aluminum Hydroxide Gel Capsules (PH: USP 32)
  • Dried Aluminum Hydroxide Gel Tablets (PH: USP 32)
  • Algeldrate (OS: Prop.INN)
  • Algeldrate (OS: USAN)
  • Algeldrato (OS: DCIT)
  • Alcid (IS)
  • Alokreen (IS)
  • Alumina hydrata (IS)
  • Aluminium hydricum (IS)
  • Aluminium hydroxydatum (IS)
  • Aluminiumhydroxid, hydratisiert (IS)
  • Aluminiumhydroxid, kolloidal (IS)
  • Aluminiumhydroxidhydrat (IS)
  • Aluminiumorthohydroxid (IS)
  • Gastralun (IS)
  • Hydrargillit (IS)
  • Tonerdehydrat (IS)
  • Trioxo-aluminium(III)-säure (IS)
  • UNII-03J11K103C (IS)
  • W 4600 (IS)
  • Aluminium Hydroxide for Adsorption Hydrated (PH: BP 2010)

Brand Names

  • Aciban (Aluminium Hydroxide and Magnesium Trisilicate)
    Be-Tabs Pharmaceuticals, South Africa


  • Acidless (Aluminium Hydroxide and Magnesium Hydroxide)
    Nakakita Yakuhin, Japan


  • Actal
    Valeant, Indonesia


  • Aflomag (Aluminium Hydroxide and Magnesium Hydroxide)
    Aflofarm, Poland


  • Airtab (Aluminium Hydroxide and Magnesium Trisilicate)
    Millimed, Thailand


  • Aisflat (Aluminium Hydroxide and Magnesium Hydroxide)
    Choseido Pharmaceutical, Japan


  • Algermin (Aluminium Hydroxide and Dicycloverine)
    Towa Yakuhin, Japan


  • Almag (Aluminium Hydroxide and Magnesium)
    B L Hua, Thailand


  • Alucol (Aluminium Hydroxide and Magnesium Hydroxide)
    Melisana, Switzerland; Sanova, Austria


  • Alum Milk (Aluminium Hydroxide and Magnesium)
    Sanofi-Aventis, Thailand


  • Alumag (Aluminium Hydroxide and Magnesium Hydroxide)
    Polfa Grodzisk, Poland


  • Alumigel
    Chugai, Japan; Sumio Yakuhin, Japan


  • Alusal
    Polfa Grodzisk, Poland


  • Alutop (Aluminium Hydroxide and Magnesium)
    General Drugs House, Thailand


  • Anacid (Aluminium Hydroxide and Magnesium Hydroxide)
    Ivax, Slovakia


  • Aquastin (Aluminium Hydroxide and Magnesium Hydroxide)
    Fuji Capseru, Japan


  • Asialum (Aluminium Hydroxide and Magnesium)
    Asian Pharmaceutical, Thailand


  • Carelox (Aluminium Hydroxide and Magnesium Hydroxide)
    Pharmacara, Oman


  • Cosaichill (Aluminium Hydroxide and Dicycloverine)
    Kyorin Rimedio, Japan


  • Crimeran (Aluminium Hydroxide and Magnesium Hydroxide)
    Takata Seiyaku, Japan


  • Daewoong Newlanta (Aluminium Hydroxide and Magnesium Hydroxide)
    Daewoong, Vietnam


  • Dicanon S (Aluminium Hydroxide and Magnesium Hydroxide)
    Nisshin Seiyaku - Yamagata, Japan


  • Dicanon (Aluminium Hydroxide and Magnesium Hydroxide)
    Nisshin Seiyaku - Yamagata, Japan


  • Digel (Aluminium Hydroxide and Magnesium Hydroxide)
    Aristopharma, Vietnam


  • Diovol (Aluminium Hydroxide and Magnesium Hydroxide)
    Church & Dwight, Canada


  • Dizicum
    Taj Pharma, India


  • Elkopas (Aluminium Hydroxide and Magnesium Carbonate)
    Demo, Greece


  • Foamcoat (Aluminium Hydroxide and Magnesium Trisilicate)
    Guardian, United States


  • Gacida (Aluminium Hydroxide and Magnesium)
    Sanofi-Aventis, Thailand


  • Gastal (Aluminium Hydroxide and Magnesium Hydroxide + Magnesium Carbonate)
    Pliva, Croatia (Hrvatska)


  • Gastro Intestinal (Aluminium Hydroxide and Alverine (veterinary use))
    Omega Pharma France, France


  • Gaviscon (Aluminium Hydroxide and Alginic Acid)
    Nordic Drugs, Norway


  • Gaviscon (Aluminium Hydroxide and Magnesium Trisilicate)
    Sanofi-Aventis, United States


  • Genaton (Aluminium Hydroxide and Magnesium Trisilicate)
    Teva USA, United States


  • Hairiesu (Aluminium Hydroxide and Magnesium Hydroxide)
    Isei, Japan


  • Hoemigel
    Mylan Pharmaceutical, Japan


  • Hydro Gel
    Iwaki Seiyaku, Japan


  • Hydroxydes Aluminium/Magnésium Sandoz Conseil (Aluminium Hydroxide and Magnesium Hydroxide)
    Sandoz, France


  • Kolantyl (Aluminium Hydroxide and Dicycloverine)
    Shionogi Seiyaku, Japan


  • Lenicet (Aluminium Hydroxide and Algeldrate)
    Athenstaedt, Germany


  • Link
    Actavis, Sweden


  • Link (Aluminium Hydroxide and Magnesium Carbonate)
    Actavis, Denmark; Actavis, Norway


  • Maalox Plus (Aluminium Hydroxide and Magnesium Hydroxide)
    Novum, Netherlands


  • Maalox (Aluminium Hydroxide and Magnesium Hydroxide)
    Sanofi Aventis, Japan; Sanofi-aventis, Greece; Sanofi-aventis, Italy; Sanofi-aventis, Vietnam; Novum, Netherlands; Sanofi-Aventis, Oman; Sanofi-Aventis, Slovakia


  • Maalox maux d'estomac (Aluminium Hydroxide and Magnesium Hydroxide)
    Sanofi-Aventis, France


  • Maaredge (Aluminium Hydroxide and Magnesium Hydroxide)
    Towa Yakuhin, Japan


  • Macmet (Aluminium Hydroxide and Magnesium Hydroxide)
    Sawai Seiyaku, Japan


  • Magtect (Aluminium Hydroxide and Magnesium Hydroxide)
    Teikoku Medix, Japan


  • Magtect U (Aluminium Hydroxide and Magnesium Hydroxide)
    Teikoku Medix, Japan


  • Malfa (Aluminium Hydroxide and Magnesium Hydroxide)
    Toyo Seiyaku KaseiOriental, Japan


  • Malugel (Aluminium Hydroxide and Magnesium Trisilicate)
    Hikma, Oman


  • Marperis (Aluminium Hydroxide and Magnesium Hydroxide)
    Sandoz, Japan


  • Medacid (Aluminium Hydroxide and Magnesium Hydroxide)
    Medpharma, Oman


  • Moxal (Aluminium Hydroxide and Magnesium Hydroxide)
    Julphar, Oman


  • Mucogel (Aluminium Hydroxide and Magnesium Hydroxide)
    Chemidex, United Kingdom; Pharmax, Oman


  • Mupax (Aluminium Hydroxide and Magnesium Hydroxide)
    Arrow, France


  • Neogelco (Aluminium Hydroxide and Magnesium Oxide)
    Kahira, Oman


  • Novagel (Aluminium Hydroxide and Magnesium Carbonate, Magnesium Hydroxide)
    Arab Pharmaceutical Manufacturing Co. LTD. - APM, Oman


  • Omacid (Aluminium Hydroxide and Magnesium hydroxide)
    National Pharmaceutical Industries Co. - NPI, Oman


  • Polmantis (Aluminium Hydroxide and Magnesium Hydroxide)
    Biogened, Poland


  • Regla-PH (Aluminium Hydroxide and Magnesium Hydroxide)
    UCB, Netherlands


  • Resporix (Aluminium Hydroxide and Dicycloverine)
    Tsuruhara Seiyaku, Japan


  • Rialox (Aluminium Hydroxide and Magnesium Hydroxide)
    Riyad Pharma, Oman


  • Ritaroks (Aluminium Hydroxide and Magnesium Hydroxide)
    Tsuruhara Seiyaku, Japan


  • Sakloft (Aluminium Hydroxide and Magnesium Hydroxide)
    Taisho Yakuhin, Japan


  • Stomafar (Aluminium Hydroxide and Magnesium Hydroxide)
    Pharmedic, Vietnam


  • Taimec (Aluminium Hydroxide and Magnesium Hydroxide)
    Taiyo Pharmaceutical, Japan


  • Takatagel
    Takata Seiyaku, Japan


  • Urusan (Aluminium Hydroxide and Magnesium Carbonate)
    Korea United Pharm, Vietnam


  • Witcop (Aluminium Hydroxide and Magnesium Hydroxide)
    Yoshindo, Japan


  • Acix
    Zentiva, Czech Republic


  • Actal
    Valeant, Sri Lanka


  • Algeldraat PCH
    Pharmachemie, Netherlands


  • Algeldraat ratiopharm
    ratiopharm, Netherlands


  • Almagel (Aluminium Hydroxide and Magnesium Hydroxide)
    Balkanpharma, Russian Federation


  • AlternaGEL
    Johnson & Johnson, United States


  • Alu-Cap
    3M, Bahrain; 3M, Israel; 3M, Kenya; 3M, Morocco; 3M, United States; 3M, Zimbabwe; IFET, Greece; Meda, United Kingdom; United Drug, Ireland


  • Aludrox
    McNeil, Ireland; Riemser, Germany; Riemser, Slovenia; Wyeth, Greece; Wyeth, India


  • Alugel
    Chefaro, Spain


  • Alumag (Aluminium Hydroxide and Aluminium Hydroxide)
    Beacons, Singapore; Teva, Israel


  • Aluminio Hidroxido L.CH
    Chile, Chile


  • Aluminio Hidroxido S.O.
    Pasteur, Chile


  • Alu-Tab
    3M, Philippines; Douglas, New Zealand; iNova, Singapore; iNova Pharmaceuticals, Australia


  • Amphojel
    Aspen Pharmacare Consumer, South Africa; Wyeth, United States


  • Antagel Katwijk (Aluminium Hydroxide and Magnesium Hydroxide)
    Apotex Europe, Netherlands


  • Antagel Kring (Aluminium Hydroxide and Magnesium Hydroxide)
    Kring, Netherlands


  • Antagel PCH (Aluminium Hydroxide and Magnesium Hydroxide)
    Pharmachemie, Netherlands


  • Antagel Ratiopharm (Aluminium Hydroxide and Magnesium Hydroxide)
    ratiopharm, Netherlands


  • Antagel Sandoz (Aluminium Hydroxide and Magnesium Hydroxide)
    Sandoz, Netherlands


  • Anti-Phosphat Gry
    Brady, Austria


  • Antiphosphat
    Teva-Gry, Germany


  • Diovol
    Wallace, India


  • Hidroxido de Aluminio
    Bestpharma, Chile; Mintlab, Chile


  • Kestomatine (Aluminium Hydroxide and Simeticone)
    Sanofi-Aventis, Belgium


  • Lenicet (Aluminium Hydroxide and Aluminium Hydroxide)
    Athenstaedt, Germany


  • Maalox
    Aventis, Ireland; Gerot, Austria; Sanofi-Aventis, Georgia


  • Maalox (Aluminium Hydroxide and Magnesium Hydroxide)
    Sanofi-Aventis, Belgium; Sanofi-Aventis, Peru; Winthrop, Germany; Winthrop, South Africa


  • Maaloxan (Aluminium Hydroxide and Magnesium Hydroxide)
    Winthrop, Germany


  • Magal II (Aluminium Hydroxide and Magnesium Hydroxide)
    Hersil, Peru


  • Maglid (Aluminium Hydroxide and Magnesium Hydroxide)
    Melisana, Belgium; Melisana, Luxembourg


  • Mayogel (Aluminium Hydroxide and Magnesium Oxide)
    Adcock Ingram Pharmaceuticals, South Africa


  • Novaluzid (Aluminium Hydroxide and Magnesium Oxide)
    BioPhausia, Denmark; BioPhausia, Norway


  • Pepsamar
    Angelini, Portugal; Gador, Argentina; Sanofi-Aventis, Colombia; Sanofi-Aventis S.A., Spain


  • Progastrit (Aluminium Hydroxide and Magnesium Hydroxide)
    Hexal, Germany


  • Rocgel
    Tonipharm, Burkina Faso; Tonipharm, Benin; Tonipharm, Central African Republic; Tonipharm, Congo; Tonipharm, Cote D'ivoire; Tonipharm, Cameroon; Tonipharm, Algeria; Tonipharm, Gabon; Tonipharm, Mali; Tonipharm, Mauritania; Tonipharm, Niger; Tonipharm, Senegal; Tonipharm, Chad; Tonipharm, Togo

International Drug Name Search

Glossary

DCITDenominazione Comune Italiana
ISInofficial Synonym
OSOfficial Synonym
PHPharmacopoeia Name
Ph. Int.Pharmacopoea Internationalis
Prop.INNProposed International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.
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Thursday 10 November 2011

Clinagel




Clinagel may be available in the countries listed below.


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

Ingredient matches for Clinagel



Gentamicin

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


  • United Kingdom

International Drug Name Search

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Wednesday 9 November 2011

Sinlestal




Sinlestal may be available in the countries listed below.


Ingredient matches for Sinlestal



Probucol

Probucol is reported as an ingredient of Sinlestal in the following countries:


  • Japan

International Drug Name Search

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Tuesday 8 November 2011

Eritax




Eritax may be available in the countries listed below.


Ingredient matches for Eritax



Erythromycin

Erythromycin is reported as an ingredient of Eritax in the following countries:


  • Brazil

International Drug Name Search

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Sunday 6 November 2011

Uriconorm




Uriconorm may be available in the countries listed below.


Ingredient matches for Uriconorm



Allopurinol

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


  • Switzerland

International Drug Name Search

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Thursday 3 November 2011

Magnesium Orotate




ATC (Anatomical Therapeutic Chemical Classification)

A12CC09

CAS registry number (Chemical Abstracts Service)

0027067-77-2

Chemical Formula

C10-H6-Mg-N4-O8

Molecular Weight

334

Therapeutic Category

Mineral supplement

Chemical Name

magnesium 2,6-dioxo-3H-pyrimidine-4-carboxylate (IUPAC)

Foreign Names

  • Magnesiumorotat (German)
  • Magnésium orotate (French)
  • Orotato de magnesio (Spanish)

Generic Names

  • Orotic acid, magnesium salt (IS)
  • Orotsäure, Magnesiumsalz (IS)
  • Hippocras (IS)
  • Magnesiumorotat-2-Wasser (IS)
  • Orotsäure, Magnesiumsalz-2-Wasser (IS)

Brand Names

  • Burgerstein Magnesiumorotat
    Antistress, Switzerland


  • Magnerot
    Mauermann, Czech Republic; Mauermann, Bulgaria; Worwag, Slovakia; Wörwag Pharma, Germany; Wörwag Pharma, Georgia; Wörwag Pharma, Hungary; Wörwag Pharma, Lithuania; Wörwag Pharma, Latvia; Wörwag Pharma, Romania


  • Magnesorot
    Wörwag Pharma, Germany


  • Power Orot
    Wörwag Pharma, Germany

International Drug Name Search

Glossary

IUPACInternational Union of Pure and Applied Chemistry
ISInofficial Synonym

Click for further information on drug naming conventions and International Nonproprietary Names.
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Tuesday 1 November 2011

Fluoxetine PCH




Fluoxetine PCH may be available in the countries listed below.


Ingredient matches for Fluoxetine PCH



Fluoxetine

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


  • Netherlands

International Drug Name Search

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Wednesday 26 October 2011

Oxipor VHC


Generic Name: coal tar topical (KOL TAR TOP ik al)

Brand Names: Balnetar, Betatar Gel, Coal Tar, Cutar, Denorex, Denorex Dry Scalp, Denorex Extra Strength, Denorex Medicated Shampoo and Conditioner, DHS Tar Shampoo, Doak Tar, Doak Tar Oil, Elta Tar, Fototar, G-TAR, Ionil T, Ionil T Plus, MG 217 Psoriasis, MG217 Medicated Tar, Neutrogena T/Derm, Neutrogena T/Gel, Neutrogena T/Gel Extra Strength, Oxipor VHC, PC Tar, Pentrax, Pentrax Gold, Polytar, Psoriasin, Psorigel, T/Gel Conditioner, Tegrin Medicated, Tegrin Medicated Soap, Therapeutic, Theraplex T, Zetar


What is coal tar?

Coal tar is a by-product of coal processing.


Coal tar topical (for the skin) is used to treat the skin symptoms of psoriasis, including dryness, redness, flaking, scaling, and itching. Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.


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


What is the most important information I should know about coal tar?


You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.


Do not use coal tar to treat the skin of your groin or rectal area.


Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result. Stop using coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.


Coal tar is not a cure for psoriasis, and it will provide only temporary relief of skin symptoms.


What should I discuss with my health care provider before using coal tar?


You should not use this medication if you are allergic to coal tar.

Before using coal tar, tell your doctor if you are allergic to any drugs, or if you are receiving ultraviolet radiation treatment for your psoriasis.


This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether coal tar passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Coal tar products may contain lanolin, mineral oil, or other emulsifiers. Check the label of any coal tar product you are using. Talk with your doctor before using coal tar if you are allergic to any of the ingredients.


How should I use coal tar?


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


Apply coal tar cream, lotion, ointment, or solution according the directions on the medication label. Some forms of coal tar may be applied 1 to 4 times per day.


To use coal tar bath oil, pour 1 to 3 capfuls into a warm bath before bathing. The oil can make the bathtub slippery. Take care to avoid a fall.


Shake the coal tar shampoo well just before each use. Use enough shampoo to create a rich lather. Massage the shampoo into your scalp and rinse thoroughly. Apply the shampoo a second time and leave it on your scalp for 5 minutes. Rinse thoroughly. Do not use coal tar to treat large skin areas. Do not use coal tar over long periods of time without your doctor's advice.

Call your doctor if your symptoms do not improve, or if they get worse after using coal tar.


Coal tar shampoo may discolor blond or colored hair. This effect is usually temporarily.


Some forms of coal tar can stain fabric or other surfaces.


Store coal tar at room temperature away from moisture and heat. Keep the medicine tightly closed with not in use.

What happens if I miss a dose?


Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


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

Symptoms of a coal tar overdose are not known.


What should I avoid while using coal tar?


Avoid getting this medication in your eyes. If this does occur, rinse with water.

Do not use coal tar to treat the skin of your groin or rectal area.


Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Coal tar can make your skin more sensitive to sunlight and sunburn may result.

Coal tar 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 coal tar and call your doctor at once if you have severe stinging, burning, swelling, or other irritation of the treated skin.

Less serious side effects may include mild skin irritation or skin rash.


This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect coal tar?


Do not use coal tar together with other psoriasis medications unless your doctor tells you to.

There may be other drugs that can interact with coal tar. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Oxipor VHC resources


  • Oxipor VHC Use in Pregnancy & Breastfeeding
  • Oxipor VHC Support Group
  • 0 Reviews for Oxipor VHC - Add your own review/rating


  • Betatar Gel Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Coal Tar Foam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Denorex Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)

  • Doak Tar Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fototar Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

  • MG217 Medicated Tar Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Psoriasin Prescribing Information (FDA)



Compare Oxipor VHC with other medications


  • Dermatitis
  • Psoriasis
  • Seborrheic Dermatitis


Where can I get more information?


  • Your pharmacist can provide more information about coal tar.


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Monday 24 October 2011

Oxybutynin Chloride




Dosage Form: tablet, film coated, extended release
Oxybutynin Chloride Extended Release Tablets

Oxybutynin Chloride Description


Oxybutynin Chloride is an antispasmodic, anticholinergic agent. Each Oxybutynin Chloride Extended Release Tablet contains 15 mg of Oxybutynin Chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin Chloride is administered as a racemate of R- and S-enantiomers.


Chemically, Oxybutynin Chloride is d,l (racemic) 4-diethylamino-2-butynyl phenylcyclohexylglycolate hydrochloride. The empirical formula of Oxybutynin Chloride is C22H31NO3•HCl.


Its structural formula is:



Oxybutynin Chloride is a white crystalline solid with a molecular weight of 393.9. It is readily soluble in water and acids, but relatively insoluble in alkalis.


Oxybutynin Chloride Extended Release Tablets also contain the following inert ingredients: cellulose acetate, hypromellose, lactose, magnesium stearate, polyethylene glycol, polyethylene oxide, synthetic iron oxides, titanium dioxide, polysorbate 80, sodium chloride, and butylated hydroxytoluene.



System Components and Performance


Oxybutynin Chloride Extended Release Tablets use osmotic pressure to deliver Oxybutynin Chloride at a controlled rate over approximately 24 hours. The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice in the semipermeable membrane on the drug-layer side of the tablet. In an aqueous environment, such as the gastrointestinal tract, water permeates through the membrane into the tablet core, causing the drug to go into suspension and the push layer to expand. This expansion pushes the suspended drug out through the orifice. The semipermeable membrane controls the rate at which water permeates into the tablet core, which in turn controls the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. The function of Oxybutynin Chloride Extended Release Tablets depends on the existence of an osmotic gradient between the contents of the bilayer core and the fluid in the gastrointestinal tract. Since the osmotic gradient remains constant, drug delivery remains essentially constant. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the feces as an insoluble shell.



Oxybutynin Chloride - Clinical Pharmacology


Oxybutynin Chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin Chloride exhibits only one-fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to ten times the antispasmodic activity. No blocking effects occur at skeletal neuromuscular junctions or autonomic ganglia (antinicotinic effects).


Oxybutynin Chloride relaxes bladder smooth muscle. In patients with conditions characterized by involuntary bladder contractions, cystometric studies have demonstrated that oxybutynin increases bladder (vesical) capacity, diminishes the frequency of uninhibited contractions of the detrusor muscle, and delays the initial desire to void. Oxybutynin thus decreases urgency and the frequency of both incontinent episodes and voluntary urination.


Antimuscarinic activity resides predominantly in the R-isomer. A metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin in in vitro studies.



Pharmacokinetics


Absorption

Following the first dose of Oxybutynin Chloride Extended Release Tablets, oxybutynin plasma concentrations rise for 4 to 6 hours; thereafter steady concentrations are maintained for up to 24 hours, minimizing fluctuations between peak and trough concentrations associated with oxybutynin.


The relative bioavailabilities of R- and S-oxybutynin from Oxybutynin Chloride Extended Release Tablets are 156% and 187%, respectively, compared with oxybutynin. The mean pharmacokinetic parameters for R- and S-oxybutynin are summarized in Table 1. The plasma concentration-time profiles for R- and S-oxybutynin are similar in shape; Figure 1 shows the profile for R-oxybutynin.
































Table 1 Mean (SD) R- and S-Oxybutynin Pharmacokinetic Parameters Following a Single Dose of Oxybutynin Chloride Extended Release Tablets 10 mg (n=43)
Parameters (units)R-OxybutyninS-Oxybutynin
Cmax (ng/mL)1.0(0.6)1.8(1.0)
Tmax (h)12.7(5.4)11.8(5.3)
t1/2 (h)13.2(6.2)12.4(6.1)
AUC(0–48) (ng∙h/mL)18.4(10.3)34.2(16.9)
AUCinf (ng∙h/mL)21.3(12.2)39.5(21.2)

Figure 1. Mean R-oxybutynin plasma concentrations following a single dose of Oxybutynin Chloride Extended Release Tablets 10 mg and oxybutynin 5 mg administered every 8 hours (n=23 for each treatment).



Steady state oxybutynin plasma concentrations are achieved by Day 3 of repeated Oxybutynin Chloride Extended Release Tablets dosing, with no observed drug accumulation or change in oxybutynin and desethyloxybutynin pharmacokinetic parameters.


Oxybutynin Chloride Extended Release Tablets steady state pharmacokinetics were studied in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The children were on Oxybutynin Chloride Extended Release Tablets total daily dose ranging from 5 to 20 mg (0.10 to 0.77 mg/kg). Sparse sampling technique was used to obtain serum samples. When all available data are normalized to an equivalent of 5 mg per day Oxybutynin Chloride Extended Release Tablets, the mean pharmacokinetic parameters derived for R- and S-oxybutynin and R- and S-desethyloxybutynin are summarized in Table 2. The plasma-time concentration profiles for R- and S-oxybutynin are similar in shape; Figure 2 shows the profile for R-oxybutynin when all available data are normalized to an equivalent of 5 mg per day.
























Table 2 Mean ± SD R- and S-Oxybutynin and R- and S-Desethyloxybutynin Pharmacokinetic Parameters in Children Aged 5–15 Following Administration of 5 to 20 mg Oxybutynin Chloride Extended Release Tablets Once Daily (n=19), All Available Data Normalized to an Equivalent of Oxybutynin Chloride Extended Release Tablets 5 mg Once Daily
R-OxybutyninS-OxybutyninR- DesethyloxybutyninS- Desethyloxybutynin
Cmax (ng/mL)0.7 ± 0.41.3 ± 0.87.8 ± 3.74.2 ± 2.3
Tmax (h)5.05.05.05.0
AUC(ng∙h/mL)12.8 ± 7.023.7 ± 14.4125.1 ± 66.773.6 ± 47.7

Figure 2. Mean steady state (± SD) R-oxybutynin plasma concentrations following administration of 5 to 20 mg Oxybutynin Chloride Extended Release Tablets once daily in children aged 5–15. Plot represents all available data normalized to an equivalent of Oxybutynin Chloride Extended Release Tablets 5 mg once daily.




Food Effects


The rate and extent of absorption and metabolism of oxybutynin are similar under fed and fasted conditions.


Distribution

Plasma concentrations of oxybutynin decline biexponentially following intravenous or oral administration. The volume of distribution is 193 L after intravenous administration of 5 mg Oxybutynin Chloride.


Metabolism

Oxybutynin is metabolized primarily by the cytochrome P450 enzyme systems, particularly CYP3A4 found mostly in the liver and gut wall. Its metabolic products include phenylcyclohexylglycolic acid, which is pharmacologically inactive, and desethyloxybutynin, which is pharmacologically active. Following Oxybutynin Chloride Extended Release Tablet administration, plasma concentrations of R- and S-desethyloxybutynin are 73% and 92%, respectively, of concentrations observed with oxybutynin.


Excretion

Oxybutynin is extensively metabolized by the liver, with less than 0.1% of the administered dose excreted unchanged in the urine. Also, less than 0.1% of the administered dose is excreted as the metabolite desethyloxybutynin.


Dose Proportionality

Pharmacokinetic parameters of oxybutynin and desethyloxybutynin (Cmax and AUC) following administration of 5–20 mg of Oxybutynin Chloride Extended Release Tablets are dose proportional.


Special Populations

Geriatric


The pharmacokinetics of Oxybutynin Chloride Extended Release Tablets were similar in all patients studied (up to 78 years of age).



Pediatric


The pharmacokinetics of Oxybutynin Chloride Extended Release Tablets were evaluated in 19 children aged 5–15 years with detrusor overactivity associated with a neurological condition (e.g., spina bifida). The pharmacokinetics of Oxybutynin Chloride Extended Release Tablets in these pediatric patients were consistent with those reported for adults (see Tables 1 and 2, and Figures 1 and 2 above).



Gender


There are no significant differences in the pharmacokinetics of oxybutynin in healthy male and female volunteers following administration of Oxybutynin Chloride Extended Release Tablets.



Race


Available data suggest that there are no significant differences in the pharmacokinetics of oxybutynin based on race in healthy volunteers following administration of Oxybutynin Chloride Extended Release Tablets.



Renal Insufficiency


There is no experience with the use of Oxybutynin Chloride Extended Release Tablets in patients with renal insufficiency.



Hepatic Insufficiency


There is no experience with the use of Oxybutynin Chloride Extended Release Tablets in patients with hepatic insufficiency.



Drug-Drug Interactions


See PRECAUTIONS: Drug Interactions.



Clinical Studies


Oxybutynin Chloride Extended Release Tablets were evaluated for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in three controlled studies and one open-label study. The majority of patients were Caucasian (89.0%) and female (91.9%) with a mean age of 59 years (range, 18 to 98 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge) as evidenced by ≥ 6 urge incontinence episodes per week and ≥ 10 micturitions per day. Study 1 was a fixed-dose escalation design, whereas the other studies used a dose-adjustment design in which each patient's final dose was adjusted to a balance between improvement of incontinence symptoms and tolerability of side effects. Controlled studies included patients known to be responsive to oxybutynin or other anticholinergic medications, and these patients were maintained on a final dose for up to 2 weeks.


The efficacy results for the three controlled trials are presented in the following tables and figures.


Number of Urge Urinary Incontinence Episodes Per Week






Indications and Usage for Oxybutynin Chloride


Oxybutynin Chloride Extended Release Tablets are a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.


Oxybutynin Chloride Extended Release Tablets are also indicated in the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).



Contraindications


Oxybutynin Chloride Extended Release Tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions.


Oxybutynin Chloride Extended Release Tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.



Warnings


Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.



Precautions



Central Nervous System Effects


Oxybutynin is associated with anticholinergic central nervous system (CNS) effects (see ADVERSE REACTIONS). A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.


Oxybutynin Chloride Extended Release Tablets should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.



General


Oxybutynin Chloride Extended Release Tablets should be used with caution in patients with hepatic or renal impairment and in patients with myasthenia gravis due to the risk of symptom aggravation.



Urinary Retention


Oxybutynin Chloride Extended Release Tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (see CONTRAINDICATIONS).



Gastrointestinal Disorders


Oxybutynin Chloride Extended Release Tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see CONTRAINDICATIONS).


Oxybutynin Chloride Extended Release Tablets, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony.


Oxybutynin Chloride Extended Release Tablets should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.


As with any other nondeformable material, caution should be used when administering Oxybutynin Chloride Extended Release Tablets to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.



Information for Patients


Patients should be informed that oxybutynin may produce angioedema that could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue oxybutynin therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.


Patients should be informed that heat prostration (fever and heat stroke due to decreased sweating) can occur when anticholinergics such as Oxybutynin Chloride are administered in the presence of high environmental temperature.


Because anticholinergic agents such as oxybutynin may produce drowsiness (somnolence) or blurred vision, patients should be advised to exercise caution.


Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents such as oxybutynin.


Patients should be informed that Oxybutynin Chloride Extended Release Tablets should be swallowed whole with the aid of liquids. Patients should not chew, divide, or crush tablets. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.


Oxybutynin Chloride Extended Release Tablets should be taken at approximately the same time each day.



Drug Interactions


The concomitant use of oxybutynin with other anticholinergic drugs or with other agents which produce dry mouth, constipation, somnolence (drowsiness), and/or other anticholinergic-like effects may increase the frequency and/or severity of such effects.


Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. This may be of concern for drugs with a narrow therapeutic index.


Mean Oxybutynin Chloride plasma concentrations were approximately 2 fold higher when Oxybutynin Chloride Extended Release Tablets were administered with ketoconazole, a potent CYP3A4 inhibitor. Other inhibitors of the cytochrome P450 3A4 enzyme system, such as antimycotic agents (e.g., itraconazole and miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), may alter oxybutynin mean pharmacokinetic parameters (i.e., Cmax and AUC). The clinical relevance of such potential interactions is not known. Caution should be used when such drugs are co-administered.



Carcinogenesis, Mutagenesis, Impairment of Fertility


A 24-month study in rats at dosages of Oxybutynin Chloride of 20, 80, and 160 mg/kg/day showed no evidence of carcinogenicity. These doses are approximately 6, 25, and 50 times the maximum human exposure, based on surface area.


Oxybutynin Chloride showed no increase of mutagenic activity when tested in Schizosaccharomyces pompholiciformis, Saccharomyces cerevisiae, and Salmonella typhimurium test systems.


Reproduction studies with Oxybutynin Chloride in the mouse, rat, hamster, and rabbit showed no definite evidence of impaired fertility.



Pregnancy


Teratogenic Effects

Pregnancy Category B


Reproduction studies with Oxybutynin Chloride in the mouse, rat, hamster, and rabbit showed no definite evidence of impaired fertility or harm to the animal fetus. The safety of Oxybutynin Chloride Extended Release Tablet administration to women who are or who may become pregnant has not been established. Therefore, Oxybutynin Chloride Extended Release Tablets should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards.



Nursing Mothers


It is not known whether oxybutynin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxybutynin Chloride Extended Release Tablets are administered to a nursing woman.



Pediatric Use


The safety and efficacy of Oxybutynin Chloride Extended Release Tablets were studied in 60 children in a 24-week, open-label trial. Patients were aged 6–15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of Oxybutynin Chloride. Study results demonstrated that administration of Oxybutynin Chloride Extended Release Tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 mL to 136 mL, an increase from baseline in mean urine volume after morning awakening from 148 mL to 189 mL, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%.


Urodynamic results were consistent with clinical results. Administration of Oxybutynin Chloride Extended Release Tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 mL to 254 mL, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm H2O to 33 cm H2O, and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm H2O) from 60% to 28%.


Oxybutynin Chloride Extended Release Tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6 (See DOSAGE AND ADMINISTRATION).



Geriatric Use


The rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations: Geriatric).



Adverse Reactions



Adverse Events with Oxybutynin Chloride Extended Release Tablets


The safety and efficacy of Oxybutynin Chloride Extended Release Tablets was evaluated in a total of 580 participants who received Oxybutynin Chloride Extended Release Tablets in 4 clinical trials (429 patients) and four pharmacokinetic studies (151 healthy volunteers). The 429 patients were treated with 5–30 mg/day for up to 4.5 months. Three of the 4 clinical trials allowed dose adjustments based on efficacy and adverse events and one was a fixed-dose escalation design. Safety information is provided for 429 patients from these three controlled clinical studies and one open-label study in the first column of Table 3 below.


Adverse events from two additional fixed-dose, active-controlled, 12-week treatment duration, postmarketing studies, in which 576 patients were treated with Oxybutynin Chloride Extended Release Tablets 10 mg/day, are also listed in Table 3 (second column). The adverse events are reported regardless of causality.




































































Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Oxybutynin Chloride Extended Release Tablets (5–30 mg/day) and % of Corresponding Adverse Events in Two Fixed-Dose (10 mg/day) Studies
Oxybutynin Chloride Extended Release TabletsOxybutynin Chloride Extended Release Tablets
Body SystemAdverse Event5–30 mg/day

(n=429)		10 mg/day

(n=576)
Generalheadache106
asthenia73
pain74
Digestivedry mouth6129
constipation137
diarrhea97
nausea92
dyspepsia75
Nervoussomnolence122
dizziness64
Respiratoryrhinitis62
Special sensesblurred vision81
dry eyes63
Urogenitalurinary tract infection55

The most common adverse events reported by the 429 patients receiving 5–30 mg/day Oxybutynin Chloride Extended Release Tablets were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related.


The discontinuation rate for all adverse events was 6.8% in the 429 patients from the 4 studies of efficacy and safety who received 5–30 mg/day. The most frequent adverse event causing early discontinuation of study medication was nausea (1.9%), while discontinuation due to dry mouth was 1.2%.


In addition, the following adverse events were reported by ≥ 1 to < 5% of all patients who received Oxybutynin Chloride Extended Release Tablets in the 6 adjustable and fixed-dose efficacy and safety studies. Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, cystitis; Psychiatric disorders: insomnia, depression, nervousness, confusional state; Nervous System Disorders: dysgeusia; Cardiac disorders: palpitations; Vascular disorders: hypertension; Respiratory, thoracic and mediastinal disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat; Gastrointestinal Disorders: gastroesophageal reflux disease, abdominal pain, loose stools, flatulence, vomiting; Skin and subcutaneous tissue disorders: dry skin, pruritis; Musculoskeletal and connective tissue disorders: back pain, arthralgia, pain in extremity; Renal and urinary disorders: urinary retention, urinary hesitation, dysuria; General disorders and administration site conditions: fatigue, edema peripheral, asthenia, chest pain; Investigations: blood pressure increased.



Postmarketing Surveillance


Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following additional adverse drug reactions have been reported from worldwide postmarketing experience with Oxybutynin Chloride Extended Release Tablets: Psychiatric Disorders: psychotic disorder, agitation, hallucinations, memory impairment; Nervous System Disorders: convulsions; Cardiac Disorders: arrhythmia, tachycardia, QT interval prolongation; Vascular Disorders: flushing; Skin and Subcutaneous Tissue Disorders: rash; Renal and Urinary Disorders: impotence; General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment; Injury, poisoning and procedural complications: fall.


Additional adverse events reported with some other Oxybutynin Chloride formulations include: cycloplegia, mydriasis, and suppression of lactation.



Overdosage


The continuous release of oxybutynin from Oxybutynin Chloride Extended Release Tablets should be considered in the treatment of overdosage. Patients should be monitored for at least 24 hours. Treatment should be symptomatic and supportive. Activated charcoal as well as a cathartic may be administered.


Overdosage with Oxybutynin Chloride has been associated with anticholinergic effects including central nervous system excitation, flushing, fever, dehydration, cardiac arrhythmia, vomiting, and urinary retention.


Ingestion of 100 mg Oxybutynin Chloride in association with alcohol has been reported in a 13-year-old boy who experienced memory loss, and a 34-year-old woman who developed stupor, followed by disorientation and agitation on awakening, dilated pupils, dry skin, cardiac arrhythmia, and retention of urine. Both patients fully recovered with symptomatic treatment.



Oxybutynin Chloride Dosage and Administration


Oxybutynin Chloride Extended Release Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed.


Oxybutynin Chloride Extended Release Tablets may be administered with or without food.



Adults


The recommended starting dose of Oxybutynin Chloride Extended Release Tablets is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.



Pediatric Patients Aged 6 Years of Age and Older


The recommended starting dose of Oxybutynin Chloride Extended Release Tablets is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day).



How is Oxybutynin Chloride Supplied


Oxybutynin Chloride Extended Release Tablets are available containing 15 mg of Oxybutynin Chloride, USP. The 15 mg round, gray tablets are imprinted on one side with M over O 17. The 15 mg Oxybutynin Chloride Extended Release Tablets are supplied in bottles of 100 tablets.





15 mg100 count bottleNDC 0378-6015-01

Storage


Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from moisture and humidity.



Manufactured by:

ALZA Corporation, Vacaville, CA 95688


Placeholder for ALZA Corporation Logo


An ALZA OROS ® Technology Product


OROS® is a registered trademark of ALZA Corporation.


Manufactured for:

Mylan Pharmaceuticals Inc.

Morgantown, WV 26505


Placeholder for Mylan Pharmaceuticals Inc. Logo


10192702


Revised July 2011



PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label


NDC 0378-6015-01


MYLAN®


OXYBUTYNIN

CHLORIDE

EXTENDED-RELEASE

TABLETS

15 mg


100 TABLETS

Rx only










Oxybutynin Chloride 
Oxybutynin Chloride  tablet, extended release










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0378-6015
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Oxybutynin Chloride (oxybutynin)oxybutynin15 mg






















Inactive Ingredients
Ingredient NameStrength
cellulose acetate 
hypromelloses 
lactose 
magnesium stearate 
polyethylene glycols 
titanium dioxide 
polysorbate 80 
sodium chloride 
butylated hydroxytoluene 


















Product Characteristics
ColorGRAYScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeM;O;17
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10378-6015-01100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07829305/10/2007


Labeler - Mylan Pharmaceuticals Inc. (059295980)

Registrant - Johnson and Johnson Pharmaceutical Research and Development (119237597)









Establishment
NameAddressID/FEIOperations
PCAS France (API)396133998API MANUFACTURE









Establishment
NameAddressID/FEIOperations
ALZA Corporation (Product)175417641ANALYSIS, MANUFACTURE
Revised: 07/2011Mylan Pharmaceuticals Inc.

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Sunday 23 October 2011

Tyluvet




Tyluvet may be available in the countries listed below.


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Ingredient matches for Tyluvet



Tylosin

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International Drug Name Search

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