Mesalamine (Mesalamine)

Trade Name : Mesalamine

Teva Pharmaceuticals USA, Inc.

CAPSULE, DELAYED RELEASE

Strength 400 mg/1

MESALAMINE Aminosalicylate [EPC],Aminosalicylic Acids [CS]

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Mesalamine (Mesalamine) which is also known as Mesalamine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 400 mg/1 per ml. Read more

Mesalamine (Mesalamine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Mesalamine delayed-release capsules are an aminosalicylate indicated for:
  • Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older ()
  • Maintenance of remission of ulcerative colitis in adults ()
  • 2.2
  • 2.3
  • Mesalamine delayed-release capsules are clear capsules imprinted with u201cTEVAu201d and u201c5907u201d on both the cap and the body in black ink. Each capsule contains four reddish-brown, film-coated 100 mg mesalamine tablets.
  • Delayed-release capsules (containing four 100 mg tablets): 400 mg ()
  • Mesalamine delayed-release capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release capsules n
  • Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release capsules (, )
  • No data
  • Renal Impairment:
  • Mesalamine-induced Acute Intolerance Syndrome:
  • Hypersensitivity Reactions, including myocarditis and pericarditis
  • Hepatic Failure:
  • The most serious adverse reactions seen in mesalamine clinical trials or with other products that contain or are metabolized to mesalamine are:
  • The most common adverse reactions (u2265 5%) are
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Adults:
  • Pediatrics:
  • No data
  • Nephrotoxic Agents including NSAIDs:
  • Azathioprine or 6-Mercaptopurine:
  • No data
  • Geriatric Patients:
  • 8.5
  • There is no specific antidote for mesalamine overdose and treatment for suspected acute severe toxicity with mesalamine should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintenance of adequate renal function. Mesalamine delayed-release capsules are a pH dependent delayed-release product and this factor should be considered when treating a suspected overdose.
  • Each mesalamine delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. Mesalamine delayed-release capsules contain acrylic based resin, methacrylic acid copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine, USP (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is:
  • CHNO M.W. 153.14
  • Inactive Ingredients:
  • No data
  • No data
  • The safety and efficacy of mesalamine has been established based on adequate and well-controlled studies of mesalamine delayed-release tablets. Below is a description of the results of the adequate and well-controlled studies of mesalamine delayed-release tablets for the treatment of mildly to moderately active ulcerative colitis in adults and pediatric patients 5 to 17 years of age and the maintenance of remission of ulcerative colitis in adults.
  • No data
  • Mesalamine delayed-release capsules are available as clear capsules imprinted with u201cTEVAu201d and u201c5907u201d on both the cap and the body in black ink. Each capsule contains four reddish-brown film-coated 100 mg mesalamine tablets.
  • NDC 0093-5907-86 Bottle of 180 capsulesn
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [See USP Controlled Room Temperature].
  • Administration
  • Renal Impairment
  • Mesalamine-Induced Acute Intolerance Syndrome
  • Hypersensitivity Reactions
  • Hepatic Failure
  • Blood Disorders
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. A 1/2018
  • NDC 0093-5907-86
  • Mesalamine Delayed-Release Capsules
  • 400 mg
  • Swallow the capsule or tablets whole; do not cut, break, crush or chew the capsule or tablets. The capsule may be carefully opened and the contents (tablets) can be swallowed.
  • Not Bioequivalent to Asacol HDn
  • Rx only
  • 180 CAPSULES
  • TEVA

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