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Mesalamine (Delzicol)

Trade Name : Delzicol

Allergan, Inc.

CAPSULE, DELAYED RELEASE

Strength 400 mg/1

MESALAMINE Aminosalicylate [EPC],Aminosalicylic Acids [CS]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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 (Delzicol) which is also known as Delzicol and Manufactured by Allergan, Inc.. It is available in strength of 400 mg/1 per ml. Read more

Mesalamine (Delzicol) 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
  • DELZICOLu00a0is an aminosalicylate indicated for:
  • Treatment of mildly to moderately active ulcerative colitis in patientsu00a05 years of age and older ()n
  • Maintenance of remission of ulcerative colitis in adults ()
  • No data
  • DELZICOLu00a0(mesalamine) delayed-release capsules are clear capsules and imprinted u201cWC 400mgu201d in black ink. Each capsuleu00a0containsu00a0four reddish-brown coatedu00a0100 mg mesalamine tablets.u00a0
  • Delayed-release capsules (containing four 100 mg tablets): 400 mg ()
  • DELZICOLu00a0is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOLu00a0n n n n n n .
  • Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOLu00a0capsules (, )
  • No data
  • Renal Impairment:
  • Mesalamine-induced Acute Intolerance Syndrome:n- u00a0
  • Hypersensitivity Reactionsn- , including myocarditis and pericarditisn- :
  • Hepatic Failurn- :
  • The most serious adverse reactions seen in DELZICOLu00a0clinical trials or with other products that contain or are metabolized to mesalamine are:
  • The most common adverse reactions (u22655%) are
  • An- dultsn- :
  • Pn- ediatricn- sn- :
  • No data
  • Nephrotoxic n- An- gents n- including NSAIDs:
  • Azathioprine or 6-n- Mn- ercaptopurinen- :
  • No data
  • Geriatric Patients:
  • 8.5
  • There is no specific antidote for mesalamine overdose and treatment for suspected acute severe toxicity with DELZICOLu00a0should be symptomatic and supportive. This may include prevention of further gastrointestinal tract absorption, correction of fluid electrolyte imbalance, and maintenance of adequate renal function. DELZICOLu00a0is a pH dependent delayed-release product and this factor should be considered when treating a suspected overdose.
  • Each DELZICOLu00a0(mesalamine) delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. DELZICOLu00a0(mesalamine) delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate 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 (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is:
  • nttu00a0u00a0u00a0u00a0u00a0ntn
  • Inactive Ingredients
  • No data
  • No data
  • The safety and efficacy of DELZICOL 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
  • DELZICOLu00a0(mesalamine) delayed-release capsules are available as clear capsules and imprinted with u201cWC 400mgu201d in black ink. Each capsule contains four reddish-brown coated 100 mg mesalamine tablets.
  • NDCu00a0u00a0u00a00023-5853-18 Bottle of 180 capsules
  • Store at controlled room temperature 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0 F); excursions are permitted 15u00b0 to 30u00b0 C (59u00b0 to 86u00b0 F). [See USP Controlled Room Temperature]
  • Administration
  • Renal Impairment
  • Mesalamine-Induced Acute Intolerance Syndrome
  • Hypersensitivity Reactions
  • Hepatic Failure
  • Blood Disorders
  • Distributed by:Allergan USA, Inc.Madison, NJ 07940
  • u00a9 2019 Allergan.u00a0 All rights reserved.
  • Patented.u00a0 See
  • Delzicolu00ae is a registered trademark of Allergan Pharmaceuticalsu00a0International Limited.
  • V1.1USPI5853
  • PRINCIPAL DISPLAY PANEL
  • NDC 0023-5853-18Delzicol400 mg180 CapsulesRx Only

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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