Trade Name: Mesalamine Rectal

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amring Pharmaceuticals Inc.

Presentation: SUPPOSITORY, HUMAN PRESCRIPTION DRUG

Strength: 1000 mg/1

Storage and handling

MESALAMINE Aminosalicylate [EPC],Aminosalicylic Acids [CS]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
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  • Mesalamine Rectal Suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
  • Mesalamine Rectal Suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. ()
  • Dosage
  • Administration Instructions:
  • Dosage
  • Administration Instructions:
  • Evaluate renal function prior to initiation of Mesalamine Rectal Suppositories and periodically while on therapy. (, )
  • Do not cut or break the suppository. ()
  • Drink an adequate amount of fluids. (, )
  • Retain the suppository for one to three hours or longer, if possible. ()
  • Mesalamine Rectal Suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel. Keep Mesalamine Rectal Suppositories away from these surfaces to prevent staining. ()
  • Mesalamine Rectal Suppository: 1000 mg mesalamine in a torpedo shaped, white to beige suppository.
  • Suppository: 1000 mg ()
  • Mesalamine Rectal Suppositories are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle .
  • Known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the formulation. (, )
  • No data
  • Renal Impairment
  • Mesalamine-Induced Acute Intolerance Syndrome
  • Hypersensitivity Reactions, including Myocarditis and Pericarditis:
  • Hepatic Failure:
  • Photosensitivity:
  • Nephrolithiasis
  • Interaction with Laboratory Test for Urinary Normetanephrine
  • The following serious or clinically significant adverse reactions are described elsewhere in labeling:
  • The most common adverse reactions (u2265 1%) are: dizziness, rectal pain, fever, rash, acne and colitis. ()n
  • To report SUSPECTED ADVERSE REACTIONS, contact Amring Pharmaceuticals Inc. at 1-844-Amring1 (1-844-267-4641) or FDA at 1-800-FDA-1088 or n
  • No data
  • Nephrotoxic Agents including NSAIDs:
  • Azathioprine or 6-Mercaptopurine:
  • No data
  • u2022
  • Geriatric Patients:
  • 8.5
  • Mesalamine absorption from the colon is limited; however, Mesalamine Rectal Suppositories are an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) involvement. There is no specific antidote for mesalamine overdose. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.
  • The active ingredient in Mesalamine Rectal Suppository 1000 mg suppositories for rectal use is mesalamine, also known as mesalazine or 5- aminosalicylic acid (5-ASA). Chemically, mesalamine is 5-amino-2-hydroxybenzoic acid, and is classified as an aminosalicylate. Each Mesalamine Rectal Suppository contains 1000 mg of mesalamine (USP) in a base of Hard Fat, NF.
  • The empirical formula is CHNO, representing a molecular weight of 153.14. The structural formula is:
  • No data
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  • Two double-blind, placebo-controlled, multicenter trials of mesalamine suppositories were conducted in North America in adult patients with mildly to moderately active ulcerative proctitis. The regimen in Study 1 was a 500 mg mesalamine suppository administered rectally three times daily and in Study 2 was a 500 mg mesalamine suppository administered rectally twice daily. In both trials, patients had an average extent of proctitis (upper disease boundary) of approximately 10 cm and approximately 80% of patients had multiple prior episodes of proctitis. A total of 173 patients were evaluated (Study 1, N=79; Study 2, N=94), of which 89 patients received mesalamine, and 84 patients received placebo. The mean age of patients was 39 years (range 17 to 73 years), 60% were female, and 97% were white.
  • The primary measures of efficacy were clinical disease activity index (DAI) and histologic evaluations in both trials. The DAI is a composite index reflecting rectal bleeding, stool frequency, mucosal appearance at endoscopy, and a physicianu2019s global assessment of disease. Patients were evaluated clinically and sigmoidoscopically after 3 and 6 weeks of treatment.
  • Compared to placebo, mesalamine suppositories were statistically (p<0.01) superior to placebo in both trials with respect to improvement in stool frequency, rectal bleeding, mucosal appearance, disease severity, and overall disease activity after 3 and 6 weeks of treatment. The effectiveness of mesalamine suppositories was statistically significant irrespective of sex, extent of proctitis, duration of current episode, or duration of disease.
  • An additional multicenter, open-label, randomized, parallel group study in 99 patients diagnosed with mildly to moderately ulcerative proctitis compared 1000 mg Mesalamine Rectal Suppositories administered rectally once daily at bedtime (N=35) to 500 mg mesalamine suppository administered rectally twice daily, in the morning and at bedtime (N=46), for 6 weeks.
  • The primary measures of efficacy included the clinical disease activity index (DAI) and histologic evaluations. Patients were evaluated clinically and sigmoidoscopically at 3 and 6 weeks of treatment.
  • The efficacy at 6 weeks was not different between the treatment groups. Both were effective in the treatment of ulcerative proctitis and resulted in a significant decrease at 6 weeks in DAI: in the mesalamine 500 mg twice daily group, the mean DAI value decreased from 6.6 to 1.6, and in the 1000 mg at bedtime group, the mean DAI value decreased from 6.2 to 1.3, which represents a decrease of greater than 75% in both groups. After 6 weeks of treatment, a DAI score of less than 3 was achieved in 78% of patients in the mesalamine 500 mg twice daily group and 86% of patients in the Mesalamine Rectal Suppositories 1000 mg once daily group. The recommended dosage of Mesalamine Rectal Suppository is 1000 mg administered rectally once daily at bedtime .
  • Mesalamine Rectal Suppositories 1000 mg for rectal administration are available as torpedo shaped, white to beige suppositories containing 1000 mg mesalamine supplied in boxes of 30 (NDC 69918-560-30).
  • Store below 25u00baC (77u00baF), may be refrigerated. Keep away from direct heat, light or humidity.
  • Advise patients to read the FDA-approved patient labeling (Patient Information)
  • Administration n
  • Renal Impairment
  • Mesalamine-Induced Acute Intolerance Syndrome and Other Hypersensitivity Reactions
  • Hepatic Failure
  • Photosensitivity
  • Nephrolithiasis
  • Blood Disorders
  • Manufactured for:n Amring Pharmaceuticals Inc.n Berwyn, PA 19312n www.amringusa.comn n n n The Amring Logo and the u201cAu201d Logo are trademarks of Amring Pharmaceuticals, Inc.n n Manufactured by:n Confab Laboratories Inc.n St-Hubert, Canada J3Y 3X3
  • Origin Canada
  • n For more information, call 1-844-Amring1 (1-844-267-4641) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: 10/2020 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0301944-04
  • Manufactured for:n Amring Pharmaceuticals Inc.n Berwyn, PA 19312n www.amringusa.comn n n n The Amring Logo and the u201cAu201d Logo are trademarks of Amring Pharmaceuticals, Inc.n n Manufactured by:n Confab Laboratories Inc.n St-Hubert, Canada J3Y 3X3
  • Origin Canada
  • n For more information, call 1-844-Amring1 (1-844-267-4641).n This Patient Information has been approved by the U.S. Food and Drug Administration. u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: 10/2020
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0301944-04
  • NDCn- 560n- Rx Only
  • Mesalamine Rectal Suppositories
  • 1000 mg
  • For Rectal Use Only
  • 30 Suppositories
  • Mesalamine Rectal Suppository, 1000 mg
  • Store below 25u00b0C (77u00b0F), may be refrigerated.
  • Rev. 07/2019I6104-02

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Mesalamine (Mesalamine Rectal) which is also known as Mesalamine Rectal and Manufactured by Amring Pharmaceuticals Inc.. It is available in strength of 1000 mg/1.

Mesalamine (Mesalamine Rectal) 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.

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