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Alosetron Hydrochloride (Alosetron Hydrochloride)

Trade Name : Alosetron Hydrochloride

West-Ward Pharmaceuticals Corp.

TABLET

Strength 0.5 mg/1

ALOSETRON HYDROCHLORIDE Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]

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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 Alosetron Hydrochloride (Alosetron Hydrochloride) which is also known as Alosetron Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 0.5 mg/1 per ml. Read more

Alosetron Hydrochloride (Alosetron Hydrochloride) 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
  • Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride tablets. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death.
  • WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
  • See full prescribing information for complete boxed warning
  • Infrequent but serious gastrointestinal adverse reactions have been reported with the use of Alosetron Hydrochloride Tablets. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery, and death.
  • 2.1n- 5.1n- 5.2
  • Array
  • Alosetron hydrochloride tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
  • Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
  • Because of infrequent but serious gastrointestinal adverse reactions associated with alosetron hydrochloride tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.
  • Clinical studies have not been performed to adequately confirm the benefits of alosetron hydrochloride tablets in men.
  • Alosetron Hydrochloride Tablets are a selective serotonin 5-HT antagonist indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
  • Severe IBS includes diarrhea and 1 or more of the following:
  • No data
  • 0.5 mg and 1 mg tablets
  • Alosetron Hydrochloride Tablets USP, 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron), are white to off-white, round biconvex tablets, debossed with 54 628 on one side and plain on the other side.
  • Alosetron Hydrochloride Tablets USP, 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron), are white to off-white, round biconvex tablets, debossed with 54 974 on one side and plain on the other side.
  • Tablets: 0.5 and 1 mg
  • No data
  • No data
  • The following adverse reactions are described in more detail in other sections of the label:
  • Most common adverse reactions (incidence >2% and >placebo) in clinical studies were constipation, abdominal discomfort and pain, nausea, and gastrointestinal discomfort and pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or n
  • In vivo
  • 4.3n- 7.1
  • No data
  • 4.2n- 8.6
  • There is no specific antidote for overdose of alosetron hydrochloride tablets. Patients should be managed with appropriate supportive therapy. Individual oral doses as large as 16 mg have been administered in clinical studies without significant adverse reactions. This dose is 8 times higher than the recommended total daily dose. Inhibition of the metabolic elimination and reduced first pass of other drugs might occur with overdoses of alosetron hydrochloride tablets [n ].
  • The active ingredient in Alosetron Hydrochloride Tablets USP is alosetron hydrochloride (HCl), a potent and selective antagonist of the serotonin 5-HT receptor type. Chemically, alosetron is designated as 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one, hydrochloride. Alosetron hydrochloride is achiral and has the empirical formula CHNOu2022HCl, representing a molecular weight of 330.81. Alosetron hydrochloride is a white to beige solid that is soluble in water, sparingly soluble in methanol. The chemical structure of alosetron is:
  • Alosetron Hydrochloride Tablets USP are supplied for oral administration as 0.5 mg or 1 mg, white to off-white tablets. The 0.5 mg tablet contains 0.562 mg alosetron hydrochloride equivalent to 0.5 mg alosetron, and the 1 mg tablet contains 1.124 mg alosetron hydrochloride equivalent to 1 mg of alosetron. Each tablet also contains the inactive ingredients: lactose (anhydrous), magnesium stearate, pregelatinized starch and silicified microcrystalline cellulose.
  • No data
  • In 2-year oral studies, alosetron was not carcinogenic in mice at doses up to 30 mg/kg/day or in rats at doses up to 40 mg/kg/day. These doses are about 60 to 160 times, respectively, the recommended human dose of alosetron of 2 mg/day (1 mg twice daily) based on body surface area. Alosetron was not genotoxic in the Ames tests, the mouse lymphoma cell (L5178Y/TK) forward gene mutation test, the human lymphocyte chromosome aberration test, the rat hepatocyte unscheduled DNA synthesis (UDS) test, or the rat micronucleus test for mutagenicity. Alosetron at oral doses up to 40 mg/kg/day (about 160 times the recommended daily human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male or female rats.
  • No data
  • 1. Thompson WG, Creed F, Drossman DA, et al. Functional bowel disease and functional abdominal pain. . 1992;5:75-91.
  • Alosetron Hydrochloride Tablets USP
  • 0.5 mg (0.562 mg alosetron HCl equivalent to 0.5 mg alosetron) tablets are supplied as white to off-white, round, biconvex tablets with product identification u201c54u201d over u201c628u201d debossed on one side and plain on the other side.
  • NDC 0054-0295-13: Bottle of 30 Tablets with child-resistant closures.
  • 1 mg (1.124 mg alosetron HCl equivalent to 1 mg alosetron) tablets are supplied as white to off-white, round, biconvex tablets with product identification u201c54u201d over u201c974u201d debossed on one side and plain on the other side.
  • NDC 0054-0296-13: Bottle of 30 Tablets with child-resistant closures.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Protect from light and moisture.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Prescriber and Patient Responsibilities
  • Patients should be fully counseled on and understand the risks and benefits of alosetron hydrochloride tablets before an initial prescription is written. The patient may be educated by the prescriber or a healthcare provider under a prescriberu2019s direction.
  • Prescribers must:
  • Additional copies of the Medication Guide are available by contacting West-Ward Pharmaceuticals Corp. at 1-800-962-8364.
  • Patients who are prescribed alosetron hydrochloride tablets should be instructed to:
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10006481/04
  • Revised January 2020
  • Alosetron (a-LOW-zeh-tron) Hydrochloride Tablets USP
  • Rx only
  • Alosetron Hydrochloride Tablets, 0.5mg
  • NDC 0054-0295-13: Bottle of 30 Tablets
  • Rx only
  • Alosetron Hydrochloride Tablets, 1mg
  • NDC 0054-0296-13: Bottle of 30 Tablets
  • Rx only

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