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Famotidine (Pepcid)

Trade Name : Pepcid

Bausch Health Americas Inc.

TABLET, FILM COATED

Strength 20 mg/1

FAMOTIDINE Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]

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 Famotidine (Pepcid) which is also known as Pepcid and Manufactured by Bausch Health Americas Inc.. It is available in strength of 20 mg/1 per ml. Read more

Famotidine (Pepcid) 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
  • PEPCID tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
  • PEPCID tablets are indicated in adults for the:
  • reduction of the risk of duodenal ulcer recurrence.
  • PEPCID is a histamine-2 (H2) receptor antagonist indicated (1):
  • In adult and pediatric patients 40 kg and greater for the treatment of:
  • In adults for the:
  • No data
  • Tablets: 20 mg, 40 mg (3)
  • PEPCID is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists.
  • History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H2 receptor antagonists. (4)
  • No data
  • Central Nervous System (CNS) Adverse Reactions:
  • GI Malignancy:
  • The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. (6.1)
  • To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or n
  • No data
  • Drugs Dependent on Gastric pH for Absorption:
  • Tizanidine (CYP1A2) Substrate:
  • No data
  • The types of adverse reactions in overdosage of PEPCID are similar to the adverse reactions encountered with use of recommended dosages n
  • In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.
  • Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for PEPCID overdosage.
  • The active ingredient in PEPCID (famotidine) tablets is a histamine-2 (H2) receptor antagonist. Famotidine is -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]- 4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C8H15N7O2S3 and its molecular weight is 337.43. Its structural formula is:
  • Each PEPCID tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (modified corn starch), sodium starch glycolate, talc, titanium dioxide and triacetin.
  • Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.
  • No data
  • Carcinogenic potential of famotidine was assessed in a 106-week oral carcinogenicity study in rats and a 92-week oral carcinogenicity study in mice. In the 106-week study in rats and the 92-week study in mice at oral doses of up to 2000 mg/kg/ day (approximately 243 and 122 times, respectively, based on body surface area, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis), there was no evidence of carcinogenic potential for famotidine.
  • Famotidine was negative in the microbial mutagen test (Ames test) using and with or without rat liver enzyme activation at concentrations up to 10,000 mcg/plate. In studies in mice, with a micronucleus test and a chromosomal aberration test, no evidence of a mutagenic effect was observed.
  • In studies with rats given oral doses of up to 2000 mg/kg/day (approximately 243 times, based on body surface area, the recommended human dose of 80 mg per day) fertility and reproductive performance were not affected.
  • No data
  • PEPCID (famotidine) tablets are supplied as follows:
  • Storage
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container.
  • Central Nervous System (CNS) Adverse Reactions
  • Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy . Report symptoms immediately to a healthcare provider.
  • QT Prolongation
  • Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation . Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider.
  • Administration
  • Advise patients:
  • u2022 Take PEPCID once daily before bedtime or twice daily in the morning and before bedtime,
  • as recommended.
  • u2022 PEPCID may be taken with or without food.
  • u2022 PEPCID may be given with antacids.
  • Manufactured for:
  • Valeant Pharmaceuticals North America LLC
  • Bridgewater, NJ 08807 USA
  • Manufactured by:
  • Carlsbad Technology, Inc. Carlsbad, CA 92008
  • PEPCIDis a brand of McNeil Consumer Pharmaceuticals Co. used under license.
  • u00a9 Valeant Pharmaceuticals North America LLC
  • 9720101
  • NDC n- Rx only
  • Pepcidn- (Famotidine)n- Tablets, USP
  • 20 mg
  • 30 Tablets
  • VALEANT
  • NDC n- Rx only
  • Pepcidn- (Famotidine)n- Tablets, USP
  • 40 mg
  • 30 Tablets
  • VALEANT

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With shifting of pharma industry from synthetic molecules to biologic

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Clinical Trials Supply

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STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

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Pricing

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Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

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Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
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