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Famotidine (Famotidine)

Trade Name : Famotidine

Teva Pharmaceuticals USA, 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 (Famotidine) which is also known as Famotidine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 20 mg/1 per ml. Read more

Famotidine (Famotidine) 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.

Read more
  • No data
  • Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
  • Famotidine tablets are indicated in adults for the:
  • Famotidine tablets are a histamine-2 (H) receptor antagonist indicated ):
  • In adult and pediatric patients 40 kg and greater for the treatment of:
  • A
  • d
  • m
  • inistration ():
  • Tablets: 20 mg, 40 mg ()
  • Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H) receptor antagonists.
  • History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H receptor antagonists. ()
  • No data
  • Central Nervous System (CNS) Adverse Reactions:
  • GI Malignancy
  • The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Drugs Dependent on Gastric pH for Absorption:
  • Tn- izanidine (CYP1A2) Substrate:
  • See 17 for Patient Counseling Informationn
  • Geriatric Use:
  • Renal Impairment:
  • The types of adverse reactions in overdosage of famotidine tablets 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.n
  • 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 famotidine tablets overdosage.n
  • The active ingredient in Famotidine Tablets USP is a histamine-2 (H) receptor antagonist. Famotidine, USP is [1-Amino-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propylidene] sulfamide and has the following structural formula:
  • CHNOSu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0M.W. 337.45
  • Famotidine, USP 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.n
  • 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.n
  • 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.n
  • No data
  • Famotidine Tablets USP, 20 mg are available as beige, round, unscored, film-coated tablets, debossed with u201c5728u201d on one side and u201cTEVAu201d on the other side, containing 20 mg famotidine, packaged in bottles of 100 (NDC 0172-5728-60), 500 (NDC 0172-5728-70) and 1000 (NDC 0172-5728-80) tablets.n
  • Famotidine Tablets USP, 40 mg are available as tan, round, unscored, film-coated tablets, debossed with u201c5729u201d on one side and u201cTEVAu201d on the other side, containing 40 mg famotidine, packaged in bottles of 100 (NDC 0172-5729-60) and 500 (NDC 0172-5729-70) tablets.n
  • Dispense in a well-closed, light-resistant container as defined in the USP, with a child-resistant closure (as required).n
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].n
  • Avoid storage of famotidine tablets at temperatures above 40u00b0C (104u00b0F).n
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.n
  • 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.n
  • QT Prolongation
  • Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation n . Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider.n
  • Administration
  • Advise patients:n
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. F 1/2019n
  • Arrayn- Array
  • Arrayn- Famotidine Tablets USP 20mg 100s Label Text
  • NDCn- 5728
  • Famotidineu00a0Tablets USPu00a020 mg
  • Rx only
  • 100 TABLETS
  • TEVA
  • Famotidine Tablets USP 40mg 100s Label Text
  • NDCn- 5729
  • Famotidineu00a0Tablets USPu00a040 mg
  • Rx only
  • 100 TABLETS
  • TEVA

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Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

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Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

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Validated Cold Chain Shipment

Validated Cold Chain Shipment

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Clinical Trials Supply

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Pharmaceutical Contract Manufacturing

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