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Famciclovir (Famciclovir)

Trade Name : Famciclovir

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 125 mg/1

FAMCICLOVIR DNA Polymerase Inhibitors [MoA],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]

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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 Famciclovir (Famciclovir) which is also known as Famciclovir and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 125 mg/1 per ml. Read more

Famciclovir (Famciclovir) 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
  • Famciclovir tablets, a prodrug of penciclovir, are a deoxynucleoside analog DNA polymerase inhibitor indicated for:
  • Immunocompetent Adult Patients
  • Human Immunodeficiency Virus (HIV)
  • 1.2
  • Limitation of Use
  • The efficacy and safety of famciclovir tablets have not been established for:
  • Famciclovir tablets may be taken with or without food.
  • Patients with renal impairment: Adjust dose based on creatinine clearance. ()
  • Famciclovir Tablets are available in three strengths:
  • Tablets: 125 mg, 250 mg, 500 mg ()
  • Famciclovir is contraindicated in patients with known hypersensitivity to the product, its components, or Denavir(penciclovir cream).
  • Known hypersensitivity to the product, its components, or Denavir (penciclovir cream). ()
  • Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir for their level of renal function. Dosage reduction is recommended when administering famciclovir to patients with renal impairment [see]n n
  • Acute renal failure: May occur in patients with underlying renal disease who receive higher than recommended doses of famciclovir for their level of renal function. Reduce dosage in patients with renal impairment. (, )
  • Acute renal failure is discussed in greater detail in other sections of the label [see]n
  • The most common adverse events reported in at least 1 indication by greater than 10% of adult patients treated with famciclovir are headache and nausea.
  • The most common adverse events reported in at least 1 indication by greater than 10% of adult patients are headache and nausea. ()
  • 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.
  • Probenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity. ()
  • No data
  • Appropriate symptomatic and supportive therapy should be given. Penciclovir is removed by hemodialysis.
  • Famciclovir Tablets contain famciclovir, USP, an orally administered prodrug of the antiviral agent penciclovir. Chemically, famciclovir, USP is known as 2-[2-(2-amino-9-purin-9-yl)ethyl]-1,3-propanediol diacetate. It is a synthetic acyclic guanine derivative and has the following structure:
  • CHNO M.W. 321.3
  • Famciclovir, USP is a white to pale yellow solid. It is freely soluble in acetone and methanol, and sparingly soluble in ethanol and isopropanol. At 25u00b0C famciclovir, USP is freely soluble (greater than 25% w/v) in water initially, but rapidly precipitates as the sparingly soluble (2% to 3% w/v) monohydrate. Famciclovir, USP is not hygroscopic below 85% relative humidity. Partition coefficients are: octanol/water (pH 4.8) = 1.09 and octanol/phosphate buffer (pH 7.4) = 2.08.
  • Each white, film-coated tablet contains famciclovir, USP. The 125 mg and 250 mg tablets are round; the 500 mg tablets are capsule-shaped. Inactive ingredients consist of croscarmellose sodium, hydroxypropyl cellulose, hypromellose, polydextrose, polyethylene glycol, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide, and triacetin.
  • No data
  • Carcinogenesis:
  • Mutagenesis:
  • in vitro
  • in vivo
  • in vitro
  • S. typhimurium
  • E. coli
  • in vivo
  • in vitro
  • in vivo
  • Impairment of fertility:
  • Famciclovir had no effect on general reproductive performance or fertility in female rats at doses up to 1000 mg/kg/day (2.7 to 10.8x the human AUC).
  • No data
  • Famciclovir Tablets are supplied as follows:
  • 125 mg u2013 White, round, film-coated, unscored tablets, debossed with u201c8117u201d on one side and u201c93u201d on the other side. Available in bottles of 30 (NDC 0093-8117-56).
  • 250 mg u2013 White, round, film-coated, unscored tablets, debossed with u201c8118u201d on one side and u201c93u201d on the other side. Available in bottles of 30 (NDC 0093-8118-56).
  • 500 mg u2013 White, capsule-shaped, film-coated, unscored tablets, debossed with u201c8119u201d on one side and u201c93u201d on the other side. Available in bottles of 30 (NDC 0093-8119-56).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • There is no evidence that famciclovir will affect the ability of a patient to drive or to use machines. However, patients who experience dizziness, somnolence, confusion or other central nervous system disturbances while taking famciclovir should refrain from driving or operating machinery.
  • Herpes Labialis (Cold Sores)
  • Patients should be advised to initiate treatment at the earliest sign or symptom of a recurrence of cold sores (e.g., tingling, itching, burning, pain, or lesion). Patients should be instructed that treatment for cold sores should not exceed 1 dose. Patients should be informed that famciclovir is not a cure for cold sores.
  • Genital Herpes
  • Patients should be informed that famciclovir is not a cure for genital herpes. There are no data evaluating whether famciclovir will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices.
  • If episodic therapy for recurrent genital herpes is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.
  • There are no data on safety or effectiveness of chronic suppressive therapy of longer than 1-year duration.
  • Herpes Zoster (Shingles)
  • There are no data on treatment initiated more than 72 hours after onset of zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In Canada By:n Toronto, Canada M1B 2K9
  • Manufactured For:n North Wales, PA 19454
  • Rev. J 12/2018
  • No data
  • No data
  • No data
  • No data

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