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Lamivudine - Hbv (Epivir)

Trade Name : EPIVIR

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 100 mg/1

LAMIVUDINE Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]

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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 Lamivudine - Hbv (Epivir) which is also known as EPIVIR and Manufactured by GlaxoSmithKline LLC. It is available in strength of 100 mg/1 per ml. Read more

Lamivudine - Hbv (Epivir) 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

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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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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
  • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV). Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of antin- hepatitis B therapy may be warranted .
  • EPIVIR-HBV is not approved for the treatment of HIV-1 infection because the lamivudine dosage in EPIVIR-HBV is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B-infected patients with unrecognized or untreated HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with EPIVIRn- HBV and periodically during treatment n
  • WARNING: EXACERBATIONS OF HEPATITIS B and RISK OF HIV-1 RESISTANCE IF EPIVIR-HBV IS USED IN PATIENTS WITH UNRECOGNIZED OR UNTREATED HIV-1 INFECTION
  • See full prescribing information for complete boxed warning.
  • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy (including EPIVIR-HBV). Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. ()
  • EPIVIRn- HBV tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as EPIVIR tablets and oral solution used to treat HIV-1 infection. HIV-1 resistance may emerge in chronic hepatitis B patients with unrecognized or untreated HIV-1 infection because the lamivudine dosage in EPIVIRn- HBV is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection. HIV counseling and testing should be offered to all patients before beginning treatment with EPIVIRn- HBV and periodically during treatment. ()
  • No data
  • EPIVIR-HBV is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation n
  • The following points should be considered when initiating therapy with EPIVIR-HBV:
  • EPIVIR-HBV is a nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. ()
  • No data
  • No data
  • EPIVIR-HBV is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.
  • EPIVIR-HBV is contraindicated in patients with previous hypersensitivity reaction to lamivudine. ()
  • No data
  • 2.6n- 5.3
  • The following adverse reactions are discussed in other sections of the labeling:
  • The most common reported adverse reactions in those receiving EPIVIR-HBV (incidence greater than or equal to 10% and reported at a rate greater than placebo) were ear, nose, and throat infections; sore throat; and diarrhea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Sorbitol: Coadministration of lamivudine and sorbitol may result in decreased lamivudine concentrations; when possible, avoid chronic coadministration. Consider more frequent monitoring of HBV viral load when chronic coadministration cannot be avoided. ()
  • No data
  • There is no known specific treatment for overdose with EPIVIR-HBV. If overdose occurs, the patient should be monitored and standard supportive treatment applied, as required. Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.
  • EPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2u2032,3u2032-dideoxy, 3u2032-thiacytidine. It has a molecular formula of CHNOS and a molecular weight of 229.3 g per mol. It has the following structural formula:
  • Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70u00a0mg per mL in water at 20u00b0C.
  • EPIVIR-HBV tablets are for oral administration. Each tablet contains 100 mg of lamivudine and the inactive ingredients hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide.
  • EPIVIR-HBV oral solution is for oral administration. One milliliter (1 mL) of EPIVIR-HBV oral solution contains 5u00a0mg of lamivudine (5 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200u00a0mg).
  • No data
  • Carcinogenesis
  • Long-term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 34u00a0times (mice), and 113 and 187u00a0times (male and female rats, respectively) those observed in humans at the recommended therapeutic dose for chronic hepatitis B.
  • Mutagenesis
  • Lamivudine was mutagenic in an L5178Y mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes. Lamivudine was not mutagenic in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver.
  • Impairment of Fertility
  • Lamivudine did not affect male or female fertility in rats at oral doses up to 4,000u00a0mg per kg per day, associated with concentrations approximately 70 times (male) or 104 times (females) higher than the concentrations (C) in humans at the dose of 100u00a0mg .
  • No data
  • EPIVIR-HBV tablets contain 100u00a0mg of lamivudine, are butterscotch-colored, film-coated, biconvex, capsule-shaped tablets imprinted with u201cGX CG5u201d on one side. Packaged as follows:
  • Bottles of 60 tablets (NDC 0173-0662-00) with child-resistant closure.
  • Store EPIVIR-HBV tablets at 25u00b0C (77u00b0F); excursions permitted between 15u00b0C and 30u00b0C (59u00b0F and 86u00b0F) [see USP Controlled Room Temperature].
  • EPIVIRu2011HBV oral solution is a clear, colorless to pale yellow, strawberryu2011banana-flavored liquid. Each mL of the solution contains 5u00a0mg of lamivudine. Packaged as follows:
  • Plastic bottles of 240u00a0mL (NDC 0173-0663-00) with child-resistant closure. This product does not require reconstitution.
  • Store EPIVIR-HBV oral solution at controlled room temperature of 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F) (see USP) in tightly closed bottles.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment
  • Inform patients that discontinuation of anti-hepatitis B therapy, including EPIVIR-HBV, may result in severe acute exacerbations of hepatitis B including decompensation of liver disease. Advise patients not to discontinue EPIVIR-HBV without first informing their healthcare provider.
  • Risk of Development of HIV-1 Resistance in Patients with HIV-1 Co-infection
  • Counsel patients on the importance of testing for HIV to avoid inappropriate therapy and development of resistance to HIV. HIV counseling and testing should be offered before starting EPIVIR-HBV and periodically during therapy. Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, EPIVIR-HBV may increase the risk of development of resistance to HIV medications. Advise patients that EPIVIR-HBV contains a lower dose of the same active ingredient (lamivudine) as HIV drugs containing lamivudine .
  • Emergence of HBV Resistance
  • Inform patients that emergence of resistant hepatitis B virus and worsening of disease can occur during treatment. Patients should promptly report any new or worsening symptoms to their physician .
  • Lactic Acidosis/Severe Hepatomegaly with Steatosis
  • Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking EPIVIR-HBV if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity .
  • Hepatitis B Transmission
  • Advise patients that treatment with EPIVIRu2011HBV has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
  • Drug Interactions
  • Inform patients that EPIVIR-HBV may interact with some drugs; therefore, patients should be advised to report to their healthcare provider the use of any prescription or non-prescription medication or herbal products. Advise patients to avoid chronic use of sorbitol-containing prescription and over-the-counter medicines when possible. Taking EPIVIR-HBV with chronically administered sorbitol-containing medicines may decrease the concentrations of lamivudine .
  • Sucrose Content of EPIVIR-HBV Oral Solution
  • Advise diabetic patients that each 20u2011mL dose of EPIVIRu2011HBV oral solution contains 4u00a0grams of sucrose (1 mLu00a0=u00a0200 mg of sucrose) .
  • Pregnancy Registry
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EPIVIR-HBV during pregnancy .
  • Missed Dosage
  • Instruct patients that if they miss a dose of EPIVIR-HBV, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose .
  • EPIVIRu2011HBV is a trademark owned by or licensed to the GSK group of companies.
  • EPIVIR is a trademark owned by or licensed to the ViiV Healthcare group of companies.
  • u00a0
  • GlaxoSmithKlineResearch Triangle Park, NC 27709
  • Manufactured under agreement fromn n Basingstoke, UK
  • u00a92018 GSK group of companies or its licensor.
  • EPH:6PI
  • u00a0
  • PHARMACISTu2011DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
  • This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Revised: 11/2018
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0663-00
  • Epivir-HBVn
  • (lamivudine)
  • Oral Solution
  • 5 mg/mL
  • Each mL contains 5 mg of lamivudine.
  • R only
  • 240 mL
  • Made in Canada
  • u00a92015, the GSK group of companies
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0662-00
  • Epivir-HBVn
  • (lamivudine)
  • Tablets
  • 100 mg
  • 60 Tablets
  • Each tablet contains 100 mg of lamivudine.
  • R only
  • See prescribing information for dosage information.
  • Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F) [see USP Controlled Room Temperature].
  • Do not use if printed safety seal under cap is broken or missing.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Manufactured under agreement from n
  • Basingstoke, UK
  • Made in Canada
  • Epivir-HBV is a registered trademark

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