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Valacyclovir Hydrochloride (Valtrex)

Trade Name : VALTREX

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 1 g/1

VALACYCLOVIR HYDROCHLORIDE DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],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 Valacyclovir Hydrochloride (Valtrex) which is also known as VALTREX and Manufactured by GlaxoSmithKline LLC. It is available in strength of 1 g/1 per ml. Read more

Valacyclovir Hydrochloride (Valtrex) 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

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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.

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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
  • VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:
  • Adult Patients ()
  • Pediatric Patients ()
  • Limitations of Use ()
  • The efficacy and safety of VALTREX have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1u2212infected patients.
  • Valacyclovir oral suspension (25u00a0mg/mL or 50u00a0mg/mL) can be prepared from the 500u00a0mg VALTREX tablets. ()
  • Tablets:
  • Tablets: 500u00a0mg (unscored), 1u00a0gram (partially scored) ()
  • VALTREX is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation .
  • Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation. ()
  • No data
  • 2.4n- 5.2
  • 2.4n- 5.3
  • The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • The most common adverse reactions reported in at least 1u00a0indication by greater than 10% of adult subjects treated with VALTREX and observed more frequently with VALTREX compared with placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in greater than 10% of pediatric subjects aged less than 18u00a0years was headache.
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No clinically significant drug-drug or drug-food interactions with VALTREX are known n
  • No data
  • Caution should be exercised to prevent inadvertent overdose . Precipitation of acyclovir in renal tubules may occur when the solubility (2.5u00a0mg/mL) is exceeded in the intratubular fluid. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored .
  • Valtrex (valacyclovir hydrochloride) is the hydrochloride salt of the u2011valyl ester of the antiviral drug acyclovir.
  • VALTREX tablets are for oral administration. Each tablet contains 556.2 mg or 1.112 grams of valacyclovir hydrochloride equivalent to 500u00a0mg or 1u00a0gram of valacyclovir, respectively, and the inactive ingredients carnauba wax, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbateu00a080, povidone, and titanium dioxide. The blue, filmu2011coated tablets are printed with edible white ink.
  • The chemical name of valacyclovir hydrochloride is -valine, 2-[(2-amino-1,6-dihydro-6-oxo-9-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:
  • Valacyclovir hydrochloride is a white to off-white powder with the molecular formula CHNOu2022HCl and a molecular weight of 360.80. The maximum solubility in water at 25u00b0C is 174u00a0mg/mL. The pks for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.
  • No data
  • The data presented below include references to the steadyu2011state acyclovir AUC observed in humans treated with 1u00a0gram of VALTREX given orally 3u00a0times a day to treat herpes zoster. Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir .
  • Carcinogenesis
  • Valacyclovir was noncarcinogenic in lifetime carcinogenicity bioassays at single daily doses (gavage) of valacyclovir giving plasma acyclovir concentrations equivalent to human levels in the mouse bioassay and 1.4 to 2.3u00a0times human levels in the rat bioassay. There was no significant difference in the incidence of tumors between treated and control animals, nor did valacyclovir shorten the latency of tumors.
  • Mutagenesis
  • Valacyclovir was tested in 5u00a0genetic toxicity assays. An Ames assay was negative in the absence or presence of metabolic activation. Also negative were an inu00a0vitro cytogenetic study with human lymphocytes and a rat cytogenetic study.
  • In the mouse lymphoma assay, valacyclovir was not mutagenic in the absence of metabolic activation. In the presence of metabolic activation (76% to 88% conversion to acyclovir), valacyclovir was mutagenic.
  • Valacyclovir was mutagenic in a mouse micronucleus assay.
  • Impairment of Fertility
  • Valacyclovir did not impair fertility or reproduction in male or female rats at acyclovir exposures (AUC) 6u00a0times higher than in humans given the MRHD. Testicular atrophy occurred in male rats (orally dosed for 97 days at 18 times the MRHD) and was reversible.
  • No data
  • VALTREX tablets (blue, filmu2011coated, capsuleu2011shaped tablets printed with u201cVALTREX 500u00a0mgu201d) containing 556.2 mg of valacyclovir hydrochloride equivalent to 500u00a0mg valacyclovir.
  • Bottle of 30 (NDC 0173-0933-08).
  • Bottle of 90 (NDC 0173-0933-10).
  • Unit dose pack of 100 (NDC 0173-0933-56).
  • VALTREX tablets (blue, filmu2011coated, capsuleu2011shaped tablets, with a partial scorebar on both sides, printed with u201cVALTREX 1u00a0gramu201d) containing 1.112 grams of valacyclovir hydrochloride equivalent to 1u00a0gram of valacyclovir.
  • Bottle of 30 (NDC 0173-0565-04).
  • Bottle of 90 (NDC 0173-0565-10).
  • Storage:
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F). Dispense in a well-closed container as defined in the USP.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Importance of Adequate Hydration
  • Patients should be advised to maintain adequate hydration.
  • Missed Dose
  • Instruct patients that if they miss a dose of VALTREX, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose.
  • Cold Sores (Herpes Labialis)
  • Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). Patients should be instructed that treatment for cold sores should not exceed 1u00a0day (2u00a0doses) and that their doses should be taken about 12u00a0hours apart. Patients should be informed that VALTREX is not a cure for cold sores.
  • Genital Herpes
  • Patients should be informed that VALTREX is not a cure for genital herpes. 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 in combination with suppressive therapy with VALTREX. Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Typeu2011specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSVu20112 acquisition exists.
  • VALTREX has not been shown to reduce transmission of sexually transmitted infections other than HSVu20112.
  • If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.
  • There are no data on the effectiveness of treatment initiated more than 72u00a0hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24u00a0hours after the onset of signs and symptoms of a recurrent episode.
  • There are no data on the safety or effectiveness of chronic suppressive therapy of more than 1u00a0yearu2019s duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6u00a0monthsu2019 duration in HIV-1u2212infected patients.
  • Herpes Zoster
  • There are no data on treatment initiated more than 72u00a0hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.
  • Chickenpox
  • Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox.
  • Trademark is owned by or licensed to the GSK group of companies.
  • Distributed by:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92019, GSK group of companies or its licensor.
  • VTX:7PI
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0PHARMACISTu2011DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
  • _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0933-08
  • Arrayn- VALTREX
  • (valacyclovir) TABLETS
  • 500 mg
  • 30 Tablets
  • R only
  • Equivalent to 556.2 mg valacyclovir hydrochloride per tablet.
  • See prescribing information for dosage information.
  • Store at 15 to 25C (59 to 77F).
  • Do not use if printed safety seal under cap is broken or missing.
  • Distributed by:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in India
  • Rev. 11/19
  • DFT-02241-4672081
  • PRINCIPAL DISPLAY PANEL
  • NDC 0173-0565-04
  • Arrayn- VALTREX
  • (valacyclovir) TABLETS
  • 1 gram
  • 30 Tablets
  • R only
  • Equivalent to 1.112 grams valacyclovir hydrochloride per tablet.
  • See prescribing information for dosage information.
  • Store at 15 to 25C (59 to 77F).
  • Do not use if printed safety seal under cap is broken or missing.
  • Distributed by:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • Made in India
  • Rev. 11/19
  • DFT-02241-4672079

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