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Valacyclovir Hydrochloride (Valacyclovir Hydrochloride)

Trade Name : Valacyclovir Hydrochloride

Major Pharmaceuticals

TABLET, FILM COATED

Strength 500 mg/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 (Valacyclovir Hydrochloride) which is also known as Valacyclovir Hydrochloride and Manufactured by Major Pharmaceuticals. It is available in strength of 500 mg/1 per ml. Read more

Valacyclovir Hydrochloride (Valacyclovir Hydrochloride) 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
  • Warnings and Precautions, Central Nervous System Effects u00a0u00a0u00a0u00a03/2010
  • Valacyclovir hydrochlorideu00a0is a nucleoside analogue DNA polymerase inhibitor indicated for:u00a0n n n n u00a0
  • Pediatric Patients
  • Limitations of Useu00a0
  • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacyclovir tablets. (2.3)
  • Tablets:
  • Tablets: 500 mg (unscored), 1 gram (partially scored) n
  • Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation .
  • u2011Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation. n
  • 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 1 indication by >10% of adult patients treated with valacyclovir hydrochloride and observed more frequently with valacyclovir hydrochloride compared to placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in >10% of pediatric patients <18 years of age was headache.
  • u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact Rising Health, LLC at 1-833-395-6928 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No clinically significant drug-drug or drug-food interactions with valacyclovir hydrochloride are known .
  • No data
  • Caution should be exercised to prevent inadvertent overdose . Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/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 .
  • Valacyclovir hydrochloride is the hydrochloride salt of the -valyl ester of the antiviral drug acyclovir.n Valacyclovir tablets, USPu00a0are for oral administration. Each tablet contains valacyclovir hydrochloride USP (hydrous)u00a0equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.n 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 USP (hydrous) is a white or almost white powder with the molecular formula CHNOu2022HCl and a molecular weight of 360.80. The maximum solubility in water at 25u00b0C is 174 mg/mL. The pks for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.
  • No data
  • The data presented below include references to the steady-state acyclovir AUC observed in humans treated with 1 gram valacyclovir hydrochloride given orally 3 times a day to treat herpes zoster. Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir .n 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 2.3 times 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.n Valacyclovir was tested in 5 genetic toxicity assays. An Ames assay was negative in the absence or presence of metabolic activation. Also negative were an cytogenetic study with human lymphocytes and a rat cytogenetic study.n 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.n Valacyclovir was mutagenic in a mouse micronucleus assay.n Valacyclovir did not impair fertility or reproduction in rats at 6 times human plasmau00a0levels.
  • No data
  • Valacyclovir Tablets USP, 500 mg are blue, film-coated, capsule shaped tablets with u201cF 82u201d on one side and plain on the other side.n Carton of 30 tablets (10 tablets each blister pack x 3) NDC 0904-6565-07u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0n Carton of 100 tablets (10 tablets each blister pack x 10) NDC 0904-6565-61n n n n 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.] n Dispense in a well-closed container as defined in the USP.
  • See .
  • Valacyclovir Tablets, USPn- (valu2019u2019 ay syeu2019 kloe vir)n- Array
  • Valacyclovir tablets used daily with the following safer sex practices can lower the chances of passing genital herpes to your partner.u00a0
  • Valacyclovir tablets are used in children:
  • Valacyclovir tablets do not cure herpes infectionsn- Arrayn- Cold sores n- Chickenpox n- Shingles n- Genital herpesn- safer sex practices
  • Ask your healthcare provider for more information about safer sex practices.n n n n n n if you are allergic to any of its ingredients or to acyclovir. The active ingredient is valacyclovir. See the end of this leaflet for a complete list of ingredients in valacyclovir tablets.n n n n n , including:
  • Arrayn- How should I take valacyclovir tablets?
  • Arrayn- Kidney failure and nervous system problems are not common, but can be serious in some patients taking valacyclovir tablets. n- Always tell your healthcare provider if you have kidney problems before taking valacyclovir tablets. Call your doctor right away if you get a nervous system problem while you are taking valacyclovir tablets.n- Talk to your healthcare provider if you develop any side effects that concern you.n- Array
  • Arrayn- Arrayn- Active Ingredient: n- Inactive Ingredients:
  • Distributed by:
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152
  • Refer to package label for Distributor's NDC Number
  • Made in India
  • Code: TS/DRUGS/19/1993
  • Revised: 11/2017
  • Valacyclovir Tablets, USP
  • 500 mg
  • 30 Tablets

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