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Valacyclovir Hydrochloride (Valacyclovir Hydrochloride)

Trade Name : Valacyclovir Hydrochloride

Sandoz Inc

TABLET

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 Sandoz Inc. 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

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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
  • Valacyclovir tablets are deoxynucleoside analogue DNA polymerase inhibitor indicated for:
  • 1.1
  • 1.2
  • 1.3
  • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacyclovir tablets. ()
  • Valacyclovir tablets, equivalent to 500 mg of valacyclovir base, are blue, capsule-shaped, coated tablets debossed u201cSZu201d on one side and 393 on the other side.
  • Valacyclovir tablets, equivalent to 1 gm of valacyclovir base, are blue, capsule-shaped, coated tablets debossed u201cSZu201d on one side and 394 on other side with partial score bar on both sides
  • Tablets: 500 mg (unscored), 1 gram (partially scored) ()
  • 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 n n n
  • 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 valacyclovir hydrochloride and observed more frequently with valacyclovir hydrochloride 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 Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n
  • 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 (2.5u00a0mg/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 n
  • Valacyclovir hydrochloride is the hydrochloride salt of the -valyl ester of the antiviral drug acyclovir.
  • Valacyclovir tablets, USP are for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500u00a0mg or 1u00a0gram valacyclovir. In addition, each tablet contains the following inactive ingredients: crospovidone, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone and titanium dioxide.
  • 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 steady-state acyclovir AUC observed in humans treated with 1u00a0gram of valacyclovir hydrochloride given orally 3u00a0times a day to treat herpes zoster. Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir n
  • 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 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
  • Valacyclovir tablets, USP, equivalent to 500 mg of valacyclovir base, are blue, capsule-shaped, film-coated tablets debossed u201cSZu201d on one side and 393 on the other side and are supplied as follows:.
  • NDC 0781-5208-31 in bottles of 30 tablets with child-resistant closure
  • NDC 0781-5208-92 in bottles of 90 tablets with child-resistant closure
  • NDC 0781-5208-01 in bottles of 100 tablets with child-resistant closure
  • NDC 0781-5208-05 in bottles of 500 tablets
  • NDC 0781-5208-13 carton of 100 tablets (10 x 10 Unit-dose)
  • Valacyclovir tablets, USP, equivalent to 1 gm of valacyclovir base, are blue, capsule-shaped, film-coated tablets debossed u201cSZu201d on one side and 394 on other side with partial score bar on both sides and are supplied as follows:
  • NDC 0781-5209-27 in bottles of 21 tablets with child-resistant closure
  • NDC 0781-5209-31 in bottles of 30 tablets with child-resistant closure
  • NDC 0781-5209-92 in bottles of 90 tablets with child-resistant closure
  • NDC 0781-5209-01 in bottles of 100 tablets with child-resistant closure
  • NDC 0781-5209-05 in bottles of 500 tablets
  • NDC 0781-5209-13 carton of 100 tablets (10 x 10 Unit-dose)
  • Storage
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [see USP Controlled Room Temperature]. Protect from moisture.
  • 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 valacyclovir tablets, 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 valacyclovir hydrochloride is not a cure for cold sores.
  • Genital Herpes
  • Patients should be informed that valacyclovir hydrochloride 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 valacyclovir hydrochloride. Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists.
  • Valacyclovir hydrochloride has not been shown to reduce transmission of sexually transmitted infections other than HSV-2.
  • 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-1u02d7infected 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.
  • Manufactured in India by Sandoz Private Limited
  • for Sandoz Inc., Princeton, NJ 08540
  • Valacyclovir Tablets, USP
  • (val ay syeu2019 kloe veer)
  • This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: January 2020
  • NDC
  • Valacyclovir Tablets, USP
  • 500 mg*
  • Rx Onlyn- 30 Tablets
  • PHARMACIST:
  • NDC
  • Valacyclovir Tablets, USP
  • 1 gm*
  • Rx only 30 Tablets
  • PHARMACIST:

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