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Valacyclovir Hydrochloride (Valacyclovir Hydrochloride)

Trade Name : Valacyclovir Hydrochloride

NorthStar Rx 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 (Valacyclovir Hydrochloride) which is also known as Valacyclovir Hydrochloride and Manufactured by NorthStar Rx LLC. It is available in strength of 1 g/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

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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
  • Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for:n n n n
  • Pediatric Patients
  • Limitations of Use
  • The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients.
  • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacyclovir tablets. ()
  • 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 .
  • u00adHypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation. n
  • No data
  • Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS): Has occurred in patients with advanced HIV-1 disease and in allogenic bone marrow transplant and renal transplant patients receiving 8 grams per day of valacyclovir hydrochloride in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. n
  • Acute renal failure: May occur in elderly patients (with or without reduced renal function), patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir hydrochloride for their level of renal function, patients who receive concomitant nephrotoxic drugs, or inadequately hydrated patients. Use with caution in elderly patients and reduce dosage in patients with renal impairment. , n
  • Central nervous system adverse reactions (e.g., agitation, hallucinations, confusion, and encephalopathy): May occur in both adult and pediatric patients (with or without reduced renal function) and in patients with underlying renal disease who receive higher-than-recommended doses of valacyclovir hydrochloride for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. Use with caution in elderly patients and reduce dosage in patients with renal impairment. , n
  • 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 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 18 years was headache.
  • To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or .
  • The most common adverse reactions reported in at least one indication by greater than 10% of adult subjectsu00a0treated with valacyclovir hydrochloride and more commonly than in subjectsu00a0treated with placebo are headache, nausea, and abdominal pain. 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 (2.5 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 556 mg or 1.112 grams of valacyclovir hydrochloride USP (hydrous)u00a0equivalent to 500 mg oru00a01 gram of valacyclovir, respectively, 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)u00a0is 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 of 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
  • 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 2.3 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.
  • Mutagenesis
  • 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.
  • 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) 6 times 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, 500 mg
  • Bottles of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 16714-698-01 Bottles of 90u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 16714-698-03 Bottles ofu00a0100u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 16714-698-02
  • Valacyclovir Tablets USP, 1 gram
  • Bottles of 30u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 16714-697-01 Bottles of 90u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 16714-697-03 Bottles ofu00a0100u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 16714-697-02
  • Store at
  • Dispense in a well-closed container as defined in the USP.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Arrayn- Importance of Adequate Hydration
  • Patients should be advised to maintain adequate hydration.
  • Missed Dose
  • Instruct patients that if they miss a dose of valacyclovir hydrochloride, 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 1 day (2 doses) and that their doses should be taken about 12 hours apart. Patients should be informed that valacyclovir hydrochloride is not a cure for cold sores.
  • Arrayn- 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 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours 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 1 yearu2019s duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 monthsu2019 duration in HIV-1-infected patients.
  • Arrayn- Herpes Zoster
  • There are no data on treatment initiated more than 72 hours 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 for:u00a0u00a0 Northstar Rx LLCu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Memphis, TN 38141.n Manufactured by:u00a0 Aurobindo Pharma Limitedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Hyderabad-500 090, India.n M.L.No.: 19/HD/AP/95/F/Rn Revised: 02/2020
  • Valacyclovir Tablets, USP n n- (valu2019u2019 ay syeu2019 kloe vir)
  • What are valacyclovir tablets?
  • Valacyclovir tablets are a prescription medicine used in adults:
  • Valacyclovir tablets are used in children to treat:
  • Valacyclovir tablets do not cure
  • Do not take valacyclovir tablets
  • Before you take valacyclovir tablets, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take,
  • How should I take valacyclovir tablets?
  • u00a0
  • What are the possible side effects of valacyclovir tablets?
  • Valacyclovir tablets can cause serious side effects including:
  • Elderly people are more likely to get certain side effects. Talk to your healthcare provider if this is a concern for you.
  • The most common side effects of valacyclovir tablets in adults include:
  • The most common side effect of valacyclovir tablets in children less than 18 years of age is headache.
  • These are not all the possible side effects of valacyclovir tablets.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
  • How should I store valacyclovir tablets?
  • Keep valacyclovir tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of valacyclovir tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use valacyclovir tablets for a condition for which it was not prescribed. Do not give valacyclovir tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about valacyclovir tablets that is written for health professionals.
  • What are the ingredients in valacyclovir tablets?
  • u00a0
  • Active ingredient:
  • Inactive ingredients:
  • This Patent Information has been approved by the U.S. Food and Drug Administration.
  • u00a0Manufactured for:u00a0 Northstar Rx LLC u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Memphis, TN 38141.n Manufactured by:u00a0 Aurobindo Pharma Limitedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Hyderabad-500 090, India.n M.L.No.: 19/HD/AP/95/F/R Revised: 02/2020
  • No data
  • No data

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