Valacyclovir Hydrochloride (Valacyclovir Hydrochloride)

Trade Name : Valacyclovir Hydrochloride

Mylan Pharmaceuticals Inc.

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 Mylan Pharmaceuticals 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

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.

Read more
  • No data
  • Valacyclovir tablets are a deoxynucleoside analogue DNA polymerase inhibitor indicated for:
  • 1.1
  • 1.2
  • 1.3
  • The efficacy and safety of valacyclovir tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1u2013infected patients.
  • Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg valacylovir tablets. ()
  • Valacyclovir Tablets, USP are available containing 611.2 mg or 1222.4 mg of valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram of valacyclovir, respectively.
  • Tablets: 500 mg (unscored), 1 gram (partial break line) ()
  • 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 .
  • 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 1 indication by greater than 10% of adult subjects treated with valacyclovir tablets and observed more frequently with valacyclovir tablets 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
  • Mylan at 1-877-446-3679 (1-877-4-INFO-RX)
  • or FDA at 1-800-FDA-1088 or n
  • No clinically significant drug-drug or drug-food interactions with valacyclovir tablets are known n
  • No data
  • Caution should be exercised to prevent inadvertent overdose . Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 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.
  • Valacyclovir tablets, USP are for oral administration. Each tablet contains 611.2 mg or 1222.4 mg of valacyclovir hydrochloride equivalent to 500 mg or 1 gram of valacyclovir, respectively, and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide. The white, film-coated tablets are printed with edible black ink which contains black iron oxide, propylene glycol and shellac glaze.
  • 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 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 174 mg/mL. The pks for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.
  • Meets USP Dissolution Test 2.
  • No data
  • The data presented below include references to the steady-state acyclovir AUC observed in humans treated with 1 gram of valacyclovir tablets 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
  • No data
  • Valacyclovir Tablets, USP are available containing 611.2 mg or 1222.4 mg of valacyclovir hydrochloride, USP equivalent to 500 mg or 1 gram of valacyclovir, respectively.
  • The 500 mg tablets are white, film-coated, oval, unscored tablets with imprinted with black ink on one side of the tablet and plain on the other side of the tablet. They are available as follows:
  • NDC 0378-4275-93bottles of 30 tablets
  • NDC 0378-4275-77bottles of 90 tablets
  • The 1 gram tablets are white, film-coated, oval tablets with a partial break line on both sides of the tablet andu00a0imprinted with black ink on one side of the tablet. They are available as follows:
  • NDC 0378-4276-93bottles of 30 tablets
  • NDC 0378-4276-77bottles of 90 tablets
  • Storage: Store at 20u00ba to 25u00baC (68u00ba to 77u00baF). [See USP Controlled Room Temperature.]
  • Advise the patient to read the FDA-approved patient labeling ().
  • Importance of Adequate Hydration:
  • Missed Dose:
  • Cold Sores (Herpes Labialis):
  • Genital Herpes:
  • Valacyclovir tablets have 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-1u2013infected patients.
  • Herpes Zoster:
  • Chickenpox:
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • For more information, call Mylan at 1-877-446-3679 (1-877-INFO-RX).
  • Manufactured for:n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n Hyderabad u2014 500 096, India
  • 75074159
  • Revised: 2/2020MX:VLCY:R8pt/MX:PL:VLCY:R7pt
  • NDC 0378-4275-93
  • Valacyclovirn- Tablets, USPn- 500 mg
  • Rx onlyu00a0u00a0u00a030 Tablets
  • Each film-coated tablet contains 500 mgof valacyclovir equivalent to 611.2 mg ofvalacyclovir hydrochloride, USP per tablet.
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Do not use if safety seal under cap isbroken or missing.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX4275H6
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89
  • NDC 0378-4276-93
  • Valacyclovirn- Tablets, USPn- 1 gram
  • Rx onlyu00a0u00a0u00a0u00a0u00a030 Tablets
  • Each film-coated tablet contains 1 gramof valacyclovir equivalent to 1222.4 mg ofvalacyclovir hydrochloride, USP per tablet.
  • Usual Dosage:
  • Keep this and all medication out ofn- the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Do not use if safety seal under cap isbroken or missing.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX4276H6
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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