Valacyclovir hydrochloride 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 [see Adverse Reactions (6.3) ].
Valacyclovir hydrochloride 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 [see Adverse Reactions (6.3) ].
Valacyclovir hydrochloride tablets may be given without regard to meals. Labeling describing use of valacyclovir HCL in pediatric patients for whom a solid dosage form is not appropriate is approved for GlaxoSmithKline’s Valtrex ® * Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that information is not approved for this valacyclovir HCL tablet product.
Tablets: 500 mg: blue, film-coated, capsule-shaped tablets debossed with “ W PI ” on one side and “ 3248 ” on the other side. 1 gram: blue, film-coated, capsule-shaped tablets, with a partial scorebar on both sides, debossed with “ WPI ” on one side and “ 324 9 ” on the other side.
Caution should be exercised to prevent inadvertent overdose [see Use in Specific Populations (8.5) , (8.6) ]. 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 [see Dosage and Administration (2.4) ].
Valacyclovir hydrochloride tablets, equivalent to 500 mg of valacyclovir base, are blue, capsule-shaped, film-coated tablets debossed "SZ" on one side and 393 on the other side and are supplied as follows: Bottles of 3 NDC 75921-208-03 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
| Name | UNII | Kind |
|---|---|---|
| VALACYCLOVIR HYDROCHLORIDE | G447S0T1VC | ACTIM |
| CROSPOVIDONE | 68401960MK | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| POVIDONE K90 | RDH86HJV5Z | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Valacyclovir hydrochloride tablets may be given without regard to meals. Labeling describing use of valacyclovir HCL in pediatric patients for whom a solid dosage form is not appropriate is approved for GlaxoSmithKline’s Valtrex ® * Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that information is not approved for this valacyclovir HCL tablet product.
Tablets: 500 mg: blue, film-coated, capsule-shaped tablets debossed with “ W PI ” on one side and “ 3248 ” on the other side. 1 gram: blue, film-coated, capsule-shaped tablets, with a partial scorebar on both sides, debossed with “ WPI ” on one side and “ 324 9 ” on the other side.
Valacyclovir hydrochloride 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 [see Adverse Reactions (6.3) ].
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1) ]. Acute Renal Failure [see Warnings and Precautions (5.2) ]. Central Nervous System Effects [see Warnings and Precautions (5.3) ]. The most common adverse reactions reported in at least 1 indication by >10% of adult patients treated with valacyclovir hydrochloride tablets and observed more frequently with valacyclovir hydrochloride tablets compared to placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in >10% of pediatric patients
No clinically significant drug-drug or drug-food interactions with valacyclovir are known [see Clinical Pharmacology (12.3) ].
Caution should be exercised to prevent inadvertent overdose [see Use in Specific Populations (8.5) , (8.6) ]. 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 [see Dosage and Administration (2.4) ].
Valacyclovir hydrochloride is the hydrochloride salt of the L -valyl ester of the antiviral drug acyclovir. Valacyclovir hydrochloride tablets are blue, film-coated tablets for oral administration. Each tablet contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram valacyclovir and the inactive ingredients croscarmellose sodium, FD&C Blue #2, hydrogenated castor oil, hypromellose, polyethylene glycol, polysorbate 80, starch (corn), and titanium dioxide. The chemical name of valacyclovir hydrochloride is L -valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H -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 C 13 H 20 N 6 O 4 •HCland a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk a s for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.
Valacyclovir hydrochloride tablets, equivalent to 500 mg of valacyclovir base, are blue, capsule-shaped, film-coated tablets debossed "SZ" on one side and 393 on the other side and are supplied as follows: Bottles of 3 NDC 75921-208-03 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.
See FDA-Approved Patient Labeling for Valacyclovir Hydrochloride Tablets manufactured by Sandoz Inc.
Official SPL XML cached by FDA.report · DailyMed PDF
| Folder | File | Date |
|---|---|---|
| prescription | 396aa302-3785-46a0-8369-256f458ebcd3.xml | 2012-03-26 |
| prescription | VALACYCLOVIR 500MG.jpg | 2012-03-26 |
| prescription | valacyclovir-hydrochloride-tablets-1.jpg | 2012-03-26 |