Valacyclovir Hydrochloride (2 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- VALACYCLOVIR HYDROCHLORIDE
- VALTREX
Dosage and Administration
Valacyclovir tablets may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg valacyclovir tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration (2.3)] .
Contraindications
Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction [e.g., anaphylaxis, severe cutaneous adverse reactions (SCARs)] to valacyclovir, acyclovir, or any component of the formulation [see Warnings and Precautions (5.4), Adverse Reactions (6.3)] .
Adverse Reactions
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)] . Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.4)] . 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.
Drug Interactions
No clinically significant drug-drug or drug-food interactions with valacyclovir tablets are known [see Clinical Pharmacology (12.3)].
Mechanism of Action
Valacyclovir is an antiviral drug active against α-herpes viruses [see Microbiology (12.4)].
Overdosage
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)] .