Valacyclovir
Generic Name: valacyclovir
Brand Names:
Valacyclovir
11 DESCRIPTION Valacyclovir hydrochloride is the hydrochloride salt of the L -valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.0 mg or 1.112 grams of valacyclovir hydrochloride USP equivalent to 500 mg or 1 gm of valacyclovir, respectively, and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.
Overview
11 DESCRIPTION Valacyclovir hydrochloride is the hydrochloride salt of the L -valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556.0 mg or 1.112 grams of valacyclovir hydrochloride USP equivalent to 500 mg or 1 gm of valacyclovir, respectively, and the inactive ingredients crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.
Uses
1 INDICATIONS AND USAGE Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment in immunocompetent patients (initial or recurrent episode) • Suppression in immunocompetent or HIV-1-infected patients • Reduction of transmission • Herpes Zoster Pediatric Patients ( 1.2 ) • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use ( 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-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis).
Dosage
2 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 )].
Side Effects
6 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 and observed more frequently with valacyclovir compared with placebo are headache, nausea, and abdominal pain.
Interactions
7 DRUG INTERACTIONS No clinically significant drug-drug or drug-food interactions with valacyclovir are known [see Clinical Pharmacology ( 12.3 )].
Warnings
5 WARNINGS AND PRECAUTIONS • 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 in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. ( 5.1 ) • 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 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. 4 CONTRAINDICATIONS Valacyclovir tabletsare 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) ].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-2510 NDC: 50090-2510-0 10 TABLET, FILM COATED in a BOTTLE NDC: 50090-2510-1 14 TABLET, FILM COATED in a BOTTLE NDC: 50090-2510-2 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-2510-3 90 TABLET, FILM COATED in a BOTTLE Product: 50090-2575 NDC: 50090-2575-0 15 TABLET, FILM COATED in a BOTTLE NDC: 50090-2575-1 21 TABLET, FILM COATED in a BOTTLE NDC:...
Frequently Asked Questions
What is Valacyclovir used for?▼
1 INDICATIONS AND USAGE Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( 1.1 ) • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment in immunocompetent patients (initial or recurrent episode) • Suppression in immunocompetent or HIV-1-infected patients • Reduction of transmission • Herpes Zoster Pediatric Patients ( 1.2 ) • Cold Sores (Herpes Labialis) • Chickenpox Limitations of Use ( 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-1-infected patients. 1.1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis).
What are the side effects of Valacyclovir?▼
6 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 and observed more frequently with valacyclovir compared with placebo are headache, nausea, and abdominal pain.
What are the important warnings for Valacyclovir?▼
5 WARNINGS AND PRECAUTIONS • 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 in clinical trials. Discontinue treatment if clinical symptoms and laboratory findings consistent with TTP/HUS occur. ( 5.1 ) • 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 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. 4 CONTRAINDICATIONS Valacyclovir tabletsare 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) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.