VALTREX 1 g/1

valacyclovir hydrochloride · TABLET, FILM COATED · GlaxoSmithKline LLC

No Recall History

Plain English

VALTREX is a tablet, film coated containing valacyclovir hydrochloride at 1 g/1, taken oral. Manufactured by GlaxoSmithKline LLC.

Key Facts

Brand Name: VALTREX
Generic Name: valacyclovir hydrochloride
NDC Code (Product): 0173-0565
Manufacturer: GlaxoSmithKline LLC
Strength: 1 g/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020487
Marketing Start: 08/12/2002

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,733 reports

nausea2,687 reports

fatigue2,591 reports

off label use2,357 reports

diarrhoea2,177 reports

pyrexia1,991 reports

headache1,989 reports

pain1,786 reports

dizziness1,579 reports

vomiting1,529 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VALTREX 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 VALTREX 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) VALTREX is indicated for treatment of cold sores (herpes labialis). The efficacy of VALTREX initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established. Genital Herpes Initial Episode: VALTREX is indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with VALTREX when initiated more than 72 hours after the onset of signs and symptoms has not been established. Recurrent Episodes: VALTREX is indicated for treatment of recurre…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION VALTREX may be given without regard to meals. Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) may be prepared extemporaneously from 500-mg VALTREX tablets for use in pediatric patients for whom a solid dosage form is not appropriate [see Dosage and Administration ( 2.3 )] . Adult Dosage ( 2.1 ) Cold Sores 2 grams every 12 hours for 1 day Genital Herpes Initial episode 1 gram twice daily for 10 days Recurrent episodes 500 mg twice daily for 3 days Suppressive therapy Immunocompetent patients 1 gram once daily Alternate dose in patients with less than or equal to 9 recurrences/year 500 mg once daily HIV-1−infected patients 500 mg twice daily Reduction of transmission 500 mg once daily Herpes Zoster 1 gram 3 times daily for 7 days Pediatric Dosage ( 2.2 ) Cold Sores (aged greater than or equal to 12 years) 2 grams every 12 hours for 1 day Chickenpox (aged 2 to less than 18 years) 20 mg/kg 3 times daily for 5 days; not to exceed 1 gram 3 times daily Valacyclovir oral suspension (25 mg/mL or 50 mg/mL) can be prepared from the 500 mg VALTREX tablets. ( 2.3 ) 2.1 Adult Dosing Recommendations Cold Sores (Herpes Labialis) The recommended dosage of VALTREX for…

Contraindications

4 CONTRAINDICATIONS VALTREX is 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 )] . Hypersensitivity to valacyclovir (e.g., anaphylaxis), acyclovir, or any component of the formulation. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS No clinically significant drug-drug or drug-food interactions with VALTREX are known [see Clinical Pharmacology ( 12.3 )].

Adverse Reactions

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 VALTREX and observed more frequently with VALTREX 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. The most common adverse reactions reported in at least one indication by greater than 10% of adult subjects treated with VALTREX and more commonly than in subjects treated with placebo are headache, nausea, and abdominal pain. ( 6.1 ) The only adverse reaction occurring in greater than 10% of pediatric subjects aged less than 18 years was headache. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmi…

Frequently Asked Questions

What is VALTREX used for?

VALTREX contains valacyclovir hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is VALTREX a controlled substance?

VALTREX is not classified as a controlled substance by the DEA.

What is the generic name for VALTREX?

The generic name for VALTREX is valacyclovir hydrochloride. There are 11 other brand versions of valacyclovir hydrochloride.

What is the NDC code for VALTREX 1 g/1?

The NDC (National Drug Code) for VALTREX 1 g/1 is 0173-0565, listed by GlaxoSmithKline LLC.

Product NDC

0173-0565

Package NDC

0173-0565-04

Other Valacyclovir Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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