Drugplain

Valacyclovir Hydrochloride 500 mg/1

Valacyclovir Hydrochloride · TABLET, FILM COATED · PD-Rx Pharmaceuticals, Inc.

1 Recall on Record
Plain English

Valacyclovir Hydrochloride is a tablet, film coated containing valacyclovir hydrochloride at 500 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..

Key Facts

Brand Name
Valacyclovir Hydrochloride
Generic Name
Valacyclovir Hydrochloride
NDC Code (Product)
72789-264
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA090682
Marketing Start
05/24/2010

Recall History

1 Recall on Record
Class II11/08/2013

Teva Pharmaceuticals USA, Inc.

Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use2,619 reports
fatigue2,366 reports
diarrhoea2,161 reports
drug ineffective1,949 reports
nausea1,899 reports
febrile neutropenia1,592 reports
pyrexia1,534 reports
pneumonia1,490 reports
headache1,415 reports
pain1,329 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Valacyclovir tablets are 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). The efficacy of valacyclovir tablets 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 Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not bee…

Dosage & Administration

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) ] . 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 valacyclovir tablets. ( 2.3 ) 2.1 Adult Dosing Recommendations Cold Sores (Herpes Labialis) The recommended…

Contraindications

4 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) ] . 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 valacyclovir tablets 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 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. The most common adverse reactions reported in at least one indication by greater than 10% of adult subjects treated with valacyclovir tablets 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 …

Frequently Asked Questions

What is Valacyclovir Hydrochloride used for?

Valacyclovir Hydrochloride contains Valacyclovir Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Valacyclovir Hydrochloride a controlled substance?

Valacyclovir Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Valacyclovir Hydrochloride?

The generic name for Valacyclovir Hydrochloride is Valacyclovir Hydrochloride. There are 1 other brand versions of Valacyclovir Hydrochloride.

What is the NDC code for Valacyclovir Hydrochloride 500 mg/1?

The NDC (National Drug Code) for Valacyclovir Hydrochloride 500 mg/1 is 72789-264, listed by PD-Rx Pharmaceuticals, Inc..

Product NDC

72789-264

Package NDC

72789-264-30

Other Valacyclovir Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)