VALACYCLOVIR HYDROCHLORIDE (Page 6 of 6)

14.3 Herpes Zoster

Two randomized double-blind clinical trials in immunocompetent adults with localized herpes zoster were conducted. Valacyclovir hydrochloride tablets were compared with placebo in patients less than 50 years of age, and with oral acyclovir in patients greater than 50 years of age. All patients were treated within 72 hours of appearance of zoster rash. In patients less than 50 years of age, the median time to cessation of new lesion formation was 2 days for those treated with valacyclovir hydrochloride tablets compared with 3 days for those treated with placebo. In patients greater than 50 years of age, the median time to cessation of new lesions was 3 days in patients treated with either valacyclovir hydrochloride tablets or oral acyclovir. In patients less than 50 years of age, no difference was found with respect to the duration of pain after healing (post-herpetic neuralgia) between the recipients of valacyclovir hydrochloride tablets and placebo. In patients greater than 50 years of age, among the 83% who reported pain after healing (post-herpetic neuralgia), the median duration of pain after healing [95% confidence interval] in days was: 40 [31, 51], 43 [36, 55], and 59 [41, 77] for 7-day valacyclovir hydrochloride tablets, 14-day valacyclovir hydrochloride tablets, and 7-day oral acyclovir, respectively.

Labeling describing clinical studies of valacyclovir HCL in pediatric patients with chickenpox (ages 2 to ≤ 18 years) for the treatment of chickenpox is approved for GlaxoSmithKline’s Valtrex® * Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of those clinical studies is not approved for this valacyclovir HCL tablet product.

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling for Valacyclovir Hydrochloride Tablets manufactured by Sandoz Inc.

17.1 Importance of Adequate Hydration

Patients should be advised to maintain adequate hydration.

17.2 Cold Sores (Herpes Labialis)

Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). Patients should be instructed that treatment for cold sores should not exceed 1 day (2 doses) and that their doses should be taken about 12 hours apart. Patients should be informed that valacyclovir hydrochloride tablets are not a cure for cold sores.

17.3 Genital Herpes

Patients should be informed that valacyclovir hydrochloride tablets are not a cure for genital herpes. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices in combination with suppressive therapy with valacyclovir hydrochloride tablets. Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists.

Valacyclovir hydrochloride tablets have not been shown to reduce transmission of sexually transmitted infections other than HSV-2.

If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.

There are no data on the effectiveness of treatment initiated more than 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours after the onset of signs and symptoms of a recurrent episode.

There are no data on the safety or effectiveness of chronic suppressive therapy of more than 1 year’s duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 months’ duration in HIV-infected patients.

17.4 Herpes Zoster

There are no data on treatment initiated more than 72 hours after onset of the zoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.

Labeling describing use of valacyclovir HCL in pediatric patients with chickenpox (ages of 2 to ≤ 18 years) for the treatment of chickenpox is approved for GlaxoSmithKline’s Valtrex® * Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that use is not approved for this valacyclovir HCL tablet product.

17.6 FDA-Approved Patient Labeling

Call your doctor for medical advice about side effects. You may report side effects to Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088
Manufactured in India by Sandoz Private Ltd.
for Sandoz, Inc., Princeton, NJ 08540
Rev. April 2010

Repackaging by:

Life Line Home Care Services, Inc.Repackaging Pharmacy

Valacyclovir Hydrochloride Tablets 500 mg Label

Valacyclovir HCl 500 mg Tablets Label
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75921-208(NDC:0781-5208)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code SZ;393
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75921-208-03 3 TABLET, COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077478 05/24/2010
Labeler — Life Line Home Care Services, Inc. (844985374)
Establishment
Name Address ID/FEI Operations
Life Line Home Care Services, Inc. 844985374 relabel, repack

Revised: 03/2012 Life Line Home Care Services, Inc.

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