Valacyclovir Hydrochloride: Package Insert and Label Information (Page 5 of 5)

14.4 Chickenpox

The use of valacyclovir hydrochloride for treatment of chickenpox in pediatric subjects aged 2 to less than 18 years is based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by safety and extrapolated efficacy data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric subjects.

The single-dose pharmacokinetic and multiple-dose safety trial enrolled 27 pediatric subjects aged 1 to less than 12 years with clinically suspected VZV infection. Each subject was dosed with valacyclovir oral suspension, 20 mg/kg 3 times daily for 5 days. Acyclovir systemic exposures in pediatric subjects following valacyclovir oral suspension were compared with historical acyclovir systemic exposures in immunocompetent adults receiving the solid oral dosage form of valacyclovir or acyclovir for the treatment of herpes zoster. The mean projected daily acyclovir exposures in pediatric subjects across all age-groups (1 to less than 12 years) were lower (Cmax : ↓13%, AUC: ↓30%) than the mean daily historical exposures in adults receiving valacyclovir 1 gram 3 times daily, but were higher (daily AUC: ↑50%) than the mean daily historical exposures in adults receiving acyclovir 800 mg 5 times daily. The projected daily exposures in pediatric subjects were greater (daily AUC approximately 100% greater) than the exposures seen in immunocompetent pediatric subjects receiving acyclovir 20 mg/kg 4 times daily for the treatment of chickenpox. Based on the pharmacokinetic and safety data from this trial and the safety and extrapolated efficacy data from the acyclovir trials, oral valacyclovir 20 mg/kg 3 times a day for 5 days (not to exceed 1 gram 3 times daily) is recommended for the treatment of chickenpox in pediatric patients aged 2 to less than 18 years. Because the efficacy and safety of acyclovir for the treatment of chickenpox in children aged less than 2 years have not been established, efficacy data cannot be extrapolated to support valacyclovir treatment in children aged less than 2 years with chickenpox. Valacyclovir is also not recommended for the treatment of herpes zoster in children because safety data up to 7 days’ duration are not available [see Use in Specific Populations (8.4)].

16 HOW SUPPLIED/STORAGE AND HANDLING

Valacyclovir tablets, USP, 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:.

NDC 0781-5208-31 in bottles of 30 tablets with child-resistant closure

NDC 0781-5208-92 in bottles of 90 tablets with child-resistant closure

NDC 0781-5208-01 in bottles of 100 tablets with child-resistant closure

NDC 0781-5208-05 in bottles of 500 tablets

NDC 0781-5208-13 carton of 100 tablets (10 x 10 Unit-dose)

Valacyclovir tablets, USP, equivalent to 1 gm of valacyclovir base, are blue, capsule-shaped, film-coated tablets debossed “SZ” on one side and 394 on other side with partial score bar on both sides and are supplied as follows:

NDC 0781-5209-27 in bottles of 21 tablets with child-resistant closure

NDC 0781-5209-31 in bottles of 30 tablets with child-resistant closure

NDC 0781-5209-92 in bottles of 90 tablets with child-resistant closure

NDC 0781-5209-01 in bottles of 100 tablets with child-resistant closure

NDC 0781-5209-05 in bottles of 500 tablets

NDC 0781-5209-13 carton of 100 tablets (10 x 10 Unit-dose)

Storage

Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Importance of Adequate Hydration

Patients should be advised to maintain adequate hydration.

Missed Dose

Instruct patients that if they miss a dose of valacyclovir tablets, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose.

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 is not a cure for cold sores.

Genital Herpes

Patients should be informed that valacyclovir hydrochloride is 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. 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 has 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-1˗infected patients.

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.

Chickenpox

Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox.

Manufactured in India by Sandoz Private Limited

for Sandoz Inc., Princeton, NJ 08540

PATIENT INFORMATION

Valacyclovir Tablets, USP

(val ay sye’ kloe veer)

What are valacyclovir tablets?

Valacyclovir tablets are a prescription medicine used in adults:

to treat cold sores (herpes labialis).
to treat or control genital herpes outbreaks in adults with normal immune systems.
to control genital herpes outbreaks in adults with human immunodeficiency virus-1 (HIV-1).
with safer sex practices to lower the chance of spreading genital herpes to others, in adults with normal immune systems. Even with safer sex practices, it is still possible to spread genital herpes.
o
Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes.
o
Use a condom made of latex or polyurethane whenever you have sexual contact.
o
Ask your healthcare provider for more information about safer sex practices.
to treat shingles (herpes zoster) in adults with normal immune systems.

Valacyclovir tablets are used in children to treat:

cold sores in children 12 years of age and older.
chickenpox in children with normal immune systems 2 years of age to less than 18 years of age.

Valacyclovir tablets do not cure cold sores, chickenpox, shingles or genital herpes.

It is not known if valacyclovir tablets are safe and effective in people with weakened immune systems, other than for control of outbreaks of genital herpes in people with HIV-1.
It is not known if valacyclovir tablets are safe and effective in people 18 years of age and older with chickenpox.
It is not known if valacyclovir tablets are safe and effective in children:
o
less than 12 years of age with cold sores
o
less than 2 years of age with chickenpox
o
less than 18 years of age with genital herpes or shingles

Do not take valacyclovir tablets if you are allergic to valacyclovir, acyclovir, or any of the ingredients in valacyclovir tablets. See the end of this leaflet for a complete list of ingredients in valacyclovir tablets.

Before you take valacyclovir tablets, tell your healthcare provider about all of your medical conditions, including if you:

have had a bone marrow transplant or kidney transplant, or if you have advanced HIV-1 infection or acquired immune deficiency syndrome (AIDS).
have kidney problems, including if you receive dialysis.
are pregnant or plan to become pregnant. It is not known if valacyclovir tablets will harm your unborn baby. You and your healthcare provider will decide if you will take valacyclovir tablets if you are pregnant.
are breastfeeding or plan to breastfeed. Valacyclovir may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your child if you take valacyclovir tablets.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take valacyclovir tablets?

Take valacyclovir tablets exactly as your healthcare provider tells you to take it.
Your dose of valacyclovir tablets and length of treatment will depend on the type of infection that you have and any other medical problems that you have.
Do not stop valacyclovir tablets or change your treatment without talking to your healthcare provider.
Take valacyclovir tablets with or without food.
Tell your healthcare provider if your child cannot swallow valacyclovir tablets. Your healthcare provider can prescribe valacyclovir as an oral suspension for your child.
If you are taking valacyclovir tablets to treat outbreaks of cold sores, chickenpox, shingles or genital herpes, take valacyclovir tablets as soon as you have the first symptoms of infection such as tingling, itching, or burning, or when the sore appears.
It is important for you to stay well hydrated during treatment with valacyclovir tablets. Be sure to drink plenty of fluids during this time.
If you miss a dose of valacyclovir tablets, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time or take more valacyclovir tablets than prescribed.
If you take too many valacyclovir tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of valacyclovir tablets?

Valacyclovir tablets can cause serious side effects including:

Thrombotic Thrombocytopenic Purpura (TTP) and Hemolytic Uremic Syndrome (HUS). TTP and HUS have happened in people with weakened immune systems taking valacyclovir tablets and have led to death. TTP and HUS are disorders that can cause small blood clots to form throughout the body and decrease blood flow to body organs such as the brain, heart, and kidneys. Your healthcare provider will stop treatment with valacyclovir tablets if you have signs or symptoms of TTP and HUS.
Kidney failure.
Nervous system problems. Tell your healthcare provider right away if you get any of these signs or symptoms of nervous system problems during treatment with valacyclovir tablets:
o
aggressive behavior
o
unsteady movement
o
shaky movements
o
confusion
o
speech problems
o
hallucinations (seeing or hearing things that are really not there)
o
seizures
o
coma

Elderly people are more likely to get certain side effects. Talk to your healthcare provider if this is a concern for you.

The most common side effects of valacyclovir tablets in adults include:

headache
nausea
stomach (abdominal) pain

The most common side effect of valacyclovir tablets in children less than 18 years of age is headache.

These are not all the possible side effects of valacyclovir tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store valacyclovir tablets?

Store valacyclovir tablets at 68º to 77ºF (20º to 25ºC) [see USP Controlled Room Temperature]. Protect from moisture.
Store valacyclovir oral suspension between 36º to 46ºF (2º to 8ºC) in a refrigerator. Throw away (discard) any remaining valacyclovir oral suspension after 28 days.
Shake valacyclovir suspension bottle well before using.
Keep valacyclovir tablets in a tightly closed container.
Keep valacyclovir tablets and all medicines out of the reach of children.

General information about the safe and effective use of valacyclovir tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use valacyclovir tablets for a condition for which it was not prescribed. Do not give valacyclovir tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about valacyclovir tablets that is written for health professionals.

What are the ingredients in valacyclovir tablets?

Active Ingredient: valacyclovir hydrochloride

Inactive Ingredients: crospovidone, FD&C Blue No. 2 Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.

Manufactured in India by Sandoz Private Limited

for Sandoz Inc., Princeton, NJ 08540

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: January 2020

PRINCIPAL DISPLAY PANEL

NDC 0781-5208-31

Valacyclovir Tablets, USP

500 mg*

Rx Only 30 Tablets

PHARMACIST: Dispense the Patient Information Leaflet with the Drug Product.

500 mg label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0781-5209-31

Valacyclovir Tablets, USP

1 gm*

Rx only 30 Tablets

PHARMACIST: Dispense the Patient Information Leaflet with the Drug Product.

1 gm label
(click image for full-size original)
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
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:0781-5208-31 30 TABLET in 1 BOTTLE None
2 NDC:0781-5208-92 90 TABLET in 1 BOTTLE None
3 NDC:0781-5208-01 100 TABLET in 1 BOTTLE None
4 NDC:0781-5208-05 500 TABLET in 1 BOTTLE None
5 NDC:0781-5208-13 100 TABLET in 1 BOX, UNIT-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077478 05/24/2010
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-5209
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (ACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
POVIDONE K90
TITANIUM DIOXIDE
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 23mm
Flavor Imprint Code SZ;394
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-5209-31 30 TABLET in 1 BOTTLE None
2 NDC:0781-5209-92 90 TABLET in 1 BOTTLE None
3 NDC:0781-5209-01 100 TABLET in 1 BOTTLE None
4 NDC:0781-5209-05 500 TABLET in 1 BOTTLE None
5 NDC:0781-5209-13 100 TABLET in 1 BOX, UNIT-DOSE None
6 NDC:0781-5209-27 21 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 — Sandoz Inc. (005387188)

Revised: 01/2020 Sandoz Inc.

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