Valacyclovir Hydrochloride (Page 6 of 7)

14.3 Herpes Zoster

Two randomized double-blind clinical trials in immunocompetent adults with localized herpes zoster were conducted. Valacyclovir hydrochloride was 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 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 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 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, 14-day valacyclovir hydrochloride, and 7-day oral acyclovir, respectively.

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

16 HOW SUPPLIED/STORAGE AND HANDLING

Valacyclovir tablets, USP are blue, oval, biconvex, film coated tablets containing valacyclovir hydrochloride, USP equivalent to 500 mg valacyclovir and debossed with “V.5” on one side and “29ecb2a7-figure-04”on the other side.

Bottle of 30 count (NDC 45963-558-30)
Bottle of 90 count (NDC 45963-558-08)
Bottle of 500 count (NDC 45963-558-04)
Blister of 100 count (NDC 45963-558-11) 10 x 10 unit dose pack

Valacyclovir tablets, USP are blue, oval, biconvex, film coated tablets containing valacyclovir hydrochloride, USP equivalent to 1 gram valacyclovir and debossed with “V 1” separated by score line on one side and “29ecb2a7-figure-05”on the other side.

Bottle of 21 count (NDC 45963-559-31)
Bottle of 30 count (NDC 45963-559-30)
Bottle of 90 count (NDC 45963-559-08)
Bottle of 500 count (NDC 45963-559-04)

Storage:
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (17.6).

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 is not a cure for cold sores.

17.3 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-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 hydrochloride in pediathc patients with chickenpox (ages of 2 — ≤ 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 tablet product.

17.6 FDA-Approved Patient Labeling

Patient labeling is provided as a tear-off leaflet at the end of this full prescribing information.

Manufactured by:
Vivimed Labs (Alathur) Private Limited,
Plot No. 101, 102, 107 & 108,
SIDCO Pharmaceutical Complex,
Alathur, Kanchipuram Dist – 603 110,
Tamilnadu, India.

Distributed by:
Actavis Inc.
60 Columbia Road, Bldg. B
Morristown, NJ 07960 USA

Revised – November 2013

50428654-02

PATIENT INFORMATION

Valacyclovir (val-a-SYE-kloe-veer) Tablets, USP

Rx only

Read the Patient Information that comes with valacyclovir hydrochloride before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Ask your healthcare provider or pharmacist if you have questions.

What is Valacyclovir Hydrochloride?
Valacyclovir hydrochloride is a prescription antiviral medicine. Valacyclovir hydrochloride lowers the ability of herpes viruses to multiply in your body.

Valacyclovir hydrochloride is used in adults:

  • to treat cold sores (also called fever blisters or herpes labialis)
  • to treat shingles (also called herpes zoster)
  • to treat or control genital herpes outbreaks in adults with normal immune systems
  • to control genital herpes outbreaks in adults infected with the human immunodeficiency virus (HIV) with CD4+ cell count greater than 100 cells/mm3
  • with safer sex practices to lower the chances of spreading genital herpes to others. Even with safer sex practices, it is still possible to spread genital herpes.
  • Valacyclovir hydrochloride used daily with the following safer sex practices can lower the chances of passing genital herpes to your partner.
  • Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes.

  • Use a condom made of latex or polyurethane whenever you have sexual contact.

Valacyclovir hydrochloride does not cure herpes infections (cold sores, shingles, or genital herpes).

The efficacy of valacyclovir hydrochloride has not been studied in children who have not reached puberty.

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

What are cold sores, shingles, and genital herpes?
Cold sores are caused by a herpes virus that may be spread by kissing or other physical contact with the infected area of the skin. They are small, painful ulcers that you get in or around your mouth. It is not known if valacyclovir hydrochloride can stop the spread of cold sores to others.

Shingles is caused by the same herpes virus that causes chickenpox. It causes small, painful blisters that happen on your skin. Shingles occurs in people who have already had chickenpox. Shingles can be spread to people who have not had chickenpox or the chickenpox vaccine by contact with the infected areas of the skin. It is not known if valacyclovir hydrochloride can stop the spread of shingles to others.

Genital herpes is a sexually transmitted disease. It causes small, painful blisters on your genital area. You can spread genital herpes to others, even when you have no symptoms. If you are sexually active, you can still pass herpes to your partner, even if you are taking valacyclovir hydrochloride. Valacyclovir hydrochloride, taken every day as prescribed and used with the following safer sex practices , can lower the chances of passing genital herpes to your partner.

  • Do not have sexual contact with your partner when you have any symptom or outbreak of genital herpes.
  • Use a condom made of latex or polyurethane whenever you have sexual contact.

Ask your healthcare provider for more information about safer sex practices.

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

Who should not take Valacyclovir Hydrochloride?

Do not take Valacyclovir Hydrochloride if you are allergic to any of its ingredients or to acyclovir. The active ingredient is valacyclovir. See the end of this leaflet for a complete list of ingredients in valacyclovir tablets.

Before taking Valacyclovir Hydrochloride, tell your healthcare provider:

About all your medical conditions, including:

  • if you have had a bone marrow transplant or kidney transplant, or if you have advanced HIV disease or “AIDS”. Patients with these conditions may have a higher chance for getting a blood disorder called thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). TTP/HUS can result in death.
  • if you have kidney problems. Patients with kidney problems may have a higher chance for getting side effects or more kidney problems with valacyclovir hydrochloride. Your healthcare provider may give you a lower dose of valacyclovir hydrochloride.
  • if you are 65 years of age or older. Elderly patients have a higher chance of certain side effects. Also, elderly patients are more likely to have kidney problems. Your healthcare provider may give you a lower dose of valacyclovir hydrochloride.
  • if you are pregnant or planning to become pregnant. Talk with your healthcare provider about the risks and benefits of taking prescription drugs (including valacyclovir hydrochloride) during pregnancy.
  • if you are breastfeeding. Valacyclovir hydrochloride may pass into your milk and it may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking valacyclovir hydrochloride.
  • about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Valacyclovir hydrochloride may affect other medicines, and other medicines may affect valacyclovir hydrochloride. It is a good idea to keep a complete list of all the medicines you take. Show this list to your healthcare provider and pharmacist any time you get a new medicine.

How should I take Valacyclovir Hydrochloride?
Take valacyclovir hydrochloride exactly as prescribed by your healthcare provider. Your dose of valacyclovir hydrochloride and length of treatment will depend on the type of herpes infection that you have and any other medical problems that you have.

  • Do not stop valacyclovir hydrochloride or change your treatment without talking to your healthcare provider.
  • Valacyclovir hydrochloride can be taken with or without food.
  • If you are taking valacyclovir hydrochloride to treat cold sores, chickenpox, shingles, or genital herpes, you should start treatment as soon as possible after your symptoms start. Valacyclovir hydrochloride may not help you if you start treatment too late.
  • If you miss a dose of valacyclovir hydrochloride, take it as soon as you remember and then take your next dose at its regular time. However, if it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time.
  • Do not take more than the prescribed number of valacyclovir tablets each day. Call your healthcare provider right away if you take too much valacyclovir hydrochloride.

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

What are the possible side effects of Valacyclovir Hydrochloride?
Kidney failure and nervous system problems are not common, but can be serious in some patients taking valacyclovir hydrochloride. Nervous system problems include aggressive behavior, unsteady movement, shaky movements, confusion, speech problems, hallucinations (seeing or hearing things that are really not there), seizures, and coma. Kidney failure and nervous system problems have happened in patients who already have kidney disease and in elderly patients whose kidneys do not work well due to age. Always tell your healthcare provider if you have kidney problems before taking valacyclovir hydrochloride. Call your doctor right away if you get a nervous system problem while you are taking valacyclovir hydrochloride.

Common side effects of valacyclovir hydrochloride in adults include headache, nausea, stomach pain, vomiting, and dizziness. Side effects in HIV-infected adults include headache, tiredness, and rash. These side effects usually are mild and do not cause patients to stop taking valacyclovir hydrochloride.

Other less common side effects in adults include painful periods in women, joint pain, depression, low blood cell counts, and changes in tests that measure how well the liver and kidneys work.

The most common side effect seen in children <18 years of age was headache.

Talk to your healthcare provider if you develop any side effects that concern you.
These are not all the side effects of valacyclovir hydrochloride. For more information ask your healthcare provider or pharmacist.

How should I store Valacyclovir Tablets, USP?

  • Store valacyclovir tablets at room temperature, 20° to 25°C (68° to 77°F).
  • Keep valacyclovir hydrochloride in a tightly closed container.
  • Do not keep medicine that is out of date or that you no longer need.
  • Keep valacyclovir hydrochloride and all medicines out of the reach of children.

Labeling describing storage of oral suspension of valacyclovir hydrochloride is approved for GlaxoSmithKline’s Valtrex® Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that storage information is not approved for this valacyclovir tablet product.

General information about Valacyclovir Hydrochloride
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use valacyclovir hydrochloride for a condition for which it was not prescribed. Do not give valacyclovir hydrochloride to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about valacyclovir hydrochloride. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about valacyclovir hydrochloride that is written for health professionals.

What are the ingredients in Valacyclovir Tablets, USP?
Active Ingredient: valacyclovir hydrochloride, USP
Inactive Ingredients: FD&C Blue No. 2, hydroxypropyl cellulose, hypromellose, polyethene glycol, magnesium stearate, microcrystalline cellulose, povidone, and titanium dioxide.

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

Manufactured by:
Vivimed Labs (Alathur) Private Limited,
Plot No. 101, 102, 107 & 108,
SIDCO Pharmaceutical Complex,
Alathur, Kanchipuram Dist – 603 110,
Tamilnadu, India.

Distributed by:
Actavis Inc.
60 Columbia Road, Bldg BMorristown, NJ 07960 USA

Revised – November 2013

50428654-02

(PIL-50428662-02/1113)

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