VALACYCLOVIR HYDROCHLORIDE (Page 7 of 7)

PATIENT INFORMATION

VALACYCLOVIR TABLETS, USP

Rx only

Read the Patient Information that comes with valacyclovir tablets, USP 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 are valacyclovir tablets, USP?

Valacyclovir tablets, USP are a prescription antiviral medicine. Valacyclovir tablets, USP lower the ability of herpes viruses to multiply in your body.

Valacyclovir tablets, USP are 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 tablets, USP 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 tablets, USP are used in children:

  • to treat cold sores (for children ≥ 12 years of age).

Valacyclovir tablets, USP do not cure herpes infections (cold sores, shingles, or genital herpes).

The efficacy of valacyclovir tablets, USP have not been studied in children who have not reached puberty.

Labeling describing use of valacyclovir HCL in pediatric patients with chickenpox (ages of 2 to ≤ 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 HCL 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 tablets, USP 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 tablets, USP 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 tablets, USP. Valacyclovir tablets, USP, 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 HCL in children with chickenpox (ages of 2 to ≤ 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 HCL tablet product.

Who should not take valacyclovir tablets, USP?

Do not take valacyclovir tablets, USP 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, USP.

Before taking valacyclovir tablets, USP, 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 tablets, USP. Your healthcare provider may give you a lower dose of valacyclovir tablets, USP.
  • 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 tablets, USP.
  • 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 tablets, USP) 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 tablets, USP.
  • about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Valacyclovir tablets, USP may affect other medicines, and other medicines may affect valacyclovir tablets, USP. 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 tablets, USP?

Take valacyclovir tablets, USP exactly as prescribed by your healthcare provider. Your dose of valacyclovir tablets, USP 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 tablets, USP or change your treatment without talking to your healthcare provider.
  • Valacyclovir tablets, USP can be taken with or without food.
  • If you are taking valacyclovir tablets, USP to treat cold sores, shingles, or genital herpes, you should start treatment as soon as possible after your symptoms start. Valacyclovir tablets, USP may not help you if you start treatment too late.
  • If you miss a dose of valacyclovir tablets, USP, 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, USP each day. Call your healthcare provider right away if you take too much valacyclovir tablets, USP.

Labeling describing use of valacyclovir HCL in pediatric patients with chickenpox (ages of 2 to ≤ 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 HCL tablet product.

What are the possible side effects of valacyclovir tablets, USP?

Kidney failure and nervous system problems are not common, but can be serious in some patients taking valacyclovir tablets, USP. 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 tablets, USP. Call your doctor right away if you get a nervous system problem while you are taking valacyclovir tablets, USP.

Common side effects of valacyclovir tablets, USP 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 tablets, USP.

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 tablets, USP. For more information ask your healthcare provider or pharmacist.

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, USP?

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

Labeling describing storage of oral suspension of valacyclovir HCL 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 HCL tablet product.

General information about valacyclovir tablets, USP

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use valacyclovir tablets, USP for a condition for which it was not prescribed. Do not give valacyclovir tablets, USP 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 tablets, USP. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about valacyclovir tablets, USP that is written for health professionals.

What are the ingredients in valacyclovir tablets, USP?

Active Ingredient: valacyclovir hydrochloride, USP (hydrous)

Inactive Ingredients: crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, polysorbate 80, povidone, and titanium dioxide.

Manufactured for

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

August 2011

VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-904
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 400
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color blue Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code RX904
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-904-03 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:63304-904-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:63304-904-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:63304-904-05 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:63304-904-77 10 BLISTER PACK (BLISTER) in 1 CARTON contains a BLISTER PACK (63304-904-11)
5 NDC:63304-904-11 10 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63304-904-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076588 01/31/2007
VALACYCLOVIR HYDROCHLORIDE
valacyclovir hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-905
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR) VALACYCLOVIR 1 g
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C BLUE NO. 2
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
POVIDONE
TITANIUM DIOXIDE
Product Characteristics
Color blue Score 2 pieces
Shape CAPSULE Size 21mm
Flavor Imprint Code RX905
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-905-03 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:63304-905-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:63304-905-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:63304-905-05 500 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
5 NDC:63304-905-77 10 BLISTER PACK (BLISTER) in 1 CARTON contains a BLISTER PACK (63304-905-11)
5 NDC:63304-905-11 10 TABLET, FILM COATED (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (63304-905-77)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076588 01/31/2007
Labeler — Ranbaxy Pharmaceuticals Inc. (937890044)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 manufacture
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 918592874 manufacture

Revised: 04/2012 Ranbaxy Pharmaceuticals Inc.

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