Zerit

Zerit is a prescription medication used with other medicines to treat human immunodeficiency virus (HIV) infection. Zerit belongs to a class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). It works by preventing the virus from multiplying.

This medication comes in capsule and liquid forms and is usually taken twice daily. Zerit can be taken with or without food.

Common side effects of Zerit include headaches, diarrhea, rash, and nausea.

Zerit is a prescription medicine used with other HIV medicines to treat human immunodeficiency virus (HIV) infection in children and adults. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bristol-Myers Squibb Co.

Zerit can cause serious side effects including:

• Zerit can cause lactic acidosis, liver problems, and pancreatitis. See “Drug Precautions”.
• Neurologic symptoms. Symptoms include: weakness of your legs, feet, arms, or hands (motor weakness) and numbness or tingling in your hands or feet (neuropathy). These problems can happen more often in people who have advanced HIV disease, have a history of peripheral neuropathy, or in people who take other medicines that also are associated with neuropathy including didanosine. In some cases, neuropathy may temporarily worsen after you stop taking Zerit . Neuropathy can be difficult to notice in children who take Zerit. Ask your child’s healthcare provider for the signs and symptoms of peripheral neuropathy in children.
  • It is important to call your healthcare provider right away if you have:
    • numbness in your hands or feet
    • tingling in your hands or feet
    • weakness in your legs, feet, arms, or hands
• Changes in body fat (fat redistribution). Changes in body fat (lipoatrophy or lipodystrophy) have been seen in some people taking HIV medicines including Zerit. Loss of body fat (lipoatrophy) happens more often in people who take Zerit than in people who take other similar HIV medicines. These changes may include: 

• more fat in or around your
  • trunk
  • upper back and neck (buffalo hump)
  • breast or chest
• loss of fat in your
  • legs
  • arms
  • face

Your healthcare provider will monitor you for changes in your body fat. It is important to tell your healthcare provider if you notice any of these changes.

• Changes in your immune system (immune reconstitution syndrome). Your immune system may begin to fight infections that have been in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after you start taking HIV medicine.

The most common side effects of Zerit include:

• headache
• diarrhea
• rash
• nausea
• vomiting

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Zerit. 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.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, or herbal supplements. Zerit may affect the way other medicines work, and other medicines may affect how Zerit works.

Especially tell your healthcare provider if you take:

• Combivir, Retrovir, Trizivir (zidovudine or AZT)
• Videx or Videx EC (didanosine)
• Adriamycin, Rubex (doxorubicin)
• Copegus, Rebetol, Ribasphere, Ribavirin, Virazole (ribavirin)
• Roferon-A, Intron-A, and others (interferon)
• Hydrea, Droxia (hydroxyurea)

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Ask your healthcare provider if you are not sure if you take one of the medicines listed above.

Zerit can cause serious side effects, including:

1. Build up of acid in your blood (lactic acidosis). Lactic acidosis can cause death and must be treated in the hospital. The risk of lactic acidosis may be higher if you:

• have liver problems
• are pregnant. There have been deaths reported in pregnant women who get lactic acidosis after taking Zerit and Videx, or Zerit and Videx EC (didanosine).
• are female
• are overweight
• have been treated for a long time with other medicines used to treat HIV

It is important to call your healthcare provider right away if you:

• feel weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with nausea and vomiting
• feel cold, especially in your arms and legs
• feel dizzy or light-headed
• have a fast or irregular heartbeat

2. Liver problems. Some people (including pregnant women) who have taken Zerit have had serious liver problems. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and death due to liver problems. Your healthcare provider should check your liver function while you are taking Zerit . You should be especially careful if you have a history of heavy alcohol use or liver problems. Use of Zerit with Videx EC or Videx (didanosine) may increase your risk for liver damage.

It is important to call your healthcare provider right away if you have:

• yellowing of your skin or the white of your eyes (jaundice)
• dark urine
• pain on the right side of your stomach
• swelling of your stomach
• easy bruising or bleeding
• loss of appetite
• nausea or vomiting

3. Swelling of the pancreas (pancreatitis) that may cause death has occurred when Zerit was used with Videx EC or Videx (didanosine). Pancreatitis can happen at any time during your treatment with Zerit.

It is important to call your healthcare provider right away if you have:

• stomach pain
• swelling of your stomach
• nausea and vomiting
• fever

Do not take Zerit if you are allergic to Zerit or any of the ingredients in Zerit.

Zerit is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using this medication. Patients should be advised that the use of Zerit has not been shown to reduce the risk of transmission of HIV-1 to others through sexual contact or blood contamination.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Zerit, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you take Zerit, tell your healthcare provider if you:

• have or had liver problems (such as hepatitis)
• have or had problems with your pancreas (pancreatitis)
• have or had kidney problems
• have or had persistent numbness, tingling, or pain in the hands or feet (neuropathy)
• have gallstones
• drink alcoholic beverages
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Zerit will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Zerit. You and your healthcare provider will decide if you should take Zerit while you are pregnant.
  Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed. It is not known if Zerit can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, or herbal supplements. Zerit may affect the way other medicines work, and other medicines may affect how Zerit works.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Zerit will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Zerit. You and your healthcare provider will decide if you should take Zerit while you are pregnant.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed. It is not known if Zerit can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

• Take Zerit exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Zerit to take and when to take it.
• If your child will be taking Zerit, your child’s healthcare provider should give you instructions on how to give this medicine. If your child is taking Zerit oral solution, shake the bottle well before measuring each dose.
• Your healthcare provider may change your dose. Do not change your dose of Zerit without talking to your healthcare provider.
• Zerit may be taken with or without food.
• Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
• Some medicines may require your healthcare provider to monitor your therapy or change your therapy. Check with your healthcare provider.
• If your kidneys are not working well, your healthcare provider will need to do regular blood and urine tests to check how they are working while you take Zerit . Your healthcare provider may also lower your dosage of Zerit if your kidneys are not working well.
• If you take too much Zerit, contact a poison control center or emergency room right away.
• You should avoid drinking alcohol while taking Zerit. Alcohol may increase your risk of getting pain and swelling of your pancreas (pancreatitis) or may damage your liver.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• your weight
• your age
• your renal function

If you take too much Zerit, contact a poison control center or emergency room right away.

• Store Zerit capsules in a tightly closed container at room temperature at 59°F to 86°F (15°C to 30°C)
• Store Zerit oral solution in the refrigerator at 36°F to 46°F (2°C to 8°C), in a tightly closed container. Throw away any unused solution after 30 days.
• Keep Zerit and all medicines out of the reach of children and pets.

WARNING: LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS; PANCREATITIS

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including Zerit and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of Zerit and didanosine with other antiretroviral agents. The combination of Zerit and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.

Fatal and nonfatal pancreatitis have occurred during therapy when Zerit was part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression.