What is the most important information I should know about Zerit?

• Lactic acidosis and severe liver problems, including fatal cases, have been reported with the use of reverse transcriptase inhibitors, such as Zerit, alone or in combination. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area. These may be early symptoms of lactic acidosis or liver problems.
• Serious cases of pancreatitis (inflammation of the pancreas) have been reported with the use of Zerit. Notify your doctor immediately if you develop symptoms of pancreatitis including nausea, vomiting, diarrhea, abdominal pain.
• Avoid alcohol while taking Zerit. Alcohol may increase the risk of damage to the pancreas and/ or liver.
• The most common side effect from Zerit therapy is peripheral neuropathy, which may cause loss of feeling, numbness, tingling, or pain in a part of the body. Approximately 20% of patients taking Zerit will experience peripheral neuropathy. Contact your doctor if you experience any of these side effects.
• Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles. Zerit is not a cure for HIV or AIDS, and you can still transmit the virus to others during therapy with this medication.

What is Zerit?

• Zerit is an antiviral medication. It is in a category of HIV medicines called reverse transcriptase inhibitors. Zerit inhibits the reproduction of HIV in the body.
• Zerit is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Zerit is not a cure for HIV or AIDS.
• Zerit may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Zerit?

• Before taking Zerit, tell your doctor if you have:
  • kidney disease;
  • liver disease;
  • pancreatitis; or
  • a history of peripheral neuropathy (numbness or tingling). or
• You may not be able to take Zerit, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• The Zerit oral solution contains 50 mg of sucrose per mL. Individuals with diabetes may need to monitor their intake of sucrose.
• Zerit is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Fatal lactic acidosis has been reported in pregnant women treated with the combination of didanosine (Videx, Videx EC) and Zerit with other antiretroviral medicines. It is very important to treat HIV/ AIDS during pregnancy to reduce the risk of infecting the baby. Talk to your doctor about your treatment options.
• It is not known whether Zerit passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed. Talk to your doctor about breast-feeding if you are taking Zerit.

How should I take Zerit?

• Take Zerit exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Zerit can be taken with or without food.
• Shake the suspension well before measuring a dose.
• To ensure that you get a correct dose, measure the liquid form of Zerit with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
• Swallow the extended-release capsules (Zerit XR) whole, without crushing or chewing. If swallowing the capsules is difficult, they can be carefully opened and the contents mixed with two tablespoons of applesauce or yogurt. The mixture should then be swallowed whole, without chewing or crushing the beads. Consume the mixture immediately, do not save it for later use.
• Treatment of HIV/ AIDS almost always requires the use of two or more drugs. If you need to stop taking one of the medicines you are taking for HIV, you should stop all of them until you can talk to your doctor.
• It is important to take Zerit regularly to get the most benefit.
• Your doctor may want you to have blood tests or other medical evaluations during treatment with Zerit to monitor progress and side effects.
• Store Zerit capsules at room temperature away from moisture and heat.
• Store the Zerit suspension in the refrigerator between 2 and 8 degrees Celsius (36 to 46 degrees Fahrenheit). Throw away any unused suspension after 30 days.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless your doctor directs otherwise.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of a Zerit overdose include liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue) and numbness, tingling, or pain in a part of the body.

What should I avoid while taking Zerit?

• Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles. Zerit is not a cure for HIV or AIDS, and you can still transmit the virus to others during therapy with this medication.
• Avoid alcohol while taking Zerit. Alcohol may increase the risk of damage to the pancreas and/ or liver.

What are the possible side effects of Zerit?

• Stop taking Zerit and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
• Lactic acidosis and severe liver problems, including fatal cases, have been reported with the use of reverse transcriptase inhibitors, such as Zerit, alone or in combination. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area. These may be early symptoms of lactic acidosis or liver problems.
• Serious cases of pancreatitis (inflammation of the pancreas) have been reported with the use of Zerit. Notify your doctor immediately if you develop symptoms of pancreatitis including nausea, vomiting, diarrhea, abdominal pain.
• The most common side effect from Zerit therapy is peripheral neuropathy, which may cause loss of feeling, numbness, tingling, or pain in a part of the body. Approximately 20% of patients taking Zerit will experience peripheral neuropathy. Contact your doctor if you experience any of these side effects.
• Other, less serious side effects may be more likely to occur. Continue to take Zerit and talk to your doctor if you experience any of the following side effects:
  • headache;
  • a fever or chills;
  • nausea, vomiting, or diarrhea;
  • insomnia;
  • decreased appetite;
  • a rash; or
  • redistribution of body fat (loss of fat from the arms, legs, and face and increased fat around the neck, breast, and trunk).
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Zerit?

• Zerit may interact with other medications resulting in reduced effectiveness and/ or side effects. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medications, including herbal products.