Retrovir

Retrovir is a prescription medication used to treat human immunodeficiency virus (HIV) infection. Retrovir is also given to HIV-positive pregnant women to reduce the chance of passing the infection to the baby. Retrovir is in a class of medications called nucleoside reverse transcriptase inhibitors (NRTIs). It works by decreasing the amount of HIV in the blood.

Retrovir comes as a capsule, tablet, and syrup to take by mouth. It is usually taken 3 to 4 times a day. In some cases it may be taken 5 times a day. 

This medication also comes as an injectable to be given directly into the vein (IV) by a healthcare professional.

Common side effects include headache, tiredness, and nausea.

​Oral/Injectable:

Retrovir is used along with other medications to treat human immunodeficiency virus (HIV) infection. Retrovir is given to HIV-positive pregnant women to reduce the chance of passing the infection to the baby. Although Retrovir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

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

• ViiV Healthcare

​Oral/Injectable:

Common side effects include headache, tiredness, nausea, anorexia, and vomiting.

Common side effects in children include fever, cough, and digestive disorders. 

This is not a complete list of this medication’s side effects. Ask your doctor or pharmacist for more information.

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

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acetaminophen
• acyclovir (Zovirax)
• aspirin
• cimetidine (Tagamet)
• fluconazole (Diflucan)
• foscarnet (Foscavir)
• ganciclovir (Cytovene)
• indomethacin (Indocin)
• interferon
• lorazepam (Ativan)
• oxazepam (Serax)
• probenecid (Benemid)
• valproic acid (Depakene, Depakote)
• vitamins

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Serious side effects have been reported with this medication, and certain precautions should be followed:

• Retrovir can cause severe side effects, such as liver damage, blood toxicities, and muscle disorders. If you experience any of the following symptoms, call your doctor immediately: unusual breathing, shortness of breath, unusual bleeding or bruising, unusual tiredness or weakness, pale skin, fever, chills, sore throat, fatigue, loss of appetite, upset stomach, vomiting, dark urine, yellowing of the skin, pale stools, muscle weakness, lack of strength, or muscle pain.
• Retrovir can cause serious damage to the liver and a condition called lactic acidosis. If you experience any of the following symptoms, call your doctor immediately: nausea, loss of appetite, excessive tiredness, weakness, dark yellow or brown urine, unusual bleeding or bruising, flu-like symptoms, yellowing of the skin or eyes, and pain in the upper right part of your stomach. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Retrovir.
• Redistribution/accumulation of body fat have been observed in those receiving antiretroviral therapy. The long-term consequences of these events are currently unknown.
• Liver complications, sometimes fatal, has occured in those who have both HIV and hepatitis C.
• Retrovir can cause a serious and sometimes life-threatening form of rash. Call you doctor right away if you suddenly develop rash.

Do not take this medication if you are allergic to Retrovir or to any of its ingredients.

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 this medication, there are no specific foods that you must exclude from your diet.

Before taking Retrovir,

• tell your doctor and pharmacist if you are allergic to Retrovir or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking.
• tell your doctor if you have or have ever had liver or kidney disease, any disease or swelling of the muscle, anemia, a history of alcohol abuse, or bleeding or other blood problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking Retrovir, call your doctor.
• tell your doctor if you drink alcohol.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

You should know that transmission of HIV infection may still occur in some cases despite therapy with Retrovir.

Talk to your doctor about participating in a pregnancy registry that monitors outcomes in pregnant women who are also taking this medication.

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed in order to avoid risking transmission of HIV infection.

Avoid doing things that can spread HIV infection to others:

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.
• Do not breastfeed. Retrovir is excreted in human breast milk. Mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

​Oral:

• Retrovir comes as a capsule, tablet, and syrup to take by mouth. It is usually taken three to four times a day. In some cases it may be taken five times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Retrovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Injectable:

• This medication also comes as an injectable to be given directly into the vein (IV) by a healthcare professional.

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:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Oral/Injectable:

• For the treatment of HIV:
  • The recommended oral (by mouth) dose in adults is 600 mg/day in divided doses in combination with other antiretroviral agents.
  • The recommended IV (into the vein) dose in adults is 1 mg/kg infused over 1 hour. This dose should be given 5 to 6 times daily (5 to 6 mg/kg daily). 
  • The recommended dose of Retrovir for children is outlined in the table below:

• For the prevention of transmitting HIV from the pregnant mother to the fetus (unborn baby):
  • The recommended dose for the pregnant mother is 100 mg by mouth 5 times per day until the start of labor. During labor and delivery, Retrovir (via injection) should be given at 2 mg/kg (total body weight) followed by a continuous 1 mg/kg/hour (total body weight) injection until clamping of the umbilical cord.
  • The recommended dose for the infant is outline in the table below:

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Retrovir tablets, capsules, and syrup at room temperature.
• Keep this and all other medications out of the reach of children.

WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS 

• Hematologic toxicity including neutropenia and severe anemia have been associated with the use of Retrovir.
• Symptomatic myopathy associated with prolonged use of Retrovir.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including Retrovir. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.