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zidovudine

Pronunciation

Generic Name: zidovudine (oral) (zye DOE vyoo deen)
Brand Name: Retrovir

What is zidovudine?

Zidovudine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Zidovudine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Zidovudine is also given during pregnancy to prevent an HIV-infected woman from passing the virus to her baby. Zidovudine is not a cure for HIV or AIDS.

Zidovudine may also be used for purposes not listed in this medication guide.

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

Do not take this medication if you have ever had an allergic reaction to Retrovir or any medicine that contains zidovudine, including Combivir or Trizivir.

Some people develop lactic acidosis while taking zidovudine. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Slideshow: Flashback: FDA Drug Approvals 2013

This medication can also cause severe or life-threatening effects on your liver. Call your doctor at once if you have any of these symptoms while taking zidovudine: pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Zidovudine can lower blood cells that help your body fight infections and help your blood clot. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

Do not take Retrovir with any other medicine that contains zidovudine or stavudine, including: Combivir, Trizivir, or Zerit.

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

Do not take this medication if you have ever had an allergic reaction to Retrovir or any medicine that contains zidovudine, including Combivir or Trizivir.

Do not take Retrovir with any other medicine that contains zidovudine or stavudine, including: Combivir, Trizivir, or Zerit.

Some people develop a life-threatening condition called lactic acidosis while taking zidovudine. You may be more likely to develop lactic acidosis if you are overweight or have liver disease, if you are a woman, or if you have taken HIV or AIDS medications for a long time. Talk with your doctor about your individual risk.

Zidovudine can also cause severe or life-threatening effects on your liver. Tell your doctor if you have liver disease, especially hepatitis C.

To make sure you can safely take zidovudine, tell your doctor if you have any of these other conditions:

  • kidney disease;

  • anemia (low red blood cell count);

  • an active infection;

  • bone marrow suppression; or

  • if you have used an HIV medication in the past, such as abacavir (Ziagen), didanosine (Videx), emtricitabine (Atripla, Complera, Emtriva, Truvada), lamivudine (Combivir, Epivir, Epzicom, Trizivir), stavudine (Zerit), tenofovir (Viread), or zidovudine (Retrovir).

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of zidovudine on the baby.

FDA pregnancy category C. It is not known whether zidovudine will harm an unborn baby. HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection.

You should not breast-feed while you are using zidovudine. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take zidovudine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Zidovudine can be taken with or without food.

If a child is taking this medication, tell your doctor if the child has any changes in weight. Zidovudine doses are based on weight in children.

HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

Zidovudine can lower blood cells that help your body fight infections and help your blood clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, drowsiness, headache, or weakness.

What should I avoid while taking zidovudine?

Avoid drinking alcohol. It may increase your risk of liver damage.

Taking this medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Zidovudine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Stop taking zidovudine and call your doctor at once if you have any of these other serious side effects:

  • severe muscle pain;

  • signs of a new infection such as fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

  • diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

  • swelling in your neck or throat (goiter);

  • problems with walking, breathing, speech, swallowing, or eye movement;

  • weakness or prickly feeling in your fingers or toes;

  • severe lower back pain, loss of bladder or bowel control;

  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • sleep problems (insomnia);

  • mild nausea, constipation;

  • joint pain;

  • headache; or

  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Zidovudine dosing information

Usual Adult Dose for HIV Infection:

Oral: 300 mg orally every 12 hours or 200 mg orally every 8 hours

IV: 1 mg/kg IV (infused over 1 hour) every 4 hours around the clock, for a total daily dose of 5 to 6 mg/kg

Duration: Therapy should be continued for as long as the patient tolerates, or until the patient is switched to another antiretroviral agent.

Usual Adult Dose for Reduction of Perinatal Transmission of HIV:

Maternal dosing: 100 mg orally 5 times a day until start of labor; however, most authorities would also consider the standard oral dosages of 300 mg every 12 hours or 200 mg every 8 hours

During labor and delivery: 2 mg/kg IV (infused over 1 hour) followed by a continuous IV infusion of 1 mg/kg/hour until clamping of the umbilical cord

Therapy should begin at 14 to 34 weeks gestation. Neonates should also be treated for 6 weeks. Despite the use of this regimen, transmission to infants may still occur in some cases.

Usual Adult Dose for Nonoccupational Exposure:

(Not approved by FDA)

Centers for Disease Control and Prevention (CDC) recommendations: 300 mg orally every 12 hours or 200 mg orally every 8 hours, in combination with (efavirenz or lopinavir-ritonavir) plus (lamivudine or emtricitabine)

Duration: 28 days

Prophylaxis should be initiated as soon as possible, within 72 hours of exposure.

Usual Adult Dose for Occupational Exposure:

(Not approved by FDA)

CDC recommendations:
Preferred basic regimen for HIV postexposure prophylaxis: 300 mg orally every 12 hours or 200 mg orally every 8 hours, in combination with lamivudine or emtricitabine

Duration: Generally 28 days; however, the exact duration of therapy may differ based on the institution's protocol.

Prophylaxis should be initiated immediately, preferably within hours after exposure.

Usual Pediatric Dose for HIV Infection:

4 weeks to less than 18 years:
Oral:
Based on body weight:
4 to less than 9 kg: 12 mg/kg orally twice a day or 8 mg/kg orally 3 times a day
9 to less than 30 kg: 9 mg/kg orally twice a day or 6 mg/kg orally 3 times a day
30 kg or more: 300 mg orally twice a day or 200 mg orally 3 times a day

Based on body surface area: 240 mg/m2 (maximum: 300 mg/dose) orally twice a day or 160 mg/m2 (maximum: 200 mg/dose) orally 3 times a day

The dosage calculated by body weight may not be the same as the dosage calculated by body surface area in some cases.

Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children recommendations:
Premature neonates (less than 35 weeks gestation):
Oral: 2 mg/kg orally every 12 hours
IV: 1.5 mg/kg IV (infused over 30 minutes) every 12 hours

Dosage frequency should increase to every 8 hours at 4 weeks of age in neonates less than 30 weeks gestation at birth and at 2 weeks of age in neonates 30 to less than 35 weeks gestation at birth.

Full-term neonates and infants less than 6 weeks:
Oral: 2 mg/kg orally every 6 hours
IV: 1.5 mg/kg IV (infused over 30 minutes) every 6 hours

6 weeks to less than 18 years:
Oral:
Based on body weight:
4 to less than 9 kg: 12 mg/kg orally twice a day
9 to less than 30 kg: 9 mg/kg orally twice a day
30 kg or more: 300 mg orally twice a day

Based on body surface area: 180 to 240 mg/m2 orally every 12 hours or 160 mg/m2 orally every 8 hours

Usual Pediatric Dose for Reduction of Perinatal Transmission of HIV:

Neonates:
Oral: 2 mg/kg orally every 6 hours
IV: 1.5 mg/kg IV (infused over 30 minutes) every 6 hours

Neonatal dosing should begin within 12 hours after birth and continue through 6 weeks of age. IV zidovudine may be administered to neonates unable to receive oral dosing.

Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children recommendations:
Neonates (less than 35 weeks gestation at birth):
Oral: 2 mg/kg orally every 12 hours
IV: 1.5 mg/kg IV (infused over 30 minutes) every 12 hours

Dosage frequency should increase to every 8 hours at 4 weeks of age in neonates less than 30 weeks gestation at birth and at 2 weeks of age in neonates 30 to less than 35 weeks gestation at birth.

Full-term neonates and infants less than 6 weeks (born at 35 weeks gestation or greater):
Oral: 4 mg/kg orally twice a day
IV: 1.5 mg/kg IV (infused over 30 minutes) every 6 hours

Zidovudine should be started as soon after birth as possible, preferably within 6 to 12 hours of delivery, and should continue through 6 weeks of age. IV zidovudine may be administered to neonates unable to tolerate oral agents.

In addition to 6 weeks of zidovudine therapy, 3 doses of nevirapine may be given in the first week of life to infants born to HIV-infected women who have not received antepartum antiretroviral therapy. The neonatal regimen (oral zidovudine plus nevirapine) should be started as soon as possible after birth.

What other drugs will affect zidovudine?

Tell your doctor about all other medicines you use, especially:

  • doxorubicin (Adriamycin);

  • ganciclovir (Cytovene);

  • interferon alfa (Alferon, Intron, Rebetron);

  • phenytoin (Dilantin);

  • ribavirin (Rebetol, Ribasphere, Copegus Virazole); or

  • drugs that weaken your immune system, such as cancer medicine, steroids, and medicines to prevent rejection of an organ transplant.

This list is not complete and other drugs may interact with zidovudine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about zidovudine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision Date: 2012-03-09, 10:28:37 AM.

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