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zidovudine (injection)

Pronunciation

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

What is zidovudine?

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

Zidovudine is used to treat HIV, the virus that can cause 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 is usually given by injection only if you are unable to take the medicine by mouth.

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 use this medicine if you have ever had a severe allergic reaction to any medicine that contains zidovudine.

This medicine may cause a serious condition called lactic acidosis. 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, fast or uneven heart rate, dizziness, or feeling very weak or tired.

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

Do not use Retrovir with any other medicine that contains zidovudine or stavudine.

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

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

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

Some people taking zidovudine develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk with your doctor about your 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 zidovudine is safe for you, tell your doctor if you have:

  • kidney disease;

  • bone marrow suppression;

  • a latex allergy;

  • muscle problems;

  • a history of bleeding or a blood cell disorder; or

  • if you drink large amounts of alcohol.

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. Take all of your HIV medicines as directed to control your infection.

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.

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 is zidovudine given?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Zidovudine is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Zidovudine must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after preparing your dose.

Mixed medicine must be used within 24 hours if you keep it at room temperature.

You may also store the mixed medicine in a refrigerator, but you must use it within 48 hours.

Do not use zidovudine if it has changed colors or has particles in it. Call your pharmacist for new medication.

Zidovudine injection must be given slowly, and the IV infusion can take up to 1 hour to complete. Zidovudine is usually given 4 times per day until you are able to take the medication orally (by mouth). Follow your doctor's dosing instructions very carefully.

Zidovudine can lower blood cells that help your body fight infections and help your blood to 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.

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.

Store unopened vials of zidovudine at room temperature away from moisture, heat, and light.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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.

What should I avoid while using zidovudine?

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

Using this medicine 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 signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: 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.

Call your doctor at once if you have:

  • low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

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

Zidovudine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with zidovudine. Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss;

  • chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

  • cold sores, sores on your genital or anal area;

  • rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

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

  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Common side effects may include:

  • headache;

  • fever, general ill feeling;

  • cough;

  • nausea, vomiting, loss of appetite; or

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

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 your current medicines and any you start or stop using, especially:

  • doxorubicin;

  • ganciclovir;

  • interferon alfa (Intron, Infergen);

  • ribavirin (Copegus, Moderiba, Rebetol, Ribasphere, RibaTab); or

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

This list is not complete. Other drugs may interact with zidovudine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about zidovudine injection.
  • 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: 2.02. Revision Date: 2016-03-10, 12:54:14 PM.

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