IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ZIDOVUDINE (AZT) – ORAL
COMMON BRAND NAME(S): Retrovir
WARNING: Zidovudine has caused severe blood problems including a decrease in red blood cells (anemia) and white blood cells (neutropenia). They occur more frequently in people with advanced HIV disease (AIDS). Blood problems may require blood transfusions or stopping your medication. Your doctor will order blood tests to monitor for this. Keep all medical appointments. Seek immediate medical attention if you develop signs of anemia (unusual tiredness, breathing problems, weakness, bluish fingernails/lips, pale skin, fast heartbeat). Low white blood cells can make you more likely to get serious (sometimes fatal) infections. Seek immediate medical attention if you develop signs of infection such as fever, chills, persistent cough, breathing problems, or sore throat.
This medication may also cause muscle problems (myopathy). Seek immediate medical attention if you develop symptoms of myopathy (such as wasting or decrease in muscle size, muscle weakness/pain/tenderness, weight loss).
Rarely, zidovudine has caused a severe (sometimes fatal) liver and blood problem (lactic acidosis). Tell your doctor right away if you develop symptoms of liver problems (persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (rapid breathing, drowsiness, muscle aches).
USES: This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Zidovudine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors-NRTIs.
Zidovudine is used in pregnant women to prevent passing the HIV virus to the unborn baby. This medication is also used in newborns born to mothers infected with HIV to prevent infection in the newborns.
Zidovudine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used in combination with other HIV medications to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.
HOW TO USE: Take this medication by mouth, usually 2-3 times daily with or without food or as directed by your doctor. Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Dosage is based on your medical condition and response to treatment. Pregnant women may need to take this medication 5 times a day. Newborns are usually given the liquid form every 6 hours for 6 weeks after birth to prevent infection.
Take this medication 2 hours before or after taking clarithromycin. Clarithromycin may prevent your body from fully absorbing zidovudine.
This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, use it at the same times each day.
It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Refill your medication before you run out.
Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.
SIDE EFFECTS: See also Warning section.
Headache, nausea, vomiting, trouble sleeping, or loss of appetite may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, anxiety, confusion), easy bruising/bleeding, skin/fingernail color changes.
Tell your doctor right away if any of these rare but very serious side effects occur: seizures.
Changes in body fat (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs) may occur while you are taking HIV medication. The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking zidovudine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), alcohol use, low red/white blood cells.
Liquid products may contain sugar. Caution is advised if you have diabetes or any other condition that requires you to limit sugar in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug.
During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment has been shown to decrease the risk of HIV transmission to the baby. Zidovudine may be part of that treatment. Discuss the risks and benefits with your doctor.
This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s approval.
Some products that may interact with this drug include: probenecid, ribavirin, stavudine, drugs that may suppress bone marrow function (such as ganciclovir, dapsone, trimethoprim, chemotherapy including doxorubicin, vincristine), drugs that may affect the kidneys (including NSAIDs such as ibuprofen or naproxen).
Other medications can affect the removal of zidovudine from your body, thereby affecting how zidovudine works. These drugs include methadone, rifampin, and some drugs used to treat seizures (such as phenytoin, valproic acid). This is not a complete list.
This medication must not be taken with other medications that contain zidovudine. Check the labels on all your other prescription medications to make sure they do not contain zidovudine. If you have any questions, consult your doctor or pharmacist.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include extreme drowsiness/tiredness, confusion, seizures.
NOTES: Do not share this medication with others.
Laboratory and/or medical tests (such as blood counts, liver tests, viral load, T-cell counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Keep all medical and laboratory appointments.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised February 2016. Copyright(c) 2016 First Databank, Inc.