Pronunciation:

zye-DOE-vue-deen

Brand Names:

• Retrovir

Dosage Forms:

• Solution

Warnings:

Zidovudine has been associated with hematologic toxicity, including neutropenia and severe anemia, particularly in patients with advanced HIV disease. Prolonged use of zidovudine has been associated with symptomatic myopathy. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Zidovudine (also known as AZT) injection is used together with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Zidovudine injection is used to slow the progression of disease in patients infected with HIV who have advanced symptoms, early symptoms, or no symptoms at all. This medicine is also used to help prevent pregnant women who have HIV from passing the virus to their babies during pregnancy and at birth.

Zidovudine injection will not cure or prevent HIV infection or AIDS, however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Zidovudine injection will not keep you from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of zidovudine injection in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zidovudine injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems which may require caution and an adjustment of dosage in patients receiving zidovudine injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Cabotegravir
• Clarithromycin
• Dapsone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Fluconazole
• Flucytosine
• Horsetail
• Levoketoconazole
• Methotrexate
• Orlistat
• Pexidartinib
• Pyrazinamide
• Pyrimethamine
• Ribavirin
• Stavudine
• Tacrolimus
• Valproic Acid
• Vinblastine
• Vincristine
• Vincristine Sulfate Liposome

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetaminophen
• Interferon Beta-1a
• Methadone
• Nelfinavir
• Probenecid
• Rifabutin
• Rifampin
• Rifapentine
• Tipranavir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems (eg, anemia, neutropenia, or pancytopenia) or
• Bone marrow problems or
• Muscle problems or
• Obesity (overweight)—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease (including hepatitis)—Effects may be increased because of slow removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. This medicine should be given slowly, so the needle will have to stay in place for at least an hour every 4 hours.

Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

The vial stopper contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before receiving this medicine.

Zidovudine injection may cause blood problems. These problems may result in a greater chance of certain infections and slow healing. Therefore, you or your child should be careful when using regular toothbrushes, dental floss, and toothpicks not to damage your gums. Check with your or your child's medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

Check with your or your child's doctor if you have muscle pain, tenderness, wasting, or unusual tiredness or weakness while you are receiving this medicine.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: abdominal discomfort or cramping, dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notices any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, or Guillain-Barré syndrome) may also occur.

This medicine may decrease or lose body fat, especially in your face, arms, legs, or buttocks, when this medicine is used for a long time. Talk to your doctor if you have concerns.

You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your or your child's doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

chills

cough

feeling of fullness

fever

lower back or side pain

painful or difficult urination

pale skin

right upper abdominal pain and fullness

sore throat

stomach pain

swelling or inflammation of the mouth

swollen lymph nodes

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Troubled breathing with exertion

Incidence not known

Back or leg pain

bleeding gums

blistering, peeling, or loosening of the skin

bloating

blood in the urine

blurred vision or other change in vision

bone pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

clay-colored stools

constipation

dark urine

decreased appetite

decreased urine output

diarrhea

difficult or labored breathing

difficulty in moving

difficulty in swallowing

dilated neck veins

dizziness

extreme fatigue

fainting

fast, irregular, or pounding heartbeat

fast, shallow breathing

general body swelling

general feeling of discomfort or illness

general tiredness and weakness

headache

high fever

hives

hoarseness

increased need to urinate

indigestion

irregular breathing

irritation or soreness of the mouth

joint or muscle pain

lack of coordination

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

muscle pain, cramp, spasm, or stiffness

muscular pain, tenderness, wasting, or weakness

nausea

nosebleeds

pains in the stomach, side, or abdomen, possibly radiating to the back

passing urine more often

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

redness, soreness, or itching skin

runny nose

seizures

shakiness in the legs, arms, hands, or feet

shivering

skin rash

sleepiness

sores, welts, or blisters

stabbing pain

stomach discomfort

sweating

swollen joints

swollen or painful glands

tightness in the chest

trouble sleeping

unexplained bleeding or bruising

unpleasant breath odor

vomiting

vomiting of blood

weight gain

yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Lack or loss of strength

Incidence not known

Actions that are out of control

belching

bloated feeling

change in taste or bad, unusual, or unpleasant (after) taste

changes in skin color

difficulty seeing at night

discouragement

dizziness or lightheadedness

excess air or gas in the stomach or intestines

fear or nervousness

feeling of constant movement of self or surroundings

feeling sad or empty

hearing loss

heartburn

impaired vision

increased sensitivity of the eyes to sunlight

irritability

itching skin

loss of interest or pleasure

mood or mental changes

pain or tenderness around the eyes and cheekbones

passing gas

redness of the skin

sensation of spinning

sleepiness or unusual drowsiness

sneezing

stuffy nose

swelling of the breasts or breast soreness in both females and males

talking, feeling, and acting with excitement

trouble concentrating

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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