Retrovir (Intravenous)

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

Zidovudine injection will not cure or prevent HIV infection or AIDS, but it helps stop HIV from reproducing and seems to slow down the destruction of the immune system. This may help delay the development of issues that usually arise from AIDS or HIV disease. Zidovudine injection will not stop you from spreading HIV to other people. People receiving this medicine may still experience the problems commonly associated with AIDS or HIV disease.

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

It is very important for your doctor to check you or your child's progress at regular visits to ensure 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. Inform your doctor if you have a latex allergy before receiving this medicine.

Zidovudine injection may cause blood problems. These problems can increase the risk of certain infections and slow healing. Therefore, you or your child should be careful when using regular toothbrushes, dental floss, and toothpicks to avoid injuring your gums. Consult 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 experience muscle pain, tenderness, wasting, or unusual tiredness or weakness while 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 immediately 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 strengthen when you start taking HIV medicines. Notify your doctor right away if you or your child notice any changes in health. Sometimes the immune system will begin to fight infections that were previously hidden in your body, such as pneumonia or tuberculosis. Autoimmune disorders (e.g., Graves' disease, polymyositis, or Guillain-Barré syndrome) may also develop.

This medicine may reduce or cause loss of body fat, especially in your face, arms, legs, or buttocks, when used for a long time. Discuss any concerns with your doctor.

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

This medicine will not prevent you from transmitting 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 prevent you from transmitting HIV to others if they are exposed to your blood. Do not reuse 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.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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.

Pediatric

Research so far has not shown any specific problems in children that would limit the usefulness of zidovudine injection.

Geriatric

Research so far has not shown any specific problems in the elderly that would limit the usefulness of zidovudine injection. However, older patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and a dosage adjustment for patients receiving zidovudine injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there may be an interaction. In these cases, your doctor may adjust the dose or take other precautions. While receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take 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 increase the risk of certain side effects, but using both drugs may be the best treatment option for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Blood problems (e.g., anemia, neutropenia, or pancytopenia) or
• Bone marrow problems or
• Muscle problems or
• Obesity (overweight)—Use with caution. This may worsen these conditions.

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

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor or nurse right away 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. Your health care professional may also be able to tell you how to prevent or lessen 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.

In the U.S.

• Retrovir

Available Dosage Forms:

• Solution

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

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.