Brand Name

    US Brand Name

    Retrovir


    Description

    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.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    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.

    Pediatric

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

    Geriatric

    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.

    Breastfeeding

    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.

    Drug Interactions

    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.

    • Atidarsagene Autotemcel
    • Bupropion
    • Cabotegravir
    • Clarithromycin
    • Dapsone
    • Doxorubicin
    • Doxorubicin Hydrochloride Liposome
    • Fluconazole
    • Flucytosine
    • Horsetail
    • Levoketoconazole
    • Methotrexate
    • Orlistat
    • Pexidartinib
    • Pyrazinamide
    • Pyrimethamine
    • Ribavirin
    • Rifampin
    • 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
    • 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

    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

    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

    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.






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