Pronunciation:

la-MIV-ue-deen, zye-DOE-vue-deen

Brand Names:

• Combivir

Dosage Forms:

• Tablet

Warnings:

Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced Human Immunodeficiency Virus (HIV-1) disease.Prolonged use of zidovudine has been associated with symptomatic myopathy.Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine. Discontinue lamivudine/zidovudine if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine/zidovudine and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Nucleoside Reverse Transcriptase Inhibitor

Uses of This Medicine:

Lamivudine and zidovudine combination is used in the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Lamivudine and zidovudine combination will not cure or prevent HIV infection or the symptoms of AIDS. This medicine helps keep HIV from reproducing, and appears to slow down the destruction of the immune system. This may help delay the development of serious health problems usually related to AIDS or HIV infection. Lamivudine and zidovudine combination will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV infection.

This medicine is available only with your doctor's prescription.

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—

Lamivudine and zidovudine combination contains a fixed amount of each medicine that cannot be decreased. Therefore, this medicine is not recommended for patients who weigh less than 30 kilograms because the amounts of lamivudine and zidovudine in this product cannot be adjusted for smaller body sizes.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of this medicine 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 in the dose for patients receiving this medicine.

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 taking 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
• Sorbitol
• 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, decreased bone marrow production) or
• Pancreatitis (inflammation of the pancreas), or history of—Use with caution. May make these conditions worse.

• Hepatitis B infection or
• Hepatitis C infection—May cause side effects to become worse.

• Kidney disease, severe or
• Liver disease—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking lamivudine and zidovudine combination without checking with your doctor first.

Keep taking lamivudine and zidovudine combination for the full time of treatment, even if you begin to feel better.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with others.

Lamivudine and zidovudine combination contains a fixed amount of each medicine.

Lamivudine and zidovudine combination may be taken with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For human immunodeficiency virus (HIV) infection:
    • Adults and children who weigh at least 30 kilograms (kg)—One tablet two times a day.
    • Children who weigh less than 30 kg—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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

Do not take any other medicine containing emtricitabine, lamivudine, or zidovudine (eg, Atripla®, Complera®, Emtriva®, Epivir®, Epzicom®, Retrovir®, Trizivir®, or Truvada®).

Do not take any other medicines without checking with your doctor first. To do so may increase the chance of side effects from lamivudine and zidovudine combination.

If you or your child have both HIV and hepatitis B virus (HBV) infections, liver disease can become worse when lamivudine and zidovudine treatment is stopped. Discuss any changes in your treatment and medicines with your doctor.

Zidovudine may cause some serious side effects, including blood or bone marrow problems. Symptoms of a blood or bone marrow problem include fever, chills, sore throat, pale skin, or unusual tiredness or weakness. These problems may require blood transfusion or temporarily stopping treatment with lamivudine and zidovudine combination. Check with your doctor if any new health problems or symptoms occur while you or your child are taking lamivudine and zidovudine combination.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. 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.

Tell your doctor if you or your child have severe muscle pain, tenderness, or weakness, especially if you take this medicine for a long time.

When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (eg, pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

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

This medicine does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

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 immediately if any of the following side effects occur:

More common

Chills

fever

pale skin

sore throat

unusual tiredness or weakness

Less common

Burning, tingling, numbness, or pain in the hands, arms, feet, or legs

muscle tenderness and weakness

nausea

severe stomach pain

skin rash

vomiting

yellow eyes or skin

Incidence not known

Blistering, peeling, or loosening of the skin

canker sores

chest discomfort or pain

chills

convulsions

dark urine

decreased appetite

difficulty with breathing

difficulty with swallowing

dizziness

faintness

fast, irregular, or pounding heartbeat

fast, shallow breathing

feeling of fullness

general feeling of discomfort

general tiredness and weakness

hives or welts, itching

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

jerking of all extremities

joint or muscle pain

light-colored stools

loss of bladder control

muscle pain, spasms, stiffness, or cramping

red skin lesions often with a purple center

red, irritated eyes

redness, soreness, or itching skin

sensation of pins and needles

sleepiness

sores, ulcers, or white spots in the mouth or on the lips or tongue

sores, welting or blisters

stabbing pain

sudden loss of consciousness

swelling of the feet or lower legs

tingling, burning, numbness, or pain in the hands, arms, feet, or legs

tightness in the chest

troubled with breathing

unsteadiness or awkwardness

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

Headache

Less common

Coughing

decreased appetite

diarrhea

dizziness

mild stomach pain

trouble sleeping

Incidence not known

Blurred vision

body fat redistribution or accumulation

darkening of the skin and mucous membranes

dry mouth

flushed, dry skin

fruit-like breath odor

hair loss

increased hunger

increased thirst

increased urination

sweating

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

swollen, painful, or tender lymph glands in the neck, armpit, or groin

thinning of the hair

troubled breathing, unexplained

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.