Pronunciation:

la-MI-vyoo-deen, zye-DOE-vyoo-deen

Brand Names:

• Combivir

Dosage Forms:

• Tablet

Warnings:

Zidovudine, one of the two active ingredients in lamivudine/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 with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals.

Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV and have discontinued lamivudine, which is one component of lamivudine/zidovudine. 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 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted .

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. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV and have discontinued lamivudine, which is one component of lamivudine/zidovudine; monitor hepatic function upon discontinuation of therapy .

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; 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 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.

The zidovudine component of this combination medicine may cause some serious side effects, including bone marrow problems. Symptoms of bone marrow problems include fever, chills, sore throat, pale skin, and 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 are taking lamivudine and zidovudine combination.

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—

Either lamivudine or zidovudine used alone may cause serious side effects, and children should receive less of these medicines than adults. However, lamivudine and zidovudine combination contains a fixed amount of each medicine that cannot be decreased. Therefore, lamivudine and zidovudine combination is not recommended for children less than 12 years of age, or children who weigh less than 50 kilograms (110 pounds) because the amounts of lamivudine and zidovudine in this product cannot be adjusted for smaller body sizes.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Many older people have problems with their liver, heart and kidneys. Your doctor may change the amount of medicine you take because of other health problems.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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—

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.

• Dapsone
• Doxorubicin Hydrochloride
• Flucytosine
• Ganciclovir
• Interferon Alfa
• Pyrazinamide
• Pyrimethamine
• Ribavirin
• Stavudine
• Vinblastine
• Vincristine
• Vincristine Liposome
• Zalcitabine

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, including decreased bone marrow production—Lamivudine and zidovudine combination may make these conditions worse

• Infection of human immunodeficiency virus (HIV) and hepatitis B virus (HBV) at the same time—This medicine could make your hepatitis worse or prevent the medicine from working properly.

• Kidney disease—Patients with kidney disease may experience an increase in side effects

• Liver disease or
• Risk factors for liver disease or
• Obesity (being overweight) or
• Use of other HIV medicines over a long period of time—This medicine may make liver disease worse in patients with liver disease, obesity or other HIV medicine use.

Proper Use of This Medicine:

Lamivudine and zidovudine combination may be taken with food or on an empty stomach.

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 health care professional.

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

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.

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

• For oral dosage form (tablets):
  • For human immunodeficiency virus (HIV) infection:
    • Adults and teenagers who weigh more than 50 kilograms (kg) (110 pounds)—150 milligrams (mg) of lamivudine and 300 mg of zidovudine (equivalent to one tablet) two times a day.
    • Adults and teenagers who weigh 50 kg (110 pounds) or less—Use is not recommended.
    • Children—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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. Lamivudine and zidovudine combination may cause blood problems, and your doctor will want to test your blood regularly.

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 have both HIV and hepatitis B virus (HBV) infections, deterioration of liver disease has occurred when lamivudine and zidovudine treatment is stopped. Discuss any changes in your treatment and medicines with your doctor.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your health care professional.

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 as soon as possible if any of the following side effects occur:

More common

Chills

fever

pale skin

sore throat

unusual tiredness or weakness

Less common

Abdominal pain (severe)

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

muscle tenderness and weakness

nausea

skin rash

vomiting

yellow eyes or skin

Incidence unknown

Blistering, peeling, loosening of skin

canker sores

chest discomfort or pain

chills

convulsions

dark urine

decreased appetite

difficulty breathing

difficulty 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 selling 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, irritated eyes

red skin lesions often with a purple center

redness, soreness, or itching skin

sensation of pins and needles

shortness of breath

sleepiness

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

sores, welting or blisters

stabbing pain

sudden loss of consciousness

swelling of feet or lower legs

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

tightness in chest

troubled breathing

unsteadiness or awkwardness

wheezing

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

Abdominal pain (mild)

coughing

decreased appetite

diarrhea

dizziness

trouble in sleeping

Incidence unknown

Abnormal breathing

blurred vision

body fat redistribution/accumulation

darkening of skin and mucous membranes

dry mouth

fatigue

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 neck, armpit, or groin

thinning of 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.