Lamivudine and zidovudine (Oral route)
Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced 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. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. 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, which is one component of lamivudine/zidovudine; monitor hepatic function upon discontinuation of therapy .
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.
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:
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.
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 (66 pounds) because the amounts of lamivudine and zidovudine in this product cannot be adjusted for smaller body sizes.
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 an adjustment in the dose for patients receiving this medicine.
|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.|
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.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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.
- Doxorubicin Hydrochloride Liposome
- Interferon Alfa
- 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.
- Interferon Beta-1a
- Valproic Acid
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 (e.g., anemia, decreased bone marrow production) or
- Pancreatitis (inflammation of the pancreas)—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, severe—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 or.
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, teenagers, and children who weigh 30 kilograms (kg) (66 pounds) or more—150 milligrams (mg) of lamivudine and 300 mg of zidovudine (one tablet) two times a day.
- Adults and teenagers who weigh less than 30 kg (66 pounds)—Use and dose must be determined by your doctor.
- Children who weigh less than 30 kg (66 pounds)—Use is not recommended.
- For human immunodeficiency virus (HIV) infection:
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.
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 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.
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 doctor.
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.
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 (e.g., 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 you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.
You should not breastfeed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
Side Effects of This Medicine:
- More common
- pale skin
- sore throat
- unusual tiredness or weakness
- Less common
- Abdominal or stomach pain (severe)
- burning, tingling, numbness, or pain in the hands, arms, feet, or legs
- muscle tenderness and weakness
- skin rash
- yellow eyes or skin
- Incidence not known
- Blistering, peeling, or loosening of the skin
- canker sores
- chest discomfort or pain
- dark urine
- decreased appetite
- difficulty with breathing
- difficulty with swallowing
- fast, irregular, or pounding heartbeat
- fast, shallow breathing
- feeling of fullness
- general feeling of discomfort
- general tiredness and weakness
- hives or welts
- 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
- shortness of breath
- 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
- More common
- Less common
- Abdominal or stomach pain (mild)
- decreased appetite
- trouble in sleeping
- Incidence not known
- Abnormal breathing
- 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
- 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
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:
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:
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.
Last Updated: 11/4/2014