Lamivudine (Oral Route)

HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Lamivudine is taken together with zidovudine (AZT) or other medications used to treat HIV.

Lamivudine 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 usually related to AIDS or HIV disease. Lamivudine 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 disease. Lamivudine is not a cure for the hepatitis B virus; the long-term effects of the drug on the infection and the liver are unknown at this time.

Lamivudine is available only with your doctor`s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although this use is not included in product labeling, lamivudine is used in certain patients with the following medical condition:

• Human immunodeficiency virus (HIV) infection due to occupational exposure (possible prevention of)

This product is available in the following dosage forms:

• Solution


• Tablet

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

Lamivudine can cause serious side effects. In one study, children with advanced AIDS were more likely than children who were less ill to develop pancreatitis (inflammation of the pancreas) and peripheral neuropathy (a problem involving the nerves). Therefore, it is especially important that you discuss with your child`s doctor the good that this medicine may do as well as the risks of using it. Your child must be seen frequently and your child`s progress carefully followed by the doctor while the child is taking lamivudine.

Geriatric

Lamivudine has not been studied specifically in older people . Therefore, it is not known whether it causes different side effects or problems in the elderly than it does in younger adults. Talk to your doctor first if you have liver, kidney, heart problems or other diseases. Your doctor may need to adjust your dose .

Pregnancy

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

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.

• Interferon Alfa


• Ribavirin


• 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:

• Combined infection of HIV and hepatitis Ba€”May make the condition of either of these infections worse

• Diabetes mellitus (sugar diabetes)a€”Lamivudine oral solution contains sucrose

• Hepatitis C or


• Hepatitis deltaa€”Caution should be used; lamivudine safety has not been determined in patients who have hepatitis infections

• Human immunodeficiency virusa€”For patients with hepatitis B virus, your physician will talk to you about HIV before you begin taking lamivudine. You may be tested for HIV. Lamivudine tablets and oral solution for hepatitis B virus contain lower amounts of the drug than the tablets and solution for HIV. If you start on the lower-dose medication and later learn that you have HIV, the higher-dose lamivudine may not then be effective against the infection caused by HIV.


• Inflamed pancreas or


• Problems with inflamed pancreas in the past or


• Other risk factors for developing an inflamed pancreas or


• Nerve damagea€”These conditions may occur or worsen when taking lamivudine

• Kidney diseasea€”Patients with kidney disease may have an increased chance of side effects

• Liver disease or


• Risk factors for liver disease or


• Obesity (being overweight)a€”This medicine may make liver disease worse in patients with liver disease, obesity and other HIV medicine use.

• Organ transplanta€”Caution should be used; lamivudine safety has not been determined in patients who have received an organ transplant

Proper Use

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 or zidovudine without checking with your doctor first.

Keep taking lamivudine 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 .

If you are using lamivudine oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid . The lamivudine oral suspension contains sucrose. Tell your doctor if you are diabetic before you start taking this medicine.

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.

• For oral dosage forms (oral solution and tablets):
  
  
  
  • For treatment of hepatitis B infection:
    
    
    
    • Adults a€”100 milligrams (mg) once a day.
    
    
    • Children younger than 16 years of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  
  
  
  • For treatment of HIV infection or AIDS:
    
    
    
    • Adults weighing 50 kilograms (kg) (110 pounds) or morea€”150 milligrams (mg) twice a day together with other HIV medications.
    
    
    • Adults weighing less than 50 kg (110 pounds)a€”2 mg per kg of body weight twice a day together with other HIV medications.
    
    
    • Children 3 months to 16 years of agea€”4 mg per kg of body weight, up to 150 mg per dose, twice a day together with other HIV medications.
    
    
    • Children younger than 3 months of agea€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Note: Patients that require treatment for both hepatitis B and either AIDS or HIV should follow the dosing schedule for HIV or AIDS

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

It is very important that your doctor check your progress at regular visits.

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

If you have both HIV and hepatitis B virus (HBV) infections, deterioration of liver disease has occurred when lamivudine 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 (a€śrubbera€ť). 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 lubricanta€”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

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 commona€”especially in children

• Abdominal or stomach pain (severe)


• Feeling of fullness


• Nausea


• Sensation or pins and needles


• Skin rash


• Stabbing pain


• Tingling, burning, numbness, or pain in the hands, arms, feet, or legs


• Unsteadiness or awkwardness


• Vomiting

Rare

• Abdominal discomfort


• Decreased appetite


• Diarrhea


• Fast, shallow breathing


• Feeling of fullness


• Fever, chills, or sore throat


• General feeling of discomfort


• Muscle pain or cramping


• Nausea


• Shortness of breath


• Sleepiness


• Unusual tiredness or weakness

Incidence not determined

• Cough


• Dark urine


• Difficulty swallowing


• Dizziness


• Fast heartbeat


• Fever


• Hives or welts


• Itching


• Light-colored stools


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Redness of skin


• Tightness in chest


• Upper right abdominal pain


• Wheezing


• Yellow eyes and 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

• Canker sores


• Difficulty in moving


• Discouragement


• Ear discharge


• Ear swelling


• Feeling sad or empty


• General feeling of discomfort or illness


• Irritability


• Loss of appetite


• Loss of interest or pleasure


• Nasal discharge or congestion


• Pain in joints


• Sores, ulcers, or white spots on lips or tongue or inside the mouth


• Stomach pain or cramps


• Swollen and painful spots on neck, armpit, or groin


• Swollen joints


• Trouble concentrating


• Trouble sleeping


• Unusually warm skin


• Weight loss

Less common

• Acid or sour stomach


• Belching


• Cough


• Heartburn


• Indigestion


• Stomach discomfort or upset

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.

Incidence not determined

• Body fat redistribution or accumulation


• Blurred vision


• Dry mouth


• Flushed, dry skin


• Fruit-like breath odor


• Hair loss


• Increased hunger or thirst


• Increased urination


• Sweating


• Thinning of hair