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Generic Name: Lamivudine 10 mg/mL Oral Solution (la-MI-vyoo-deen)
Brand Name: Epivir
High levels of lactic acid in the blood and severe, life-threatening liver problems have been reported with the use of Lamivudine Solution alone or with other medicines. Lamivudine Solution contains a higher dose of the same active ingredient
(lamivudine) in Epivir-HBV. These formulations are not interchangeable. Worsening of hepatitis B virus infection has been reported in patients who also have HIV and stop taking Lamivudine Solution. Patients with both HIV and hepatitis B virus infection should have their liver function monitored closely for at least several months after stopping use of Lamivudine Solution.
Lamivudine Solution is used for:
Treating HIV infection in combination with other medicines.
Lamivudine Solution is a nucleoside
analogue. It works by blocking the growth of HIV.
Do NOT use Lamivudine Solution if:
- you are allergic to any ingredient in Lamivudine Solution
- you have an enlarged liver, abnormal liver function tests, or high levels of lactic acid in the blood (lactic acidosis)
- you are taking zalcitabine or other medicines containing lamivudine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Lamivudine Solution:
Some medical conditions may interact with Lamivudine Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of muscle problems, pancreas problems, abnormal blood cell counts, liver disease (eg, hepatitis) or other liver problems (eg, abnormal liver function tests), lactic acidosis, kidney problems, diabetes, or a nerve disorder
- if you are very overweight
Some MEDICINES MAY INTERACT with Lamivudine Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Trimethoprim/sulfamethoxazole because it may increase the risk of Lamivudine Solution"s side effects
- Zalcitabine because it may decrease the effectiveness of Lamivudine Solution
- Interferon alfa or ribavirin because severe liver problems may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if Lamivudine Solution may interact with other medicines that you
take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Lamivudine Solution:
Use Lamivudine Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Lamivudine Solution may be taken with or without food.
- Use a measuring device marked for medicine dosing. Ask your pharmacist if you are unsure of how to measure your dose.
- Continue to take Lamivudine Solution even if you feel well. Do not miss any doses.
- Taking Lamivudine Solution at the same time(s) each day will help you remember to take it.
- If you miss a dose of Lamivudine Solution, take it as soon as possible. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Lamivudine Solution.
Important safety information:
- Lamivudine Solution may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Lamivudine Solution. Using Lamivudine Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- When your medicine supply begins to run low, get more from your doctor or pharmacist as soon as possible. The virus may develop resistance to Lamivudine Solution and become more difficult to treat if you stop taking it, even for a short period of time.
- Lamivudine Solution is not a cure for HIV infection and patients may continue to acquire illnesses and infections associated with HIV. Remain under the care of your doctor.
- Lamivudine Solution offers no protection from the transmission of HIV to others through sexual contact or blood contamination. Use barrier forms of contraception
(eg, condoms) if you are infected with HIV. Do not share
needles, other injection equipment, or personal items such as toothbrushes or razor blades.
- Cases of worsening liver disease have been reported when Lamivudine Solution is stopped in patients with both HIV and hepatitis B virus infection. Discuss any medicine changes with your doctor.
- If you have hepatitis B virus infection, your doctor will perform lab tests for several months after you stop taking Lamivudine Solution. Some patients have had worsening hepatitis B virus after stopping use of Lamivudine Solution. Tell your doctor about any new or unusual symptoms that you notice after stopping treatment.
- Diabetes patients - Lamivudine Solution contains sucrose and may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some
patients taking Lamivudine Solution. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
- LAB TESTS, including liver and kidney function tests, may be required to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use Lamivudine Solution with caution in CHILDREN younger than 3 months of age, children who have taken other HIV medicines, or those who have a history of pancreas problems because they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Lamivudine Solution during pregnancy. Lamivudine Solution is excreted in breast milk. Do not breast-feed while taking Lamivudine Solution. HIV-infected mothers should not breast-feed their infants because of the risk of transmitting the HIV infection or Lamivudine Solution.
Possible side effects of Lamivudine Solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Changes in body fat; chills; cough; diarrhea; dizziness; general body discomfort; headache; indigestion; loss of appetite; muscle or joint pain;
nausea; runny/stuffy nose; sleeplessness; stomach cramps.
Children: Abnormal breathing sounds/wheezing; cough; diarrhea; ear problems;
fever; mouth inflammation; nasal discharge; nausea; stuffy nose; swollen lymph nodes; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; depression
(mental or mood changes); enlarged stomach; increased heart rate; numbness, tingling, or weakening of the arms or legs; persistent sore throat, chills, or fever; severe muscle or joint pain; severe or persistent nausea; stomach
tenderness or pain; unusual bleeding or bruising; unusual weakness or exhaustion;
vomiting; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.
Proper storage of Lamivudine Solution:
Store Lamivudine Solution in a tightly closed bottle at room temperature, 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lamivudine Solution out of the reach of children and away from pets.
- If you have any questions about Lamivudine Solution, please talk with your doctor, pharmacist, or other health care provider.
- Lamivudine Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Lamivudine Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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