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Lamivudine Brand And Generic Names

Pharmaceutical form


Film-coated tablets, white or almost white, 150 mg

Who can use Lamivudine


HIV treatment as part of standard antiretroviral therapy in adults and children. Postexposure prophylaxis of infection in persons who received injections or cuts when working with materials contaminated with HIV or had sexual relations with persons infected with HIV. Treatment of acute and chronic hepatitis B. Lamivudine is highly active against hepatitis B virus (HBV) in all cell lines tested and in all experimentally infected animals.

Lamivudine is an antiviral agent inhibiting HIV reverse transcriptase. Has viralstatic activity against HIV-1. Penetrates into the virus-induced cells, inhibits the activity of reverse transcriptase.

Lamivudine is rapidly and almost completely absorbed after ingestion. The presence of food in the stomach slows absorption.

For children and patients who can not use the drug in form of tablets, it is recommended to use solution for oral administration.

How to use Lamivudine


The drug is administered in the complex antiretroviral therapy in adults for the treatment of HIV, orally, regardless of the meal. Tablets should be swallowed whole with a glass of water. The average daily dose is 300 mg of Lamivudine, 150 mg twice daily or 300 mg once a day. Duration of therapy is determined by the physician by monitoring the amount of CD 4 lymphocytes in patient.

For the treatment of HIV infection in children, the drug is administered in the complex antiretroviral therapy internally, with food, in average therapeutic dose of 4 mg/kg per day, dividing the daily dose into two doses. The maximum daily dose should not exceed 300 mg of Lamivudine. The duration of therapy is determined individually. Patients must adjust the dose depending on the child's weight every three months.

For post-exposure prophylaxis of HIV infection in adults, the drug is prescribed not later than 72 hours after the injection/cut with HIV-infected materials or sexual contact with an HIV-infected person in combination with other antiretroviral agents in a dose of 150 mg of Lamivudine twice daily for 4 weeks.

Dosage correction in renal failure


Patients with clinical manifestations of renal insufficiency and creatinine clearance of 30 to 50 ml per minute should reduce the daily dose to 150 mg of Lamivudine once daily. Patients with creatinine clearance ‚ȧ 30 ml per minute require breaks in the administration of the drug to increase creatinine clearance indicator followed by the appointment of not more than 150 mg of Lamivudine once daily.

Cautions


Drug treatment should be supervised by a doctor who has experience in treating patients infected with human immunodeficiency virus and AIDS patients.

During treatment, the patient should be informed that the drug does not prevent infection with human immunodeficiency virus through sexual contact or through contaminated blood and does not cure HIV infection, while patients remain at risk of development of full-scaled picture of the disease with immunosuppression and the occurrence of opportunistic infections and malignant neoplasms.

In monotherapy with Lamivudine, patients with impaired liver function may not correct dosing due to the fact that the active ingredient of the drug is mainly excreted unchanged by the kidneys. However, Lamivudine should be used with caution in patients with severe concomitant liver cirrhosis caused by hepatitis B, given the risk of exacerbation of hepatitis after discontinuation of Lamivudine.

When using Lamivudine, especially in pediatric patients, it is necessary to monitor the emergence of symptoms of pancreatitis.

If patients suffer from abdominal pain, nausea, vomiting or high level of pancreatic enzymes in the blood serum, Lamivudine should be canceled as long as the diagnosis of pancreatitis is excluded.

Lactic acidosis, hepatomegaly with steatosis which are observed in the treatment with antiretroviral drugs and cause severe irreversible damage of liver and kidney function, may occur within a few months of the drug administration in a combination therapy with other antiretroviral agents. Therefore, during combination therapy patients need to control body weight, liver size, blood biochemical parameters.

In case of clinical manifestations of lactic acidosis and a significant deterioration in liver function, the treatment should be stopped.

Patients should keep in mind the possibility of secondary infections caused by saprophytic microorganisms during treatment.

Pregnancy and lactation


Despite the absence of direct evidence of teratogenic effects and changes in reproductive function, Lamivudine should be used during pregnancy only after careful assessment of the expected benefits and potential risks of side effects. It is not recommended to breast feed in HIV-positive mothers because of the danger of infecting the baby. STOP breastfeeding during treatment.

Side effects of Lamivudine


Common symptoms: possible weakness, malaise, fatigue, chills, fever.
Central and peripheral nervous system: possible headache, dizziness, paresthesia, peripheral neuropathy and neuritis, anxiety, insomnia, depression.
Hematopoietic system: anemia, neutropenia, thrombocytopenia.
Digestive system: loss of appetite, anorexia, nausea, vomiting, dyspepsia, diarrhea  pain or abdominal cramps, possible pancreatitis (more common in pediatric patients), increased levels of bilirubin, liver enzymes, amylase, rarely - hepatomegaly with steatosis (observed when using the drug in combination therapy with nucleotide analogue reverse transcriptase inhibitors).
Skin: possible itching, skin rash, urticaria.
Musculoskeletal system: bone pain, arthralgia, myalgia.
Endocrine system and metabolism: development of lactic acidosis.
Respiratory system: respiratory tract infections.

Lamivudine contraindications


Hypersensitivity to Lamivudine or components that are part of the drug, pregnancy up to 14 weeks, lactation, infants up to 3 months (no available data on efficacy and safety).

The drug is not prescribed for patients with a hemoglobin level of less than 75 g/L and the amount of neutrophils in peripheral blood less than 0.75 x 109/L.

Lamivudine interaction


The simultaneous use of Lamivudine and Zidovudine showed a moderate increase in peak concentration of Zidovudine in plasma, but no significant changes in AUC index were noted. Zidovudine does not affect the pharmacokinetics of Lamivudine.

Simultaneous usage of didanosine, sulfanilamide, zalcitabine increases risk of pancreatitis, peripheral neuropathy.

Trimethoprim increases the level of Lamivudine in plasma.

Overdosage


Overdose symptoms: fatigue, nausea, vomiting, increasing incidence of side effects.

Treatment: gastric lavage, activated carbon, symptomatic therapy. The use of hemodialysis is also possible, but the appropriateness of its application has been insufficiently studied.

Synonyms


Heptovir, Zeffix, Epivir, Epivir-HBV
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