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Lamivudin 150 ICA (Lamivudine 150 mg)

Each film-coated tablet contains lamivudine 150 mg and excipients q.s. (microcrystalline cellulose, pregelatinized starch, low-substituted hydroxypropyl cellulose, magnesium stearate, film coating excipient).

Dosage form
Film-coated tablets.

Box of 1 bottle x 60 film-coated tablets.

Lamivudine in combination with other antiretroviral agents is indicated for treatment of HIV infection.

Hypersensitivity to lamivudine or to any of its ingredients.
Severely impaired renal function.

In pediatric patients with history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis. Treatment with lamivudine should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur.
Particular precautions should be exercised when lamivudine is administered to any patient with known risk factors for liver disease; however, care should also be taken to patients with no known risk factors. Discontinuance of treatment with lamivudine should be required in patients who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).
The dose should be adjusted in patients with impaired renal function.
Patients with HIV and hepatitis B virus co-infection: Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. In non-HIV-infected patients treated with lamivudine for chronic hepatitis B, emergence of lamivudine-resistant HBV has been detected and has been associated with diminished treatment response. Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-infected patients who have received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus. Posttreatment exacerbations of hepatitis have also been reported.

Use in pregnancy and lactation
Use in pregnancy: Lamivudine should be used during pregnancy only if the potential benefits outweigh the risks. Patients who receiving lamivudine during pregnancy or being pregnant should immediately inform to the physician.
Use in lactation: Mothers who are receiving lamivudine should discontinue breast-feeding.

Side effects
Frequent side effects during therapy with lamivudine 150 mg (twice daily) plus zidovudine 200 mg (3 times daily): Headache, fatigue, fever, nausea and vomiting, diarrhea, anorexia, neuropathy, insomnia and other sleep disorders, dizziness, nasal signs and symptoms, cough, musculoskeletal pain …
Frequent side effects in pediatric patients during therapy with lamivudine 4 mg/kg (twice daily) plus zidovudine 5.33 mg/kg (3 times daily): Fever, hepatomegaly, skin rashes…
Pancreatitis (may associate with severe complications) have been observed in pregnant women and pediatric patients in the studies who received lamivudine 150 mg alone or in combination with other antiretroviral agents.
Paresthesia and peripheral neuropathy also have been reported.
Insufficient observations of side effects in neonates and infants: Anemia, diarrhea, electrolyte disturbances, hypoglycemia, jaundice, hepatomegaly, rash, respiratory infections.
Frequent adverse events with lamivudine in patients with chronic hepatitis B: Ear, nose, and throat infections, malaise and fatigue, headache. The most frequent laboratory abnormalities reported: elevated ALT, elevated serum lipase, elevated CPK.
Side effects observed during clinical practice: Redistribution, stomatitis, hyperglycemia, weakness, anemia, lactic acidosis, pancreatitis, anaphylaxis, urticaria, rash, wheezing…
Inform your doctor any side effect occurs during the therapy.

Drug interactions
The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system (e.g., trimethoprim).
Trimethoprim (TMP) 160 mg/ sulphamethoxazol (SMX) 800 mg once daily has been shown to increase lamivudine exposure (AUC) by 44%).There is no information regarding the effect on lamivudine pharmacokinetics of higher doses of TMP/SMX (such as those used to treat Pneumocystis carinii pneumonia).
Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of lamivudine in combination with zalcitabine is not recommended.

Dosage and Administration
Adults: 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral drugs. If lamivudine is administered to a patient dually infected with HIV and HBV, the dosage indicated for HIV therapy should be used as part of an appropriate combination regimen.
Pediatric patients (infants/children, adolescents): The recommended oral dose for pediatric patients 3 months up to 16 years of age is 4 mg/kg twice daily (up to a maximum daily dose of 150 mg twice daily), in combination with other antiretroviral drugs.
Dose adjustment: It is recommended that doses be adjusted in accordance with renal function as follow:

 Creatinine Clearance (mL/minute)  Recommended Dosage
30 - 49
15 - 29
5 - 14
 150 mg twice daily or 300 mg once daily
 150 mg once daily
 150 mg first dose, then 100 mg once daily
 150 mg first dose, then 50 mg once daily
 50 mg first dose, then 25 mg once daily

Insufficient data are available to recommend a dosage in patients undergoing dialysis. Although there are insufficient data to recommend a specific dose adjustment in pediatric patients with renal impairment, a reduction in the dose  and/or an increase in the dosing interval should be considered.

36 months.

Store in a dry and cool place, below 300C. Keep out of reach of children.

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