Lamone 150 Tablets

Rx

Indications

Lamone 150 Tablets is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.

Dosage

Adults, adolescents and children (weighing at least 25 kg):

300 mg daily. This may be administered as either 150 mg (1 tablet) twice daily or 300 mg (2 tablets) once daily.

Children (weighing less than 25 kg):

• Children weighing ≥ 20 kg to < 25 kg: 225 mg daily. This may be administered as either 75 mg (½ tablet) taken in the morning and 150 mg (1 tablet) taken in the evening, or 225 mg (1 and ½ tablets) taken once daily.
• Children weighing 14 to < 20 kg: 150 mg daily. This may be administered as 75 mg (½ tablet) taken twice daily, or 150 mg (1 tablet) taken once daily.
• Children less than three months of age: The limited data available are insufficient to propose specific dosage recommendations.

Renal impairment:

Adolescents and children (weighing at least 25 kg):

• ClCr ≥ 50 ml/min: First dose is 300 mg (2 tablets) or 150 mg (1 tablet), maintenance dose is 300 mg (2 tablets) once daily or 150 mg (1 tablet) twice daily.
• ClCr 30 to < 50 ml/min: First dose is 150 mg (1 tablet), maintenance dose is 150 mg (1 tablet) once daily.
• ClCr < 30 ml/min: As doses below 150 mg are needed the use of the oral solution is recommended.

Children aged at least 3 months and weighing less than 25 kg: The oral solution may be the most appropriate formulation.

Usage

Lamone 150 Tablets is taken orally with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi­solid food or liquid, all of which should be consumed immediately.

• Hypersensitivity to any of the ingredients.
• Severe renal impairment.
• The preperations in combination of lamivudine with antiretroviral drugs are not recommended for patients with creatinine clearance ≤ 50 ml/ min, patients with hepatic impairment.

Common

• Headache, insomnia,
• Cough,
• Nasal symptoms,
• Nausea, vomiting,
• Abdominal pain or cramps, diarrhea,
• Rash,
• Alopecia,
• Arthralgia.

Uncommon

Neutropenia and anaemia (both occasionally severe), thrombocytopenia, transient elevations in liver enzymes (AST, ALT).

• Lamivudine is not a cure for HIV infection and they may continue to experience illnesses associated with HIV infection, including opportunistic infections. Patients must remain under continuous observation and care. Lamivudine does not reduce the risk of transmission of HIV. These patients must therefore learn to understand that condoms are absolutely needed to protect the sexual partners.
• Lactic acidosis generally occurred after a few or several months of treatment. Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis.
• In HIV infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii
• Treatment with lamivudine should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
• Lamivudine is not recommended for use as monotherapy.
• In patients with moderate to severe renal impairment, the terminal plasma half-life of lamivudine is increased due to decreased clearance; therefore the dose should be adjusted.
• Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse events. In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
• Cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
• Lamivudine should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
• The combination of lamivudine with cladribine is not recommended.
• As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account.
• It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
• Patients should be aware of how they react to drug before driving or operating machinery.