Patients with mild hepatic impairment may be treated with Efavirenz, Lamivudine and Tenofovir disoproxil fumarate without any adjustment in dose If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.Efavirenz, Lamivudine and Tenofovir disoproxil fumarate is a fixed-dose combination tablet for oral administration. Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg.Prior to initiation of Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets, test patients for hepatitis B virus infection It is recommended that serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein be assessed before initiating Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets and during therapy in all patients as clinically appropriate Monitor hepatic function prior to and during treatment with Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets are a three-drug fixed-dose combination product containing 400 mg of efavirenz (EFV), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF). When psychiatric symptoms similar to those noted above were combined and evaluated as a group in a multifactorial analysis of data from a study using EFV 600 mg, treatment with EFV was associated with an increase in the occurrence of these selected psychiatric symptoms. An increased risk of adverse pregnancy-related outcomes was not observed; 2 stillbirths were identified, and there was 1 major birth defect (talipes) and 1 occurrence of multiple congenital abnormalities (not further specified) in tenofovir disoproxil fumarate-exposed infants. These symptoms were severe in 2.0% of patients and 2.1% of patients discontinued therapy as a result. General. Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 2 weeks of initiating therapy with EFV (median time to onset of rash in adults was 11 days) and, in most patients continuing therapy with EFV, rash resolves within 1 month (median duration, 16 days).

Each tablet contains 400 mg of efavirenz, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Therefore, coadministration of drugs that are inhibitors of these efflux transporters is unlikely to affect the disposition and elimination of 3TC.Table 10 summarizes pharmacokinetic effects of coadministered drug on tenofovir pharmacokinetics. EFV and 3TC have been evaluated in a limited number of women as reported to the APR. Reports have included patients with underlying hepatic disease, including coinfection with hepatitis B or C, and patients without pre-existing hepatic disease or other identifiable risk factors.EFV, a component of Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets, is not recommended for patients with moderate or severe hepatic impairment. Appropriate antihistamines and/or corticosteroids may improve the tolerability and hasten the resolution of rash. WARNING: POST TREATMENT ACUTE EXACERBATIONS OF HEPATITIS BSevere acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine or tenofovir disoproxil fumarate, two components of Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets. Dosing at bedtime may improve the tolerability of nervous system symptoms Because Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets are a fixed-dose combination tablet and cannot be dose adjusted, they are not recommended for patients with impaired renal function (creatinine clearance less than 50 mL/min) or patients with end-stage renal disease (ESRD) requiring hemodialysis Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets are not recommended in patients with moderate or severe hepatic impairment (Child-Pugh B or C) The 400 mg/300 mg/300 mg tablets are white to off-white, film-coated, oval, biconvex tablets debossed with “L40” on one side and plain on other side.Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets are contraindicated:Lactic acidosis and severe hepatomegaly with steatosis, including The concomitant use of Efavirenz, Lamivudine and Tenofovir disoproxil TDF, a component of Efavirenz, Lamivudine and Tenofovir disoproxil fumarate tablets is principally eliminated by the kidney. The most common adverse reactions were mild to moderate gastrointestinal events and dizziness. containing 600 mg of efavirenz (EFV), 300 mg of lamivudine (3TC), and 300 mg of tenofovir disoproxil fumarate (TDF). Methodological limitations of the APR include the use of MACDP as the external comparator group.

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) Coadministration of single doses of 3TC and sorbitol resulted in a sorbitol dose-dependent reduction in 3TC exposures.
When possible, avoid use of sorbitol-containing medicines with 3TC Prospective pregnancy data from the APR are not sufficient to adequately assess this risk of birth defects or miscarriage.

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