Avonza Dosage/Direction for Use

Therapy should be prescribed by a physician experienced in the management of HIV-1 infection.
Posology: Adults and adolescents: The recommended dose of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets is one tablet taken orally once daily.
Method of administration: It is recommended that Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets be swallowed whole with water.
It is recommended that Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets be taken on an empty stomach since food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see Precautions and Adverse Reactions).
In order to improve the tolerability of efavirenz with respect to undesirable effects on the nervous system, bedtime dosing is recommended (see Adverse Reactions).
It is anticipated that tenofovir exposure will be approximately 35% lower following administration of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets on an empty stomach as compared to the individual component tenofovir disoproxil fumarate when taken with food (see Pharmacology: Pharmacokinetics under Actions). In virologically suppressed patients, the clinical relevance of this reduction can be expected to be limited (see Pharmacology: Pharmacodynamics under Actions).
Children: Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets is not recommended for use in children weighing less than 35 kg.
Elderly: Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets should be administered with caution to elderly patients (see Precautions).
Dose adjustments: Where discontinuation of therapy with one of the components of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets is indicated or where dose modification is necessary, separate preparations of tenofovir disoproxil fumarate, lamivudine and efavirenz are available. Please refer to the Summary of Product Characteristics for these medicinal products.
If Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets is co-administered with rifampicin, an additional 200 mg/day of efavirenz may be considered (see Interactions).
Renal impairment: Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets is not recommended for patients with moderate or severe renal impairment (creatinine clearance (CrCl) < 50 ml/min). Patients with moderate or severe renal impairment require dose interval adjustment of lamivudine and tenofovir disoproxil fumarate that cannot be achieved with the combination tablet (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: The pharmacokinetics of Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets have not been studied in patients with hepatic impairment. Patients should be monitored carefully for adverse reactions, especially nervous system symptoms related to efavirenz (see Contraindications and Precautions).
If Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets is discontinued in patients co-infected with HIV and HBV, these patients should be closely monitored for evidence of exacerbation of hepatitis (see Precautions).
If therapy with Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz 300 mg/300 mg/400 mg Tablets is discontinued, consideration should be given to the long half-life of efavirenz (see Pharmacology: Pharmacokinetics under Actions) and long intracellular half-lives of tenofovir and lamivudine. Because of interpatient variability in these parameters and concerns regarding development of resistance, HIV treatment guidelines should be consulted, also taking into consideration the reason for discontinuation.