Isentress Dosage/Direction for Use

Therapy should be initiated by a physician experienced in the management of HIV infection.
Posology: ISENTRESS should be used in combination with other active anti-retroviral therapies (ARTs) (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Elderly: There is limited information regarding the use of raltegravir in the elderly (see Pharmacology: Pharmacokinetics under Actions). Therefore, ISENTRESS should be used with caution in this population.
Renal impairment: No dosage adjustment is required for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dosage adjustment is required for patients with mild to moderate hepatic impairment. The safety and efficacy of raltegravir have not been established in patients with severe underlying liver disorders. Therefore, ISENTRESS should be used with caution in patients with severe hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
400-mg: Adults: The recommended dosage is 400 mg (one tablet) twice daily.
Children and adolescents: If at least 6 years of age and weighing at least 25 kg, the recommended dosage is 400 mg (one tablet) twice daily.
Paediatric population: Safety and efficacy of raltegravir 400 mg tablets in children below 6 years of age have not been established.
Method of administration: Oral use.
ISENTRESS 400 mg tablets can be administered with or without food.
The tablets should not be chewed, crushed or split due to anticipated changes in the pharmacokinetic profile.
600-mg: Adults and paediatric population: In adults and paediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.
Additional formulations and strengths available: ISENTRESS is also available as a 400 mg tablet for twice daily use in HIV infected adults or children and adolescents at least 25 kg. The 400 mg tablet should not be used to administer 1,200 mg once daily regimen (refer to the 400 mg Summary of Product Characteristics).
Hepatic impairment: ISENTRESS 600 mg film-coated tablet formulation should not be used in children weighing less than 40 kg.
Method of administration: Oral use.
ISENTRESS 600 mg tablets can be administered with or without food as a 1,200 mg once daily dose.
The tablets should not be chewed, crushed or split due to anticipated changes in the pharmacokinetic profile.