Dosage & Administration Drug label Financial assistance

Isentress

(raltegravir)

Isentress 25 MG Chewable TabletIsentress 100 MG Chewable Tablet

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NO BLACK BOX WARNING

Dosage & administration

ISENTRESS and ISENTRESS HD can be administered with or without food .

Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg or 600 mg film-coated tablet.

See specific dosing guidance for chewable tablets and the formulation for oral suspension .

Adults

* Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily:
* 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or
* 400 mg film-coated tablet orally, twice daily .

* Treatment-experienced patients:
* 400 mg film-coated tablet orally, twice daily .

* During coadministration with rifampin in adults, 800 mg (2 × 400 mg) twice daily .

Pediatrics

* If weighing at least 40 kg, and either
* treatment-naïve patients or
* patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily:
* 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or
* 400 mg film-coated tablet orally, twice daily or
* 300 mg (3 × 100 mg) chewable tablets, twice daily .

* If weighing at least 25 kg: One 400 mg film-coated tablet orally, twice daily. If unable to swallow a tablet, consider the chewable tablet, as specified in Table 2 .
* If weighing at least 3 kg to less than 25 kg: Weight-based dosing using the chewable tablet or oral suspension, as specified in Table 4 .
* For neonates (birth to 4 weeks [28 days] of age): Weight-based dosing of the oral suspension as specified in Table 5 .