Isentress Dosage

Generic name: raltegravir
Dosage form: tablet, film coated; tablet, chewable; oral granules for suspension

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

General Dosing Recommendations

  • ISENTRESS Film-Coated Tablets, Chewable Tablets and For Oral Suspension can be administered with or without food [see Clinical Pharmacology (12.3)].
  • Because the formulations are not bioequivalent, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension.
  • During coadministration of ISENTRESS 400 mg film-coated tablets with rifampin, the recommended dosage of ISENTRESS is 800 mg twice daily in adults. There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age [see Drug Interactions (7.2)].
  • Maximum dose of chewable tablets is 300 mg twice daily.
  • Maximum dose of oral suspension is 100 mg twice daily.
  • Each single-use packet for oral suspension contains 100 mg of raltegravir which is suspended in 5 mL of water giving a final concentration of 20 mg/mL.

Adults

For the treatment of adult patients with HIV-1 infection, the dosage of ISENTRESS is one 400 mg film-coated tablet administered orally, twice daily.

Pediatrics

  • If 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 1.
Table 1: Alternative Dose* with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight
(kg)
Dose Number of Chewable Tablets
*
The weight-based dosing recommendation for the chewable tablet is based on approximately 6 mg/kg/dose twice daily [see Clinical Pharmacology (12.3)].
The 100 mg chewable tablet can be divided into equal halves.
25 to less than 28 150 mg twice daily 1.5 × 100 mg twice daily
28 to less than 40 200 mg twice daily 2 × 100 mg twice daily
At least 40 300 mg twice daily 3 × 100 mg twice daily
  • If at least 4 weeks of age and weighing at least 3 kg to less than 25 kg: Weight based dosing, as specified in Table 2.
  • For patients weighing between 11 and 20 kg, either the chewable tablet or oral suspension can be used, as specified in Table 2. Patients can remain on the oral suspension as long as their weight is below 20 kg. Refer to Table 2 for appropriate dosing [see Clinical Studies (14.3)].
Table 2: Recommended Dose* for ISENTRESS For Oral Suspension and Chewable Tablets in Pediatric Patients Weighing Less than 25 kg
Body Weight
(kg)
Volume (Dose) of Suspension to be Administered Number of Chewable Tablets
*
The weight-based dosing recommendation for the chewable tablet and oral suspension is based on approximately 6 mg/kg/dose twice daily [see Clinical Pharmacology (12.3)].
For weight between 11 and 20 kg either formulation can be used.
Note: The chewable tablets are available as 25 mg and 100 mg tablets.
The 100 mg chewable tablet can be divided into equal halves.
3 to less than 4 1 mL (20 mg) twice daily
4 to less than 6 1.5 mL (30 mg) twice daily  
6 to less than 8 2 mL (40 mg) twice daily  
8 to less than 11 3 mL (60 mg) twice daily  
11 to less than 14 4 mL (80 mg) twice daily 3 × 25 mg twice daily
14 to less than 20 5 mL (100 mg) twice daily 1 × 100 mg twice daily
20 to less than 25 1.5 × 100 mg twice daily

Method of Administration

ISENTRESS Film-Coated Tablets

  • Film-Coated Tablets must be swallowed whole

ISENTRESS Chewable Tablets

  • Chewable Tablets may be chewed or swallowed whole

ISENTRESS For Oral Suspension

Each single-use ISENTRESS packet for oral suspension contains 100 mg of raltegravir which is to be suspended in 5 mL of water giving a final concentration of 20 mg/mL.

  • Pour packet contents of ISENTRESS for oral suspension into 5 mL of water and mix
  • Once mixed, measure the recommended volume (dose) of suspension with a syringe and administer the dose orally
  • The volume (dose) of suspension should be administered orally within 30 minutes of mixing
  • Discard any remaining suspension
  • For more details on preparation and administration of the suspension, see Instructions for Use.
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