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Isentress Dosage

Generic name: RALTEGRAVIR POTASSIUM 400mg
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

  • Because the formulations have different pharmacokinetic profiles, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet or the ISENTRESS HD 600 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension.
  • Because the extent to which ISENTRESS may be dialyzable is unknown, dosing before a dialysis session should be avoided [see Clinical Pharmacology (12.3)].
  • ISENTRESS film-coated tablets must be swallowed whole.
  • ISENTRESS chewable tablets may be chewed or swallowed whole. Maximum daily dose is 300 mg taken by mouth twice daily.
  • ISENTRESS for oral suspension:
    • Pour packet contents of ISENTRESS for oral suspension into 5 mL of water and mix. 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 per mL. Maximum daily dose is 100 mg taken by mouth twice daily.
    • Once mixed, measure the recommended volume (dose) of suspension with a syringe and administer the dose orally. The 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.

Adults

The recommended adult dosage of ISENTRESS film-coated tablets is displayed in Table 1. ISENTRESS and ISENTRESS HD should be taken by mouth and may be taken with or without food [see Clinical Pharmacology (12.3)].

Table 1: Dosing Recommendations for ISENTRESS and ISENTRESS HD in Adult Patients
Population Recommended Dose
Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily 1200 mg (2 × 600mg) once daily or 400 mg twice daily
Treatment-experienced 400 mg twice daily
Treatment-naïve or treatment-experienced when coadministered with rifampin [see Drug Interactions (7.1)] 800 mg (2 × 400 mg) twice daily

Pediatrics

The recommended pediatric dosage of ISENTRESS is displayed in Table 2. ISENTRESS film-coated tablets, chewable tablets and for oral suspension should be taken by mouth and may be taken with or without food [see Clinical Pharmacology (12.3)].

Table 2: Dosing Recommendations for ISENTRESS and ISENTRESS HD in Pediatric Patients
Recommended Pediatric Dosage and Formulation
Population/Weight Film-Coated Tablets 400 mg Film-Coated Tablets 600 mg Chewable Tablets 100 mg and 25 mg For Oral Suspension 100 mg
*
If able to swallow a tablet
If at least 40 kg and either
  • treatment-naïve or
  • virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily
400 mg twice daily 1200 mg (2 × 600mg) once daily 300 mg twice daily (see Table 3) NA
If at least 25 kg 400 mg twice daily* NA Weight-based dosing twice daily (see Table 3) NA
If at least 4 weeks of age and weighing 3 kg to less than 25 kg NA NA Weight-based dosing twice daily (see Table 4) Weight-based dosing twice daily up to 20 kg (see Table 4)
Table 3: Alternative Dosage* 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
Table 4: Recommended Dosage* for ISENTRESS For Oral Suspension and Chewable Tablets in Pediatric Patients at Least 4 weeks of Age and Weighing Less than 25 kg
Body Weight
(kg)
Volume (Dose) of Suspension to be Administered Number of Chewable Tablets
Note: The chewable tablets are available as 25 mg and 100 mg tablets.
Patients can remain on ISENTRESS for oral suspension formulation as long as their weight is below 20 kg.
*
The weight-based dosing recommendation for the chewable tablet and for 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.
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
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