ISENTRESS

ISENTRESS- raltegravir potassium tablet, film coated
REMEDYREPACK INC.

1 INDICATIONS AND USAGE

Adult Patients:

ISENTRESS® and ISENTRESS® HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

Pediatric Patients:

ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg.

ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg.

2 DOSAGE AND ADMINISTRATION

2.2 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 1,200 mg (2 × 600 mg) 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

2.3 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 . 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 1,200 mg (2 × 600 mg) 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)
From birth to 4 weeks (28 days) weighing at least 2 kg NA NA NA Weight-based dosing once daily or twice daily (see Table 5)
Table 3: Alternative Dosage * with ISENTRESS Chewable Tablets for Pediatric Patients Weighing at Least 25 kg
Body Weight (kg) Dose Number of 100 mg 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 at Least 3 kg and 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)] .
The chewable tablets are available as 25 mg and 100 mg tablets.
May be administered as a crushed tablet(s); see General Dosing Recommendations (2.1) for guidance.
§
The 100 mg chewable tablet can be divided into equal halves.
3 to less than 4 2.5 mL (25 mg) twice daily 1 × 25 mg twice daily
4 to less than 6 3 mL (30 mg) twice daily
6 to less than 8 4 mL (40 mg) twice daily 2 × 25 mg twice daily
8 to less than 10 6 mL (60 mg) twice daily
10 to less than 14 8 mL (80 mg) twice daily 3 × 25 mg twice daily
14 to less than 20 10 mL (100 mg) twice daily 1 × 100 mg twice daily
20 to less than 25 Not applicable 1.5 × 100 mg § twice daily
  • For full-term neonates (birth to 4 weeks [28 days] of age): Weight-based dosing of the oral suspension as specified in Table 5.
  • No data are available in pre-term neonates. The use of ISENTRESS is not recommended in pre-term neonates.
Table 5: Recommended Dose for ISENTRESS For Oral Suspension in Full-Term Neonates (Birth to 4 Weeks [28 days] of Age)
Body Weight (kg) Volume (Dose) of Suspension to be Administered
Note: If the mother has taken ISENTRESS or ISENTRESS HD 2-24 hours before delivery, the neonate’s first dose should be given between 24-48 hours after birth.
*
The dosing recommendations are based on approximately 1.5 mg/kg/dose.
The dosing recommendations are based on approximately 3 mg/kg/dose.
Birth to 1 Week — Once daily dosing *
2 to less than 3 0.4 mL (4 mg) once daily
3 to less than 4 0.5 mL (5 mg) once daily
4 to less than 5 0.7 mL (7 mg) once daily
1 to 4 Weeks — Twice daily dosing
2 to less than 3 0.8 mL (8 mg) twice daily
3 to less than 4 1 mL (10 mg) twice daily
4 to less than 5 1.5 mL (15 mg) twice daily

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.