Isentress Dosage

Generic name: RALTEGRAVIR POTASSIUM 400mg
Dosage form: tablet, film coated
Drug class: Integrase strand transfer inhibitor

Medically reviewed by Drugs.com. Last updated on Nov 15, 2023.

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.
For children who have difficulty chewing the 25 mg chewable tablet, the tablet may be crushed.
- Preparation of the crushed 25 mg chewable tablet:
  - Place the tablet(s) in a small, clean cup. For each tablet, add a teaspoonful (~5 mL) of liquid (for example, water, juice, or breast milk).
  - Within 2 minutes, the tablet(s) will absorb the liquid and fall apart.
  - Using a spoon, crush any remaining pieces of the tablet(s). Immediately administer the entire dose orally.
  - If any portion of the dose is left in the cup, add another teaspoonful (~5 mL) of liquid, swirl and administer immediately.
ISENTRESS for oral suspension:
- See Instructions for Use for details on preparation and administration of ISENTRESS for oral suspension.
- Using the provided mixing cup, combine 10 mL of water and the entire contents of one packet of ISENTRESS for oral suspension and mix. Each single-use packet for oral suspension contains 100 mg of raltegravir which is suspended in 10 mL of water giving a final concentration of 10 mg per mL. Maximum daily dose is 100 mg taken by mouth twice daily.
- Gently swirl the mixing cup for 45 seconds in a circular motion to mix the powder into a uniform suspension. Do not shake.
- Once mixed, measure the prescribed dose volume of suspension with a syringe and administer the dose orally. The dose should be administered orally within 30 minutes of mixing.
- Discard any remaining suspension into the trash.

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 × 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

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 × 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