Medically reviewed by Drugs.com. Last updated on May 18, 2021.
Generic name: RALTEGRAVIR POTASSIUM 400mg
Dosage form: tablet, film coated; tablet, chewable; oral granules for suspension
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.
- Preparation of the crushed 25 mg chewable tablet:
- 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.
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)].
|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|
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)].
|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 at least 40 kg and either:
||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)|
|Dose||Number of 100 mg Chewable Tablets|
|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|
|Volume (Dose) of Suspension to be Administered||Number of Chewable Tablets†|
|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.
|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.|
|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|
More about Isentress (raltegravir)
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- Drug class: integrase strand transfer inhibitor
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- Isentress (Raltegravir Chewable Tablets)
- Isentress (Raltegravir Powder for Oral Suspension)
- Isentress (Raltegravir Tablets)
- Other brands
- Isentress HD
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