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.
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||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|
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||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)|
|Dose||Number of 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|
|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.|
|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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- Drug class: integrase strand transfer inhibitor
Other brands: Isentress HD