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
- ISENTRESS Film-Coated Tablets, Chewable Tablets and For Oral Suspension can be administered with or without food [see Clinical Pharmacology (12.3)].
- Because the formulations are not bioequivalent, do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension.
- During coadministration of ISENTRESS 400 mg film-coated tablets with rifampin, the recommended dosage of ISENTRESS is 800 mg twice daily in adults. There are no data to guide co-administration of ISENTRESS with rifampin in patients below 18 years of age [see Drug Interactions (7.2)].
- Maximum dose of chewable tablets is 300 mg twice daily.
- Maximum dose of oral suspension is 100 mg twice daily.
- 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/mL.
For the treatment of adult patients with HIV-1 infection, the dosage of ISENTRESS is one 400 mg film-coated tablet administered orally, twice daily.
- If at least 25 kg: One 400 mg film-coated tablet orally, twice daily.
- If unable to swallow a tablet, consider the chewable tablet, as specified in Table 1.
|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|
- If at least 4 weeks of age and weighing at least 3 kg to less than 25 kg: Weight based dosing, as specified in Table 2.
- For patients weighing between 11 and 20 kg, either the chewable tablet or oral suspension can be used, as specified in Table 2. Patients can remain on the oral suspension as long as their weight is below 20 kg. Refer to Table 2 for appropriate dosing [see Clinical Studies (14.3)].
|Volume (Dose) of Suspension to be Administered||Number of Chewable Tablets|
|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|
Method of Administration
ISENTRESS For Oral Suspension
Each single-use ISENTRESS packet for oral suspension contains 100 mg of raltegravir which is to be suspended in 5 mL of water giving a final concentration of 20 mg/mL.
- Pour packet contents of ISENTRESS for oral suspension into 5 mL of water and mix
- Once mixed, measure the recommended volume (dose) of suspension with a syringe and administer the dose orally
- The volume (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.