This dosage information may not include all the information needed to use Raltegravir safely and effectively. See additional information for Raltegravir.
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Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for HIV Infection
Film-coated tablets: 400 mg orally twice a day
Usual Pediatric Dose for HIV Infection
2 to less than 12 years:
10 to less than 14 kg: 75 mg orally twice a day
14 to less than 20 kg: 100 mg orally twice a day
20 to less than 28 kg: 150 mg orally twice a day
28 to less than 40 kg: 200 mg orally twice a day
At least 40 kg: 300 mg orally twice a day
The dosage for the chewable tablets is based on approximately 6 mg/kg/dose (maximum: 300 mg/dose) orally twice a day.
6 to less than 12 years, weighing at least 25 kg: 400 mg orally twice a day
12 years or older: 400 mg orally twice a day
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Mild to moderate impairment: No adjustment recommended.
Severe impairment: Data not available
Film-coated tablets: Raltegravir dosage should be increased to 800 mg orally twice a day.
Less than 18 years: Data not available
Severe, potentially life-threatening, and fatal skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported. Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure) have also been reported. Raltegravir and other suspect agents should be discontinued at once if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. A life-threatening reaction may result if discontinuation of raltegravir or other suspect agents is delayed following onset of severe rash.
Close monitoring of liver enzymes has been recommended.
The 25 and 100 mg chewable tablets contain about 0.05 and 0.1 mg phenylalanine, respectively, which can be harmful to patients with phenylketonuria.
Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.
Myopathy and rhabdomyolysis have been reported during clinical trials but the relationship of raltegravir to these events is unknown. Patients at greater risk of myopathy or rhabdomyolysis should take raltegravir with caution.
Raltegravir should be administered in combination with other antiretroviral agents. Use with other active agents will increase the likelihood of treatment response.
Safety and effectiveness have not been established in pediatric patients less than 2 years of age.
Hemodialysis: Raltegravir should be administered after a dialysis session since it is unknown how much may be removed by hemodialysis.
CAPD: Data not available
Raltegravir may be administered with or without food.
The film-coated tablets must be swallowed whole. The chewable tablets may be chewed or swallowed whole.
Due to lack of bioequivalence, the chewable tablets must not be substituted for the 400 mg film-coated tablet.