Raltegravir Dosage

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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

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Occupational Exposure

(Not approved by FDA)

US Public Health Service working group recommendations:
Film-coated tablets: 400 mg orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-Raltegravir plus tenofovir plus emtricitabine is recommended as the preferred regimen for HIV postexposure prophylaxis; raltegravir is also recommended as a component in various alternative regimens.
-Prophylaxis should be started as soon as possible, preferably within hours after exposure.
-The optimal duration of prophylaxis is unknown and may differ based on the institution's protocol.
-The most current therapeutic guidelines should be consulted for more information.

Usual Pediatric Dose for HIV Infection

At least 4 weeks of age:
Oral suspension:
3 to less than 4 kg: 20 mg orally twice a day
4 to less than 6 kg: 30 mg orally twice a day
6 to less than 8 kg: 40 mg orally twice a day
8 to less than 11 kg: 60 mg orally twice a day
11 to less than 14 kg: 80 mg orally twice a day
14 to less than 20 kg: 100 mg orally twice a day

Chewable tablets:
11 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

Film-coated tablets:
At least 25 kg: 400 mg orally twice a day

Maximum dose:
-Oral suspension: 100 mg twice a day
-Chewable tablets: 300 mg twice a day

Comments:
-The weight-based dosing recommendation for the oral suspension and chewable tablets is based on approximately 6 mg/kg/dose twice a day.
-After mixing a single-use packet for oral suspension with 5 mL water, the final concentration is 20 mg/mL; the oral suspension can be used as long as weight is less than 20 kg.
-Either the oral suspension or the chewable tablet formulation can be used when weight is between 11 and 20 kg.
-The film-coated tablet is the recommended formulation for patients weighing at least 25 kg; if unable to swallow a tablet, the chewable tablet regimen should be considered.

Approved indication: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Data not available

Dose Adjustments

Concomitant rifampin:
Adults:
Film-coated tablets: Raltegravir dosage should be increased to 800 mg orally twice a day.

Less than 18 years: Data not available

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Hemodialysis: Should be used after a dialysis session (unknown how much may be removed by hemodialysis)
CAPD: Data not available

Other Comments

Administration advice:
-May be taken without regard to food
-Film-coated tablets: Swallow whole.
-Chewable tablets: May be chewed or swallowed whole.
-Oral suspension: Use within 30 minutes of mixing.
-Due to lack of bioequivalence, do not substitute the chewable tablets or oral suspension for the 400 mg film-coated tablets.
-Do not use with antacids that contain aluminum and/or magnesium.

Storage requirements:
-Chewable tablets: Should be stored in original package with bottle closed tightly; desiccant should be kept in bottle to protect from moisture.
-Oral suspension: Should be stored in the original container; foil packet should not be opened until ready for use.

Reconstitution/preparation techniques:
-Oral suspension: The manufacturer's product information should be consulted.

General:
-Use with other active agents increases likelihood of treatment response.
-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.
-Each single-use packet for oral suspension contains 100 mg of raltegravir; when suspended, the final concentration is 20 mg/mL.

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