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Raltegravir Dosage

Medically reviewed on November 30, 2017.

Applies to the following strengths: 400 mg; 25 mg; 100 mg; 600 mg

Usual Adult Dose for HIV Infection

Therapy-naive patients or patients virologically-suppressed on an initial regimen of film-coated tablets 400 mg twice a day:
-Film-Coated Tablets 600 mg: 1200 mg orally once a day
-Film-Coated Tablets 400 mg: 400 mg orally twice a day

Therapy-experienced patients:
-Film-Coated Tablets 400 mg: 400 mg orally twice a day

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

Usual Adult Dose for Occupational Exposure

US Public Health Service Working Group Recommendations:
-Film-Coated Tablets 400 mg: 400 mg orally twice a day
Duration of therapy: 28 days, if tolerated

Comments:
-This drug plus emtricitabine-tenofovir disoproxil fumarate is recommended as the preferred regimen for HIV postexposure prophylaxis; this drug 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 institution protocol.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Nonoccupational Exposure

US CDC Recommendations:
-Film-Coated Tablets 400 mg: 400 mg orally twice a day
Duration of therapy: 28 days

Comments:
-This drug is recommended as a component of a preferred 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection; if other alternatives are considered, this drug is recommended as a component in various regimens.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

ORAL SUSPENSION:
Full-term neonates (birth to 4 weeks [28 days] of age):
Birth to 1 week:
-Weight 2 to less than 3 kg: 4 mg orally once a day
-Weight 3 to less than 4 kg: 5 mg orally once a day
-Weight 4 to less than 5 kg: 7 mg orally once a day

1 to 4 weeks:
-Weight 2 to less than 3 kg: 8 mg orally twice a day
-Weight 3 to less than 4 kg: 10 mg orally twice a day
-Weight 4 to less than 5 kg: 15 mg orally twice a day

Pediatric patients at least 4 weeks of age:
-Weight 3 to less than 4 kg: 25 mg orally twice a day
-Weight 4 to less than 6 kg: 30 mg orally twice a day
-Weight 6 to less than 8 kg: 40 mg orally twice a day
-Weight 8 to less than 11 kg: 60 mg orally twice a day
-Weight 11 to less than 14 kg: 80 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day

CHEWABLE TABLETS:
-Weight 11 to less than 14 kg: 75 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day
-Weight 20 to less than 28 kg: 150 mg orally twice a day
-Weight 28 to less than 40 kg: 200 mg orally twice a day
-Weight at least 40 kg: 300 mg orally twice a day

FILM-COATED TABLETS 400 MG:
-Weight at least 25 kg: 400 mg orally twice a day

FILM-COATED TABLETS 600 MG:
-Weight at least 40 kg and either therapy-naive or virologically-suppressed on an initial regimen of film-coated tablets 400 mg twice a day: 1200 mg orally once a day

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

Comments:
-Neonates: If the mother used this drug 2 to 24 hours before delivery, the neonate's first dose should be administered between 24 and 48 hours after birth.
-Neonates, birth to 1 week of age: The dosing recommendations are based on about 1.5 mg/kg/dose.
-Neonates, 1 to 4 weeks of age: The dosing recommendations are based on about 3 mg/kg/dose.
-Pediatric patients at least 4 weeks of age: The weight-based dosing recommendation for the oral suspension and chewable tablets is based on about 6 mg/kg/dose twice a day.
-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 for weight between 11 and 20 kg.

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

Usual Pediatric Dose for Nonoccupational Exposure

US CDC Recommendations:
ORAL SUSPENSION:
Pediatric patients at least 4 weeks of age:
-Weight 3 to less than 4 kg: 25 mg orally twice a day
-Weight 4 to less than 6 kg: 30 mg orally twice a day
-Weight 6 to less than 8 kg: 40 mg orally twice a day
-Weight 8 to less than 11 kg: 60 mg orally twice a day
-Weight 11 to less than 14 kg: 80 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day

CHEWABLE TABLETS:
-Weight 11 to less than 14 kg: 75 mg orally twice a day
-Weight 14 to less than 20 kg: 100 mg orally twice a day
-Weight 20 to less than 28 kg: 150 mg orally twice a day
-Weight 28 to less than 40 kg: 200 mg orally twice a day
-Weight at least 40 kg: 300 mg orally twice a day

FILM-COATED TABLETS 400 MG:
-Weight 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

Duration of therapy: 28 days

Comments:
-This drug is recommended as a component of a preferred (or alternative) 3-drug regimen for nonoccupational postexposure prophylaxis of HIV infection in children at least 4 weeks of age; if other alternatives are considered, this drug is recommended as a component in various regimens.
-A pediatric HIV-specialist should be consulted for neonates (aged 0 to 27 days).
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-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 for weight between 11 and 20 kg.
-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Film-Coated Tablets 400 mg, Chewable Tablets, Oral Suspension:
-Mild to moderate liver dysfunction: No adjustment recommended.
-Severe liver dysfunction: Data not available

Film-Coated Tablets 600 mg:
-Liver dysfunction: Not recommended.

Dose Adjustments

Concomitant rifampin:
Adults (therapy-naive or therapy-experienced):
-Film-Coated Tablets 400 mg: 800 mg orally twice a day

Pediatrics patients (younger than 18 years): Data not available

Precautions

CONTRAINDICATIONS: None

This drug is not recommended for use in preterm neonates or pediatric patients weighing less than 2 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:
-Dosing before a dialysis session should be avoided; extent that drug may be dialyzable unknown.

Other Comments

Administration advice:
-May administer without regard to food
-Film-coated tablets: Swallow whole.
-Chewable tablets: May chew or swallow whole
-Oral suspension: Do not shake; administer within 30 minutes of mixing.
-Due to different pharmacokinetic profiles, do not substitute the chewable tablets or oral suspension for either film-coated tablet and do not substitute the film-coated tablet 400 mg for the film-coated tablet 600 mg to create a 1200 mg once daily dose.
-If a pediatric patient weighing at least 25 kg is unable to swallow a film-coated tablet 400 mg, use the chewable tablet regimen.
-Do not use with antacids that contain aluminum and/or magnesium; do not coadminister film-coated tablets 600 mg with calcium carbonate antacids.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
-Film-coated and chewable tablets: Store in original package with bottle closed tightly; keep desiccant in bottle to protect from moisture.
-Oral suspension: Store in original container; do not open foil packet until ready for use.

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

General:
-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 10 mg/mL.

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
-If rash develops, contact healthcare provider at once; if rash develops with fever, general ill feeling, extreme tiredness, muscle/joint aches, blisters, oral lesions, eye inflammation, facial swelling, swelling of the eyes/lips/mouth, difficulty breathing, and/or signs/symptoms of liver problems, stop therapy immediately and seek medical care.
-Notify healthcare provider at once of any symptoms of infection.
-If unexplained muscle pain, tenderness, or weakness occurs, contact healthcare provider at once.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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