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Raltegravir Dosage

Medically reviewed by Drugs.com. Last updated on Aug 6, 2020.

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 the 400 mg film-coated tablets twice a day:
600 mg film-coated tablets: 1200 mg orally once a day
400 mg film-coated tablets: 400 mg orally twice a day

Therapy-experienced patients:
400 mg film-coated tablets: 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:
400 mg film-coated tablets: 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:
400 mg film-coated tablets: 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 10 kg: 60 mg orally twice a day
-Weight 10 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:
Pediatric Patients At Least 4 Weeks of Age:
-Weight 3 to less than 6 kg: 25 mg orally twice a day
-Weight 6 to less than 10 kg: 50 mg orally twice a day
-Weight 10 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

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

600 MG FILM-COATED TABLETS:
-Weight at least 40 kg and either therapy-naive or virologically-suppressed on an initial regimen of the 400 mg film-coated tablets 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 in patients who weigh 2 to less than 20 kg; the chewable tablets can be used in patients at least 4 weeks of age who weigh at least 3 kg.
-The 400 mg film-coated tablets may be used in pediatric patients who weigh at least 25 kg if able to swallow a tablet.

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 10 kg: 60 mg orally twice a day
-Weight 10 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:
Pediatric Patients At Least 4 Weeks of Age:
-Weight 3 to less than 6 kg: 25 mg orally twice a day
-Weight 6 to less than 10 kg: 50 mg orally twice a day
-Weight 10 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

400 MG FILM-COATED TABLETS:
-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 (and a postmenstrual age of at least 42 weeks); 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 in patients who weigh less than 20 kg; the chewable tablets can be used in patients who weigh at least 3 kg.
-The 400 mg film-coated tablets may be used in pediatric patients who weigh at least 25 kg if able to swallow a tablet.
-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Any degree of renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

400 mg film-coated tablets, chewable tablets, oral suspension:
-Mild to moderate liver dysfunction: No adjustment recommended.
-Severe liver dysfunction: Data not available

600 mg film-coated tablets:
-Liver dysfunction: Not recommended.

Dose Adjustments

Concomitant rifampin:
400 mg film-coated tablets:
-Adults (therapy-naive or therapy-experienced): 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:
-Due to different pharmacokinetic profiles, do not substitute the chewable tablets or oral suspension for either film-coated tablet and do not substitute the 400 mg film-coated tablet for the 600 mg film-coated tablet to create a 1200 mg once-daily dose.
-Administer with or without food.
-Film-coated tablets: Swallow whole.
-If a pediatric patient weighing at least 25 kg is unable to swallow a 400 mg film-coated tablet, use the chewable tablet regimen.
-Chewable tablets: May chew or swallow whole; the 25 mg chewable tablet may be crushed if a child has difficulty chewing it.
---After preparation of the crushed tablet, immediately administer the entire dose orally; if any portion of the dose remains in the cup, add another teaspoonful (about 5 mL) of liquid, swirl, and administer immediately.
-Oral suspension: Do not shake; administer within 30 minutes of mixing.
-Do not use this drug with antacids that contain aluminum and/or magnesium; additionally, do not coadminister the 600 mg film-coated tablets 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:
-To prepare the crushed 25 mg chewable tablet for children with difficulty chewing it:
---Place tablet(s) in small clean cup.
---Add a teaspoonful (about 5 mL) of liquid (e.g., water, juice, breast milk) for each tablet; the tablet will absorb the liquid and fall apart within 2 minutes.
---Crush any remaining pieces of the tablet(s) with a spoon.
-Oral suspension: The manufacturer product information should be consulted.

General:
-The 100 mg chewable tablet can be divided into equal halves.
-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).
-Contact healthcare provider at once if rash develops; stop this drug and other suspect agents immediately and seek medical attention if rash associated with any of the following symptoms develop: fever, general ill feeling, extreme tiredness, muscle/joint aches, blisters/peeling of skin, oral blisters/lesions, eye inflammation, facial swelling, swelling of eyes/lips/mouth, difficulty breathing, and/or signs/symptoms of liver problems (e.g., yellowing of skin/whites of eyes, dark/tea-colored urine, pale-colored stools/bowel movements, nausea, vomiting, loss of appetite, pain/aching/sensitivity on right side below ribs).
-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.