CV: MI.
Derm: rash, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS.
GI: diarrhea, abdominal pain, gastritis, hepatitis, nausea, vomiting.
GU: renal failure/impairment.
Hemat: anemia, neutropenia.
Metab: lipodystrophy.
MS: ↑ creatine kinase, myopathy, RHABDOMYOLYSIS.
Neuro: headache, depression, dizziness, fatigue, insomnia, SUICIDAL THOUGHTS, weakness.
Misc: fever, immune reconstitution syndrome.
Do not substitute the chewable tablets or oral suspension for the film-coated tablets.
- PO (Adults): Treatment-naive patients or patients who are virologically suppressed on an initial regimen of raltegravir 400 mg twice daily: Two 600-mg tablets (1200 mg) once daily or 400 mg twice daily; Treatment-experienced patients: 400 mg twice daily; Concurrent use of rifampin (either treatment-naive or treatment-experienced patients): 800 mg twice daily.
- PO (Children ≥40 kg and either treatment-naive or virologically suppressed on an initial regimen of raltegravir 400 mg twice daily): Tablet: Two 600-mg tablets (1200 mg) once daily or 400 mg twice daily; Chewable tablets: 300 mg twice daily.
- PO (Children 28–39 kg): Tablet: 400 mg twice daily; Chewable tablets (if unable to swallow tablet): 200 mg twice daily.
- PO (Children 25–27 kg): Tablet: 400 mg twice daily; Chewable tablets (if unable to swallow tablet): 150 mg twice daily.
- PO (Children ≥4 wk and 20–<25 kg): Chewable tablets: 150 mg twice daily.
- PO (Children ≥4 wk and 14–19 kg): Oral suspension: 100 mg twice daily; Chewable tablets: 100 mg twice daily.
- PO (Children ≥4 wk and 10–13 kg): Oral suspension: 80 mg twice daily; Chewable tablets: 75 mg twice daily.
- PO (Children ≥4 wk and 8–9 kg): Oral suspension: 60 mg twice daily; Chewable tablets: 50 mg twice daily.
- PO (Children ≥4 wk and 6–7 kg): Oral suspension: 40 mg twice daily; Chewable tablets: 50 mg twice daily.
- PO (Children ≥4 wk and 4–5 kg): Oral suspension: 30 mg twice daily; Chewable tablets: 25 mg twice daily.
- PO (Children ≥4 wk and 3–<4 kg): Oral suspension: 25 mg twice daily; Chewable tablets: 25 mg twice daily.
- PO (Neonates 1–4 wk and 4–<5 kg): Oral suspension: 15 mg twice daily.
- PO (Neonates 1–4 wk and 3–<4 kg): Oral suspension: 10 mg twice daily.
- PO (Neonates 1–4 wk and 2–<3 kg): Oral suspension: 8 mg twice daily.
- PO (Neonates 0–1 wk and 4–<5 kg): Oral suspension: 7 mg once daily.
- PO (Neonates 0–1 wk and 3–<4 kg): Oral suspension: 5 mg once daily.
- PO (Neonates 0–1 wk and 2–<3 kg): Oral suspension: 4 mg once daily.
Therapeutic Classification: antiretrovirals
Pharmacologic Classification:
Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Metabolism/Excretion: Mostly metabolized by the uridine diphosphate glucuronosyltransferase (UGT) A1A enzyme system; 23% excreted in urine as parent drug and metabolite.
Half-life: 9 hr.