Isentress HD

Isentress HD

raltegravir

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Raltegravir
Indications/Uses
In combination w/ other antiretroviral agents for HIV-1 infection in adults, childn & adolescents ≥2 yr.
Dosage/Direction for Use
Adult, childn & adolescent (at least 40 kg) who are treatment-naïve Recommended dose: 1,200 mg once daily.
Administration
May be taken with or without food.
Special Precautions
Discontinue use if severe skin or hypersensitivity reactions develop. Risk for severe, potentially life-threatening, & fatal skin reactions (including Stevens-Johnson syndrome & toxic epidermal necrolysis) when concomitantly used w/ other drugs. Not recommended to be coadministered w/ Al- & Mg-containing antacids; atazanavir; tipranavir/ritonavir; strong inducers of UGT1A1 (eg, rifampin). Risk of immune reconstitution syndrome; autoimmune disorders (eg, Graves' disease) may also occur in the immune reconstitution setting. Risk of osteonecrosis particularly in patients w/ advanced HIV disease &/or long-term exposure to combination anti-retroviral therapy. Not to be taken by patients w/ rare hereditary problems of galactose intolerance. Severe hepatic impairment; monitor patients w/ preexisting liver dysfunction including chronic hepatitis; increased risk for severe & potentially fatal hepatic adverse events in patients w/ chronic hepatitis B or C. Pregnancy. Breastfeeding is not recommended during therapy. Infant <4wk. Elderly ≥65 yr.
Adverse Reactions
Diarrhea, nausea, headache, nasopharyngitis, fatigue, upper resp tract infection, bronchitis, pyrexia & vomiting.
Drug Interactions
Reduced plasma conc w/ potent UGT1A1 inducers (eg, rifampin). Increased plasma levels w/ potent UGT1A1 inhibitors (eg, atazanavir). May reduce absorption by chelation resulting to decrease plasma levels when co-administered w/ antacids containing divalent metal cations (Al- &/or Mg-containing antacids). May increase plasma levels w/ drugs known to increase gastric pH (eg, omeprazole).
MIMS Class
ATC Classification
J05AJ01 - raltegravir ; Belongs to the class of integrase inhibitors. Used as direct acting antiviral in the systemic treatment of viral infections.
Presentation/Packing
Form
Isentress HD FC tab 600 mg
Packing/Price
60's
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