Isentress

Isentress

raltegravir

Manufacturer:

MSD

Distributor:

Zuellig
Concise Prescribing Info
Contents
Raltegravir
Indications/Uses
400 mg FC tab In combination w/ other antiretroviral agents for the treatment of HIV-1 infection in adult patients, adolescents & childn from 6 yr of age weighing at least 25 kg. 600 mg FC tab In combination w/ other antiretroviral agents for the treatment of HIV-1 infection in adult & childn weighing at least 40 kg.
Dosage/Direction for Use
400 mg FC tab Adult 400 mg bd. 800 mg bd can be considered in adults when co-administered w/ rifampicin. Childn & adolescent ≥6 yr & weighing ≥25 kg 400 mg bd. 600 mg FC tab Adult & childn (at least 40 kg) 1,200 mg once daily for treatment-naïve patients or patients virologically suppressed on initial regimen of Isentress 400 mg bd.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Risk of sexual transmission of HIV. Patients w/ pre-existing history of depression or psychiatric illness. Osteonecrosis. Risk of immune reactivation syndrome during initiation of combination anti-retroviral therapy (CART). Myopathy & rhabdomyolysis. Severe skin & hypersensitivity reactions including Stevens-Johnson syndrome & toxic epidermal necrolysis. Rash. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ atazanavir, tipranavir/ritonavir, antacids, or strong inducers of drug metabolizing enzymes. May influence ability to drive & use machines. Severe hepatic impairment. Pregnancy & lactation. Elderly. 400 mg FC tab: Childn <6 yr. 600 mg FC tab: Should not be used in childn <40 kg.
Adverse Reactions
Dizziness, headache, psychomotor hyperactivity; abdominal distention, abdominal pain, diarrhoea, flatulence, nausea, vomiting, dyspepsia; vertigo; decreased appetite; abnormal dreams, insomnia, nightmare, abnormal behavior, depression; rash; asthenia, fatigue, pyrexia; atypical lymphocytes, increased ALT, AST, blood triglycerides, lipase, blood pancreatic amylase.
Drug Interactions
Reduced plasma conc w/ rifampicin & other strong UGT1A1 inducers, tipranavir/ritonavir, antacids eg, Ca carbonate & Al/Mg-containing antacids & other agents that increase gastric pH. Increased plasma conc w/ atazanavir & other UGT1A1 inhibitors; tenofovir disoproxil fumarate.
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 tab 400 mg
Packing/Price
60's
Form
Isentress tab 600 mg
Packing/Price
60's
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