Zuellig Pharma
Concise Prescribing Info
HIV infected adults & adolescents >12 yr in combination w/ other antiretroviral drugs.
Dosage/Direction for Use
Patient infected w/ HIV-1 w/o documented/clinically suspected resistance to integrase class 50 mg once daily. Patient infected w/ HIV-1 w/ resistance to integrase class (documented/clinically suspected) 50 mg bd. Adolescent 12-<18 yr & at least 40 kg infected w/ HIV-1 w/o resistance to integrase class 50 mg once daily.
May be taken with or without food.
Hypersensitivity. Co-administration w/ dofetilide.
Special Precautions
Discontinue use if signs or symptoms of hypersensitivity reactions develop. Opportunistic & other complications of HIV infection. Immune reactivation syndrome; osteonecrosis. Monitor liver biochemistries in patients w/ HBV &/or HCV co-infection. Co-administration w/ Mg- or Al-containing antacid, Fe & Ca supplements, multivit & inducing agents, etravirine (w/o boosted PIs), tipranavir/ritonavir, rifampicin, St. John's wort & certain anti-epileptics; metformin. May affect ability to drive & use machines. Severe hepatic impairment (Child-Pugh grade C). Women of childbearing potential should use effective contraception during treatment. Avoid during 1st trimester of pregnancy. Lactation. Childn <12 yr or <40 kg.
Adverse Reactions
Headache; nausea, diarrhoea. Insomnia, abnormal dreams, depression, anxiety; dizziness; vomiting, flatulence, upper abdominal pain, abdominal pain & discomfort; rash, pruritus; fatigue; ALT &/or AST & creatine phosphokinase elevations.
Drug Interactions
Decreased AUC & Cmax w/ etravirine (w/o boosted PIs), darunavir/ritonavir + etravirine, efavirenz, nevirapine, tipranavir/ritonavir, fosamprenavir/ritonavir, darunavir/ritonavir, carbamazepine, oxcarbazepine, phenytoin, phenobarb, St. John's wort, Mg- & Al-containing antacid, Ca, Fe supplements, multivit, rifampicin. Increased AUC & Cmax w/ atazanavir, atazanavir/ritonavir, telaprevir. Increased dofetilide, metformin conc.
MIMS Class
ATC Classification
J05AX12 - dolutegravir ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.
Tivicay FC tab 50 mg
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