Myltega

Myltega

dolutegravir

Manufacturer:

Mylan Lab

Distributor:

Unimed
Concise Prescribing Info
Contents
Dolutegravir
Indications/Uses
HIV infected adults & adolescents >12 yr in combination w/ other anti-retrovirals.
Dosage/Direction for Use
Adult infected w/ HIV-1 w/o documented/clinically suspected resistance to integrase class 50 mg once daily. Adult infected w/ HIV-1 w/ resistance to integrase class (documented/clinically suspected) 50 mg bd. Adolescent 12 to <18 yr, at least 40 kg infected w/ HIV-1 w/o resistance to integrase class 50 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ OCT2 substrates eg, fampridine/dalfampridine.
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 antacids, 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. 1st trimester of pregnancy. Lactation. Childn <12 yr or <40 kg. Elderly ≥65 yr.
Adverse Reactions
Headache; nausea, diarrhoea. Insomnia, abnormal dreams, depression, anxiety; dizziness; vomiting, flatulence, upper abdominal pain, abdominal pain & discomfort; ALT &/or AST elevations; rash, pruritus; fatigue; creatine phosphokinase elevations.
Drug Interactions
Decreased AUC & Cmax w/ etravirine (w/o boosted PIs), efavirenz, tipranavir/ritonavir, fosamprenavir/ritonavir, carbamazepine, rifampicin. Decreased levels w/ nevirapine, oxcarbazepine, phenytoin, phenobarb, St. John's wort. Increased AUC & Cmax w/ atazanavir, atazanavir/ritonavir. Increased plasma conc of fampridine, metformin. Decreased AUC & Cmax w/ Mg- & Al-containing antacids, Ca- & Fe supplements, multivit.
MIMS Class
Antivirals
ATC Classification
J05AJ03 - dolutegravir ; Belongs to the class of integrase inhibitors. Used as direct acting antiviral in the systemic treatment of viral infections.
Presentation/Packing
Form
Myltega FC tab 50 mg
Packing/Price
30's
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