Dolutegravir Mylan

Dolutegravir Mylan

dolutegravir

Manufacturer:

Viatris GmbH & Co

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare
Concise Prescribing Info
Contents
Dolutegravir Na
Indications/Uses
In combination w/ other anti-retrovirals for HIV-infected adult & adolescents >12 yr.
Dosage/Direction for Use
Adult infected w/ HIV-1 w/o documented or clinically suspected resistance to the integrase class 50 mg once daily. In combination w/ efavirenz, nevirapine, tipranavir/ritonavir or rifampicin: 50 mg bid. Adult infected w/ HIV-1 w/ resistance to the integrase class 50 mg bid. Adolescents ≥12 yr at least 40 kg infected w/ HIV-1 w/o resistance to the integrase class 50 mg once daily.
Administration
May be taken with or without food. Patients infected w/ HIV w/ resistance to the integrase class: Should be taken with food.
Contraindications
Hypersensitivity. Concomitant use w/ dofetilide.
Special Precautions
Hypersensitivity reactions. Activity is considerably compromised for viral strains harbouring Q148+≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I in the presence of integrase class resistance. Monitor liver biochemistries in patients w/ hepatitis B &/or C co-infection. Immune reactivation syndrome. Opportunistic infections. Concomitant use w/ drugs that reduce dolutegravir exposure [eg, Mg- or Al-containing antacid, Fe & Ca supplements, multivit & inducing agents, etravirine (w/o boosted PIs), tipranavir/ritonavir, rifampicin, St. John's wort & antiepileptics]. Monitor renal function in patients co-treated w/ metformin; may increase risk for lactic acidosis in patients w/ moderate renal impairment. Osteonecrosis in patients w/ advanced HIV-disease &/or long-term exposure to CART. Pregnancy & lactation.
Adverse Reactions
Headache; nausea, diarrhoea. Insomnia, abnormal dreams, depression; dizziness; vomiting, flatulence, upper abdominal pain, abdominal pain & discomfort; rash; pruritis; fatigue; ALT &/or AST elevations; creatine phosphokinase elevations.
Drug Interactions
Plasma conc & therapeutic effect may be decreased by UGT1A3, UGT1A9, CYP3A4, Pgp & BCRP enzyme inducers. Decreased AUC, Cmax & Ct w/ etravirine w/o boosted PIs, efavirenz, tipranavir/ritonavir, carbamazepine, rifampicin. Decreased levels w/ nevirapine, oxcarbazepine, phenytoin & phenobarb. Increase conc of dofetilide. Decreased AUC & Cmax w/ Mg- & Al-containing antacids, Ca- & Fe supplements, & multivit. Increased AUC & Cmax of metformin.
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
Dolutegravir Mylan FC tab 50 mg
Packing/Price
30's
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