Santigrase

Santigrase

dolutegravir

Manufacturer:

Cipla

Distributor:

Phil Pharmawealth
Concise Prescribing Info
Contents
Dolutegravir Na
Indications/Uses
In combination w/ other antiretroviral medicines for HIV infected adults & adolescents (at least 40 kg).
Dosage/Direction for Use
Adult & adolescent (at least 40 kg) HIV-1 infection not resistant to integrase inhibitors 50 mg once daily. Adult HIV-1 infection known or suspected to be resistant to integrase inhibitors 50 mg bid. In combination w/ efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin 50 mg bid. Childn over 6 yr 1 mg/kg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ dofetilide.
Special Precautions
Discontinue immediately if hypersensitivity reactions develop. May reduce the risk of sexual transmission but not eliminated entirely. Reduced activity for viral strains w/ Q148 + ≥2 secondary mutations from G140A/C/S, E138A/K/T, L74I. Uncertain efficacy when used to treat HIV-1 w/ type of resistance to integrase inhibitors. Inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise in patients w/ severe immune deficiency & may cause serious clinical conditions or aggravation of symptoms. Autoimmune disorders (eg, Graves' disease). Patient may still develop opportunistic infection & other HIV infection complications. Osteonecrosis in patients w/ advanced HIV disease or following long-term combination therapy. Monitor liver function in patients w/ hepatitis B or C co-infection. Severe hepatic impairment (Child-Pugh grade C). Pregnancy & lactation. Childn <6 yr. Elderly ≥65 yr.
Adverse Reactions
Headache; nausea, diarrhoea. Insomnia, abnormal dreams, depression; dizziness; flatulence, upper abdominal pain, abdominal pain/discomfort; rash pruritus; fatigue; raised ALT, AST, & creatine kinase.
Drug Interactions
Reduced blood levels w/ Mg- or Al-containing antacid, Fe & Ca supplements, multivitamins & inducing agents, etravirine (w/o boosted PIs), tipranavir/ritonavir, rifampicin, St. John's wort, & certain antiepileptic medicines. May decrease plasma conc & reduce therapeutic effect w/ UGT1A3, UGT1A9, CYP3A4, P-gp, & BCRP enzyme inducers. May increase plasma conc w/ UGT1A3, UGT1A9, CYP3A4, P-gp, & BCRP enzyme inhibitors. Increased metformin conc. May increase plasma conc of medicines whose excretion involves organic cation transporter 2 (OCT2) & multidrug & toxin extrusion transporter 1 (MATE-1) (eg, dofetilide, metformin) or dependent upon organic anion transporters 3.
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
Santigrase FC tab 50 mg
Packing/Price
30's
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