Tegrad

Tegrad

dolutegravir

Manufacturer:

Hetero Labs

Distributor:

Camber
Concise Prescribing Info
Contents
Dolutegravir
Indications/Uses
Treatment of HIV-1 infection in adults & childn weighing at least 40 kg.
Dosage/Direction for Use
Adult Treatment-naive or treatment-experienced integrase strand transfer inhibitor (INSTI)-naive 50 mg once daily. Treatment-naive or treatment-experienced INSTI-naive when co-administered w/ certain UGT1A or CYP3A inducers, & INSTI-experienced w/ certain INSTI-associated resistance substitution or clinically suspected INSTI resistance 50 mg bid. Childn ≥40 kg 50 mg once daily, 30 kg-40 kg 35 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ dofetilide.
Special Precautions
Discontinue use if hypersensitivity reactions occur. Monitor clinical status including liver aminotransferases. Increased risk of development of transaminase elevations in patients w/ hepatitis B or C. Monitor for hepatotoxicity during therapy especially in patients w/ underlying hepatic disease. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement & "cushingoid appearance". Immune reconstitution syndrome; autoimmune disorders (eg, Graves' disease, polymyositis & Guillain-Barre syndrome). Not recommended during lactation. Pregnancy.
Adverse Reactions
Drug Interactions
May increase plasma conc of drugs eliminated via OCT2 or MATE1 (dofetilide & metformin). Reduced therapeutic effect w/ drugs that induce UGT1A1, UGT1A3, UGT1A9, BCRP & P-gp. Decreased conc w/ etravirine, efavirenz, nevirapine, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, oxcarbazepine, phenytoin, phenobarb, St. John's wort, drugs containing polyvalent cations (eg, Mg or Al), antacids or laxatives sucralfate, buffered medications, oral Ca or Fe supplements, metformin, rifampicin.
MIMS Class
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
Tegrad FC tab 50 mg
Packing/Price
30's
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