DTV 50 Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Dolutegravir

Indications/Uses

Combination therapy w/ other anti-retroviral drugs in HIV-infected adults & adolescents >12 yr.

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Dosage/Direction for Use

Adult HIV-1 w/o resistance to the integrase class 50 mg once daily. Co-administration w/ efavirenz, nevirapine, tipranavir/ritonavir, rifampicin: 50 mg bd. HIV-1 w/ resistance to the integrase class 50 mg bd. Adolescent 12-17 yr weighing at least 40 kg HIV-1 w/o resistance to the integrase class 50 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Co-administration w/ dofetilide.

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Special Precautions

Discontinue use if signs or symptoms of hypersensitivity reactions develop. Residual risk of sexual transmission cannot be excluded. Viral strains harbouring Q148+>2 secondary mutations from G140A/C/S, E138A/K/T, L74I. HIV-infected patients w/ severe immune deficiency. Patients w/ advanced HIV disease &/or long-term CART exposure. Monitor clinical status including liver aminotransferases & bilirubin; liver biochemistries in some hepatitis B &/or C co-infected patients at the start of therapy; inflammatory symptoms; opportunistic infections. Severe hepatic impairment. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Headache; nausea, diarrhoea. Insomnia, abnormal dreams; dizziness; vomiting, flatulence, upper abdominal pain, abdominal pain/discomfort; rash, pruritus; fatigue; creatine phosphokinase, ALT &/or AST elevations.

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Drug Interactions

Plasma conc may be decreased by UGT1A1, UGT1A3, UGT1A9, CYP3A4, P gp, & BCRP inducers. Plasma conc may be increased by UGT1A1, UGT1A3, UGT1A9, CYP3A4, P gp & BCRP inhibitors. Reduced absorption by certain antacids. Decreased plasma conc w/ etravirine. Potential life-threatening toxicity w/ dofetilide. Co-administration w/ St. John's wort is strongly discouraged. Mg/Al-containing antacids, Ca/Fe supplements, multivit, metformin.

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Storage

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Description

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Action

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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.

Regulatory Classification

POM

Presentation/Packing

Form

DTV 50 FC tab 50 mg

Packing/Price

30's

DTV 50

dolutegravir

Manufacturer:

Zifam Pinnacle

Distributor:

Pinnacle House