Tivicay 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 Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Dolutegravir

Indications/Uses

HIV infected adults & childn at least >6 yr in combination w/ other antiretroviral drugs.

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Dosage/Direction for Use

Patient infected w/ HIV-1 w/o documented or clinically suspected resistance to integrase class 50 mg once daily. Patient infected w/ HIV-1 w/ resistance to integrase class (documented or clinically suspected) 50 mg bd. Adolescent 12 to <18 yr & ≥20 kg, childn at least 6 yr & weighing at least 20 kg infected w/ HIV-1 w/o resistance to 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, pilsicainide or fampridine.

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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. Avoid co-administration w/ Mg- or Al-containing antacid, Fe & Ca supplements, multivit & inducing agents, etravirine (w/o boosted PIs), tipranavir/ritonavir, rifampicin, St. John's wort & certain anti-epileptics. Concomitant use w/ 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 <6 yr or <20 kg.

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Use In Pregnancy & Lactation

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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; increased wt.

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Drug Interactions

Decreased AUC & C_max w/ etravirine (w/o boosted PIs), efavirenz, nevirapine, tipranavir/ritonavir, fosamprenavir/ritonavir, darunavir/ritonavir, carbamazepine, oxcarbazepine, phenytoin, phenobarb, St. John's wort, Mg- & Al-containing antacid, Ca & Fe supplements, multivit, rifampicin. Increased AUC & C_max w/ atazanavir, atazanavir/ritonavir. Increased dofetilide, pilsicainide, fampridine, metformin conc. Increased extent & slowed absorption rate w/ food.

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Caution For Usage

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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

Presentation/Packing

Form

Tivicay FC tab 50 mg

Packing/Price

30's

Tivicay

dolutegravir

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma