Naivex 50Mg Tablets

Dolutegravir is a human immunodeficiency virus type 1( HIV 1 ) Integrase strand transfer inhibitors ( INSTI ). The Chemical name of Dolutegravir is (4R, 12aS)-N-(2,4-Difluorobenzyl)-7-Hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a hexahydro-2H-pyrido[1'',2'':4,5]pyrazino[2,1-b][1,3]oxazine-9 carboxamide.

Indication:- Dolutegravir is indicated in combination with other anti-retroviral agents for the treatment of HIV-1 Infection in adults weighing more than 40 KG.

Administration:-Dolutegravir can be taken with or without food . In the presence of integrase class resistance, Dolutegravir should preferably be taken with food to enhance exposure.

Details-

1.         Brand name – Naivex

2.         Generic - Dolutegravir

3.         Strength – 50 Mg

4.         Dosage form – Tablets

5.         Packaging – 1 x 30 Tablets

6.         Manufactured By – Hetero Labs Ltd

7.         Marketed By - Hetero Healthcare Ltd

8.         Storage – Store protected from moisture at a temperature not exceeding 30° C.

9.         Delivery time – 4 to 7 days (worldwide) & 24 hours to 48 hours (India)

Contraindications:-

Dolutegravir in contraindicated in

·         Hypersensitivity to the Dolutegravir or to any of the excipirnts of product

·         Combination with dofetilide due to the potential for increased dofetilide plasma concentration and the risk for serious and/or life-threatening events.

Overdose:-

There is limited experience with the over dosage in Dolutegravir. Limited experience of single higher doses revealed no specific symptoms or signs, apart from those listed as adverse reactions. then management in case of over dosage should be as clinically indicated or as recommended by the national poison center, where available. There is no Specific treatment for an overdose of Dolutegravir. if overdose occurs, the patient should be treated supportively with appropriate monitoring, as necessary. As Dolutegravir is highly bound plasma proteins, it is unlikely that it will be significantly removed by dialysis.

Clinical Pharmacology

Mechanism of action:- Dolutegravir inhibits HIV integrase by binding to the intergrase active site and blocking the stand transfer step of retroviral Deoxyribonucleic acid integration which is essential for the HIV replication Cycle.