DARUVIR 600(CIPLA)

Composition
Each film-coated tablet contains:
Darunavir Ethanolate equivalent to Darunavir 600 mg
Colours: Titanium Dioxide & Sunset Yellow FCF
Dosage Form: Oral tablet
 
Pharmacology
Pharmacodynamics
Mechanism of Action
Darunavir is an inhibitor of the human immunodeficiency virus (HIV)-1 protease. It selectively inhibits the cleavage of HIV-1 encoded Gag-Pol polyproteins in infected cells, thereby preventing the formation of mature virus particles.
Cardiac Electrophysiology
In a thorough QT/QTc study in 40 healthy subjects, darunavir/ritonavir doses of 1.33 times the maximum recommended dose did not affect the QT/QTc interval.
Pharmacokinetics
Pharmacokinetics in Adults
General
Darunavir is primarily metabolized by CYP3A. Ritonavir inhibits CYP3A, thereby increasing the plasma concentrations of darunavir. When a single dose of darunavir 600 mg was given orally in combination with 100 mg ritonavir twice daily, there was an approximate 14-fold increase in the systemic exposure of darunavir. Therefore, darunavir should only be used in combination with 100 mg of ritonavir to achieve sufficient exposures of darunavir.
The pharmacokinetics of darunavir, co-administered with low-dose ritonavir (100 mg), has been evaluated in healthy adult volunteers and in HIV-1-infected subjects. Table 1 displays the population pharmacokinetic estimates of darunavir after oral administration of darunavir/ritonavir 600/100 mg twice daily (based on sparse sampling in 285 patients in trial TMC114-C214, 278 patients in trial TMC114-C229 and 119 patients from trials TMC114-C202 and TMC114-C213).
 
NOTE: THIS HAS TO BE TAKEN ONLY UNDER SUPERVISION OF A REGISTERED MEDICAL PRACTITIONER