Synthivan – Atazanavir/Ritonavir Tablets

Synthivan – Atazanavir/Ritonavir Tablets

Brand Name: Synthivan
Generic Name: Atazanavir/Ritonavir Tablets
Contents: Atazanavir sulfate 300mg
Ritonavir 100 mg
Form: Tablets
Manufacturer Cipla
Pricing: Price Per Pack of 30 Tablets

INDICATIONS
SYNTHIVAN Tablets are indicated in combination with other antiretroviral agents in HIV-infected adults and children (weighing at least 39 kg and between 6 to 18 years of age).

The following points should be considered when initiating therapy with atazanavir/ritonavir:

  • In Study AI424-045, atazanavir/ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in HIV RNA level. This study was not large enough to reach a definitive conclusion that atazanavir/ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the HIV RNA lower limit of detection.
  • The number of baseline primary protease inhibitor mutations affects the virological response to atazanavir/ritonavir.

DOSAGE AND ADMINISTRATION
General Dosing Recommendations

  • SYNTHIVAN Tablets must be taken with food.
  • The recommended oral dosage of SYNTHIVAN Tablets depends on the treatment history of the patient and the use of other co-administered drugs. When co-administered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required.
  • When co-administered with didanosine buffered or enteric-coated (EC) formulations, SYNTHIVAN Tablets should be given with food 2 hours before or 1 hour after didanosine.
  • Efficacy and safety of atazanavir with ritonavir in doses greater than 100 mg once daily have not been established. The use of higher ritonavir doses might alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended.