Prezista

Prezista Dosage/Direction for Use

darunavir

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Dosage/Direction for Use
Adult Patients: PREZISTA must be co-administered with ritonavir to exert its therapeutic effect. Failure to correctly co-administer PREZISTA with ritonavir will result in plasma levels of darunavir that will be insufficient to achieve the desired antiviral effect and will alter some drug interactions.
Patients who have difficulty swallowing PREZISTA tablets can use the 100 mg/mL PREZISTA oral suspension.
Treatment-Naïve Adult Patients: The recommended oral dose of PREZISTA is 800 mg (one 800 mg tablet or two 400 mg tablets) taken with ritonavir 100 mg (one 100 mg tablet/capsule or 1.25 mL of a 80 mg/mL ritonavir oral solution) once daily and with food.
Treatment-Experienced Adult Patients: See Table 15.

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For antiretroviral treatment-experienced patients genotypic testing is recommended. However, when genotypic testing is not feasible, PREZISTA/ritonavir 600/100 mg twice daily dosing is recommended.
Pediatric Patients (age 6 to less than 18 years): Do not use once daily dosing in pediatric patients.
Healthcare professionals should pay special attention to accurate dose selection of PREZISTA, transcription of the medication order, dispensing information and dosing instruction to minimize risk for medication errors, overdose, and underdose.
Prescribers should select the appropriate dose of PREZISTA/ritonavir for each individual child based on body weight (kg) and should not exceed the recommended dose for treatment-experienced adults.
Before prescribing PREZISTA, children weighing greater than or equal to 20 kg should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a tablet, the use of PREZISTA tablets may not be appropriate.
The recommended dose of PREZISTA/ritonavir for pediatric patients (6 to less than 18 years of age and weighing at least 44lbs (20 kg) is based on body weight (see Table 16) and should not exceed the recommended treatment-experienced adult dose (PREZISTA/ritonavir 600/100 mg b.i.d.). PREZISTA tablets should be taken with ritonavir twice daily and with food. (See Table 16.)

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Do not use PREZISTA/ritonavir in pediatric patients below 6 years of age [see Use in Children under Precautions].
Patients with Hepatic Impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available regarding the use of PREZISTA/ritonavir when co-administered to subjects with severe hepatic impairment; therefore, PREZISTA/ritonavir is not recommended for use in patients with severe hepatic impairment [see Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics: Special Populations: Hepatic Impairment under Actions].
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