Durart

Durart Dosage/Direction for Use

darunavir

Manufacturer:

Viatris

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare
Full Prescribing Info
Dosage/Direction for Use
Darunavir must always be given with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products. This prescribing information of ritonavir must therefore be consulted prior to initiation of therapy with darunavir/rtv.
After therapy with darunavir has been initiated, patients should be advised not to alter the dosage, dosage form, or discontinue therapy without instruction of their physician.
Posology: Adults: See Table 3.

Click on icon to see table/diagram/image

For antiretroviral treatment-experienced patients HIV genotype testing is recommended. However, when HIV genotype testing is not feasible, the once daily dosing regimen is recommended in HIV protease inhibitor-naïve patients and the twice daily dosing regimen is recommended in HIV protease inhibitor-experienced patients.
The type of food does not affect the exposure to darunavir. Ritonavir is used as a pharmacokinetic enhancer of darunavir (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Pediatric patients: Antiretroviral Treatment-experienced pediatric patients weighing 40 kg or more (see Pharmacology: Pharmacodynamics under Actions): The recommended dose of darunavir/rtv for pediatric patients is based on body weight and should not exceed the recommended adult dose. The adult dose of darunavir/rtv (600/100 mg b.i.d.) may be used in pediatric patients of 40 kg or more. Darunavir tablets should be taken with ritonavir twice daily and with food.
The type of food does not affect the exposure of darunavir. Ritonavir is used as a pharmacokinetic enhancer of darunavir (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Antiretroviral Treatment-experienced children weighing less than 40 kg and antiretroviral Treatment-naïve pediatric patients: The safety and efficacy of darunavir/rtv in children 3 years or more and weighing less than 40 kg and in an antiretroviral treatment naïve pediatric patients have not been evaluated.
Darunavir/rtv should not be used in children below 3 years of age (see Precautions and Pharmacology: Toxicology under Actions).
Pregnancy and postpartum: No dose adjustment is required for darunavir/rtv during pregnancy and postpartum. Caution should be used in patients with concomitant medications which may further decrease darunavir exposure (see Use in Pregnancy & Lactation and Pharmacology: Pharmacokinetics: Special Populations: Pregnancy and postpartum under Actions).
Missed dose(s): If using the once daily regimen: in case a dose of darunavir and/or ritonavir was missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible. If this was noticed later than 12 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
If using the twice daily regimen: in case a dose of darunavir and/or ritonavir was missed within 6 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible. If this was noticed later than 6 hours after the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Special populations: Elderly (65 years of age and older): Limited information is available on the use of Darunavir in patients 65 and older. Therefore, darunavir should be used with caution in this age group [see Precautions and Pharmacology: Pharmacokinetics: Special Population Elderly (65 years of age and older) under Actions].
Renal impairment: No dose adjustment is required in patients with renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. There are no data regarding the use of darunavir when co-administered to patients with severe hepatic impairment; therefore, specific dosage recommendations cannot be made. Darunavir should be used with caution in patients with severe hepatic impairment. (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Administration: Method of administration: Oral administration.
Darunavir must be taken with food. The type of food does not affect the exposure to darunavir (see Pharmacology: Pharmacokinetics: Absorption under Actions).
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