HIV-1 infection

Active Ingredient: Ritonavir

Indication for Ritonavir

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 - 65 years old)
Therapeutic intent: Curative procedure

Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older).

For this indication, competent medicine agencies globally authorize below treatments:

300 mg twice daily for 3 days and thereafter increase by 100 mg twice daily increments up to 600 mg twice daily over a period of no longer than 14 days

For:

Dosage regimens

Oral, 300 milligrams ritonavir, 2 times every minute to meals, over the duration of 3 days. Afterwards, oral, between 400 milligrams ritonavir and 600 milligrams ritonavir, 2 times every minute to meals, over the duration of 11 days.

Detailed description

Ritonavir dosed as an antiretroviral agent

The recommended dose of ritonavir is 600 mg twice daily (total of 1,200 mg per day) by mouth.

Gradually increasing the dose of ritonavir when initiating therapy may help to improve tolerance. Treatment should be initiated at 300 mg twice daily for a period of three days and increased by 100 mg twice daily increments up to 600 mg twice daily over a period of no longer than 14 days. Patients should not remain on 300 mg twice daily for more than 3 days.

Ritonavir dosed as a pharmacokinetic enhancer

The following HIV-1 protease inhibitors have been approved for use with ritonavir as a pharmacokinetic enhancer at the noted doses:

Amprenavir 600 mg twice daily with ritonavir 100 mg twice daily.

Atazanavir 300 mg once daily with ritonavir 100 mg once daily.

Fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily.

Lopinavir co-formulated with ritonavir (lopinavir/ritonavir) 400 mg/100 mg or 800 mg/200 mg.

Saquinavir 1,000 mg twice daily with ritonavir 100 mg twice daily in ART experienced patients. Initiate treatment with saquinavir 500 mg twice daily with ritonavir 100 mg twice daily for the first 7 days, then saquinavir 1,000 mg twice daily with ritonavir 100 mg twice daily in ART-naïve patients.

Tipranavir 500 mg twice daily with ritonavir 200 mg twice daily. Tipranavir with ritonavir should not be used in treatment-naïve patients.

Darunavir 600 mg twice daily with ritonavir 100 mg twice daily in antiretroviral treatment. (ART) experienced patients. Darunavir 800 mg once daily with ritonavir 100 mg once daily may be used in some ART experienced patients. Refer to the darunavir Summary of Product Characteristics for further information on once daily dosing in ART experienced patients.

Darunavir 800 mg once daily with ritonavir 100 mg once daily in ART-naïve patients.

Dosage considerations

It should be ingested with food.

250 mg/m² twice daily and thereafter increase at 2 to 3 day intervals by 50 mg/m² twice daily

For:

Dosage regimens

Oral, 250 milligrams ritonavir per square meter of body surface, 2 times daily, over the duration of 2 to 3 days. Afterwards, oral, 300 milligrams ritonavir per square meter of body surface, 2 times daily, over the duration of 2 to 3 days. Afterwards, oral, 350 milligrams ritonavir per square meter of body surface, 2 times daily.

Detailed description

Ritonavir dosed as an antiretroviral agent

The recommended dosage of ritonavir in children is 350 mg/m² by mouth twice daily and should not exceed 600 mg twice daily. Ritonavir should be started at 250 mg/m² and increased at 2 to 3 day intervals by 50 mg/m² twice daily.

Ritonavir is not recommended in children below 2 years of age due to lack of data on safety and efficacy.

Ritonavir dosed as a pharmacokinetic enhancer

Ritonavir is recommended for children 2 years of age and older. For further dosage recommendations, refer to the product information of other Protease Inhibitors approved for co-administration with ritonavir.

Dosage considerations

It should be ingested with food.

Active ingredient

Ritonavir

Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism.

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