Ritonavir

RITONAVIR

Manufacturer: Aurobindo Pharma Limited

Score: 148.0

Quick Summary

Ritonavir is an HIV protease inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection. It has a complex pharmacokinetic profile and is known to interact with various other drugs, which can lead to serious and/or life-threatening adverse events. The recommended dosage is 600 mg twice daily with meals, and dose modification is necessary when used with other protease inhibitors. Ritonavir is contraindicated in patients with known hypersensitivity to ritonavir or any of its ingredients, and its use is not recommended during pregnancy due to the potential risk of ethanol exposure. Special population considerations include pediatric use, geriatric use, and use in nursing mothers.

Key Clinical Findings and Indications

Treatment of HIV-1 infection
HIV protease inhibitor
Used in combination with other antiretroviral agents

Important Safety Information

Warning

Co-administration with several classes of drugs may result in potentially serious and/or life-threatening adverse events

Contraindications

Known hypersensitivity to ritonavir or any of its ingredients
Drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions

Adverse Reactions

Gastrointestinal side effects (diarrhea, nausea, vomiting, abdominal pain)
Neurological disturbances (paresthesia, oral paresthesia)
Rash
Fatigue/asthenia

Dosing Recommendations

General Guidance

Dose modification is necessary when used with other protease inhibitors

HIV-1 infection

Adult Dose

600 mg twice daily with meals

Pediatric Dose

350 to 400 mg per m2 twice daily with meals (for patients older than 1 month)

Special Population Considerations

Pregnancy

Ritonavir oral solution is not recommended during pregnancy due to the potential risk of ethanol exposure
Use of ritonavir during pregnancy may reduce the efficacy of combined hormonal contraceptives

Nursing Mothers

Use of ritonavir may reduce the efficacy of combined hormonal contraceptives
Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception

Pediatric Use

Ritonavir has been studied in pediatric patients older than 1 month to 21 years
The antiviral activity and adverse event profile seen during clinical trials and through postmarketing experience were similar to that for adult patients

Geriatric Use

Clinical studies of ritonavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range