LOPINAVIR AND RITONAVIR

Other

Brand names: Lopinavir and Ritonavir

Oral

Mechanism of Action

12.1 Mechanism of Action Lopinavir and ritonavir tablets are a fixed-dose combination of HIV-1 antiviral drugs lopinavir [see Microbiology ( 12.4 )] and ritonavir. As co-formulated in lopinavir and ritonavir tablets, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS Lopinavir and ritonavir is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g.
• toxic epidermal necrolysis
• Stevens-Johnson syndrome
• erythema multiforme
• urticaria

FDA Warnings

5 WARNINGS AND PRECAUTIONS The following have been observed in patients receiving lopinavir and ritonavir: The concomitant use of lopinavir and ritonavir and certain other drugs may result in known or potentially significant drug interactions
2) Pancreatitis: Fatalities have occurred; suspend therapy as clinically appropriate
3 ) Hepatotoxicity: Fatalities have occurred
1 Risk of Serious Adverse Reactions Due to Drug Interactions Initiation of lopinavir and ritonavir, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving lopinavir and ritonavir, may increase plasma concentrations of medications metabolized by CYP3A

Known Side Effects

6 documented side effects by frequency

Depression

>10%

Diarrhea

1-10%

Nausea

1-10%

Anxiety

1-10%

Vomiting

1-10%

Fever

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Oral