Ritonavir (11 brand names, 6 dosage forms, 1 route)
Available dosage forms: TABLET, TABLET, EXTENDED RELEASE, CAPSULE, SOLUTION, POWDER, PELLETS.
Routes of administration: ORAL.
Brand Names
- ATAZANAVIR SULFATE AND RITONAVIR
- ATAZANAVIR SULFATE; RITONAVIR
- ATAZANAVIR SULFATE;RITONAVIR;LAMIVUDINE;ZIDOVUDINE
- KALETRA
- LOPINAVIR AND RITONAVIR
- LOPINAVIR; RITONAVIR
- NORVIR
- PAXLOVID (COPACKAGED)
- RITONAVIR
- TECHNIVIE
- VIEKIRA XR
Boxed Warning
Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir [see Contraindications (4) , Warnings and Precautions (5.1) ].
Indications and Usage
Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Contraindications
When co-administering ritonavir tablets with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. Ritonavir tablets are contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients. Ritonavir tablets are contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. Alpha 1- Adrenoreceptor Antagonist : alfuzosin Antianginal: ranolazine Antiarrhythmics: amiodarone, dronedarone, flecainide, propafenone, quinidine Antifungal: voriconazole Anti-gout: colchicine Antipsychotics: lurasidone, pimozide Ergot Derivatives: dihydroergotamine, ergotamine, methylergonovine GI Motility Agent: cisapride HMG-CoA Reductase Inhibitors: lovastatin, simvastatin Microsomal triglyceride transfer protein (MTTP) Inhibitor: lomitapide PDE5 Inhibitor: sildenafil (Revatio®) when used for the treatment of pulmonary arterial hypertension Sedative/Hypnotics: triazolam, orally administered midazolam Ritonavir tablets are contraindicated with drugs that are potent CYP3A inducers where significantly reduced ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. Anticancer Agents: apalutamide Herbal Products: St. John’s Wort (hypericum perforatum)
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling. Drug Interactions [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.3)] Pancreatitis [see Warnings and Precautions (5.4)] Allergic Reactions/Hypersensitivity [see Warnings and Precautions (5.5)] When co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions.
Drug Interactions
When co-administering ritonavir with other protease inhibitors (atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir), see the full prescribing information for that protease inhibitor including important information for drug interactions.
Mechanism of Action
Ritonavir is an antiretroviral drug [see Microbiology (12.4)].
Overdosage
Acute Overdosage - Human Overdose Experience Human experience of acute overdose with ritonavir is limited. One patient in clinical trials took ritonavir 1500 mg per day for two days. The patient reported paresthesias which resolved after the dose was decreased. A post-marketing case of renal failure with eosinophilia has been reported with ritonavir overdose. The approximate lethal dose was found to be greater than 20 times the related human dose in rats and 10 times the related human dose in mice. Management of Overdosage Ritonavir oral solution contains ethanol and propylene glycol. Ingestion of the product over the recommended dose by a young child could result in significant toxicity and could potentially be lethal. Treatment of overdose with ritonavir consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with ritonavir. If indicated, elimination of unabsorbed drug should be achieved by gastric lavage; usual precautions should be observed to maintain the airway. Administration of activated charcoal may also be used to aid in removal of unabsorbed drug. Since ritonavir is extensively metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the drug. However, dialysis can remove both ethanol and propylene glycol in the case of overdose with ritonavir oral solution. A Certified Poison Control Center should be consulted for up-to-date information on the management of overdose with ritonavir.