Generic Name and Formulations:
Ritonavir 100mg; tabs, soft-gel caps (contains alcohol).

Company:
AbbVie
Indications for NORVIR:
HIV infection, in combination with other antiretroviral agents.

Adult:
Swallow tabs whole. Take with meals. Oral soln: may be mixed with chocolate milk, Ensure, or Advera within 1hour of dosing. Initially at least 300mg twice daily, increase every 2‒3 days by 100mg twice daily to 600mg twice daily. Concomitant other PIs (eg, amprenavir, atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir); reduce ritonavir dose. See literature.

Children:
<1month: not recommended. Swallow tabs whole. Take with meals. Oral soln: may be mixed with chocolate milk, Ensure, or Advera within 1hour of dosing. >1month: initially 250mg/m2 twice daily, increase every 2‒3 days by 50mg/m2 twice daily to 350‒400mg/m2 twice daily; max 600mg twice daily. Consider alternative therapy if 400mg/m2 twice daily is not tolerated.

Contraindications:
Concomitant alfuzosin HCl, amiodarone, flecainide, quinidine, propafenone, voriconazole, ergots, oral midazolam, triazolam, pimozide, cisapride, St. John's Wort, lovastatin, simvastatin, sildenafil (Revatio; only when used to treat PAH).

Warnings/Precautions:
Discontinue if pancreatitis occurs. Impaired hepatic function, liver enzyme abnormalities, hepatitis; consider monitoring ALT/AST, GGT at baseline and for first 3 months of therapy. Pre-existing conduction system disease, cardiomyopathy, ischemic heart or underlying structural heart disease. Monitor blood, CPK, uric acid, triglycerides, cholesterol, and for hyperglycemia. Hemophilia. Diabetes. Elderly. Pregnancy (Cat.B). Oral soln for preterm neonates in immediate postnatal period not recommended unless benefits outweigh risks. Nursing mothers: not recommended.

Interactions:
See Contraindications. Rifampin, high-dose or long-term meperidine: not recommended. Potentiates other protease inhibitors, PDE5 inhibitors, fentanyl (monitor), tramadol, propoxyphene, dasatinib, nilotinib, desipramine, colchicine, clarithromycin, bosentan (reduce doses; see literature); fluticasone and salmeterol (avoid). May be affected by, potentiate, or antagonize drugs that are metabolized by or induce CYP3A4, 2D6, 2C9, 3A, 1A2, 2C19, 2B6, or glucuronyl transferase, including: delavirdine, maraviroc, antiarrhythmics (eg, disopyramide, lidocaine, mexiletine), digoxin, anticoagulants, anticonvulsants, most antidepressants (eg, SSRIs, tricyclics, nefazodone, bupropion, trazodone), antiemetics (eg, dronabinol), antihypertensives (eg, calcium channel blockers, β-blockers), antiparasitics, corticosteroids, immunosuppressants, neuroleptics, sedative/hypnotics, CNS stimulants, statins, vinca alkaloids (eg, vincristine, vinblastine; consider withholding ritonavir); monitor these and others closely. Antagonizes theophylline, oral contraceptives, methadone. Avoid metronidazole, disulfiram; itraconazole or ketoconazole >200mg/day. Reduce rifabutin dose by at least ¾. See full labeling.

See Also:
NORVIR ORAL SOLUTION

Pharmacological Class:
HIV protease inhibitor.

Adverse Reactions:
GI upset, abdominal pain, asthenia, headache, malaise, anorexia, paresthesias, dizziness, taste perversion, fever, hyperlipidemia, throat irritation, myalgia, somnolence, insomnia, sweating, vasodilation, pancreatitis, immune reconstitution syndrome, fat redistribution, anaphylaxis, rash (may be serious), PR interval prolongation; others.

Note:
Register pregnant patients exposed to ritonavir by calling (800) 258-4263.

Metabolism:
Hepatic (CYP3A; CYP2D6).

Elimination:
Fecal (primarily); renal.

Generic Availability:
NO

How Supplied:
Tabs—30; Caps—30, 120; Soln—8oz