NORVIR Rx

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NORVIR

Viral infections
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Generic Name and Formulations:

Ritonavir 100mg; tabs, soft-gel caps (contains alcohol).

Company:

AbbVie

Select therapeutic use:

Indications for NORVIR:

HIV-1 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, atazanavir, darunavir, fosamprenavir, saquinavir, tipranavir); reduce ritonavir dose. See full labeling.

Children:

<1month or before postmenstrual age <44weeks: 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 (w. ritonavir ≥400mg every 12hrs), 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. Severe hepatic impairment: not recommended. 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. Simeprevir, salmeterol, high-dose or long-term meperidine, ketoconazole or itraconazole >200mg/day: not recommended. May affect or be affected by CYP3A4, 2D6, 2C9, 1A2, 2C19, 2B6, or glucuronyl transferase substrates. Potentiates other protease inhibitors, maraviroc, tramadol, propoxyphene, antidepressants (eg, SSRIs, tricyclics, nefazodone, desipramine, trazodone), vinca alkaloids (eg, vincristine, vinblastine), dasatinib, nilotinib, dronabinol, quinine, bosentan, β-blockers, CCBs, PDE-5 inhibitors, neuroleptics, sedative/hypnotics, statins, methamphetamine; may need dose reductions. Increases levels of disopyramide, lidocaine, mexiletine, carbamazepine, clonazepam, ethosuximide, digoxin, immunosuppressants; monitor. Antagonizes raltegravir, divalproex, lamotrigine, phenytoin, bupropion, atovaquone, theophylline, methadone, oral contraceptives. Antagonized by rifampin. Avoid metronidazole, disulfiram, colchicine (in renal or hepatic impairment), glucocorticoids (eg, fluticasone, budesonide, dexamethasone, prednisone; increased steroid effects), rivaroxaban (increased bleeding risk). Reduce rifabutin dose by at least ¾, quetiapine to ⅙ of current dose, clarithromycin dose in renal dysfunction. Concomitant bedaquiline: use only if benefit outweighs the risk. Monitor fentanyl, parenteral midazolam, warfarin. See full labeling.

See Also:

NORVIR ORAL SOLUTION

Pharmacological Class:

HIV protease inhibitor.

Adverse Reactions:

Diarrhea, nausea, paresthesias, fatigue/asthenia, vomiting, rash (may be serious), abdominal pain, cough; hepatotoxicity, pancreatitis, immune reconstitution syndrome, lipid disorders, fat redistribution, hyperglycemia, anaphylaxis, PR interval prolongation.

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—240mL

NORVIR 100mg tablets (Qty:30)

appx. price $269.00