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5 Warnings And Precautions
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The following have been observed in patients receiving NORVIR: Drug Interactions: Consider drug-drug interaction potential to reduce risk of serious or life-threatening adverse reactions. (5.1) Hepatic Reactions: Fatalities have occurred. Monitor liver function before and during therapy, especially in patients with underlying hepatic disease, including hepatitis B and hepatitis C, or marked transaminase elevations. (5.2, 8.6) Pancreatitis: Fatalities have occurred; suspend therapy as clinically appropriate. (5.3) Allergic Reactions/Hypersensitivity: Allergic reactions have been reported and include anaphylaxis, toxic epidermal necrolysis, Stevens-Johnson syndrome, bronchospasm and angioedema. Discontinue treatment if severe reactions develop. (5.4, 6.3) PR interval prolongation may occur in some patients. Cases of second and third degree heart block have been reported. Use with caution with patients with preexisting conduction system disease, ischemic heart disease, cardiomyopathy, underlying structural heart disease or when administering with other drugs that may prolong the PR interval. (5.5, 12.3) Total cholesterol and triglycerides elevations: Monitor prior to therapy and periodically thereafter. (5.6) Patients may develop new onset or exacerbations of diabetes mellitus, hyperglycemia. (5.7) Patients may develop immune reconstitution syndrome. (5.8) Patients may develop redistribution/accumulation of body fat. (5.9) Hemophilia: Spontaneous bleeding may occur, and additional factor VIII may be required. (5.10)
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Co-administration of NORVIR can alter the concentrations of other drugs. The potential for drug-drug interactions must be considered prior to and during therapy. (4, 5.1, 7, 12.3)
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3 Dosage Forms And Strengths
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Capsule, Soft Gelatin: 100 mg. (3)
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Package Label.principal Display Panel
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Spl Patient Package Insert Section
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The most common adverse reactions (greater than 5% and of moderate to severe intensity) were abdominal pain, asthenia, headache, malaise, anorexia, diarrhea, dyspepsia, nausea, vomiting, paresthesia, circumoral paresthesia, peripheral paresthesia, dizziness, and taste perversion. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Abbott Laboratories at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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Contraindications (4) 12/2011 Warnings and Precautions, Drug Interactions (5.1) 12/2011 Warnings and Precautions, Allergic Reactions (5.4) 12/2011 Warnings and Precautions, Immune Reconstitution Syndrome (5.8) 02/2012
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Warning: Drug-drug Interactions Leading To Potentially Serious And/or Life Threatening Reactions
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WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS See full prescribing information for complete boxed warning Co-administration of NORVIR 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 NORVIR on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing NORVIR or when prescribing other medications to patients already taking NORVIR [see Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Clinical Pharmacology (12.3)].
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2 Dosage And Administration
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Dose modification for NORVIR is necessary when used with other protease inhibitors. (2) Adult patients: 600 mg twice-daily with meals if possible. (2.1) Pediatrics patients: The recommended twice daily dose for children greater than one month of age is based on body surface area and should not exceed 600 mg twice daily with meals if possible. (2.2)
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Created by
fda_medical_bot
on
1/7/2012
