Classes
DEA Class; Rx
Common Brand Names; Relafen
NSAIDs
Description
NSAID of the acetic acid chemical class; requires conversion to active metabolite for anti-inflammatory, analgesic, and antipyretic activity; causes an increased risk of serious gastrointestinal adverse effects; may cause an increased risk of serious cardiovascular events; use lowest effective dose for the shortest possible duration; once daily administration.
Indications
Contraindications
Absolute: Aspirin allergy, severe renal impairment; perioperative pain in setting of coronary artery bypass graft (CABG) surgery
Relative: Duodenal/gastric/peptic ulcer, stomatitis, systemic lupus erythematosus, ulcerative colitis, late pregnancy (may cause premature closure of ductus arteriosus)
Adverse Effects
>10%
Diarrhea (14%)
Dyspepsia (13%)
Abdominal pain (12%)
1-10%
Constipation (3-9%)
Dizziness (3-9%)
Edema (3-9%)
Flatulence (3-9%)
Headache (3-9%)
Nausea (3-9%)
Positive stool guaiac (3-9%)
Pruritus (3-9%)
Rash (3-9%)
Tinnitus (3-9%)
Dry mouth (1-3%)
Fatigue (1-3%)
Gastritis (1-3%)
Increased sweating (1-3%)
Insomnia (1-3%)
Nervousness (1-3%)
Somnolence (1-3%)
Stomatitis (1-3%)
Vomiting (1-3%)
Warnings
Use caution in asthma (bronchial), bleeding disorders, cardiac disease, hepatic impairment, hypertension, renal impairment
Therapy may lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to increased incidence of CV events; patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs; use with caution in patients with hypertension; monitor blood pressure (BP) closely during initiation of treatment and throughout the course of therapy
May not be sufficiently activated in patients with hepatic dysfunction; use with caution
Borderline elevations of 1 or more liver function tests may occur in up to15% of patients; laboratory abnormalities may progress, remain unchanged, or may be transient with continuing therapy; notable elevations of ALT or AST (approximately 3 or more times the upper limit of normal) reported in approximately 1% of patients in clinical trials with NSAIDs; If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue therapy
Pregnancy and Lactation
Pregnancy category: C; D if used for prolonged periods or near term (premature closure of ductus arteriosus)
Lactation: Unknown whether drug is excreted in breast milk; effect on infant unknown; do not give to nursing mothers
Maximum Dosage
2000 mg/day PO.
2000 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tablet
- 500mg
- 750mg
