Classes
DEA Class; Rx
Common Brand Names;
NSAIDs
Description
Anthranilic acid (fenamate) NSAID for mild to moderate pain; may cause an increased risk of serious gastrointestinal adverse effects and serious cardiovascular events; use lowest effective dose for the shortest possible duration.
Indications
Indicated for relief of signs and symptoms of rheumatoid arthritis, including acute exacerbations of chronic disease
Indicated for relief of signs and symptoms of osteoarthritis, including acute exacerbations of chronic disease
Indicated for acute or long-term use for relief of signs and symptoms of ankylosing spondylitis
Indicated for acute or long-term use for relief of signs and symptoms of acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis)
Contraindications
Hypersensitivity
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; severe, rarely fatal, anaphylacticlike reactions to NSAIDs have been reported in such patients
In the setting CABG surgery
Adverse Effects
>10%
Diarrhea (10-33%)
Nausea, with or without vomiting (11%)
1-10%
Pyrosis (3-9%)
Flatulence (3-9%)
Rash (3-9%)
Headache (3-9%)
Dizziness (3-9%)
Anorexia (1-3%)
Constipation (1-3%)
Stomatitis (1-3%)
Peptic ulcer (1-3%)
Edema (1-3%)
Pruritus (1-3%)
Urticaria (1-3%)
Tinnitus (1-3%)
Warnings
Increased risk of serious CV thrombotic events, including MI, and stroke, which can be fatal (see Black Box Warnings)
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of MI and stroke (see Contraindications)
Use of NSAIDs in the post-MI period increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment in an observational study; avoid use after a recent MI (see Black Box Warnings)
Can lead to new-onset hypertension or worsening of preexisting hypertension; patients taking thiazides or loop diuretics may have impaired response to these treatments while taking an NSAID
May cause fluid retention and edema; avoid use with severe heart failure
Can cause serious GI adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal
Long-term administration has resulted in renal papillary necrosis and other renal injury; patients at greatest risk include those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and elderly individuals
Pregnancy and Lactation
Pregnancy category: C; D in third trimester (may cause premature closure of ductus arteriosus)
Lactation:
Drug excreted in breast milk with multiple doses
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Maximum Dosage
400 mg/day PO.
400 mg/day PO.
14 to 17 years: 400 mg/day PO.
13 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Capsule
- 50mg
- 100mg