Oral
DOSAGE AND ADMINISTRATION
Analgesia, primary dysmenorrhea.
Adults: 50 mg t.i.d. of immediate-release tablets. In some, an initial dose of 100 mg followed by 50-mg doses may achieve better results. After the first day, the total daily dose should not exceed 150 mg.
Rheumatoid arthritis.
Adults: 100-200 mg/day in divided doses (e.g., 50 mg t.i.d. or q.i.d.; 75 mg b.i.d. of the sodium salt). For chronic therapy, use extended-release tablets, 100 mg once or twice daily, not to exceed 225 mg/day
Osteoarthritis.
Adults: 100-150 mg/day in divided doses (e.g., 50 mg b.i.d. or t.i.d.; 75
mg b.i.d. of the sodium salt). For chronic therapy, use extended-release
tablets, 100 mg/day. Doses greater than 200 mg/day have not been evaluated.
Ankylosing spondylitis.
Adults: 25 mg q.i.d. with an extra 25-mg dose at bedtime, if necessary. Doses greater than 125 mg/day have not been evaluated.
Ophthalmic Solution, 0.1% Following
cataract surgery.1 gtt in the affected eye q.i.d. beginning 24 hr after
cataract surgery and for 2 weeks thereafter.
Corneal refractive surgery.
1-2 gtt within 1 hr prior to surgery; then, apply 1-2 gtt within 15 min of surgery and continue q.i.d. for three days or less.
2. THERAPEUTIC / DIAGNOSTIC CLAIMS
Treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis. Potassium salt is approved for management of pain and primary dysmenorrhea, when prompt pain relief is needed.
3. DESCRIPTION OF DOSAGE FORM
Anti-inflammatory analgesic often used to treat inflammation and pain arising from arthritis, gout or rheumatic disease. Normally taken orally (tablets) but also available for injection or as suppositories
4. CONTRAINDICATIONS
Sensitivity to aspirin or any NSAID; soft contact lenses (ophthalmic); benzyl alcohol, polyethylene glycol monomethyl ether 350, and hyaluronate sodium (topical).
WARNING AND PRECAUTIONS
DRUG INTERACTIONS
Cyclosporine: May increase nephrotoxicity.
Digoxin: May increase digoxin serum concentrations.
Diuretics: May inhibit diuretic and antihypertensive effects.
Lithium: May decrease lithium clearance.
Methotrexate: May increase methotrexate levels.
Warfarin: May increase risk of gastric erosion and bleeding
Precautions
Pregnancy: Category B.
Lactation: Undetermined.
Children: Safety and efficacy not established.
Elderly: Increased risk of adverse reactions.
GI effects: Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms.
Renal effects: Acute renal insufficiency; interstitial nephritis; hyperkalemia; hyponatremia; and renal papillary necrosis may occur.
5. SIDE EFFECTS
Following ophthalmic use: Keratitis, increased intraocular pressure, ocular allergy, N&V, anterior chamber reaction, viral infections, transient burning and stinging on administration. When used with soft contact lenses, may cause ocular irritation, including redness and burning.
6. TOXIC EFFECTS
Toxic symptoms in gastrointestinal
system (from irritation to bleeding from gastrointestinal tract), hypotension,
respiratory depression, signs of nephrotoxicity (even till acute renal failure),
and toxicity in central nervous system (from lethargy and somnolence to
convulsions and coma) may occur.
As soon as possible vomiting should be induced or gastric lavage performed,
and medical charcoal administered. Treatment is symptomatic and supportive.
In case of renal impairment, dopamine or dobutamine is administered. In
case of severe hypotension, plasma expanders should be given, and if convulsions
occur diazepam or other benzodiazepine anticonvulsants. Vital functions
should be monitored.