Classes
DEA Class; OTC Rx
Common Brand Names; Nexcede
NSAIDs
Description
Propionic acid NSAID; immediate-release formulation used for acute pain; available as Rx and OTC; 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.
Indications
For the treatment of rheumatoid arthritis or osteoarthritis.
For the treatment of acute gouty arthritis
For the treatment of acute mild pain and moderate pain including arthralgia, bone pain†, dental pain, dysmenorrhea, myalgia.
Contraindications
Absolute: ASA allergy
Relative: Bleeding disorders, hepatic disease, peptic ulcer, stomatitis, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of the ductus arteriosus)
Adverse Effects
>10%
Increased liver function test (up to 15%)
Dyspepsia (12%)
1-10%
Dizziness (3-9%)
Headache (3-9%)
Impaired renal function disorder (3-9%)
Upper GI ulcers, 3-6 mth treatment; 2-4%,1 yo treatment)
Nausea (>3%)
Diarrhea (>3%)
Abdominal pain (>3%)
Constipation (>3%)
Flatulence (>3%)
Rash (1-3%)
Stomatitis (1-3%)
Insomnia (1-3%)
Malaise (1-3%)
Warnings
Use caution in asthma (bronchial), cardiac disease, CHF, HTN, renal impairment, SLE
Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include the elderly, or those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, and individuals taking diuretics, ACE inhibitors, or ARBs
Heart Failure (HF) risks
Pregnancy and Lactation
Pregnancy Category: B; D in late pregnancy because of inhibition of ductus arteriosus closure
Lactation: unknown whether excreted in breast milk, not recommended
Maximum Dosage
300 mg/day PO for immediate-release capsules; 200 mg/day PO for extended-release capsule. Non-prescription use (product off market): 75 mg/day PO.
300 mg/day PO for immediate-release capsules; 200 mg/day PO for extended-release capsule. Non-prescription use (product off market): 75 mg/day PO.
Safety and efficacy have not been established. Non-prescription use at a maximum of 75 mg/day was allowed for adolescents 16 to 17 years, but products are now off market.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Tablet/capsule
50mg
75mg
Capsule, extended-release
200mg
Oral film
12.5mg (OTC)