Ketoprofen

DEA Class; OTC Rx

Common Brand Names; Nexcede

NSAIDs

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.

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.

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)

>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%)

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 Category: B; D in late pregnancy because of inhibition of ductus arteriosus closure

Lactation: unknown whether excreted in breast milk, not recommended

Adults

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.

Geriatric

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.

Adolescents

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.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Tablet/capsule

  • 50mg

  • 75mg

Capsule, extended-release

  • 200mg

Oral film

  • 12.5mg (OTC)

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