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NDC 51552-0307-07

Ketoprofen 1 g/g POWDER

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NDC
51552-0307-07
Generic Name
Ketoprofen
Brand Name
—
Strength
1 g/g
Dosage Form
POWDER
Route
—
Package Size
—
Labeler
Fagron Inc

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ketoprofen extended-release capsules before deciding to use ketoprofen extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen extended-release capsules are indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen extended-release capsules are not recommended for…

Important Warnings

WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar f…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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