Ketoprofen

Carefully consider the potential benefits and risks of Ketoprofen Capsules USP and other treatment options before deciding to use Ketoprofen Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Ketoprofen Capsules, USP is indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen Capsules, USP is indicated for the management of pain. Ketoprofen Capsules, USP indicated for treatment of primary dysmenorrhea.

Carefully consider the potential benefits and risks of Ketoprofen Capsules, USP and other treatment options before deciding to use Ketoprofen Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. After observing the response to initial therapy with Ketoprofen Capsules, USP, the dose and frequency should be adjusted to suit an individual patient's needs. Concomitant use of Ketoprofen Capsules, USP and ketoprofen extended-release capsules is not recommended. If minor side effects appear, they may disappear at a lower dose which may still have an adequate therapeutic effect. If well tolerated but not optimally effective, the dosage may be increased.

Ketoprofen Capsules, USP is contraindicated in patients who have shown hypersensitivity to ketoprofen. Ketoprofen Capsules, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients. Ketoprofen Capsules, USP is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

BOXED WARNING Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Ketoprofen Capsules, USP is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. General Ketoprofen Capsules, USP cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Ketoprofen Capsules-treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 patients treated with ketoprofen extended-release capsules in trials lasting from 4 to 16 weeks. Minor gastrointestinal side effects predominated, upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of ketoprofen extended-release capsules once a day or 75 mg of ORUDIS (ketoprofen) TID (255 mg/day).

The following drug interactions were studied with ketoprofen doses of 200 mg/day. The possibility of increased interaction should be kept in mind when Ketoprofen Capsules, USP doses greater than 50 mg as a single dose or 200 mg of ketoprofen per day are used concomitantly with highly bound drugs. ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Antacids Concomitant administration of magnesium hydroxide and aluminum hydroxide does not interfere with the rate or extent of the absorption of ketoprofen administered as Keoprofen Capsules, USP.

Store at 20° to 25°C (68° to 77°F).