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Dosage and administration

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Individualize greater than equal to 16yrs: 1 tab every 4 to 6 hours as needed; max>5 tabs/24hrs. Renal or severe hepatic impairment: initiate at lower dose. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling). Withdraw gradually by 25 to 50% every 2 to 4 days.

Side Effects

• Trouble breathing or shortness of breath
• Fast heartbeat
• Chest pain
• Swelling of your face, tongue, or throat
• Extreme drowsiness
• Lightheadedness when changing positions
• A fainting spell
• Agitation
• High body temperature
• Trouble walking
• Stiff muscles
• Mental changes such as confusion
• weakness in one part or side of your body
• slurred speech

Contraindications

VICOPROFEN 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-like reactions to NSAIDs have been reported in such patients

VICOPROFEN is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. Patients known to be hypersensitive to other opioids may exhibit crosssensitivity to hydrocodone.

In the setting of coronary artery bypass graft (CABG) surgery

Warnings

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, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events .

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke

NSAID-containing products, including VICOPROFEN, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAID-containing products, including VICOPROFEN, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.WIKI

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