Dex-Ketoprofen Trometamol is indicated for the management of the signs and symptoms of-

• management of pain
• primary dysmenorrhea
• dental pain

Pain	Primary dysmenorrhea

• Adults:

According to the nature and severity of pain, the recommended dosage is generally 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg.

• Hepatic impairment

Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Dex-Ketoprofen Trometamol tablets should not be used in patients with severe hepatic dysfunction.

• Renal impairment

The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 60 - 89 ml / min) (see section 4.4). Dex-Ketoprofen Trometamol tablets should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤ 59 ml / min)

Commonly reported side effects include-

• Dyspepsia
• nausea
• abdominal pain
• diarrhea
• constipation
• flatulence
• anorexia
• vomiting
• stomatitis
• headache
• insomnia

Dyspepsia	Nausea	Abdominal Pain
Diarrhea	Headache	Insomnia (Difficulty in Falling asleep)

• Dex-Ketoprofen Trometamol, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death.
• Dex-Ketoprofen Trometamol like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death.
• Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Dex-Ketoprofen Trometamol.
• Anemia is sometimes seen in patients receiving NSAIDs, including Dex-Ketoprofen Trometamol.
• Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, Dex-Ketoprofen Trometamol should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.