Etogesic SR Tablet (Sustained Release)

Etogesic SR is indicated-

• For acute and long-term use in the management of signs and symptoms: Osteoarthritis, Rheumatoid arthritis
• For the management of acute pain
• Acute gout

Etogesic SR is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti inflammatory, analgesic and antipyretic activities. The mechanism of action of Etogesic SR, like that of other NSAIDs related to prostaglandin synthesis inhibition

Similar to other NSAIDs, the anti-inflammatory effects of etodolac result from inhibition of the enzyme cycooxygenase (COX). This decreases the synthesis of peripheral prostaglandins involved in mediating inflammation. Etodolac binds to the upper portion of the COX enzyme active site and prevents its substrate, arachidonic acid, from entering the active site. Etodolac was previously thought to be a non-selective COX inhibitor, but it is now known to be 5-50 times more selective for COX-2 than COX-1. Antipyresis may occur by central action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat loss.

Adults and over 18 years:

• Etodolac 300 mg capsule: 600 mg daily in 1-2 divided doses
• Etodolac 600 mg ER tablet: Once daily

Pediatric: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

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. When Etogesic SR is administered with Aspirin, its protein binding is reduced, although the clearance of free Etogesic SR is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Etogesic SR and Aspirin is not generally recommended because of the potential of increased adverse effects.

Etodolac is contraindicated in patients with known hypersensitivity to Etodolac. Etodolac should not be given to patients who have experienced asthma, urticaria or other allergic type reactions after taking Aspirin or other NSAIDs.

The common side effects of Etogesic SR involve the gastrointestinal system. It can cause abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, nausea, Gl ulcers, vomiting. Other events including abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus etc.

There are no adequate and well-controlled studies in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Etodolac is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Etogesic SR should be given with caution in patients with severe hepatic reactions, pre existing asthma, fluid retention, hypertension or heart failure. If clinical sings and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash etc.), it should be discontinued.

Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain which are generally reversible with supportive care.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Do not store above 30°C. Keep away from light and out of the reach of children.