Insaid®

Indometacin

Prescribing Details



Description

lnsaid® is a preparation of lndometacin. lndometacin is a non­steroidal anti-inflammatory indole derivative with anti-inflammatory and analgesic properties. Its mechanism of action is largely based on inhibition of prostaglandin synthesis. lndometacin affords relief of symptoms; it does not alter the progressive course of the underlying disease.


Uses

No Data


Indications

Moderate to severe rheumatoid arthritis including acute flares of chronic diseases.

• Moderate to severe ankylosing spondylitis.
• Moderate to severe osteoarthritis.
• Acute painful shoulder (bursitis & tendinitis)
• Acute gouty arthritis


Dosage and administration

Adult

Rheumatic diseases : 50-200 mg daily in divided doses

Acute gout : 150-200 mg daily in divided doses

Dysmenorrhea : up to 75 mg daily 

Children

Safety and effectiveness in pediatric patients 14 years of age

and younger have not been established.

Geriatric use

As with any NSAID, caution should be exercised in treating the elderly (65 years and older) since advancing age appears to increase the possibility of adverse reactions.


Use in pregnancy & lactation

Pregnancy category C. lndometacin should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. lndometacin is excreted in the milk of lactating mothers. lndometacin is not recommended for use in nursing mothers.


Geriatric use
As with any NSAID, caution should be exercised in treating the elderly (65 years and older) since advancing age appears to increase the possibility of adverse reactions.

Precautions

lndometacin should be used with care in patients with a history of GI disease, asthma, or allergic disease, impaired renal & hepatic function.


Side effects
The most common side effects of lndometacin are nausea, vomiting, dyspepsia, diarrhea, epigastric & abdominal pain, constipation, headache, dizziness, vertigo, somnolence, depression fatigue & tinnitus.

Contraindications

lndometacin is contraindicated in patients with known hypersensitivity to lndometacin or to any of the components of the product. lndometacin 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/anaphylactoid reactions to NSAIDs have been reported in such patients. lndometacin is also contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. 


Drug interactions

lndometacin may interact with ACE inhibitors and angiotensin II antagonists, Aspirin, Beta-Adrenoreceptor Blocking agents, Cyclosporin, Diflunisal, Digoxin, Diuretics, Lithium, Methotrexate, Oral anticoagulants & Probenecid.


Overdose
The symptoms of overdose are nausea, vomiting, intense headache, dizziness, mental confusion, disorientation, or lethargy, paresthesias, numbness and convulsions. Treatment of overdose is symptomatic and supportive. The stomach should be emptied as quickly as possible if the ingestion is recent. Depending on the condition of the patient, close medical observation and nursing care may be required.

Preparation

No Data


Pharmaceutical precautions

• Store in a cool and dry place protected from light.
• Keep out of the reach of children.


Presentation

lnsaid® 25 capsule: Each capsule contains lndometacin BP 25 mg.


Package quantities

lnsaid® 25 capsule: Carton of 100 capsules.