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Chemical name

1 H - Indole - 3 - acetic acid, 1 - (4 - chlorobenzoyl) - 5 - Methoxy - 2 -methyl -.

Category

Antirheumatic ; Anti - inflammatory nonsteroidal ; Antigout agent ; Antipyretic ; Antidysmenorrheal ; Vascular headache prophylactic ; Vascular headache suppressant ; Prostaglandin synthesis inhibitor, renal (Bartter's syndrome) ; Ductus arteriosus, patent, closure adjunct.

Mechanism of action

Indomethacin inhibits the activity of the enzyme cyclo - oxygenase, resulting in decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid.

Indications

Treatment: Rheumatic disease, such as: Arthritis, rheumatoid - Arthritis, psoriatic - Reiter's disease - Rheumatic complications associated with Paget's disease of bone; Gouty arthritis, acute; Calcium pyrophosphate deposition disease, acute; Fever, due to malignancy; Headache, vascular; Bartter's syndrome; Ductus arteriosus, patent; Bursitis and Tendinitis.
It is indicated for the relief of: Osteoarthritis - Ankylosing spondylitis -Arthritis, juvenile - Pericarditis.

Precautions to consider

Risk - benefit should be considered when the following medical problems exist: Conditions predisposing to renal insufficiency, such as:
Congestive heart failure - Extracellular volume depletion - Hepatic function impairment.
Contraindications are: Bleeding, active, especially intracranial or gastrointestinal - Coagulation defects - Enterocolitis, necrotizing, proven or suspected - Heart disease - Lesions - Infection untreated - Jaundice, severe - Renal function impairment - Allergic reaction - Anemia - Asthma - Epilepsy - Mental depression - Parkinsonism - Stomatitis - Systemic lupus erythematosus.

Pregnancy / Breast - feeding

Although studies in humans have not been done, but it has been shown that indomethacin crosses the placenta.
Indomethacin is distributed into breast milk. Risk benefit must be considered.

Drug interactions

In addition to the interactions listed below, the possibility should be considered that additive or multiple effects leading to impaired blood clotting and / or increased risk of bleeding may occur if indomethacin is used concurrently with any medication having a significant potential for causing hypoprothrombinemia, thrombocytopenia, or gastrointestinal ulceration or hemorrhage.
Digoxin - Cyclosporine - Dipyridamole - Penicillamine Sympathomimetics - Thiazide diuretics - Ranitidine - Cimetidine - Probenecid - Salicylates - Anticoagulants - ACE inhibitors - Beta blockers - Methotrexate - Lithium - Hydantoins - Loop diuretics - Alcohol - Antidiabetic agents - Zidovudine - Acetaminophen - Valproic acid.

Side / Adverse effects

Those indicating need for medical attention:
Incidence more frequent - Gastrointestinal problems; Renal and hepatic function impairment; Hypersensitivity; CNS effects; Headache (severe); Hyperkalemia; Edema; Tinnitus; Dermatitis. Incidence less frequent -Bleeding problems; hypoglycemia.

Administration and dosage

Capsules - Usual adult dose:
Antirheumatic - Oral, initially 25 or 50 mg 2 to 4 times a day; if well tolerated, the dosage per day may be increased by 25 or 50 mg at weekly intervals until a satisfactory response is obtained or up to a maximum dose of 200 mg per day. After a satisfactory response has been achieved, dosage should be reduced to the lowest dose that provides continuing control of symptoms.
Antigout agent - Oral, 100 mg initially, then 50 mg 3 times a day until pain is relieved, with the dosage then being reduced until medication is discontinued.
Anti - inflammatory - 75 to 150 mg per day in 3 or 4 divided doses.
Antipyretic - Oral, 25 to 50 mg 3 or 4 times a day.
Usual adult prescribing limits: Oral, 200 mg a day.
Usual pediatric dose:
Antirheumatic - Oral, 1.5 to 2.5 mg per kg of body weight per day, administered in 3 or 4 divided doses, up to a maximum of 4 mg per kg of body weight per day or 150 to 200 mg per day, whichever is less. After a satisfactory response has been obtained, dosage should be reduced to the lowest dose that provides continuing control of symptoms.
Patent ductus arteriosus closure adjunct - Infants up to 48 hours, 2 to 7 days and over 7 days of age at time of first dose: Oral, via nasogastric tube, 0.2 mg anhydrous indomethacin per kg of body weight initially. If necessary, 1 or 2 additional doses of 0.1 (for infants up to 48 hours of age) or 0.2 (for infants 2 to 7 days of age) or 0.25 (for infants over 7 days of age) mg of anhydrous indomethacin per kg of body weight may be given at 12 to 24 hour intervals.

How supplied

Box of 100 capsules.
Each capsule contains 25 mg indomethacin.

Storage

Store below 30°C.
Protect from moisture.

References

1 - USP DI Vol: 1 (1997). Pages: 379 - 401, 1646 - 1648.
2 - Drug facts and comparisons (1994).
3 - USP 23 page: 800.
   
 

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