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Chemical
name1 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
suppliedBox of 100
capsules. Each capsule contains 25 mg indomethacin.
StorageStore below 30°C. Protect from moisture.
References1 - 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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