International generic name
Drug form and composition
Enterosolvent film-coated tablets. One enterosolvent film-coated tablet contains
25 mg Indometacin. Suppositories. One suppository contains 50 mg or 100 mg Indometacin.
Ointment. 1g ointment (10%) contains 100 mg Indometacin.
Rheumatoid arthritis; osteoarthritis; coxarthrosis; Bechterew’s disease; acute
gout arthritis; psoriatic arthritis; juvenile arthritis; Reiter’s disease; periarticular
diseases - tendinitis, bursitis, etc; dysmenorrhea; some cases of vascular headache.
Dosage and administration
Indometacin, enterosolvent film-coated tablets are used orally in dose 25-50
mg, 2-3 times daily after nutrition. In children older than 14 years recommended
dose is 1.5-2.5 mg per kg body weight, divided in three takes. Suppositories are
applied rectally in dose 50-100 mg, 1-2 times daily. In children older than 14 years
the recommended dose is 1.5-2.5 mg per kg body weight, divided in two takes. Maximal
dose in adults should not exceed 200 mg /24 hours and for children older than 14
years - 150 mg /24 hours. Treatment courses longer than 7 days are not recommendable.
Indometacin - ointment is indicated in mild clinical manifestations. It is applied
as follows: 1-2 cm ointment is spread on the affected region 2-3 times daily.
Hypersensitivity to indometacin, salicylates, and other nonsteroid antiinflammatory
drugs; ulcer disease; severe liver and renal diseases; epilepsy and mental diseases;
parkinsonysm; proctitis (valid for suppositories); pregnancy and lactation; children
younger than 14 years.
Special warnings and precautions
Indometacin should be used with care in patients with renal and liver diseases;
ulcer disease in remission (it is obligatory to add H2-blocker or other gastroprotective
medicines). Systemic application of Indometacin may cause changes in several laboratory
tests, including: elevation of the glucose, bilirubin, transaminases, creatine,
and urea serum level; prolongs the bleeding time; reduced the creatine clearance;
and reduces osmolality of the urine. Application of the tablets and suppositories
in drivers and machine operating persons is not recommendable, as the medicine may
provoke side reactions (somnolence, color sensitivity disorders, and diplopia),
disturbing the concentration capabilities.
Indometacin potentiates cumarin anticoagulant activity, activity of the oral
antidiabetics, corticosteroids, nifedipin, and verapamil. Concomitant administration
with other NSAID and aspirin increases the risk of ulceration. Indometacin reduces
the renal clearance of lithium preparation; inhibits the vasodilating effect of
nitroglycerin; increases toxicity of the aminoglycoside antibiotics.
Nausea; vomiting; epigastral pain; ulcerogenic effect; diarrhea; dizziness; headache;
somnolence; visual disorders; leucopenia; hematuria; water and electrolytes retention.
Indometacin is a derivative of indol, possessing prominent anti-inflammatory
action, significantly exceeding the antiinflammatory effect of the salicyllates
and phenylbutazone. It exerts analgesic, antipyretic, and uricosuric activity also.
The mechanism of the analgesic, antipyretic and antiinflammatory effects is related
to depression of the prostacycline (PGE1, PGD, and PGI2) synthesis by inhibition
of the enzyme cyclooxygenase activity. Indometacin possesses certain ganglion-blocking
and antiaggregant effect.
30 or 1350 Indometacin Sopharma enterosolvent film-coated tablets of 25 mg. 6
Indometacin suppositories of 50 mg or 100 mg. Tube, containing 40 g Indometacin
Enterosolvent film-coated tablets - 5 years. Suppositories - 2 years. Ointment
- 3 years.