International generic name

Indomethacin

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.

Indications

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.

Contraindications

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.

Drug interactions

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.

Adverse reactions

Nausea; vomiting; epigastral pain; ulcerogenic effect; diarrhea; dizziness; headache; somnolence; visual disorders; leucopenia; hematuria; water and electrolytes retention.

Pharmacological mechanisms

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.

Supplied

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 Sopharma ointment.

Expiry

Enterosolvent film-coated tablets - 5 years. Suppositories - 2 years. Ointment - 3 years.