INDYLON Hard gelatine capsule Ref.[28122] Active ingredients: Indometacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2016  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory with analgesic, antipyretic effect
ATC code: M01AB01

Indomethacin is an anti-inflammatory drug of non-steroid type with antipyretic and analgesic effect. The mechanism of action is mainly considered to the effective inhibition of prostaglandin synthesis. A reversible inhibition of platelet aggregation can happen. The effect disappears within 24 hours after discontinuation.

Indomethacin inhibits renal prostaglandin synthesis. In patients with normal renal function, this effect, is of no significance. In patients with chronic renal insufficiency, cardiac or hepatic insufficiency, changes in plasma volume may be the inhibiting stage of prostaglandin synthesis, leading to acute renal insufficiency, fluid retention and heart failure. See “Contraindications”.

Indomethacin gives a good effect in conditions where inflammation is part of the disease, either primary or secondary. Indomethacin can be used both in inflammatory conditions of chronic or acute nature.

5.2. Pharmacokinetic properties

The absorption is rapid and almost complete. The maximum plasma concentration of indomethacin is reached within ½ -2 hours. After a 100 mg rectal administration at night the effect has duration of up to 16 hours. The half-life of indomethacin is about 7 hours, but may vary due to enterohepatic circulation. Steady-state is achieved after 1-2 days. Indomethacin is bound in about 90% to plasma proteins. Excretion occurs mainly through the kidney in the form of glucuronide while the rest is excreted in the faeces, either linked to glucuronic acid or in free form. Approximately 90% of the absorbed amount is excreted within 24-48 hours.

5.3. Preclinical safety data

Not applicable.

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