Source: Υπουργείο Υγείας (CY) Revision Year: 2016 Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Indomethacin is a non-steroidal anti-inflammatory agent indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute musculoskeletal disorders, degenerative joint disease of the hip, low-back pain, and acute gouty arthritis.
Also indicated in inflammation, pain and oedema following orthopaedic procedures; and the treatment of pain and associated symptoms of primary dysmenorrhoea.
Treatment should begin with the lowest effective dose, which is to be adjusted later according to the response of therapy and the possible undesirable effects. The risk of undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
In chronic conditions, starting therapy with a low dosage, increasing this gradually as necessary, and continuing a trial of therapy for an adequate period (in some cases, up to one month) will give the best results with a minimum of unwanted reactions. The recommended oral dosage range is 50 mg to 200 mg daily in divided doses.
Dosage in dysmenorrhoea: Up to 75 mg a day, starting with onset of cramps or bleeding, and continuing for as long as the symptoms usually last.
Dosage in acute gouty arthritis: 150 mg to 200 mg daily in divided doses until all symptoms and signs subside.
Paediatric dosage has not been established.
Indylon should be used with particular care in older patients who are more prone to adverse reactions.
Indylon capsules are for oral administration. They should be swallowed whole with a glass of water. In order to reduce the possibility of gastro-intestinal disturbances, Indylon should always be taken with food or an antacid.
10 times the therapeutic dose to four premature children lead in one of the cases to transient creatinine elevation. 75-175 mg to toddlers gave mild intoxication. 175-1,500 mg for adults led to mild intoxication, while about 800 mg to 18-year-old gave moderate intoxication.
Nausea, vomiting, diarrhoea, epigastric pain, ulcers, maybe accompanied with bleeding or perforation. Drowsiness, headache, confusion, nervousness, agitation, in severe cases, convulsions and coma. Fluid retention, oedema, hyperkaliemia. Renal effects.
If needed gastric lavage and activated charcoal, which maybe repeated. If necessary, antacids. Good urine output should be ensured. The treatment is symptomatic.
5 years.
Store below 25°C in the original package, in order to be protected from moisture.
PVC-Al blisters.
Pack of 30, 50 and hospital packs of 1000 capsules are available.
None.
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