METHACIN Capsule

For treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, other rheumatic disorders and acute gout.

Dosage and Administration

Adults: Oral, 25mg 2-4 times daily, the dosage may be increased to 150-200mg daily, if necessary, as tolerated.

Note: Some types of arthritis may require up to 2 weeks therapy for noticeable improvement and up to 1 month for maximum effectiveness.

In patients with peptic ulcer or a history of gastrointestinal lesions, or to those who are sensitive to aspirin.

Headache, dizziness or lightheadedness, gastrointestinal disturbances, depression, tinnitus and blurred vision with prolonged therapy, gastrointestinal ulceration and bleeding, oedema, weight gain and skin rashes.

- Co-administration of alcohol or other anti-inflammatory medications may enhance the risk of ulcerogenic effects.

- Concurrent use with aspirin or other salicylates may increase of gastrointestinal side effects without providing additional symptomatic relief.

- Caution in patients receiving the following drug therapy Frusemide, anticoagulants, lithium, probenecid.

Safety for use has not been established in children under 14 years of age, and in pregnancy and lactation.

RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID

Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.

Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious adverse events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.

- Caution in patients with impaired renal or hepatic function, and to those with bleeding disorders; epilepsy, parkinsonism, psychiatric disorders; or conditions predisposing to fluid retention such as compromised cardiac failure.

- This drug is preferably administered after meals or with food to reduce gastrointestinal irritation.

- This medication may cause drowsiness in some patients. Caution when driving or operating machinery. Avoid alcoholic beverages.

- Elderly patients may be more susceptible to the toxic effects of indomethacin.

- Indomethacin may mask the signs of infections, the drug should be used with extra care in the presence of existing controlled infection.

Indomethacin has analgesic, anti-inflammatory and antipyretic actions. Its mode of action may involve inhibition of prostaglandin synthesis.

Oral absorption is rapid but is delayed by antacids. Plasma protein binding is extensive; it undergoes hepatic metabolism and both renal and faecal excretions.