(and dosage form):
Each suppository contains 100 mg Indomethacin.
A.3.1 Antirheumatics (anti-inflammatory agents)
Indomethacin has anti-inflammatory and analgesic-antipyretic properties. Indomethacin inhibits prostaglandin synthesis and inhibits motility of polymorphonuclear leucocytes.
Pharmacokinetics and Metabolism: Indomethacin is 90% bound to plasma proteins and also extensively bound to tissues. The concentration of Indomethacin in the cerebrospinal fluid is low.
Indomethacin is largely converted to inactive metabolites which are 0-demethylated and conjugated with glucuronic acid by the hepatic microsomal enzymes. A portion is also N-deacylated by a non-microsomal system. Some of these metabolites are detectable in plasma, and free and conjugated metabolites are eliminated in the urine, bile and faeces. Entero-hepatic cycling of the conjugates takes place.
Indomethacin is indicated for the symptomatic treatment of ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, acute gout and acute musculoskeletal disorders. As an antipyretic in Hodgkin's disease.
Indomethacin should be administered with caution to patients with impaired renal function, epilepsy, parkinsonism or psychiatric disorders. It should not be given to patients with peptic ulcer or a history of gastrointestinal lesions or to those who are sensitive to aspirin. Pregnancy and lactation.
Serious interactions have been reported after the use of high doses of methotrexate with Indomethacin. The combined use of Indomethacin with diflunisal has been associated with fatal gastro-intestinal haemorrhage. Indomethacin and diflunisal should therefore not be used concommitantly.
DOSAGE AND DIRECTIONS FOR USE:
One suppository (100 mg Indomethacin ) per rectum at bedtime.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The commonest side-effects occurring with Indomethacin are gastro-intestinal complaints and complications consisting in anorexia, nausea, and abdominal pain.
Gastro-intestinal ulceration and bleeding may also occur. Peptic ulceration with perforation and haemorrhage may occur.
Anaemia due to blood loss and pancreatitis may occur.
The most frequent central nervous system effect in chronic use is severe frontal headache. Dizziness, vertigo, light-headedness, and mental confusion are also frequent. Severe depression, psychosis, hallucinations, and suicide have occurred.
Prolonged therapy with Indomethacin requires regular ophthalmological examinations. Ocular effects such as blurred vision and corneal opacities may occur.
Hematopoietic reactions include neutropenia, thrombocytopenia, and rarely, aplastic anaemia. Deaths in children have occurred from what was probably overwhelming sepsis due to activation of latent infections.
Several reports that Indomethacin masked symptoms of infection or activated latent bacterial infection in the same way as corticosteroids have also been received.
Hypersensitivity reactions are manifested as rashes, itching, urticaria, and more seriously, acute attacks of asthma.
Other side-effects include drowsiness, tinnitus, insomnia, syncope, convulsions, coma, peripheral neuropathy, oedema and mass gain, hypertension, haematuria, skin rashes, pruritis, stomatitis and alopecia. Leucopenia, purpura, haemolytic anaemia, agranulocytosis, epistaxis, hyperglycaemia, hyperkalaemia, and vaginal bleeding have been reported.
There have also been reports of hepatitis, jaundice and renal failure.
The concurrent administration of oral anticoagulant agents leads to increased risk of gastro-intestinal bleeding. Indomethacin antagonises the natriuretic and antihypertensive effects of furosemide. The total plasma concentration in Indomethacin is increased by concurrent administration of probenecid.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Gastro-intestinal complaints and complications occur with overdosage presenting as anorexia, nausea, abdominal pain, and peptic ulcers sometimes with perforations and haemorrhage. Acute pancreatitis has been reported. The most frequent central nervous system effect is severe frontal headache. Treatment is symptomatic and supportive
A cream-coloured torpedo-shaped suppository.
Cartons containing 10 suppositories.
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
XIXIA Pharmaceuticals (Pty) Ltd
15 Thora Crescent
Wynberg Ext. 3
P.O. Box 2080, Gallo Manor, 2052
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
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