INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ARTHREXIN®-25 and ARTHREXIN®-50 CAPSULES

SCHEDULING STATUS:
S2 – The emergency treatment of acute gout attacks.
S3 – Indomethacin is used to relieve the painful symptoms of ankylosing spondylitis and osteoarthritis and to relieve the pain and swelling in gout, rheumatoid arthritis, and acute musculoskeletal disorders. It has also been used to reduce symptoms in some febrile conditions.

PROPRIETARY NAME
(and dosage form):

ARTHREXIN®-25 and ARTHREXIN®-50 CAPSULES

COMPOSITION:
Capsules containing 25 mg and 50 mg
Indomethacin.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics - Anti-inflammatory agents.

PHARMACOLOGICAL ACTION:
Indomethacin has analgesic, anti-inflammatory and antipyretic properties.
Like the salicylates and related anti-inflammatory agents, indomethacin, inhibits the biosynthesis of prostaglandins; this action may be the basis of its anti-inflammatory and antipyretic properties and certain of its other effects. It inhibits motility of polymorphonuclear leucocytes and like salicylates, it uncouples oxidative phosphorylation in supratherapeutic concentrations and depresses the biosynthesis of mucopolysaccharides.
Indomethacin is readily absorbed from the gastro-intestinal tract with peak plasma concentrations reached about 2 hours after a dose. The absorption of indomethacin may be slowed by food or aluminium or magnesium containing antacids.
About 99% of indomethacin is bound to plasma proteins and indomethacin is distributed into synovial fluid, the central nervous system and the placenta. Low concentrations can be detected in breast milk.

INDICATIONS:
S2 The emergency treatment of acute gout attacks.
S3 Indomethacin is used to relieve the painful symptoms of ankylosing spondylitis and osteoarthritis, and to relieve the pain and swelling in gout, rheumatoid arthritis, and acute musculoskeletal disorders. It has also been used to reduce symptoms in some febrile conditions.

CONTRA-INDICATIONS:
Indomethacin should not be used by pregnant and nursing women, children, persons operating machinery, or patients with psychiatric disorders, epilepsy, or Parkinsonism. It is also contra-indicated in individuals with renal or hepatic disease or ulcerative lesions of the stomach or intestines, patients with bleeding disorders, gastritis, regional enteritis, ulcerative colitis and asthmatic patients sensitive to aspirin.
Indomethacin is contra-indicated in patients who are allergic to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs and it should not be administered to patients with hepatic disease.
Sensitivity to indomethacin.
Active peptic ulcers.

WARNINGS:
The combined use of indomethacin with diflunisal has been associated with fatal gastro-intestinal haemorrhage.

DOSAGE AND DIRECTIONS FOR USE:
In chronic musculoskeletal and joint disorders, the usual initial dose is 25 mg twice or thrice daily with food, increased, if required, by 25 to 50 mg daily at weekly intervals up to 150 mg to 200 mg daily in divided doses.
In acute periarticular disorders and in low back pain 50 mg may be given twice or thrice daily for about 10 days.
In acute gout and gouty arthritis, 50 mg may be given three times daily initially with rapidly reducing doses. Up to 200 mg daily may be required.
The total combined daily dose by mouth should not generally exceed 200 mg.
IT IS RECOMMENDED THAT INDOMETHACIN CAPSULES BE TAKEN WITH FOOD, MILK OR AN ANTACID.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side-effects are gastro-intestinal disturbances, headache and dizziness. Gastro-intestinal perforation, ulceration and bleeding may occur, Vertigo, light headedness and mental confusion are frequent. Psychiatric disturbances, hallucinations, confusion and depression have been reported. Blurred vision, corneal opacities, visual-field changes, and pallor of the optic disc have also occurred. Anorexia, nausea, abdominal pain, and diarrhoea may occur. Severe frontal headache may occur in patients using indomethacin for long periods.
Neutropenia, haemolytic anaemia, thrombocytopenia, agranulocytosis, leucopenia, aplastic anaemia and purpura may also occur. Other reported toxic effects are oedema, hypertension and angioneurotic oedema. Platelet function is impaired by indomethacin.
Other adverse effects include: drowsiness, tinnitus, insomnia, syncope, convulsions, coma and peripheral neuropathy. Oedema and weight gain, hypertension, haematuria, stomatitis, alopecia and epistaxis have also occurred. Hyperglycaemia, hyperkalaemia and vaginal bleeding have been reported. There have also been reports of hepatitis, jaundice, renal failure and acute pancreatitis.
Hypersensitivity reactions are manifested in skin rashes, itching, urticaria, and, more seriously, acute attacks of asthma. Patients allergic to salicylates may exhibit cross-reaction to indomethacin.
Elderly patients may be specially susceptible to the toxic effects of indomethacin.
If indomethacin fails to provide benefit in 2 to 3 weeks, alternative therapy must be considered.
Prolonged therapy will require regular ophthalmological examination.

INTERACTIONS:
Concurrent administration of indomethacin with probenecid increases the risk of gastro-intestinal bleeding; probenecid inhibits the tubular secretion of indomethacin and thereby increases its plasma level and risk of systemic toxicity.
Concurrent administration of oral anticoagulant agents leads to increased risk of gastro-intestinal bleeding.
The administration of anti-inflammatory doses of aspirin decreases indomethacin blood concentrations by about 20%.
When diflunisal and indomethacin are given together, the renal clearance of indomethacin decreases and the plasma concentration increases, and the combined use can result in fatal gastro-intestinal haemorrhage.
False-negative results in the dexamethasone suppression test have been reported in patients taking indomethacin.
Indomethacin antagonizes the natriuretic and antihypertensive effects of furosemide, the antihypertensive effects of thiazide diuretics, beta-adrenergic blocking agents, or inhibitors of angiotensin converting enzyme may also be reduced. Acute renal failure associated with the concomitant administration of indomethacin and triamterene have been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
C.N.S. symptoms including headache and vertigo, gastro-intestinal irritation resulting in anorexia, nausea, vomiting, dyspepsia, peptic ulceration often with bleeding, acute pancreatitis.
In acute poisoning, the stomach should be emptied by inducing emesis or by aspiration and lavage.
Blood-electrolyte balance should be maintained. Treatment is supportive and symptomatic.

IDENTIFICATION:
Arthrexin®-25 Bright yellow, opaque gelatine capsules imprinted with mortar and pestle and "LENNON" on one side and "ARTHREXIN 25" on the other side, containing a whitish powder.
Arthrexin®-50 Bright yellow, opaque gelatine capsules imprinted with mortar and pestle and "LENNON on one side and "ARTHREXIN 50" on the other side, containing a whitish powder.

PRESENTATION:
Arthrexin®-25 Plastic containers containing 100, 500 and 1000 capsules.
Arthrexin®-50 Plastic containers containing 30, 100, 500 and 1000 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C.
Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
25 mg - K/3.1/285.
50 mg - K/3.1/286.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
Building 12
Healthcare Park
Woodlands Drive
Woodmead Sandton
2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 May 1978

        A262 UNIPRINT-P

Updated on this site: April 2005
Source: Hospital Pharmacy

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