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

Logo GULF INDOMETHACIN 25

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

GULF INDOMETHACIN 25

COMPOSITION:
Each GULF INDOMETHACIN 25 capsule contains 25 mg
Indomethacin.

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (Anti-inflammatory agents)

PHARMACOLOGICAL ACTION:
Indomethacin is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic properties, which are mediated through its mode of action as an inhibitor of prostaglandin synthesis.

INDICATIONS:
Indomethacin is indicated for the symptomatic treatment of rheumatoid arthritis, ankylosing/spondylitis, osteoarthritis, other musculoskeletal inflammatory disorders and acute attacks of gout.

CONTRA-INDICATIONS:
GULF INDOMETHACIN 25
is contra-indicated in persons hypersensitive to it or to aspirin, persons operating machinery, or patients with psychiatric disorders, epilepsy or Parkinson’s. It is contra-indicated in persons with renal disease or ulcerative lesions of the stomach or intestines. GULF INDOMETHACIN 25 is also contra-indicated in patients with bleeding disorders, active peptic ulcers, gastritis, regional enteritis and ulcerative colitis, history of gastrointestinal bleeding or perforation (PUBs) related to previous NSAIDS, active or history of recurrent ulcer/haemorrhage/perforations, heart failure as well as in pregnant and nursing women and in children.

WARNINGS:
Serious interactions have been reported after the use of high dose methotrexate with Indomethacin. The combined use of Indomethacin with diflunisal has been associated with fatal gastro-intestinal hemorrhage. Indomethacin and diflunisal should therefore not be used concomitantly.
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with Gulf Indomethacin 25 therapy. The risk of gastrointestinal bleeding or perforation (PUBs) is higher with increasing doses of Gulf Indomethacin 25, in patients with a history of ulcers, and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving Gulf Indomethacin 25, treatment with Gulf Indomethacin 25 should be stopped. Gulf Indomethacin 25 should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Gulf Indomethacin 25 should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Elderly: the elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs) which may be fatal.

INTERACTIONS:
NSAIDs: use of two or more NSAIDs concomitantly could result in an increase in side-effects.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (PUBs).
Anti-coagulants: Gulf Indomethacin 25 may enhance the effects of anti-coagulants such as warfarin.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding
Serious interactions have been reported after the use of high dose methotrexate with Indomethacin
The combined use of Indomethacin with diflusinal has been associated with fatal gastro-intestinal haemorrhage.
Bioavailability may be reduced with antacids containing aluminium hydroxide, magnesium carbonate and magnesium hydroxide.
Acute renal failure may result after concomitant use of triamterene.
Concurrent administration of oral anticoagulant agents leads to increased risk of gastrointestinal bleeding.
Indomethacin antagonizes the natriuretic and antihypertensive effects of Furosemide.
The total plasma concentration of Indomethacin plus its inactive metabolites is increased by concurrent administration of Probenecid

PREGNANCY AND LACTATION:
Contraindicated in pregnancy and lactation. Regular use of non-steroidal anti-inflammatory drugs during the third trimester of pregnancy, may result in premature closure of the foetal ductus arteriosus in utero, and possibly, in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.

DOSAGE AND DIRECTIONS FOR USE:
The recommended dosage is 25 mg to 200 mg divided in two to four equal doses, given with food, milk or an antacid. Therapy may be initiated with low doses and gradually increasing them where necessary according to the patients’response and requirements. Use the lowest effective dose for the shortest possible duration of the treatment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side effects with Indomethacin are gastrointestinal disturbances, headaches and dizziness. The most commonly observed adverse events are gastrointestinal in nature: Peptic ulcers, perforation or gastrointestinal bleeding (sometimes fatal), nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis. Bullous reactions that may occur include Stevens-Johnson syndrome and toxic epidermal necrolysis. Other adverse effects may be depression, anorexia, drowsiness, tinnitus, confusion, light-headedness, insomnia, psychiatric disturbances, syncope, convulsions, coma, peripheral neuropathy, blurred vision, corneal opacities and other ocular effects, oedema and mass gain, hypertension, cardiac failure, haematuria, skin rashes, pruritis, urticaria, stomatitis, alopecia and hypersensitivity reactions. Prolonged therapy will require regular ophthalmological examinations. Renal failure may occur. Anaemia due to blood loss and pancreatitis may also occur. Leucopoenia, purpura, thrombocytopenia, aplastic anaemia, haemolytic anaemia, agranulocytosis, neutropenia, epistaxis, hyperglycaemia, hyperkalaemia and vaginal bleeding have been reported. Hypersensitivity reactions may also occur in aspirin-sensitive patients, which may be manifested in states of respiratory distress, dyspnoea and asthma and in skin rashes. Jaundice and hepatitis have been reported in conjunction with the use of Indomethacin. Elderly patients may be especially susceptible to the toxic effects of Indomethacin. Indomethacin is excreted in the breast milk of breast-feeding mothers.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See “Side-effects and special Precautions”. Treatment is supportive and symptomatic.

IDENTIFICATION:
Yellow gelatin capsules containing a white to off-white powder.

PRESENTATION:
Patient ready packs of 15 and 84 capsules
Plastic containers containing 100; 500 and 1000 capsules

STORAGE INSTRUCTIONS:
Store in a dry place, below 25ºC. Protect from light. KEEP OUT OF REACH OF CHILDREN

REGISTRATION:
27/3.1/0136

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300

www.gulfdrug.co.za       

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
20 May 2000

New addition to this site: July 2010
Source: Pharmaceutical Industry

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