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Indecin
 

DESCRIPTION
CAPSULE
Capsule Colour: White/Blue
Capsule Size: # 4
Granules Colour: White


EACH CAPSULE CONTAINS
Indomethacin ................................. 25 mg


PHARMACODYNAMICS
Indomethacin is an anti-inflammatory, antipyretic substance with analgesic properties. It is effective in relieving pain and swelling in cases of gout and of rheumatoid and allied forms of arthritis and painful symptoms in other disorders of bone and joint, such as osteoarthritis and ankylosing spondylitis. It may also reduce fever and relieve symptoms in febrile inflammatory conditions such as glandular fever.


PHARMACOKINETICS
Indomethacin is rapidly absorbed when taken by mouth and is excreted largely by the kidneys. Its action begins within 2 hours of ingestion.


INDICATIONS
It is indicated in active stages of rheumatoid arthritis; moderate to severe juvenile rheumatoid arthritis; osteoarthritis; degenerative joint disease of the hip, ankylosing spondylitis; gout. It is also indicated for acute musculoskeletal disorders, e.g. bursitis, tendinitis, synovitis, tenosynovitis, capsulitis of the shoulder, sprains and strains; lumbago; inflammatory conditions following orthopedic procedures; pain and associated symptoms of primary dysmenorrhea.


RECOMMENDED DOSAGE
The recommended dosage is 50 to 200 mg daily in divided doses and should be adjusted to the individual patient's response and tolerability to the drug.


In treatment of acute gouty arthritis, 150 mg to 200 mg in divided doses is given until all. symptoms and signs subside. In primary dysmenorrhoea, 75 mg daily as a single or divided doses, starting at the onset of cramps or bleeding and continuing for as long as symptoms usually last.


After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.
 

CONTRAINDICATIONS
It is contraindicated in patients hypersensitive to Indomethacin, patients in whom acute asthmatic attacks, urticaria, or rhinitis are precipitated by Aspirin or other non-steroidal anti-inflammatory agents (NSAIDS). It should not be given to patients with active peptic ulcer or with a recurrent history of gastrointestinal ulceration.


PRECAUTIONS
If patient experiences drowsiness or dizziness, he must be warned not to drive or operate machinery. To reduce GIT disturbances, Indomethacin may be taken after meals or with food, milk or antacids. Indomethacin should be administered with caution to patients with impaired renal function and to those with bleeding disorders, epilepsy, parkinsonism or psychiatric disorders. Elderly patients may be especially susceptible to the toxic effects of Indomethacin. Indomethacin is not recommended for children under 14 years.


CARDIOVASCULAR THROMBOTIC EVENTS
Observational studies have indicated that non-selective NSAIDS may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patient taking NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should be used for the shortest possible duration.


There is no consistent evidence that the concurrent use of Aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAID use.


HYPERTENSION
NSAIDS may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking antihypertensive with NSAIDS may have an impaired antihypertensive response. Caution is advised when prescribing NSAIDS to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAID treatment and at regular intervals thereafter.


HEART FAILURE
Fluid retention and oedema have been observed in some patients taking NSAIDS, therefore caution is advised in patients with fluid retention or heart failure.

 

GASTROINTESTINAL EVENTS
All NSAIDs can cause gastrointestinal discomfort and rarely serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, but can occur at any time without warning. Caution is advised in patients with risk factors for gastrointestinal events e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulceration occur in patients receiving NSAIDS, the drug should be withdrawn immediately. Doctors should warn patient about signs and symptoms of serious gastrointestinal toxicity. The concurrent use of Aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.


SEVERE SKIN REACTIONS
NSAIDS may very rarely cause serious cutaneous adverse events such a exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Steven-Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity.

 

WARNINGS
RISK OF GI ULCERATION, BLEEDING AND PERFORATION WITH NSAID

Serious G: 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 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 G1 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 GI 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.


DRUG INTERACTIONS
Indomethacin increases GIT side effects of Aspirin and it was found that chronic concurrent administration of Aspirin decreases Indomethacin blood levels. When Indomethacin is given to patients receiving Probenecid, the plasma levels of Indomethacin likely to be increased. Caution should be used if Indomethacin is administered simultaneously with methotrexate. Indomethacin has been reported to decrease the tubular secretion of methotrexate and to potentiate toxicity. In some patients, the administration of Indomethacin can reduce the diuretic, natriuretic and antihypertensive effect of loop, potassium-sparing, and thiazide diuretics. A decrease in the antihypertensive effect of beta-adrenergic receptor blocking agents by NSAIDS including Indomethacin has been reported.


PREGNANCY AND LACTATION
Use in pregnancy and in nursing mother is not recommended because of possible toxic effects to the fetus and Indomethacin is excreted in breast milk.


SIDE EFFECTS/ADVERSE REACTIONS
CNS: Headache, dizziness, mental confusion, anxiety, insomnia, muscle weakness.
GIT: Nausea, a vomiting, epigastric distress, abdominal pain, constipation, diarrhoea. GIT ulceration and
bleeding may occur.
Hypersensitivity: Pruritus, urticaria, erythema nodosum, skin rashes, exfoliative dermatitis, Stevens-Johnson syndrome may occur.


SYMPTOMS AND TREATMENT OF OVERDOSE
Symptoms include headache, dizziness, gastrointestinal irritation or erosion with hemorrhage or perforation, tinnitus, confusion, blurred vision, mental disturbances, skin rash, stomatitis, edema, leukopenia, reduced retinal sensitivity, corneal deposits, and aplastic anemia.


PACKING/PACK SIZE(S)
Plastic containers of 500's & 1000's (For EXPORT/TENDER Only).

Blister pack of 100 x 10's.


SHELF LIFE
4 years from date of manufacture.

STORAGE CONDITIONS
KEEP OUT OF REACH OF CHILDREN

Keep Container Tightly Closed

Store In Dry Place Below 25C

Protect From Light

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