Capsule Colour: White/Blue
Capsule Size: # 4
Granules Colour: White
EACH CAPSULE CONTAINS
Indomethacin ................................. 25 mg
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.
Indomethacin is rapidly absorbed when taken by mouth and is excreted largely
by the kidneys. Its action begins within 2 hours of ingestion.
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.
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.
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.
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
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.
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
Fluid retention and oedema have been observed in some patients taking NSAIDS,
therefore caution is advised in patients with fluid retention or heart
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
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.
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.
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
SIDE EFFECTS/ADVERSE REACTIONS
CNS: Headache, dizziness, mental confusion, anxiety, insomnia, muscle
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.
Plastic containers of 500's & 1000's (For EXPORT/TENDER Only).
Blister pack of 100 x 10's.
4 years from date of manufacture.
KEEP OUT OF REACH OF CHILDREN
Keep Container Tightly Closed
Store In Dry Place Below 25°C
Protect From Light