INDOMETHACIN
-
| StockNo |
Product description |
| EB0280-421-09 |
INDOMETHACIN
ENTEROSOLVENT FILMTABS 25 MG X 30 |
| EB0280-421-22 |
INDOMETHACIN
SUPPOSITORIES 50 MG X 6 |
| EB0280-421-23 |
INDOMETHACIN
SUPPOSITORIES 100 MG X 6 |
-
- COMPOSITION:
Indomethacin -
- 50 mg and 100 mg in one suppository;
25 mg in one filmtablet
ACTION:
Indomethacin belongs to the group of indol derivatives and is a
highly effective non-steroid antiphlogistic preparation, with
strongly manifested antipyretic and analgesic properties. It
decreses edema and muscular tension, increases the functional
capacities of the affected joints. It has certain anti-aggregating
properties as well. The mechanism of action is connected inhibition
of prostaglandin synthesis. In contrast to corticosteroids, it dose
not influence the hypophysis-adrenal system. The advantage of
Indomethacin over corticosteroids and phenylbutazon is that its
application does not cause retention of water in organism, which
does not lead to increased edema and body weight.
PHARMACOKINETICS:
Indomethacin is quickly absorbed, the maximum serum level is reached
within 1-2 h; its biological half-life is 90 min.
About 90-98 % of Indomethacin are bound to the plasma proteins. It
can replace other drugs and enhance their therapeutic effect at
simultaneous application. It is excreted through the kidneys in
60-75 %, the rest is eliminated with feces. The preparation is
disintegrated in the liver and a part of it is excreted through the
biliary tract into the intestines. The time of half-elimination of
Indomethacin is between 2.6 to 11.2 h, or 5.8 h on the average.
INDICATIONS:
Inflammatory joint diseases: Bechterew's disease (spondylarthritis
ankylopoietica), rheumatoid arthritis (especially its initial form),
symptomatic arthritis.
Degenerative joint diseases: spondylarthosis, coxarthosis,
gonarthrosis.
Metabolic arthropathies: gout in its acute form.
Periarticular diseases: tendinitis, bursitis, tendobursitis,
tendovaginitis, etc.
Inflammation, pain, trismus and edema after stomatological,
gynecological and other surgical interventions.
CONTRAINDICATIONS:
Active peptic ulcer, hemorrhages colitis, bleeding hemorrhoids, fits
of bronchial asthma, urticaria or acute rhinitis.
SIDE EFFECTS:
1. Gastrointestinal disturbances: nausea, vomiting, loss of
appetite, epigastric pains, diarrhea, sometimes constipation.
2. Headache, dizziness, fatigability, decrease of the vision
sharpness, difficult concentration, somnolence, sometimes psychic
disturbances with depressin.
3. Allergic symptoms: eruptions, itching, stomatitis.
4. Very rarely one may observe hepatic lesions (hepatitis, icterus),
hematuria and proliferative glomerulonephritis; transitory
hypertension, increase of blood urea level; leucopenia and
neutropenia up to suppression of the bone marrow function;
disturbances of carbohydrate metabolism, cardiac arrythmia. |
PRECAUTIONS:
In order to reduce the degree of gastrointestinal tract damage, it
is advisable to take Indomethacin during meals together with some
milk, even with antiacid drugs. It should be taken with increased
attention by drivers or high-ranking people. Antihistamine
preparations are administered when allergic symptoms appear. The
side effects usually appear after higher therapeutic doses, and the
reduction of the doses or the discontinuation of the treatment lead
to their disappearance.
DRUG INTERACTIONS:
The action of Indomethacin decreases when it is administered
together with ACE-inhibitors, beta0blockers, prazosin, aspirine. The
danger of hemorrhages in the gastrointestinal tract increases after
simultaneous administration of acetylsalicylic acid, irrespective of
the way of application of Indomethacin. Simultaneous administration
with dogitalis preparations causes an increase of the toxicity of
the cardiac glucosides, which is due to decreased renal clearance
and an increase of their plasma levels. The effects of the oral
anticoagulants may be enhanced by simultaneous administration with
Indomethacin, as a result of anticoagulant substitution at their
binding with the plasma proteins.
DOSAGE AND ADMINISTRATION:
The oral daily dose for adults is 1 tablet (0.025 g), 2-3 times, in
case of good tolerance it may be increased up to 0.1 g (4 intakes);
in acute fits of gout the dose may be increased up to 0.15 g (2
tablets, 3 times daily). The tablets are recommended to be taken
during meals or immediately after meals.
The rectal daily dose of Indomethacin is one suppository (of 50 mg
or 100 mg when well tolerated) 2 times.
MEDICINAL FORM AND PACKAGE:
Suppositories of 50 mg and 100 mg in packs of 6.
Enterosolvent filmtablets of 25 mg - in packs of 30.
STORAGE:
At moderate temperature (15-30° C).
EXPIRY:
Suppositories - 2 (two) years.
Filmtablets - 4 (four) years.
|
