Indometacin
Producer: Actavis Ltd. (Aktavis Ltd.) Switzerland
Code of automatic telephone exchange: M01AB02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: indometacin of 25 mg.
Excipients: lactose, wheat starch, gelatin, talc, magnesium stearate, microcrystallic cellulose, Eudrazhit (L-12,5 of % and S-12,5 of %), titanium dioxide, a macrogoal 6000, a macrogoal 400, sikovit a varnish (10E172, 30E172), diethyl phthalate, acetone, isopropanol, the purified water.
Description: Tablets are round, a biconvex form, covered with a thin layer cover, light brown color.
Pharmacological properties:
Renders antiinflammatory, analgetic, febrifugal and anti-aggregation action. Suppresses pro-inflammatory factors, reduces aggregation of thrombocytes. Oppressing a tsikloksigenaza 1 and 2, breaks metabolism of arachidonic acid, reduces amount of prostaglandins (Pg) both in the inflammation center, and in healthy fabrics, suppresses exudative and proliferative phases of an inflammation. Causes easing or disappearance of a pain syndrome of rheumatic and not rheumatic character (including at joint pains at rest and at the movement, reduction of morning constraint and a swelling of joints, promotes increase in volume of movements; at the inflammatory processes arising after operations and injuries quickly facilitates both spontaneous pain, and an oxycinesia, reduces inflammatory hypostasis on site of a wound).
Indications to use:
Inflammatory and degenerative diseases of a musculoskeletal system: a pseudorheumatism, the psoriasis, juvenile chronic arthritis ankylosing a spondylitis; rheumatic defeats of soft tissues; gouty arthritis.
As supportive application as a part of a combination therapy at infectious and inflammatory diseases of ENT organs, an adnexitis, prostatitis, cystitis, neuritis, algodismenory, head and a dentagra.
Route of administration and doses:
Inside, in time or after food, washing down with milk, adult - in an initial dose 25 mg 2-3 times a day. At insufficient expressiveness of clinical effect the dose is increased to 50 mg by 3 times a day. The maximum daily dose - 200 mg. At achievement of effect treatment is continued during 4 weeks in the same or reduced dose. At prolonged use the maximum daily dose - 75 mg.
Features of use:
During treatment control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary. In need of definition 17 - ketosteroids drug should be cancelled for 48 h prior to a research.
It is necessary to control functions of a liver, cellular composition of peripheral blood.
During treatment it is necessary to abstain from driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
For the prevention and reduction of the dispepsichesky phenomena it is necessary to use antiacid drugs.
Side effects:
From the alimentary system: NPVP - a gastropathy, abdominal pains, nausea, vomiting, heartburn, anorexia, diarrhea, an abnormal liver function (increase in blood of bilirubin, "hepatic" transaminases). At prolonged use in high doses - an ulceration of a mucous membrane of digestive tract.
From a nervous system: headache, dizziness, insomnia, excitement, irritability, fatigue, drowsiness, depression, peripheral neuropathy.
From sense bodys: decrease in hearing, sonitus, taste disturbance, diplopia, sight illegibility, opacification of a cornea, conjunctivitis.
From CCC: heart failure, takhiartmiya, increase in arterial pressure.
From an urinary system: renal failure, proteinuria, hamaturia, intersticial nephrite, nephrotic syndrome, necrosis of nipples.
From system of a hemostasis: bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), thrombocytopenia.
Allergic reactions: skin rash, itch, small tortoiseshell, Quincke's edema, bronchospasm; seldom - a Lyell's disease, a knotty erythema, an acute anaphylaxis.
Laboratory indicators: agranulocytosis, leukopenia, hyperglycemia, glucosuria, hyperpotassemia.
Others: aseptic meningitis (is more often at patients with autoimmune diseases), aplastic anemia, autoimmune hemolitic anemia, an edematous syndrome sweating strengthening.
Interaction with other medicines:
Reduces efficiency of uricosuric drugs, hypotensive and diuretics (saluretics); strengthens effect of indirect anticoagulants, antiagregant, fibrinolitik, side effects of mineralokortikosteroid, estrogen, other NPVP; strengthens hypoglycemic effect of derivatives of sulphonylurea.
Sharing with paracetamol increases risk of development of nephrotoxic effects. Ethanol, colchicine, glucocorticosteroids - increase risk of development of the gastrointestinal complications accompanied with bleedings.
Antacids and Colestyraminum reduce absorption.
Increases concentration in blood of drugs of lithium, a methotrexate and digoxin. Cyclosporine, drugs of gold increase nephrotoxicity. Tsefamandol, цефаперазон, цефотетан, valproic acid, пликамицин - increase risk of development of prothrombinopenias and danger of bleedings. Exponentiates toxic action of a zidovudine.
Contraindications:
Hypersensitivity, "aspirinovy" asthma, peptic ulcer of a stomach and duodenum, ulcer colitis, bleeding (intracranial, gastrointestinal), inborn heart diseases (aorta coarctation, an atresia of a pulmonary artery, Fallo's tetrad), disturbance of color sight, cirrhosis with portal hypertensia, diseases of an optic nerve, bronchial asthma, heart failure, arterial hypertension, hemophilia, hypocoagulation, a liver failure, a chronic renal failure, decrease in hearing, pathology of a vestibular mechanism, deficit glyukozo-6-fosfatdegidrogenazy; hemopoiesis disturbances; rectal bleeding, proctitis, hemorrhoids.
Pregnancy, the lactation period, children's age up to 14 years.
With care - the hyperbilirubinemia, thrombocytopenia, epilepsy, parkinsonism, a depression, children is more senior than 14 years and advanced age.
Overdose:
Symptoms: nausea, vomiting, severe headache, dizziness, memory disturbance, disorientation. In hard cases of paresthesia, numbness of extremities, spasms. Treatment: symptomatic therapy, a hemodialysis it is inefficient.
Storage conditions:
List B. In the dry place protected from light, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity of 5 years. Not to use upon termination of a period of validity.
Issue conditions:
According to the recipe
Packaging:
30 tablets covered with a kishechnorastvorimy cover in the blister from a polyvinyl chloride film and aluminum foil.
On 1 or 5 blisters together with the application instruction place in a cardboard pack.