INDOMETATSIN-ALTFARM

General characteristics. Structure:

Active agent: indometacin of 50 mg or 100 mg.
Excipient: витепсол H15.

Description: suppositories from color, white to white with a creamy or yellowish shade, a torpedo-shaped form without visible impregnations on longitudinal section.

Pharmacological properties:

Pharmacodynamics. Indometacin renders antiinflammatory, analgetic, febrifugal and anti-aggregation action. Suppresses activity of antiinflammatory factors, reduces aggregation of thrombocytes. Oppressing cyclooxygenase 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).

Pharmacokinetics. Absorption - bystry. Bioavailability at a rectal way of introduction - 80-90%. Communication with proteins of plasma - 90%, an elimination half-life - 4-9 h. It is metabolized, generally in a liver, in an invariable look 30% of drug are removed. 70% are removed by kidneys, 30% - through digestive tract. Is not removed at dialysis. Gets into breast milk.

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 at infectious and inflammatory diseases of ENT organs, an adnexitis, prostatitis, cystitis, neuritis, algodismenory. Head and a dentagra (as a part of a combination therapy).

Route of administration and doses:

Rektalno (enter into a rectum). Before use of suppository it is recommended to release intestines. Wash up hands, exempt suppository from planimetric packaging, having cut it by means of scissors or having opened it with hands, having pulled in the different ends of edge of planimetric packaging, and enter suppository into an anus the pointed end, whenever possible deeply. For more convenient use of suppository it is recommended to bend down or sit down; it is possible to enter lying on one side.
Suppositories of 50 mg adult 1-3 once a day; to children (14 years are more senior) 1 time a day;
Suppositories of 100 mg - 1 times a day;
During a gout attack to 200 mg a day.
It is recommended to apply for the night.

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 of 17 ketosteroids drug should be cancelled for 48 h prior to a research.
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.

Side effects:

From the alimentary system: The NPVP-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, sleeplessness, 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, tachyarrhythmia, increase in the ABP.
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.

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. Increases concentration in blood of drugs of lithium, a methotrexate and digoxin. Cyclosporine, drugs of gold increase nephrotoxicity of indometacin. Tsefamandol, цефоперазон, valproic acid - increase risk of development of a prothrombinopenia 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, hypostases, arterial hypertension, hemophilia, hypocoagulation, a liver failure, a chronic renal failure, decrease in hearing, pathology of a vestibular apprat, deficit glyukozo-6-fosfatdegidrogenazy; blood diseases; proctitis, hemorrhoids.
Pregnancy, the period of lactations, children's age up to 14 years.
With care - a hyperbilirubinemia, thrombocytopenia, epilepsy, parkinsonism, a depression, children's 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. The hemodialysis is inefficient.

Storage conditions:

List B. In the dry, protected from light place, at a temperature not above 25 °C. To store in the places unavailable to children.

Period of validity 2 years. After a period of validity not to use.

Issue conditions:

According to the recipe

Packaging:

Suppositories rectal 50 mg and 100 mg
Suppositories on 5 pieces in a blister strip packaging from a film polyvinyl chloride. 2 planimetric packagings together with the application instruction in a cardboard pack.