Indomethacin-Biosynthesis - instructions for use, doses, side effects, contraindications

auxiliary substances: (milk sugar, potato starch, microcrystalline cellulose, sugar powder, polyvinylpyrrolidone with Mm 12600 ± 2700, magnesium stearic acid, acetylphthalyl cellulose, titanium dioxide, tween-80, dye brown) - a sufficient amount to prepare a tablet weighing 0.125 g.

Description:

The tablets covered with a cover of light brown color. Two layers are visible on the cross-section.

Pharmacotherapeutic group:NSAIDs

ATX: & nbsp

C.01.E.B.03 Indomethacin

S.01.B.C.01 Indomethacin

M.02.A.A.23 Indomethacin

Pharmacodynamics:

Indomethacin has anti-inflammatory, analgesic, antipyretic and anti-aggregation effect. Suppresses inflammatory factors, reduces platelet aggregation. By depressing cyclooxygenase 1 and 2, it breaks the metabolism of arachidonic acid, reduces the amount of prostaglandins (Pg) both in the focus of inflammation, and in healthy tissues, suppresses the exudative and proliferative phases of inflammation. It causes a weakening or disappearance of the pain syndrome of a rheumatic and non-rheumatic nature (incl.with pain in the joints at rest and during movement, a decrease in morning stiffness and swelling of the joints, contributes to an increase in the volume of movements; in inflammatory processes that occur after surgery and trauma, quickly alleviates both spontaneous pain and pain during movement reduces inflammatory edema at the wound site).

Pharmacokinetics:

Absorption is fast. Bioavailability at ingestion - 98% The maximum concentration at intake (0,69 mkg / ml) is reached through - 2h. The connection with plasma proteins is 90%. The half-life (T_1/2) - 4-9 hours Metabolized, mainly in the liver. It is excreted through the gastrointestinal tract - 30%. It is not removed during dialysis. Penetrates into breast milk.

Indications:

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis, rheumatic soft tissue disorders, gouty arthritis.

As an adjuvant in the combination therapy for infectious inflammatory diseases of the ENT organs, adnexitis, prostatitis, cystitis, neuritis, algodismenorrhea, headache and toothache.

Contraindications:

Hypersensitivity, "aspirin" asthma, peptic ulcer and duodenal ulcer, ulcerative colitis, bleeding (intracranial, gastrointestinal), congenital heart defects (coarctation of the aorta, pulmonary atresia, tetralogy of Fallot), impaired color vision, cirrhosis with portal hypertension , optic nerve diseases, bronchial asthma, heart failure, arterial hypertension, hemophilia, hypocoagulation, hepatic insufficiency, chronic renal failure, hearing loss, pathology vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase, blood diseases, rectal bleeding, proctitis, hemorrhoids.

Pregnancy, lactation, children under 14 years.

Carefully:Hyperbilirubinemia, thrombocytopenia, epilepsy, parkinsonism, depression, childhood and advanced age

Dosing and Administration:

Inside during or after a meal, squeezed milk.

Adults - in the initial dose of 25 mg 2-3 times a day. If the clinical effect is inadequate, the dose is increased to 50 mg 3 times a day.

The maximum daily dose is 200 mg.

When the effect is achieved, the treatment is continued for 4 weeks in the same or reduced dose.

With prolonged use, the maximum daily dose is 75 mg.

Side effects:

From the digestive system: NSAIDs-gastropathy, abdominal pain, nausea, vomiting, heartburn, anorexia, diarrhea, impaired liver function (increase in the blood of bilirubin, "liver" transaminases). With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract.

From the nervous system: headache, dizziness, insomnia, agitation, irritability, fatigue, drowsiness, depression, peripheral neuropathy.

From the sense organs: hearing loss, tinnitus, taste disorder, diplopia, blurred vision, corneal opacity, conjunctivitis.

On the part of the CAS: heart failure, tachyarrhythmia, increased blood pressure.

From the urinary system: impaired renal function, proteinuria, hematuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

From the side of the hemostasis system: Bleeding (gastrointestinal, gingival, uterine, hemorrhoids), thrombocytopenia.

Allergic reactions: skin rash, itching, urticaria, Quincke's edema, bronchospasm; rarely - Lyell's syndrome, erythema nodosum, anaphylactic shock.

Laboratory indicators: agranulocytosis, leukopenia, hyperglycemia, glucosuria, hyperkalemia.

Other: aseptic meningitis (more often in patients with autoimmune diseases), aplastic anemia, autoimmune hemolytic anemia, edematous sweating syndrome.

Local reactions: burning, itching, heaviness in the anorectal area exacerbation of hemorrhoids.

Overdose:

Symptoms: nausea, vomiting, severe headache, dizziness, memory impairment, disorientation. In severe cases of paresthesia, numbness of the limbs, convulsions.

Treatment: symptomatic therapy, hemodialysis is ineffective.

Interaction:

Reduces the effectiveness of uricosuric drugs, hypotensive and diuretics (saluretics); strengthens the effect of indirect anticoagulants, antiaggregants, fibrinolytics, side effects of mineralocorticosteroids, estrogens, other NSAIDs; enhances the hypoglycemic effect of sulfonylurea derivatives.

Sharing with paracetamol increases the risk of developing nephrotoxic effects.

Ethanol, colchicine, glucocorticosteroids - increase the risk of developing gastrointestinal complications accompanied by bleeding.

Antacids and colestramine reduce absorption.

Increases the concentration of lithium, methotrexate and digoxin in the blood.

Cyclosporine, gold preparations increase nephrotoxicity.

Cefamandol, cefapperazone, cefotetan, valproic acid, plikamycin - increase the risk of hypoprothrombinemia and the risk of bleeding.

Potentiates the toxic effect of zidovudine.

In newborns, the risk of toxic effects of aminoglycosides increases.

Special instructions:

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

It is necessary to monitor liver function, cellular composition of peripheral blood.

To prevent and reduce dyspepsia, antacids should be used.

Effect on the ability to drive transp. cf. and fur:

During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets coated with a coating, 0.025 g.

Packaging:

For 30 tablets in cans of orange glass, plastic containers or polymer cans.

10 tablets per contour cell pack.

For 10 tablets in a contour non-jawed package.

Each jar, container, 2 or 3 contour-cell or non-jawed packages with instructions for use are placed in a bundle.

Storage conditions:

In a dry place, protected from light, out of reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N001072 / 02-2003

Date of registration:08.12.2008

Expiration Date:Unlimited

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia

Information update date: & nbsp31.10.2017

Illustrated instructions

Instructions

Indomethacin-Biosynthesis (Indometacin-Biosynthes)