Indomethacin 50 Berlin-Chemie - instructions for use, dose, side effects, contraindications

NSAID, an indoleacetic acid derivative. The mechanism of action is associated with inhibition of the enzyme cyclooxygenase (COX) 1 and 2 types, which leads to inhibition of the synthesis of prostaglandins from arachidonic acid. It suppresses the exudative and proliferative phases of inflammation.

In vitro indomethacin causes a slowdown in the synthesis of proteoglycan in the cartilage in concentrations corresponding to those that are achieved in humans. Suppresses the aggregation of platelets. With rheumatic diseases anti-inflammatory and analgesic properties cause weakening of such symptoms as pain in a state of rest and motion, morning stiffness, swelling of the joints and improve the functional capacity of the joints.Has analgesic effect with moderate pain non-rheumatic. In inflammatory processes that occur after surgery and trauma, reduces their severity, quickly alleviates both spontaneous pain and pain during movement.

Pharmacokinetics:

Absorption is fast. Bioavailability in the rectal route of administration is 80-90%. The maximum concentration in the blood plasma after the administration of the drug is achieved after 30-120 minutes. Connection with plasma proteins - 90%, half-life - 2 hours. Undergoes intestinal-hepatic recirculation. In the blood is determined in the form of unchanged substance and unconjugated metabolites. 60% of the drug is excreted in the urine (metabolites and unchanged substance - indomethacin), 33% - through the intestines in the form of metabolites. It is not removed during dialysis. Penetrates into breast milk.

Indications:

- Symptomatic treatment of acute and chronic inflammatory diseases of the musculoskeletal system (including rheumatoid arthritis, ankylosing spondylitis, gout);

- rheumatic affections of soft tissues;

- pain syndrome after injuries and surgical interventions accompanied by inflammation.

As an auxiliary agent for infectious and inflammatory diseases of the ENT organs, adnexitis, prostatitis, cystitis, algodismenore (as part of a combination therapy).

The drug is intended for symptomatic therapy, reducing inflammation and pain at the time of use, the progression of the disease is not affected.

Contraindications:

- Hypersensitivity to indomethacin or other components of the drug;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis);

- peptic ulcer of stomach and duodenum, inflammatory bowel disease (ulcerative colitis, Crohn's disease);

- proctitis, hemorrhoids;

- bleeding (intracranial, from the intestinal tract, including rectal);

- Congenital heart defects (severe coarctation of the aorta, pulmonary atresia, heavy tetralogy of Fallot), period after coronary artery bypass grafting;

- disorders of blood clotting (including hemophilia, lengthening bleeding time, a tendency to bleed);

- hepatic insufficiency, active liver disease;

- chronic renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease;

- disorders of hematopoiesis (leukopenia and anemia);

- confirmed hyperkalemia;

- pregnancy, lactation;

- children's age (up to 14 years).

Carefully:

Coronary heart disease, cerebrovascular diseases, chronic heart failure, dyslipidemia, hyperlipidemia, diabetes mellitus, thrombocytopenia, peripheral arterial disease, hypertension, smoking, chronic renal failure (creatinine clearance 30-60 ml / min), cirrhosis with portal hypertension, hyperbilirubinemia, history of gastrointestinal lesions, presence of infection Helicobacter pylori, long-term use of H11VP, frequent use of alcohol, severe physical illnesses; mental disorders, epilepsy, parkinsonism, depression, elderly age; concomitant therapy with the following drugs:

- anticoagulants (incl. warfarin);

- antiaggregants (incl. acetylsalicylic acid, clopidogrel);

- oral glucocorticosteroids (incl. prednisolone);

- selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

Pregnancy and lactation:

The drug is contraindicated during pregnancy.

Indomethacin excreted in breast milk, so if you need long-term use of the drug Indomethacin 50 Berlin-Chemie during lactation breastfeeding for the period of taking the drug should be discontinued.

Dosing and Administration:

Rectally. Suppositories are released from the contoured package and injected after emptying the intestine, possibly deep into the rectum. Adults are recommended to use one suppository (50 mg) 1-3 times a day (50-150 mg of indomethacin). During a gout attack, the daily dose of the drug can be increased to 200 mg.

The maximum daily dose of the drug is 200 mg.

The duration of the course of treatment is set individually.

Use the lowest effective dose as short a course as possible.

Side effects:

Possible side effects of the drug Indomethacin 50 Berlin-Chemie are listed below in the descending frequency of occurrence: often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000), including individual messages.

Disorders from the gastrointestinal tract:

Often: NSAID-gastropathy, abdominal pain, nausea, vomiting, anorexia, diarrhea, heartburn, liver dysfunction (increase in blood concentrations of bilirubin, "liver" transaminases), ulcerative stomatitis, exacerbation of colitis.

Rarely: gastritis.

With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract.

Impaired nervous system:

Often: headache.

Often: dizziness, drowsiness, fatigue, fatigue, irritability, depression.

Infrequently: peripheral neuropathy, muscle weakness, convulsions, agitation, insomnia.

Impaired sensory organs:

Often: noise in the ears, diplopia, corneal opacity, blurred vision, conjunctivitis, taste disorder.

Infrequently: hearing loss.

Disorders from the cardiovascular system:

Rarely: heart failure, tachyarrhythmia, increased blood pressure, edematous syndrome.

Disorders from the kidneys and urinary tract:

Infrequently: peripheral edema (especially in patients with hypertension or renal insufficiency).

Rarely: interstitial nephritis, nephrotic syndrome, papillary necrosis, impaired renal function, proteinuria, hematuria.

Violations from the blood and lymphatic system:

Rarely: bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), anemia (including hemolytic and aplastic), leukopenia, agranulocytosis, eosinophilia, thrombocytopenia, thrombocytopenic purpura.

Disturbances from the skin and subcutaneous tissues:

Rarely: skin rash, itching, urticaria, angioedema, bronchospasm; in isolated cases - toxic epidermal necrolysis (Lyell's syndrome), erythema nodosum, anaphylactic shock, photosensitivity.

Laboratory indicators:

Glucosuria, hyperkalemia, hyperglycemia.

Local reactions:

Burning, itching, heaviness in the anorectal area, exacerbation of hemorrhoids.

Other:

Aseptic meningitis (more often in patients with autoimmune diseases), increased sweating.

Overdose:

When rectal, indomethacin is very rare.

Possible Symptoms: nausea, vomiting, abdominal pain, severe headache, dizziness, disorientation.In severe cases: gastrointestinal bleeding, loss of consciousness, convulsions.

Treatment: symptomatic therapy, forced diuresis. Hemodialysis is ineffective.

Interaction:

Increases the concentration in the plasma of digoxin, phenytoin, methotrexate and lithium preparations, which can lead to an increase in their toxicity.

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

Strengthens the hypoglycemic effect of insulin and oral hypoglycemic drugs, increases the effect of indirect anticoagulants, antiaggregants, thrombolytics (streptokinase and urokinase) - increases the risk of bleeding.

Reduces the effect of diuretics, against the background of the use of potassium-sparing diuretics, there is a risk of hyperkalemia; reduces the effectiveness of uricosuric drugs, hypotensive and diuretics (saluretics); enhances the side effects of glucocorticosteroids, acetylsalicylic acid and other NSAIDs.

Joint application with paracetamol increases the risk of developing nephrotoxic effects.

Indomethacin weakens the effect of ACE inhibitors, increases the risk of functional kidney damage.

Cyclosporine and preparations Au increases the nephrotoxicity of indomethacin (by suppressing the synthesis of prostaglandins in the kidneys).

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

Reduces the elimination of penicillins.

When combined with probenecid, the excretion of indomethacin slows down.

Myelotoxic medicinal treatments increase the manifestation of hematotoxicity of the drug.

Increases the toxicity of zidovudine (due to inhibition of metabolism).

Special instructions:

If signs of liver damage (itchy skin, yellowing of the skin, nausea, vomiting, abdominal pain, darkening of urine) should stop taking the drug and contact your doctor.

It is not recommended simultaneous use with acetylsalicylic acid and other NSAIDs.

The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy.

After two weeks of using the drug, it is necessary to monitor the liver function (activity of "liver" transaminases), kidneys and the control of the picture of peripheral blood.

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

Effect on the ability to drive transp. cf. and fur:AT the period of treatment should be refrained from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Suppositories rectal, 50 mg.

Packaging:

For 5 suppositories in a contour squad packaging (blister), made of white PVC / PE film.

For 2, 6 or 10 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N008995

Date of registration:06.08.2010 / 11.09.2013

Expiration Date:Unlimited

The owner of the registration certificate:BERLIN-PHARMA, CJSC BERLIN-PHARMA, CJSC Russia

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Representation: & nbspBERLIN-PHARMA, CJSCBERLIN-PHARMA, CJSC

Information update date: & nbsp31.10.2017

Illustrated instructions

Instructions

Indomethacin 50 Berlin-Chemie (Indometacin 50 Berlin-Chemie)