Indomethacin 50 Berlin-Chemie 10 Pieces suppositories 50mg


Indomethacin 50 Berlin-Chemie 10 Pieces suppositories 50mg



Active substance:
1 suppository contains: Indomethacin – 50.0 mg.
Corn starch, fat solid.
White with yellowish tinge suppositories torpedo-shaped with a recess in the base.
Product form:
50 mg rectal suppositories.
5 suppositories in blisters (blister) made of white PVC / PE film.
2, 6 or 10 blisters together with instructions for use in a cardboard package.
Hypersensitivity to indomethacin or other components of the formulation; complete or incomplete combination of bronchial asthma, pollinosis recurrent nasal and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (including history); gastric ulcer and 12 duodenal ulcer, inflammatory bowel disease (ulcerative colitis, Crohn’s disease); proctitis, hemorrhoids; bleeding (intracranial, of the intestine, rectal incl..); congenital heart disease (severe coarctation of aorta, pulmonary atresia, severe tetralogy of Fallot), the period after coronary artery bypass surgery; bleeding disorders (including hemophilia, prolonged bleeding, bleeding tendency..); hepatic failure, active liver disease; chronic renal failure (creatinine clearance less than 30 mL / min), progressive renal disease; disorders of blood (leucopenia and anemia); confirmed by hyperkalemia; pregnancy, lactation; children’s age (14 years).
Ischemic heart disease, cerebrovascular disease, chronic heart failure, dyslipidaemia, hyperlipidemia, diabetes, thrombocytopenia, peripheral artery disease, hypertension, smoking, chronic renal failure (creatinine clearance of 30-60 ml / min), cirrhosis with portal hypertension, hyperbilirubinemia , ulcerative lesions gastrointestinal history, the presence of infection Helicobacter pylori, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases; psychiatric disorders, epilepsy, Parkinson’s disease, depression, old age; concomitant therapy following drugs: anticoagulant (.. in t h warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), oral steroids (including prednisone), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
50 mg
Symptomatic treatment of acute and chronic inflammatory diseases of the musculoskeletal system (including rheumatoid arthritis, ankylosing spondylitis, gout); rheumatic soft tissue; pain after injuries and surgical interventions involving inflammation.
As an adjuvant in infectious and inflammatory diseases of the upper respiratory tract, adnexitis, prostatitis, cystitis, algodismenoree (in combination therapy).
The drug is intended for symptomatic therapy, reduce inflammation and pain at the time of use, does not affect the progression of the disease.
Interaction with other drugs
Increasing the concentration in plasma digoxin, phenytoin, methotrexate and lithium drugs that may lead to increased toxicity. Ethanol, colchicine, corticosteroids and corticotropin increase the risk of gastrointestinal bleeding complications.
Enhances the hypoglycemic effect of insulin and of oral hypoglycemic drugs, enhances the action of anticoagulants, antiplatelet agents, thrombolytics (streptokinase and urokinase) – increased risk of bleeding.
Reduces the effect of diuretics during treatment with potassium-sparing diuretics, there is a risk of hyperkalemia; reduces the efficiency of uricosuric drugs, antihypertensives and diuretics (saluretics); It increases the side effects of corticosteroids, aspirin and other NSAIDs.
The combined use of paracetamol increases the risk of nephrotoxic effects.
Indomethacin reduces the effect of the ACE inhibitors, the risk of functional disorders of the kidneys.
Cyclosporin preparations and Au indomethacin nephrotoxicity increases (due to the suppression of prostaglandin synthesis in the kidneys).
Cefamandole, tsefaperazon, tsefotetan, valproic acid, plikamitsin – increase the risk of hypoprothrombinemia and the risk of bleeding. It reduces the elimination of penicillin. When combined with probenecid excretion of indomethacin is slowing.
Myelotoxicity drugs increase the expression gematotoksichnosti drug.
It enhances the toxicity of zidovudine (due to inhibition of metabolism).
When rectal indomethacin is extremely rare. Possible symptoms: nausea, vomiting, abdominal pain, severe headache, dizziness, disorientation. In severe cases: gastrointestinal bleeding, loss of consciousness, seizures.
Treatment: symptomatic therapy, forced diuresis. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
It has anti-inflammatory, analgesic, antipyretic, and antiplatelet properties.
Pharmacodynamics. NSAIDs, indoleacetic acid derivative. The mechanism of action is related to inhibition of the enzyme cyclooxygenase (COX) types 1 and 2, which leads to inhibition of prostaglandin synthesis from arachidonic acid. Suppresses exudative and proliferative phase of inflammation.
In vitro indomethacin causes deceleration of proteoglycan synthesis in cartilage in concentrations corresponding to those achieved in humans. Inhibits platelet aggregation. In rheumatic diseases inflammatory and analgesic properties cause a weakening of symptoms such as pain at rest and in motion, morning stiffness, joint swelling and improve functional ability of joints. It has analgesic effect in moderate pain rheumatic nature. In inflammatory processes that occur after operations and injuries, reducing their severity, quickly facilitates both spontaneous pain and pain on movement.
Absorption – fast. Bioavailability in rectal route of administration – 80-90%. The maximum plasma concentration after administration of the drug is achieved through 30-120 minutes. Communication with plasma proteins of> 90%, half-life – 2 hr. Undergoes enterohepatic recycling. The blood is determined as unchanged substance and unconjugated metabolites. 60% of the drug excreted in the urine (unchanged substance and metabolite – indomethacin), 33% – through the intestine as metabolites. Not removed by dialysis. It passes into breast milk.
Pregnancy and breast-feeding
The drug is contraindicated during pregnancy.
Indomethacin is excreted in breast milk, so long as necessary the drug indomethacin 50 Berlin-Chemie lactation breastfeeding during the drug should be stopped.
Conditions of supply of pharmacies
On prescription.
side effects
Possible side effects when using the drug Indomethacin 50 Berlin-Chemie listed below in descending frequency of occurrence: often (> 1/100, 1/1000, 1/10000,
Disorders of the gastrointestinal tract:
Often: NSAID gastropathy, abdominal pain, nausea, vomiting, anorexia, diarrhea, heartburn, liver dysfunction (increased blood levels of bilirubin, “liver” transaminases), ulcerative stomatitis, exacerbation of colitis.
Rare: gastritis.
With prolonged use at high doses – ulceration of the mucous membranes of the gastrointestinal tract.
Disorders of the nervous system:
Very common: headache.
Common: dizziness, drowsiness, fatigue, fatigue, irritability, depression.
Uncommon: peripheral neuropathy, muscle weakness, seizures, agitation, insomnia.
Violations by the senses:
Common: tinnitus, diplopia, corneal clouding, blurred vision, conjunctivitis, taste disturbance.
Uncommon: decreased hearing.
Violations of the cardiovascular system:
Very rare: congestive heart failure, tachyarrhythmia, increased blood pressure, edema syndrome.
Violations of the kidneys and urinary tract:
Uncommon: peripheral edema (especially in patients with hypertension or renal failure).
Very rarely, interstitial nephritis, nephrotic syndrome, papillary necrosis, renal dysfunction, Proteinuria, hematuria. Blood disorders and lymphatic system:
Very rare: bleeding (gastrointestinal, gingival, uterine, hemorrhoids), anemia (including haemolytic and aplastic), leukopenia, agranulocytosis, eosinophilia, thrombocytopenia, thrombocytopenic purpura.
Violations of the skin and subcutaneous tissue disorders:
Very rare: skin rash, pruritus, urticaria, angioedema, bronchospasm; in rare cases – toxic epidermal necrolysis (Lyell’s syndrome), erythema nodosum, anaphylactic shock, photosensitization. Laboratory findings: glycosuria, hyperkalaemia, hyperglycaemia.
Local reactions: burning, itching, heaviness in the anorectal area, worsening of hemorrhoids.
Other: aseptic meningitis (usually in patients with autoimmune diseases), increased sweating.
special instructions
If signs of liver disease (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine) should stop taking the drug and consult a doctor.
Not recommended simultaneous application of acetylsalicylic acid and other NSAIDs.
Use of the drug can impair female fertility and is not recommended for women planning pregnancy. After two weeks of drug application necessary to monitor liver function ( “liver” transaminase), kidney and picture peripheral blood. If necessary, definition of 17-ketosteroids drug should be discontinued 48 hours before the study.
Effects on ability to drive vehicles and management of potentially dangerous machinery: in the period of treatment should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children!.
Dosing and Administration
Rectally. Suppositories are exempt from contour packaging and administered after a bowel movement, possibly deep into the rectum. Adults recommended one suppository (50 mg) 1-3 times a day (50-150 mg indomethacin). During the attack of gout daily dose may be increased to 200 mg.
The maximum daily dose of 200 mg of the drug.
Duration of treatment is determined individually.
It should use the minimum effective dose for the shortest possible rate.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg

Berlin Chemie

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