Indometacin 50 Berlin-Chemie, rectal suppositories 50mg, 10pcs

Composition

Active ingredients:

Indometacin 50 mg.

Auxiliary substances:

solid fat-800 mg,

corn starch-100 mg

Pharmacological action

Pharmacodynamics

The drug from the group of NSAIDs, has anti-inflammatory, analgesic, antipyretic and antiplatelet effects. Suppresses the activity of pro-inflammatory factors, reduces platelet aggregation.

By inhibiting cycloxygenase 1 and 2, it disrupts arachidonic acid metabolism, reduces the amount of prostaglandins (Pg) both in the inflammatory focus and in healthy tissues, and suppresses the exudative and proliferative phases of inflammation. Causes weakening or disappearance of rheumatic and non-rheumatic pain syndrome (including joint pain at rest and during movement, reduction of morning stiffness and joint swelling, helps to increase the volume of movement; in inflammatory processes that occur after operations and injuries, quickly relieves both spontaneous pain and pain during movement, reduces inflammatory edema at the wound site).

Pharmacokinetics

Absorption is fast. Bioavailability in the rectal route of use is 80-90%. Plasma protein binding is 90%, T1 / 2-4-9 h. It is mainly metabolized in the liver, and 30% of the drug is excreted unchanged. 70% is excreted by the kidneys,30% – through the intestines. It is not removed during dialysis. Penetrates into breast milk.

Indications

Joint syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout); pain in the spine, neuralgia, myalgia, traumatic inflammation of the soft tissues and musculoskeletal system; rheumatism, diffuse connective tissue diseases; dysmenorrhea.

As an auxiliary agent for infectious and inflammatory diseases of Ent organs, adnexitis, prostatitis, cystitis.

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

Contraindications

peptic ulcer and duodenal ulcer; ulcerative colitis; bleeding (intracranial, gastrointestinal); congenital heart defects (coarctation of aorta atresia of the pulmonary artery, tetralogy of Fallot); heart failure; hypertension; impaired color vision; a disease of the optic nerve; liver cirrhosis with portal hypertension; liver failure; asthma; hemophilia, hypocoagulation, other blood diseases; chronic renal failure; hearing loss; pathology of the vestibular apparatus; deficiency of glucose-6-phosphate dehydrogenase; proctitis, hemorrhoids, pregnancy and the period of breastfeeding; childhood and adolescence to 18 years; hypersensitivity to Indometacin and other NSAIDs, including “aspirin” asthma.

With caution: hyperbilirubinemia, thrombocytopenia, epilepsy, Parkinsonism, depression, as well as in elderly patients.

Side effects

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

Nervous system disorders: headache, dizziness, insomnia, agitation, irritability, fatigue, drowsiness, depression, peripheral neuropathy.

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

From the cardiovascular system: heart failure, tachyarrhythmia, increased blood pressure.

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

From the hemostatic system: bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), thrombocytopenia.

Allergic reactions: skin rash, pruritus, urticaria, angioedema, bronchospasm; rarely-Lyell’s syndrome, erythema nodosum, anaphylactic shock.

From the hematopoietic system: agranulocytosis, leukopenia, aplastic anemia, autoimmune hemolytic anemia.

From the side of metabolism: hyperglycemia, glucosuria.

From the side of the water-electrolyte balance: hyperkalemia.

Others: aseptic meningitis (more common in patients with autoimmune diseases), increased sweating, edematous syndrome.

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

Interaction

Reduces the effectiveness of uricosuric drugs, antihypertensive and diuretics (saluretics); increases the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics, side effects of mineralocorticosteroids, estrogens, other NSAIDs; increases the hypoglycemic effect of sulfonylurea derivatives.

Combined use with paracetamol increases the risk of developing nephrotoxic effects. Ethanol, colchicine, and glucocorticosteroids increase the risk of gastrointestinal complications accompanied by bleeding.

Increases blood concentrations of lithium, methotrexate, and digoxin.

Cyclosporine, gold preparations increase the nephrotoxicity of Indometacin. Cefamandol, cefoperazone, valproic acid-increase the risk of hypoprothrombinemia and the risk of bleeding. Reduces the elimination of penicillins. Potentiates the toxic effect of zidovudine.

How to take, course of use and dosage

Rectally (injected into the rectum). Before using the suppository, it is recommended to release the intestines.

Adult suppositories 100 mg 1 candle 1 time / day; suppositories 50 mg 1 candle 1-3 times / day.

During a gout attack, up to 200 mg / day.

Overdose

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

Treatment: perform symptomatic therapy. Hemodialysis is ineffective.

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 study.

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Suppositories

Storage conditions

Store at a temperature not exceeding 25 °C out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Indometacin

Conditions of release from pharmacies

By prescription

Dosage form

rectal suppositories