Instruction for use: Indometacin 50 Berlin-Chemie

Active substance Indomethacin

ATX Code ÀÒÕ M01AB01 Indomethacin

Pharmacological group

NSAIDs - Acetic acid derivatives and related compounds

Nosological classification (ICD-10)

H60 Otitis externa

Infections of ENT organs, Infections of the external auditory canal, Infectious-inflammatory diseases of the ear, Acute catarrhal inflammation of the external auditory canal, Infections of the external ear

H66 Suppurative and unspecified otitis media

Bacterial ear infections, Inflammation of the middle ear, Infections of the upper respiratory tract, Infectious-inflammatory diseases of ENT organs, Infectious-inflammatory diseases of upper respiratory tract, Infectious-inflammatory diseases of the ear, Infectious diseases of ENT organs with marked pain syndrome, ear Infection, Otitis media infection, Persistent inflammation of the middle ear in children, Ear pain of otitis

H70 Mastoiditis and related conditions

Mastoiditis

J01 Acute sinusitis

Inflammation of the sinuses, Inflammatory diseases of the paranasal sinuses, Purulent inflammation of the paranasal sinuses, Infectious-inflammatory diseases of ENT organs, Infection of the sinuses, Combined sinusitis, Exacerbation of sinusitis, Acute inflammation of the paranasal sinuses, Acute bacterial sinusitis, Acute sinusitis in adults, Subacute sinusitis, acute Sinusitis, sinusitis

J02.9 Acute pharyngitis, unspecified

purulent pharyngitis, Acute nasopharyngitis,Limfonodulyarny pharyngitis

J03.9 Acute tonsillitis, unspecified (angina agranulocytic)

Sore throat infections, Acute tonsillitis, Angina, Follicular tonsillitis, Angina alimentary-hemorrhagic, Secondary sore throat, Sore throat primary, Angina follicular, Angina, Inflammatory diseases of the tonsils, Catarrhal angina, Lacunar angina, Acute Sore Throat, Tonsillitis, Tonsillitis acute, Tonsillar angina, Follicular sore throat, Bacterial tonsillitis

J04 Acute laryngitis and tracheitis

Cough in diseases of the upper respiratory tract, Laryngitis, acute Laryngitis, tracheitis sharp, pharyngolaryngitis, Infectious-inflammatory diseases of ENT organs

K08.8.0 * Painful toothache

Dentinal pain, Dentinal pains, Pain pulpitis, Anesthesia in dentistry, Pain syndromes in dental practice, Pain after removal of tartar, Pain when extracting a tooth, Toothache, Pain after dental interventions

M06.9 Other specified rheumatoid arthritis

Rheumatoid arthritis,Pain syndrome in rheumatic diseases, Pain in rheumatoid arthritis, Inflammation in rheumatoid arthritis, Degenerative forms of rheumatoid arthritis, Children's rheumatoid arthritis, Exacerbation of rheumatoid arthritis, Acute articular rheumatism, Rheumatic arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatic polyarthritis, Rheumatoid arthritis, Rheumatoid arthritis of active course, Rheumatoid arthritis, Rheumatoid polyarthritis, Acute rheumatoid arthritis, Acute rheumatism

M08 Juvenile [juvenile] Arthritis

Juvenile arthritis, Juvenile chronic polyarthritis, Juvenile chronic arthritis, Juvenile rheumatoid arthritis, Arthritis juvenile chronic

M10 Gout

Exacerbation of gout, Acute articular attack with gout, Acute gouty attack, Gouty attack, Recurrent gout attacks, Chronic gout

M13.8 Other specified arthritis

Arthritis of temporomandibular joint

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

M77.9 Other unspecified

Capsule, Periarthritis, Tendonitis, Tendopathy, Periarthropathy

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

N30 Cystitis

urethrocystitis, recurrent cystitis, fibrous cystitis, cystopyelitis, Exacerbation of chronic cystitis, Acute bacterial cystitis

N41 Inflammatory diseases of the prostate

Prostatitis, Disease of the prostate, Infection of the genitals, Chronic non-specific prostatitis

N70 Salpingitis and oophoritis

Adnexitis, Inflammatory diseases of female genitalia, Inflammatory diseases of female genital organs, Infection of the genitals, Oophoritis, Acute adnexitis, Salpingitis, Salpingo-oophoritis, Chronic inflammatory diseases of the ovaries, Inflammation of the ovaries

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R51 Headache

Pain in the head, Cephalgia, Pain with sinusitis, Pain in the back of the head, Painful headache, Headache of vasomotor genesis, Headache of vasomotor origin, Headache with vasomotor disorders, Headache, Neurological headache, Serial headache

Composition and form of release

Indomethacin 50 Berlin-Chemie

Suppositories for rectal administration 1 supp.

indomethacin 50 mg

auxiliary substances: solid fat, corn starch

in the planar cell pack 5 pcs .; in a pack of cardboard 2, 6 or 10 packages.

Indomethacin 100 Berlin-Chemie

Suppositories for rectal administration 1 supp.

indomethacin 100 mg

auxiliary substances: solid fat, corn starch

in the planar cell pack 5 pcs .; in a pack of cardboard 2, 6 or 10 packages.

Description of dosage form

Suppositories are white with a yellowish tinge, torpedo-shaped.

Characteristic

NSAIDs (non-steroidal anti-inflammatory drugs).

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, antiaggregational, analgesic.

Suppresses the activity of proinflammatory factors, reduces platelet aggregation. By depressing cyclooxygenase 1 and 2, it breaks the metabolism of arachidonic acid, reduces the amount of PG in both the inflammation focus and in healthy tissues, suppresses the exudative and proliferative phases of inflammation.

Pharmacodynamics

It causes weakening or disappearance of the pain syndrome of rheumatic and non-rheumatic nature (including pain in joints at rest and during movement, reduces morning stiffness and swelling of joints, promotes an increase in the volume of movements, inflammatory processes that occur after operations and trauma, quickly facilitates both spontaneous pain and pain during movement, reduces inflammatory edema at the wound site).

Pharmacokinetics

Absorption is fast. Bioavailability in the rectal route of administration is 80-90%. Binding to plasma proteins - 90%, T1 / 2 - 4-9 hours Metabolized mainly in the liver. 30% of the drug is excreted unchanged. 70% is excreted by the kidneys, 30% by the digestive tract. 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 affections of soft tissues; gouty arthritis.

As an auxiliary agent for infectious and inflammatory diseases of ENT, adnexitis, prostatitis, cystitis, algodismenore, neuritis, headache and toothache (as part of combination therapy).

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 disease, bronchial asthma, heart failure, edema, arterial hypertension, hemophilia, hypocoagulation, hepatic insufficiency, chronic renal failure, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; blood diseases; proctitis, hemorrhoids; pregnancy, the period of breastfeeding, children and adolescence to 18 years.

With caution - hyperbilirubinemia, thrombocytopenia, epilepsy, parkinsonism, depression, children and the elderly.

pregnancy and lactation

Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.

Side effects

On the part of the digestive system: NSAIDs-gastropathy, abdominal pain, nausea, vomiting, heartburn, anorexia, diarrhea, impaired liver function (increased blood bilirubin, hepatic transaminases). With prolonged use in large doses - ulceration of the mucosa of the gastrointestinal tract.

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

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

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

On the part of the urinary system: a violation of kidney function, proteinuria, hematuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

On the part of the system of hemostasis: bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), 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, aplastic anemia, autoimmune hemolytic anemia.

Other: aseptic meningitis (more often 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, 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.

Increases the concentration of lithium, methotrexate and digoxin in the blood. Cyclosporine, gold preparations increase the nephrotoxicity of indomethacin. 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.

Dosing and Administration

Rectally. Before using the suppository it is recommended to empty the intestine.

Indomethacin 50 Berlin-Chemie

For adults it is 1 soup. (50 mg) 1-3 times a day, during an attack of gout - 200 mg / day.

Indomethacin 100 Berlin-Chemie

For adults it is 1 soup. (100 mg) once a day, during an attack of gout - 200 mg / day (2 soups).

Overdose

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

Treatment: symptomatic therapy. Hemodialysis is ineffective.

Precautionary measures

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.

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

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.