Indomethacin candles prescription in Latin. Formulary of medicines indomethacin (indomethacin)

Description of the dosage form Indomethacin injection solution

Pharmacological action Indomethacin injection solution

NSAIDs, a derivative of indoleacetic acid; It has anti-inflammatory, analgesic and antipyretic effects associated with indiscriminate suppression of COX1 and COX2, which regulate the synthesis of Pg. It has an antiplatelet effect.

Pharmacokinetics of Indomethacin Injection Solution

Absorption is fast. Bioavailability when administered orally to conventional tablets, dragees or capsules is 90-98%, when using prolonged-release tablets for 12 hours, 90% of the administered dose is absorbed, with rectal use - 80-90%. After oral administration, TCmax - 2 hours, Cmax - 0.69 μg / ml.

Communication with plasma proteins - 90%. Metabolized mainly in the liver.

T1 / 2 - 4-9 hours (the indicator may vary depending on the severity of systemic metabolism, enterohepatic circulation and reabsorption). It is excreted by the kidneys by 70%, with 30% unchanged, and the gastrointestinal tract - 30%. Penetrates into breast milk, when used by the mother 200 mg of the drug per day in milk is determined from 0.5 to 2 mg. The drug is not removed by dialysis.

Precautions for injection Indomethacin

IHD, cerebrovascular disease, CHF, dyslipidemia, hyperlipidemia, diabetes mellitus, thrombocytopenia, diabetes mellitus, peripheral arterial disease, arterial hypertension, smoking, CC less than 60 ml/min, liver cirrhosis with portal hypertension, hyperbilirubinemia, history of gastrointestinal ulcer, presence Helicobacter pylori infections, long-term use of NSAIDs, frequent alcohol use, severe physical illness; concomitant therapy with the following drugs: anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), oral corticosteroids (including prednisolone), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline); mental disorders, epilepsy, parkinsonism, depression, old age.

Dosing regimen Indomethacin injection solution

Inside, in / m, rectally.

Inside, during or after a meal, drinking milk, adults - in the initial dose of 25 mg 2-3 times a day. With insufficient severity of the effect, the dose is increased to 50 mg 3 times a day. Retard tablets (75 mg) - 1-2 times a day. The maximum daily dose is 200 mg. When the effect is achieved, treatment is continued for 4 weeks at the same or reduced dose. With prolonged use, the maximum daily dose is 75 mg.

For the treatment of acute conditions or relief of an exacerbation of a chronic process - intramuscularly, 60 mg 1-2 times a day. The duration of the course of intramuscular injections is 7-14 days, subsequently they switch to oral or rectal administration of suppositories (for the treatment of acute conditions or the relief of an exacerbation of a chronic process - 1 suppository (0.05-0.1 g) 2 times a day (in some cases as an addition to the oral administration of the drug), while the maximum daily dose should not exceed 0.2 g; for maintenance treatment - 0.05-0.1 g once a night.

Rectally: after bowel emptying, if possible deep into the rectum, 50 mg 1-3 times a day or 100 mg at bedtime, during a gout attack 200 mg per day (as an addition to oral administration). The maximum daily dose is 200 mg.

Children over 14 years of age, 1.5-2.5 mg / kg / day.

Contraindications Indomethacin injection solution

Hypersensitivity; bronchial asthma, urticaria or acute rhinitis provoked by taking ASA or other NSAIDs; peptic ulcer of the stomach and duodenum, inflammatory bowel disease (ulcerative colitis, Crohn's disease), bleeding (including intracranial, from the digestive tract), congenital heart defects (severe coarctation of the aorta, pulmonary atresia, severe tetralogy of Fallot ), the period after coronary artery bypass grafting; blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), liver failure, active liver disease; CRF (CC less than 30 ml / min), progressive kidney disease, hematopoietic disorders (leukopenia and anemia); confirmed hyperkalemia; pregnancy, lactation;

For rectal use - rectal bleeding, proctitis, hemorrhoids, children's age (up to 14 years).

Indications for use Indomethacin injection solution

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis, arthritis in Paget's and Reiter's disease, neuralgic amyotrophy (Parsonage-Turner's disease), ankylosing spondylitis (Bechterew's disease), gouty arthritis forms), rheumatism.

Pain syndrome: headache (including menstrual syndrome) and toothache, lumbago, sciatica, neuralgia, myalgia, after injuries and surgical interventions, accompanied by inflammation, bursitis and tendinitis (most effective when localized in the shoulder and forearm).

Algodysmenorrhea; Bartter's syndrome (secondary hyperaldosteronism); pericarditis (symptomatic treatment); childbirth (as an analgesic and tocolytic agent); inflammatory processes in the pelvis, incl. Adnexitis.

Non-closure of the ductus arteriosus.

Infectious and inflammatory diseases of ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media.

Feverish syndrome (including with lymphogranulomatosis, other lymphomas and hepatic metastases of solid tumors) - in case of ineffectiveness of ASA and paracetamol. The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Side effects of Indomethacin injection solution

From the digestive system: NSAID-gastropathy, abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, abnormal liver function (increased activity of "liver" transaminases, hyperbilirubinemia).

With prolonged use in large doses - ulceration of the gastrointestinal mucosa.

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

From the senses: taste disturbance, hearing loss, tinnitus, diplopia, blurred vision, corneal clouding, conjunctivitis.

From the CCC: the development (aggravation) of CHF phenomena, tachyarrhythmia, edematous syndrome, increased blood pressure.

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

On the part of the hematopoietic organs and the hemostasis system: bleeding (gastrointestinal, gingival, uterine, hemorrhoidal), anemia (including hemolytic and aplastic), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura.

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

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

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

Others: aseptic meningitis (more often in patients with autoimmune diseases), increased sweating, aplastic anemia, autoimmune hemolytic anemia.

Overdose solution for injection Indomethacin

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

Treatment: rapid elimination of the drug from the body, symptomatic therapy. Hemodialysis is ineffective.

Indomethacin injection solution

During treatment, it is necessary to control 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.

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

To prevent and reduce dyspeptic symptoms, antacid drugs should be used.

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions. To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible course.

Interaction solution for injection Indomethacin

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

Joint use with paracetamol increases the risk of nephrotoxic effects.

Ethanol, colchicine, GCS and corticotropin increase the risk of bleeding in the gastrointestinal tract.

Enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs; enhances the effect of indirect anticoagulants, antiplatelet agents, thrombolytics (alteplase, streptokinase and urokinase) - there is a risk of bleeding.

Reduces the effect of diuretics, against the background of the use of potassium-sparing diuretics, the risk of hyperkalemia increases; reduces the effectiveness of uricosuric and antihypertensive drugs (including beta-blockers); enhances the side effects of the ISS, ASA, GCS, estrogen, other NSAIDs.

Cyclosporine and Au preparations increase nephrotoxicity (apparently by suppressing Pg synthesis in the kidneys).

Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia and the risk of bleeding.

Antacids and cholestyramine reduce the absorption of indomethacin.

Enhances the toxicity of zidovudine (due to inhibition of metabolism); in newborns, it increases the risk of developing the toxic effects of aminoglycosides (because it reduces renal clearance and increases blood concentration).

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

• external gel 10% tube 40g
• external gel 5% tube 40g
• dragee 25mg bl
• caps 2.5mg bl
• caps 25mg
• caps 25mg ban
• caps 25mg cont
• caps 25mg fl
• caps 25mg fl stack
• caps 50mg
• caps 50mg fl
• caps 50mg fl stack
• caps prolongir action 75mg
• ointment 10% tube 40g
• ointment for external use 10% tube 40g
• suppositories 100mg
• candles 100mg bl
• suppositories 100mg cont.
• candles 25mg bl
• suppositories 50mg
• candles 50mg bl
• suppositories 50mg cont.
• subpack p/ethyl 2-sl
• supp rect 100mg bl
• supp rect 50mg bl
• tb 2.5mg bl
• tb 25mg
• tb 25mg boom lamin
• tb p/o 2.5mg bl
• TB p/o intestinal 25mg bl
• film tb 25mg bl

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• Indomethacin 50 Berlin-Chemie
• Indomethacin Vramed
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• Metindol

Indications for use

Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, tendonitis, synovitis, acute gouty arthritis, reactive arthritis.

Dosage and administration

[caps 25mg], [tb 25mg] Inside, during or immediately after a meal, without chewing, drinking plenty of water. Adults: 25 mg 2-3 times a day, if necessary, the daily dose can be increased to 100 mg, divided into 4 doses, with an acute attack of gout - up to 50 mg 3 times a day. Children over 14 years old: 1.5-2.5 mg / kg / day, divided into 3-4 doses. [gel 10% 40g], [gel 5% 40g] Externally. The gel is rubbed with a thin layer into the skin of painful areas of the body: 5% - 3-4 times a day, 10% - 2-3 times a day. The amount of gel applied at a time is 4-5 cm for adults and 2-2.5 cm for children over 14 years old; per day - no more than 20 cm of 5% gel or 15 cm of 10% gel for adults and no more than 10 cm of 5% or 7.5 cm of 10% gel for children. [ointment 10% 40g] Outwardly. The ointment is rubbed with a thin layer into the skin of painful areas of the body 2-3 times a day. The total amount of ointment applied per day should not exceed 15 cm for adults and 7.5 cm for children over 14 years old. [100 mg suppositories], [50 mg suppositories] Rectally, 1 supp. (50 mg) 1-3 times a day or 1 supp. (100 mg) at night, during an attack of gout - 200 mg / day.

Contraindications

Hypersensitivity, rhinitis, conjunctivitis or bronchospasm while taking NSAIDs, erosive and ulcerative lesions of the gastrointestinal tract, bleeding (especially intracranial or from the gastrointestinal tract), thrombocytopenia, hypocoagulation, suspected necrotizing enterocolitis, severe renal failure, congenital heart defects (Tetralogy of Fallot, pulmonary atresia ), proctitis (suppositories), pregnancy (teratogenicity may occur).

Side effects

Nausea, vomiting, epigastric pain, erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, rectal bleeding, toxic hepatitis, constipation, arterial hypertension, cardiac arrhythmias, bone marrow hypoplasia, aplastic anemia, autoimmune hemolytic anemia, agranulocytosis, thrombocytopenia, impaired platelet function, fluid retention, hyperglycemia, glucosuria, hyperkalemia, pruritus, urticaria, exfoliative dermatitis, hair loss, erythema nodosum, Stevens-Johnson syndrome, anaphylactic shock, bronchospasm, vasculitis, pulmonary edema.

Overdose

Symptoms: Nausea, vomiting, severe headache, dizziness, memory impairment, disorientation. In more severe cases, paresthesia, numbness of the extremities and convulsions are observed. Treatment: Symptomatic. Indomethacin cannot be removed from the body by hemodialysis.

Pharmacological group

Anti-inflammatory drugs - derivatives of indoleacetic acid

pharmachologic effect

Anti-inflammatory, antipyretic, analgesic. By inhibiting cyclooxygenase, it reduces the synthesis of prostaglandins, which cause the development of pain in the focus of inflammation, an increase in temperature and an increase in tissue permeability. Intensively binds to plasma proteins. The half-life is 4-9 hours. Biotransformed mainly in the liver. It is excreted mainly by the kidneys and gastrointestinal tract.

Compound

Active ingredient: Indomethacin.

Interaction

Reduces the diuretic effect of potassium-sparing, thiazide and loop diuretics, hypotension caused by beta-blockers. Increases (mutually) the risk of side effects (primarily gastrointestinal lesions) other NSAIDs. Enhances the toxicity of methotrexate (reduces its tubular secretion). Causes an increase in the levels of lithium, digoxin in plasma.

special instructions

Particularly careful medical supervision is required for: - diseases of the gastrointestinal tract - chronic heart failure - arterial hypertension - impaired blood clotting - impaired liver function - senile age - immediately after surgery - mental disorders, depression, parkinsonism, epilepsy - bronchial asthma - allergic rhinitis, polyps nasal mucosa - chronic respiratory diseases and chronic respiratory tract infections. Indomethacin should be prescribed with caution to people involved in potentially hazardous activities that require increased concentration and quick mental and motor reactions. When used together with cyclosporine, it is necessary to monitor kidney function.

Storage conditions

[dr 25mg], [suppositories 100mg], [caps 50mg], [caps 75mg], [subst], [suppositories 25mg] List B. In a place protected from light, at room temperature. [gel 10% 40g], [gel 5% 40g], [caps 25mg], [ointment 10% 40g], [tb 25mg] List B. In a dry, dark place, at room temperature. [50mg suppositories] At room temperature.

Indomethacin Enteric-coated tablets 25 mg - blister pack 30, cardboard pack 1 - No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia)

Latin name

Indometacin

Active substance

Indomethacin*(Indomethacin*)

ATX

M01AB01 Indomethacin

Pharmacological group

NSAIDs - Derivatives of acetic acid and related compoundsDescription of the active substance. The scientific information provided is general and cannot be used to make a decision on the possibility of using a particular medicinal product.

Indications of the drug

For systemic use (orally, intramuscularly, rectally)

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis, arthritis in Paget's and Reiter's disease, neuralgic amyotrophy (Parsonage-Turner's disease), ankylosing spondylitis (Bekhterev's disease), gouty arthritis, rheumatism. Pain syndrome: headache (including menstrual syndrome) and toothache, lumbago, sciatica, neuralgia, myalgia, after injuries and surgical interventions accompanied by inflammation, bursitis and tendonitis (most effective when localized in the shoulder and forearm). Algodysmenorrhea, to maintain pregnancy, Bartter's syndrome (secondary hyperaldosteronism), pericarditis (symptomatic treatment), childbirth (as an analgesic and tocolytic agent for premature birth), inflammatory processes in the small pelvis, incl. adnexitis, non-closure of the ductus arteriosus. Infectious and inflammatory diseases of the ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media. Feverish syndrome (including with lymphogranulomatosis, other lymphomas and liver metastases with% 26oacute-lid tumors) - in case of ineffectiveness of acetylsalicylic acid and paracetamol.

For topical use (when applied to the skin)

Traumatically caused inflammation of the tendons, ligaments, muscles and joints (as a result of sprains, dislocations, after exercise and bruises). Localized forms of soft tissue inflammation, incl. tendovaginitis, tendonitis, shoulder-arm syndrome, bursitis, myalgia-sciatica (sciatica, lumbago). Inflammatory and degenerative diseases of the musculoskeletal system (deforming osteoarthritis, rheumatoid arthritis, psoriatic arthritis, rheumatoid arthritis, humeroscapular periarthritis, ankylosing spondylitis, osteochondrosis with radicular syndrome), with the exception of degenerative diseases of the hip joints.

In ophthalmology (eye drops): inhibition of miosis during cataract surgery - inflammatory process caused by surgery - prevention and treatment of cystoid macular edema after cataract surgery - treatment and prevention of inflammatory processes of the eyeball - non-infectious conjunctivitis.

In dentistry (systemic and cutaneous application): arthritis and arthrosis of the temporomandibular joint, inflammatory diseases of oral tissues, myalgia, neuralgia, postoperative period.

Contraindications

Hypersensitivity.

For systemic use: "aspirin" triad (combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, as well as intolerance to acetylsalicylic acid and pyrazolone drugs), peptic ulcer of the stomach and duodenum, ulcerative colitis, bleeding (including intracranial or from the gastrointestinal tract), congenital heart defects, in which an open ductus arteriosus is necessary to maintain pulmonary or systemic circulation, incl. severe coarctation of the aorta, pulmonary atresia, tetralogy of Fallot - color vision disorder, optic nerve disease, bronchial asthma, cirrhosis of the liver with portal hypertension, chronic heart failure, edema, arterial hypertension, blood clotting disorders (including hemophilia, lengthening of time bleeding, bleeding tendency), liver failure, chronic renal failure, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; hematopoietic disorders (leukopenia and anemia), pregnancy, lactation, children's age (up to 14 years) rectal application (optional): rectal bleeding, proctitis, hemorrhoids; for cutaneous application: pregnancy (III trimester - for application to large surfaces), violation of the integrity of the skin, children under 1 year of age.

Use during pregnancy and lactation

teratogenic effects. Teratogenicity studies conducted in rats and mice at doses of 0.5-1.0-2.0 and 4.0 mg/kg/day showed that at a dose of 4 mg/kg/day there was no increase in the incidence of malformations according to compared with the control group, with the exception of delayed ossification in the fetuses (considered as secondary to a decrease in the average weight of the fetuses). In other studies in mice using higher doses (5-15 mg/kg/day), toxicity and lethality to females, increased resorption, and fetal malformations have been found. A comparative study in rodents using high doses of acetylsalicylic acid showed similar effects for females and their fetuses. However, animal reproduction studies do not always predict effects in humans. There are no adequate and well-controlled studies in pregnant women.

non-teratogenic effects. Since the adverse effect of NSAIDs on the fetal cardiovascular system (premature closure of the ductus arteriosus) is known, use during pregnancy (especially in the later stages) should be avoided.

The effects of indomethacin and other drugs of this class on the human fetus in the third trimester of pregnancy include: intrauterine closure of the arterial duct, tricuspid valve insufficiency and pulmonary hypertension; non-closure of the arterial duct in the postnatal period, resistant to drug correction; degenerative changes in the myocardium; bleeding, intracranial bleeding, renal dysfunction or insufficiency, kidney damage/malformation that can lead to renal failure, oligohydramnios, gastrointestinal bleeding or perforation, increased risk of necrotizing enterocolitis.

In studies in rats and mice treated with indomethacin at doses of 4 mg/kg/day in the last 3 days of pregnancy, there was a decrease in body weight in females and a small number of deaths of females and fetuses. An increase in the frequency of neuronal necrosis in the diencephalon in live-born fetuses has been noted. At a dose of 2.0 mg / kg / day, there was no increase in the frequency of neuronal necrosis compared with the control group. The introduction of 0.5 or 4.0 mg/kg/day in the first 3 days of life did not cause an increase in the frequency of neuronal necrosis.

Childbirth and childbirth. Studies in rats have shown that NSAIDs, as well as other drugs that inhibit PG synthesis, increase the number of cases of obstructed labor, delay the onset of labor and delivery, and reduce the number of surviving pups.

Indomethacin passes into breast milk, so breastfeeding should be discontinued during treatment or indomethacin should be avoided during breastfeeding.

Side effects

Systemic side effects

From the nervous system and sensory organs: headache, dizziness, vertigo, agitation, irritability, excessive fatigue, drowsiness, depression, peripheral neuropathy, taste disturbance, hearing loss, tinnitus, diplopia, blurred vision, corneal clouding, conjunctivitis.

On the part of the cardiovascular system and blood (hematopoiesis, hemostasis): development (aggravation) of chronic heart failure, tachyarrhythmia, edematous syndrome, increased blood pressure, bleeding (from the gastrointestinal tract, gingival, uterine, hemorrhoidal), anemia (including autoimmune hemolytic and aplastic), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura.

On the part of the digestive tract: NSAID-gastropathy, nausea, vomiting, abdominal pain, heartburn, loss of appetite, diarrhea, impaired liver function (increased activity of hepatic transaminases, hyperbilirubinemia) - with prolonged use in high doses - erosive and ulcerative lesions of the gastrointestinal tract.

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

Allergic reactions: pruritus, rash, urticaria, exfoliative dermatitis, erythema nodosum, anaphylactic shock, bronchospasm, angioedema, toxic epidermal necrolysis (Lyell's syndrome).

Others: hyperglycemia, glucosuria, hyperkalemia, photosensitivity - aseptic meningitis (more often in patients with autoimmune diseases), increased sweating - local reactions with rectal use: burning, itching of the skin, heaviness in the anorectal region, exacerbation of hemorrhoids.

When applied to the skin: allergic reactions - itching and hyperemia of the skin, rash at the site of application, dry skin, burning; in isolated cases - exacerbation of psoriasis; with prolonged use - systemic manifestations.

When instilled into the eye: allergic reactions; with prolonged use - clouding of the cornea, conjunctivitis, systemic side effects.

Precautionary measures

Particularly careful medical supervision is required when a history of allergic reactions to drugs of the “aspirin” series, the “aspirin” triad, peptic ulcer of the stomach and duodenum, as well as in violation of blood coagulation, hyperbilirubinemia, thrombocytopenia, epilepsy, parkinsonism, depression, in childhood and advanced age.

Risk of cardiovascular complications. NSAIDs, incl. and indomethacin, may increase the risk of serious cardiovascular complications, incl. myocardial infarction and stroke, which can be fatal, especially with prolonged use. Patients with cardiovascular disease or risk factors for cardiovascular disease are at especially high risk.

risk of gastrointestinal complications. NSAIDs, incl. and indomethacin cause an increased risk of serious gastrointestinal side effects, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal, especially with prolonged use. These complications may occur at any time during use without warning symptoms. Elderly patients have a higher risk of serious gastrointestinal complications.

When indicated in the anamnesis of allergic reactions to NSAIDs, they are used only in urgent cases.

During treatment, it is necessary to control 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.

For eye drops: after removing contact lenses, instillation is carried out after 5 minutes. In the presence of an infection or the threat of its development, local antibacterial treatment is simultaneously prescribed.

Avoid contact with eyes, mucous membranes and open wounds of forms for dermal application.

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

special instructions

In an acute attack of gout, fast-acting dosage forms are preferred.

Storage conditions of the drug Indomethacin

In a place protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Indomethacin

3 years.

Other options for packaging the drug - Indomethacin.

Indomethacin Gel for external use 5% - aluminum tube 40 g, carton pack 1 - EAN code: 3800009130053 - No. P N012767/02, 2009-05-14 from Actavis Group hf. (Iceland) - manufacturer: Balkanpharma-Troyan (Bulgaria) Indomethacin Capsules 25 mg - bottle (vial) 30 - EAN code: 5709932004197 - No. P-8-242 N003365, 1993-09-28 from Nycomed DAK (Denmark) - Expired 2001-03-02Indomethacin Capsules 50mg - vial (bottle) 30- EAN code: 5709932004203- No. P-8-242 N003365, 1993-09-28 from Nycomed DAK (Denmark) - Expired 2001-03-02 Indomethacin Ointment for external applications 10% - aluminum tube 40 g, cardboard pack 1- EAN code: 3800009130077- No. P N012767/01, 2005-05-13 from Balkanpharma (Bulgaria) - manufacturer: Balkanpharma-Troyan (Bulgaria) - Expired 2010-06- 01Indomethacin Ointment for external use 10% - aluminum tube 30 g, cardboard pack 1- EAN code: 4600053020749 - No. LSR-004806 / 10, 2010-05-27 from Murom Instrument-Making Plant (Russia) Indomethacin Ointment for external use 10% - tube aluminum 15 g, cardboard pack 1- EAN code: 4600053021449- No. LSR-004806/10, 2010-05-27 from Murom Instrument-Making Plant (Russia) Indomethacin Ointment for external application 10% - aluminum tube 30 g, cardboard pack 1 - No. R N001072 / 01, 2010-09-29 from Biosintez (Russia) Indomethacin Ointment for external use 10% - polymer tube 30 g, cardboard pack 1 - No. P N001072 / 01, 2010-09-29 from Biosintez (Russia) Indomethacin Ointment for external use 10% - aluminum tube 40 g, carton pack for external use 10% - jar (jar) 10 g, cardboard pack 1- No. LP-002242, 2013-09-23 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Ointment for external use 10% - tube 40 g, cardboard pack 1- No. LP-002242, 2013-09-23 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Ointment for external use 10% - can (jar) 15 g, cardboard pack 1- No. LP-002242, 2013-09-23 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Ointment for external use 10% - jar (jar) 20 g, cardboard pack -002242, 2013-09-23 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) 23 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Ointment for external use 10% - jar (jar) 30 g, cardboard pack 1- No. LP-002242, 2013-09-23 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Ointment for external use 10% - jar (jar) 40 g, cardboard pack 1- No. LP-002242, 2013-09-23 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia )Indomethacin Substance-powder-bag (bag) polyethylene two-layer 25 kg, cardboard drum 1- No. LSR-004133/09, 2009-05-26 from Taicang Pharmaceutical Factory (China)Indomethacin Substance-powder-bag (pouch) polyethylene two-layer 10 kg - No. LSR-007749/09, 2009-10-02 from CSPC Ouyi Pharmaceutical Co. (China) Indomethacin Substance-powder-bag (pouch) polyethylene two-layer 15 kg-No. LSR-007749/09, 2009-10-02 from CSPC Ouyi Pharmaceutical Co. (China) Indomethacin Substance-powder- bag (pouch) polyethylene two-layer 20 kg - No. LSR-007749/09, 2009-10-02 from CSPC Ouyi Pharmaceutical Co. (China) Indomethacin Substance-powder-bag (pouch) polyethylene two-layer 25 kg-No. LSR-007749/09, 2009-10-02 from CSPC Ouyi Pharmaceutical Co. (China) Indomethacin Substance-powder-bag (pouch) polyethylene two-layer 30 kg-No. LSR-007749/09, 2009-10-02 from CSPC Ouyi Pharmaceutical Co. (China) Indomethacin Substance-powder-bag (pouch) polyethylene two-layer 40 kg-No. LSR-007749/09, 2009-10-02 from CSPC Ouyi Pharmaceutical Co. (China) Indomethacin Substance-powder-bag (pouch) polyethylene two-layer 50 kg-No. LSR-007749/09, 2009-10-02 from CSPC Ouyi Pharmaceutical Co. (China) Indomethacin Suppositories for rectal use 100 mg - strip 5, box (box) 2 - EAN code: 3850104085963- No. P-8-242 N007918, 1996-10-31 from BELUPO d.d. (Republic of Croatia) - Expired 2001-10-30 Indomethacin Suppositories for rectal use 50 mg - blister pack 3, cardboard pack 2 - EAN code: 4840456000171 - No. P N015202/01, 2008-12-24 from Pharmaprim (Republic of Moldova) Indomethacin Suppositories for rectal use 50 mg - blister pack 6, cardboard pack 1 - No. P N015202/01, 2008-12-24 from Farmaprim (Republic of Moldova) Indomethacin Suppositories for rectal use 50 mg - blister pack 5, cardboard pack 2 - No. R N001072/03, 2009-09-07 from Biosintez (Russia) Indomethacin Suppositories for rectal use 100 mg - blister pack 5, carton pack 2 - EAN code: 4602884012566 - No. R N001072/03, 2009-09-07 from Biosintez (Russia) Indomethacin Enteric-coated tablets 25 mg - blister pack 30, cardboard pack 1- No. P N012784 / 01, 2011-04-28 from Actavis LLC (Russia) - manufacturer: Balkanpharma-Dupnitza (Bulgaria) Indomethacin Ki-coated tablets soluble shell 25 mg - blister pack 30, carton pack 1 - EAN code: 3800712810719 - No. P N012784/01, 2003-10-04 from Balkanpharma (Bulgaria) - manufacturer: Balkanpharma-Dupnitza (Bulgaria) - Expired 2008-12 -11 Indomethacin Enteric coated tablets 25 mg - blister pack 10, cardboard pack 1 - No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric coated tablets 25 mg - blister pack 10, cardboard pack 2 - No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric coated tablets 25 mg - blister pack 10, pack cardboard 3- No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) 2013-07-05 from Atoll LLC (Russia) - manufacturer driver: Ozon LLC (Russia) Indomethacin Enteric-coated tablets 25 mg - blister pack 10, cardboard pack 5- No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric-coated tablets 25 mg - blister pack 10, cardboard pack 6- No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric-coated tablets 25 mg - blister pack 10, cardboard pack 8- No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric-coated tablets 25 mg - blister pack 10, cardboard pack 10 - No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) 07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric-coated tablets 25 mg - blister pack 30, cardboard pack 2- No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Tablets, enteric-coated 25 mg - blister pack 30, cardboard pack 3 - No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric-coated tablets 25 mg - contour packaging cell 30, cardboard pack 4- No. LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) LP-002131, 2013-07-05 from Atoll LLC (Russia) - manufacturer: Ozon LLC (Russia) Indomethacin Enteric coated tablets 25 mg - blister pack 30, box pack

Active ingredient (INN) Bismuth subnitrate (Bismuth subnitrate)
Application:on the I am a stomach ache and two on the

Application restrictions: Hypersensitivity, kidney on the I am insufficiency.

Side effects: Goals on the on the language

Interaction:on the

Dosage and administration: In dermatology - on the

• Bismuth subnitrate (-)

Bismuth ointment 10%
latin on the rank: Unguentum Bismuthi 10%
Pharmacological groups:
pharmachologic effect

Application: Inflammatory diseases of the skin and mucous membranes (dermatitis, ulcers, erosion, eczema); gastroduodenitis, ulcer on the I am a stomach ache and two on the duodenal ulcer, reflux esophagitis, enteritis, colitis.

Application restrictions: Hypersensitivity, kidney on the I am insufficiency.

Side effects: Goals on the i pain, swelling of the eyelids and gums, vesicles and pigmentation on the language, nausea, vomiting, methemoglobinemia.

Interaction: Compatible with anticholinergic, antispasmodic drugs often used for gastric ulcer and two on the duodenal ulcer. With the simultaneous administration of tetracyclines, the formation of non-absorbable complexes is possible.

Dosage and administration: In dermatology - on the externally, in the form of ointment and powder (5-10%). In case of gastrointestinal pathology - orally, 15-30 minutes before meals (with plenty of water), adults - 0.25-0.5 g 4-6 times a day, children - 0.1-0.5 g 3 -4 times a day.

• Bismuth ointment 10% (Unguentum Bismuthi 10%)

Bismuth subnitrate
latin on the rank: Bismuthi subnitras
Pharmacological groups:
pharmachologic effect

Active ingredient (INN) Bismuth subnitrate (Bismuth subnitrate)
Application: Inflammatory diseases of the skin and mucous membranes (dermatitis, ulcers, erosion, eczema); gastroduodenitis, ulcer on the I am a stomach ache and two on the duodenal ulcer, reflux esophagitis, enteritis, colitis.

Application restrictions: Hypersensitivity, kidney on the I am insufficiency.

Side effects: Goals on the i pain, swelling of the eyelids and gums, vesicles and pigmentation on the language, nausea, vomiting, methemoglobinemia.

Interaction: Compatible with anticholinergic, antispasmodic drugs often used for gastric ulcer and two on the duodenal ulcer. With the simultaneous administration of tetracyclines, the formation of non-absorbable complexes is possible.

Dosage and administration: In dermatology - on the externally, in the form of ointment and powder (5-10%). In case of gastrointestinal pathology - orally, 15-30 minutes before meals (with plenty of water), adults - 0.25-0.5 g 4-6 times a day, children - 0.1-0.5 g 3 -4 times a day.

• Bismuth subnitrate (Bismuthi subnitras)

Bismuth nitrate basic
latin on the rank: Bismuthi subnitras
Pharmacological groups: Antacids and adsorbents. Antiseptics and disinfectants
pharmachologic effect

Active ingredient (INN) Bismuth subnitrate (Bismuth subnitrate)
Application: Inflammatory diseases of the skin and mucous membranes (dermatitis, ulcers, erosion, eczema); gastroduodenitis, ulcer on the I am a stomach ache and two on the duodenal ulcer, reflux esophagitis, enteritis, colitis.

Application restrictions: Hypersensitivity, kidney on the I am insufficiency.

Side effects: Goals on the i pain, swelling of the eyelids and gums, vesicles and pigmentation on the language, nausea, vomiting, methemoglobinemia.

Interaction: Compatible with anticholinergic, antispasmodic drugs often used for gastric ulcer and two on the duodenal ulcer. With the simultaneous administration of tetracyclines, the formation of non-absorbable complexes is possible.

Dosage and administration: In dermatology - on the externally, in the form of ointment and powder (5-10%). In case of gastrointestinal pathology - orally, 15-30 minutes before meals (with plenty of water), adults - 0.25-0.5 g 4-6 times a day, children - 0.1-0.5 g 3 -4 times a day.

• Bismuth nitrate basic (Bismuthi subnitras)

Active ingredient (INN) Be on the zepril (Benazepril)
Application:on the I am insufficiency.

Contraindications:on the i'm beautiful on the i'm lupus, systems on theon theon the on the

Side effects: Hypotension, dry cough, on the years on the language, almonds on theon the

Interaction:

Dosage and administration: Inside, for adults on the chal on theon theon the I dose - 80 mg.

• Benazepril (Benazepril) (-)

Lotensin
latin on the rank: Lotensin
Pharmacological groups: ACE inhibitors
pharmachologic effect

Active ingredient (INN) Be on the zepril (Benazepril)
Application: Hypertension, symptomatic arterial hypertension, heart on the I am insufficiency.

Contraindications: Hypersensitivity, angioedema, systems on the i'm beautiful on the i'm lupus, systems on the i scleroderma, bone marrow hypoplasia, cerebrovascular on the I insufficiency, hyperkalemia, renal artery stenosis, the only on the I am a kidney, kidney transplant, on the dysfunction of the liver and kidneys.

Side effects: Hypotension, dry cough, on the years on the language, almonds on the x and pharynx, chest pain, symptoms of hyperkalemia (arrhythmias, tremor of the limbs and lips, increased on the I irritability, shortness of breath), exacerbation of pancreatitis, dyspepsia, neutropenia, agranulocytosis, allergic reactions (skin rashes, joint pain, angioedema).

Interaction: The effect is enhanced by alcohol, diuretics, antihypertensives, weakened by estrogens and sympathomimetics. Potassium-sparing diuretics, potassium-containing drugs increase the risk of developing hyperkalemia. Increases the toxicity of lithium salts.

Dosage and administration: Inside, for adults on the chal on the i dose - 5-10 mg once, then it is gradually increased until the desired effect is achieved, usually on the i maintenance dose - 20-40 mg, the highest daily on the I dose - 80 mg.

• Lotensin (Lotensin)

Fervex for sore throat
latin on the rank: Fervex sore throat
Pharmacological groups: Antiseptics and disinfectants
B35-B49 Mycoses. J00-J06 Acute respiratory infections of the upper respiratory tract. J03 Acute tonsillitis [angi on the]. K05.0 Acute gingivitis. K12 Stomatitis and related lesions. K13.7 Other and unspecified lesions of oral mucosa K14.0 Glossitis
Composition and form of release: 1 lozenge (sugar substitute - sorbitol) contains chlorhexide on the gluco on the that 2 mg; in a bottle on the x 20 pcs., 1 bottle in a box.

Pharmachologic effect:antiseptic.
Indications: Infections of the oral cavity and upper respiratory tract, mycosis, stomatitis, ulceration, glossitis, tonsillitis, gingivitis; prevention of infections of the oral cavity after the removal of the tonsils or tooth; diseases of the oral mucosa associated with erosion (auxiliary on the i therapy).

Contraindications: Hypersensitivity (rare).

Side effects: Taste disturbance and burning sensation in language(v on the beginning of treatment), diarrhea, staining of teeth and tongue in yellow-brown color (with prolonged use), allergic reactions (rarely).

Dosage and administration: Inside, after eating, 1 table. (keep in the mouth until completely resorbed) 3-4 times a day.

Precautionary measures: After taking the drug, it is recommended to refrain from eating and drinking for 1-2 hours. After the symptoms of the infection disappear, the intake should be continued.

• Fervex sore throat

Active ingredient (INN) Indomethacin(Indomethacin)
Application:

Contraindications: on the on the on the

Side effects:on the i hypertension, on theon the on theon the, a on the

Interaction: on theon the in plasma.

Dosage and administration: Inside, after eating. Adults on the h on the tea in on theon the I am a day on theon the on the

Special instructions:

• Indomethacin (Indomethacin) (-)

Indomethacin
latin on the rank: Indometacin
Pharmacological groups: Not on the rkotic a on the
Nosological classification (ICD-10):on theon theon theon the I am. R51 Heads on the i am pain. R52.1 Constant on theon theon the
pharmachologic effect

Active ingredient (INN) Indomethacin(Indomethacin)
Application: Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, tendonitis, synovitis, acute gouty arthritis, reactive arthritis.

Contraindications: Hypersensitivity, rhinitis, conjunctivitis, or bronchospasm on the against the background of taking NSAIDs, erosive and ulcerative lesions of the gastrointestinal tract, bleeding (especially intracranial or from the gastrointestinal tract), thrombocytopenia, hypocoagulation, suspicion on the necrotizing enterocolitis, severe renal on the i failure, congenital heart defects (tetralogy of Fallot, pulmonary atresia), proctitis (suppositories), pregnancy (teratogenicity may occur).

Side effects: Nausea, vomiting, epigastric pain, erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, rectal bleeding, toxic hepatitis, constipation, arterial on the i hypertension, on the heart rhythm disturbances, bone marrow hypoplasia, aplastic anemia, autoimmune on the I hemolytic anemia, agranulocytosis, thrombocytopenia, on the platelet dysfunction, fluid retention, hyperglycemia, glucosuria, hyperkalemia, pruritus, urticaria, exfoliative dermatitis, hair loss, erythema nodosum, Stevens-Jonso syndrome on the, a on the phylactic shock, bronchospasm, vasculitis, pulmonary edema.

Interaction: Reduces the diuretic effect of potassium-sparing, thiazide and loop diuretics, hypotension caused by beta-blockers. Increases (mutually) the risk of side effects (primarily gastrointestinal lesions) other NSAIDs. Enhances the toxicity of methotrexate (reduces its tubular secretion). calls on the melting levels of lithium, digoxy on the in plasma.

Dosage and administration: Inside, after eating. Adults on the h on the tea in on the initial dose of 25 mg 2-3 times a day, with insufficient severity of the effect - 50 mg 3 times a day, retard tablets (75 mg) - 1-2 times a day, maximum on the I am a day on the I dose - 200 mg, with prolonged use - should not on the exceed 75 mg. When the effect is achieved, treatment is continued for 4 weeks at the same or reduced dose. For the treatment of acute conditions or relief of an exacerbation of a chronic process, 60 mg is administered intramuscularly 1–2 times a day for 7–14 days, after which they are switched on the tablets or suppositories (0.05 or 0.1 g 2 times a day).

Special instructions: When used together with cyclosporine, it is necessary to monitor kidney function.

• Indomethacin (Indomethacin)

Apo- Indomethacin
latin on the rank: Apo-Indomethacin
Pharmacological groups: Not on the rkotic a on the relievers, including non-steroidal and other anti-inflammatory drugs
Nosological classification (ICD-10): G54.1 Lesions of the lumbosacral plexus. G60-G64 Polyneuropathies and other lesions of the peripheral nervous system. H60 Otitis externa H66 Purulent and unspecified otitis media H70 Mastoiditis and related conditions. I80 Phlebitis and thrombophlebitis. J01 Acute sinusitis. J02 Acute pharyngitis. J03 Acute tonsillitis [angi on the]. J04 Acute laryngitis and tracheitis. K08.8.0 Tooth pain on the I am. L40.5 Arthropathic psoriasis. M00-M25 Arthropathy. M05 Seropositive rheumatoid arthritis. M06.9 Rheumatoid arthritis, unspecified M08 Juvenile [juvenile] arthritis. M10 Gout. M13.8 Other specified arthritis M15-M19 Arthrosis. M16 Coxarthrosis [arthrosis of the hip joint]. M25.5 Pain in the joint. M30-M36 Systemic lesions of connective tissue. M42 Osteochondrosis of the spine. M45 Ankylosing spondylitis. M54.3 Sciatica M65 Synovitis and tendosynovitis. M71 Other bursopathies. M77.9 Enthesopathy, unspecified on the I am. M79.0 Rheumatism, unspecified M79.1 Myalgia M79.2 Neuralgia and neuritis, unspecified N30 Cystitis. N41 Inflammatory diseases of the prostate. N70 Salpingitis and oophoritis. N94.6 Dysmenorrhea, unspecified on the I am. R51 Heads on the i am pain. R52.1 Constant on the I am inexorable pain. R52.2 Other constant on the i am pain. R68.8 Other specified general symptoms and symptoms on the ki. T08-T14 Injury of unspecified part of trunk, limb or body region
pharmachologic effect

Active ingredient (INN) Indomethacin(Indomethacin)
Application: Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, tendonitis, synovitis, acute gouty arthritis, reactive arthritis.

Contraindications: Hypersensitivity, rhinitis, conjunctivitis, or bronchospasm on the against the background of taking NSAIDs, erosive and ulcerative lesions of the gastrointestinal tract, bleeding (especially intracranial or from the gastrointestinal tract), thrombocytopenia, hypocoagulation, suspicion on the necrotizing enterocolitis, severe renal on the i failure, congenital heart defects (tetralogy of Fallot, pulmonary atresia), proctitis (suppositories), pregnancy (teratogenicity may occur).

Side effects: Nausea, vomiting, epigastric pain, erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, rectal bleeding, toxic hepatitis, constipation, arterial on the i hypertension, on the heart rhythm disturbances, bone marrow hypoplasia, aplastic anemia, autoimmune on the I hemolytic anemia, agranulocytosis, thrombocytopenia, on the platelet dysfunction, fluid retention, hyperglycemia, glucosuria, hyperkalemia, pruritus, urticaria, exfoliative dermatitis, hair loss, erythema nodosum, Stevens-Jonso syndrome on the, a on the phylactic shock, bronchospasm, vasculitis, pulmonary edema.

Interaction: Reduces the diuretic effect of potassium-sparing, thiazide and loop diuretics, hypotension caused by beta-blockers. Increases (mutually) the risk of side effects (primarily gastrointestinal lesions) other NSAIDs. Enhances the toxicity of methotrexate (reduces its tubular secretion). calls on the melting levels of lithium, digoxy on the in plasma.

Dosage and administration: Inside, after eating. Adults on the h on the tea in on the initial dose of 25 mg 2-3 times a day, with insufficient severity of the effect - 50 mg 3 times a day, retard tablets (75 mg) - 1-2 times a day, maximum on the I am a day on the I dose - 200 mg, with prolonged use - should not on the exceed 75 mg. When the effect is achieved, treatment is continued for 4 weeks at the same or reduced dose. For the treatment of acute conditions or relief of an exacerbation of a chronic process, 60 mg is administered intramuscularly 1–2 times a day for 7–14 days, after which they are switched on the tablets or suppositories (0.05 or 0.1 g 2 times a day).

Special instructions: When used together with cyclosporine, it is necessary to monitor kidney function.

• Apo-Indomethacin (Apo-Indomethacin)

Gross formula

C 19 H 16 ClNO 4

Pharmacological group of the substance Indomethacin

Nosological classification (ICD-10)

CAS code

53-86-1

Characteristics of the substance Indomethacin

NSAIDs, a derivative of indoleacetic acid.

White or slightly yellowish powder, odorless or almost odorless. Practically insoluble in water. Sparingly soluble in ethanol, chloroform, ether. Soluble in alkali solutions.

Pharmacology

pharmachologic effect- anti-inflammatory, antipyretic, analgesic.

Inhibits cyclooxygenase (COX-1 and COX-2), reduces the synthesis of GHGs, which cause the development of pain in the focus of inflammation, an increase in temperature and an increase in tissue permeability. It has an antiplatelet effect.

Causes a weakening or disappearance of pain syndrome of a rheumatic and non-rheumatic nature (including pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints, increases the range of motion; in inflammatory processes that occur after operations and injuries, quickly relieves both spontaneous pain and pain on movement, reduces inflammatory edema at the wound site).

After ingestion of a single dose of 25 or 50 mg is rapidly absorbed, T max - about 2 hours; with rectal use, the absorption rate is higher. When administered orally, bioavailability is 90-98%, with rectal use it is slightly less - 80-90%, which is probably due to the suppository retention time insufficient to ensure complete absorption (less than 1 hour). Plasma protein binding - 90-98%. T1 / 2 - 4-9 hours. With a daily intake of 25 or 50 mg of indomethacin three times a day, the equilibrium concentration is on average 1.4 times higher than the concentration after a single dose. Biotransformirovatsya mainly in the liver. In the blood plasma, it is in the form of an unchanged substance and desmethyl-, desbenzoyl- and desmethyl-desbenzoyl metabolites present in an unconjugated form. It is excreted mainly by the kidneys - 70% (30% - unchanged) and the gastrointestinal tract - 30%. Passes through the BBB, placenta, penetrates into breast milk. Not removed by hemodialysis.

When instilled with eye drops, it penetrates into the anterior chamber of the eye. After a single instillation, it is determined in the moisture of the anterior chamber for several hours.

Carcinogenicity, mutagenicity, effect on fertility

In an 81-week chronic toxicity study in rats, oral doses up to 1 mg/kg/day showed no carcinogenic effect. In carcinogenicity studies in rats (study period 73–110 weeks) and mice (study period 62–88 weeks), at doses up to 1.5 mg/kg/day, indomethacin caused neoplastic or hyperplastic changes.

No mutagenicity of indomethacin was detected in a number of bacterial tests in vitro(Ames test, test with E.Coli with/without metabolic activation) and in a series of tests in vivo, including test for sex-linked recessive lethal Drosophila, micronucleus test in mice.

In reproduction studies, incl. in two generations, at dose levels up to 0.5 mg/kg/day, indomethacin had no effect on fertility in mice and rats.

The use of the substance Indomethacin

For systemic use (orally, intramuscularly, rectally)

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis, arthritis in Paget's and Reiter's disease, neuralgic amyotrophy (Parsonage-Turner's disease), ankylosing spondylitis (Bekhterev's disease), gouty arthritis, rheumatism. Pain syndrome: headache (including menstrual syndrome) and toothache, lumbago, sciatica, neuralgia, myalgia, after injuries and surgical interventions accompanied by inflammation, bursitis and tendonitis (most effective when localized in the shoulder and forearm). Algodysmenorrhea, to maintain pregnancy, Bartter's syndrome (secondary hyperaldosteronism), pericarditis (symptomatic treatment), childbirth (as an analgesic and tocolytic agent for premature birth), inflammatory processes in the small pelvis, incl. adnexitis, non-closure of the ductus arteriosus. Infectious and inflammatory diseases of the ENT organs with severe pain syndrome (as part of complex therapy): pharyngitis, tonsillitis, otitis media. Feverish syndrome (including with lymphogranulomatosis, other lymphomas and hepatic metastases of solid tumors) - in case of ineffectiveness of acetylsalicylic acid and paracetamol.

For topical use (when applied to the skin)

Traumatically caused inflammation of the tendons, ligaments, muscles and joints (as a result of sprains, dislocations, after exercise and bruises). Localized forms of soft tissue inflammation, incl. tendovaginitis, tendonitis, shoulder-arm syndrome, bursitis, myalgia; sciatica (sciatica, lumbago). Inflammatory and degenerative diseases of the musculoskeletal system (deforming osteoarthritis, rheumatoid arthritis, psoriatic arthritis, rheumatoid arthritis, humeroscapular periarthritis, ankylosing spondylitis, osteochondrosis with radicular syndrome), with the exception of degenerative diseases of the hip joints.

In ophthalmology (eye drops): inhibition of miosis during cataract surgery; inflammatory process caused by surgery; prevention and treatment of cystoid macular edema after cataract surgery; treatment and prevention of inflammatory processes of the eyeball; noninfectious conjunctivitis.

In dentistry(systemic and cutaneous application): arthritis and arthrosis of the temporomandibular joint, inflammatory diseases of oral tissues, myalgia, neuralgia, postoperative period.

Contraindications

Hypersensitivity.

For systemic use:"aspirin" triad (combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses, as well as intolerance to acetylsalicylic acid and drugs of the pyrazolone series), peptic ulcer of the stomach and duodenum, ulcerative colitis, bleeding (including intracranial or from the gastrointestinal tract), congenital heart defects, in which an open ductus arteriosus is necessary to maintain pulmonary or systemic circulation, incl. severe coarctation of the aorta, pulmonary atresia, tetralogy of Fallot; color vision disorders, optic nerve diseases, bronchial asthma, liver cirrhosis with portal hypertension, chronic heart failure, edema, arterial hypertension, blood clotting disorders (including hemophilia, prolongation of bleeding time, bleeding tendency), liver failure, chronic renal failure, hearing loss, pathology of the vestibular apparatus, deficiency of glucose-6-phosphate dehydrogenase; hematopoietic disorders (leukopenia and anemia), pregnancy, lactation, children's age (up to 14 years); for rectal use(optional): rectal bleeding, proctitis, hemorrhoids; for skin application: pregnancy (III trimester - for application to large surfaces), violation of the integrity of the skin, children under 1 year of age.

Application restrictions

For skin application: pregnancy (I and II trimesters), lactation, children under 6 years of age.

In ophthalmology (eye drops) Key words: epithelial herpetic keratitis (including history), pregnancy, lactation, childhood.

Use during pregnancy and lactation

teratogenic effects. Teratogenicity studies conducted in rats and mice using doses of 0.5; 1.0; 2.0 and 4.0 mg/kg/day showed that at the dose of 4 mg/kg/day there was no increase in the incidence of malformations compared with the control group, with the exception of delayed ossification in fetuses (considered as secondary to a decrease average fruit weight). In other studies in mice using higher doses (5-15 mg/kg/day), toxicity and lethality to females, increased resorption, and fetal malformations have been found. A comparative study in rodents using high doses of acetylsalicylic acid showed similar effects for females and their fetuses. However, animal reproduction studies do not always predict effects in humans. There are no adequate and well-controlled studies in pregnant women.

non-teratogenic effects. Since the adverse effect of NSAIDs on the fetal cardiovascular system (premature closure of the ductus arteriosus) is known, use during pregnancy (especially in the later stages) should be avoided.

The effects of indomethacin and other drugs of this class on the human fetus in the third trimester of pregnancy include: intrauterine closure of the arterial duct, tricuspid valve insufficiency and pulmonary hypertension; non-closure of the arterial duct in the postnatal period, resistant to drug correction; degenerative changes in the myocardium, platelet disorders leading to bleeding, intracranial bleeding, renal dysfunction or insufficiency, kidney damage / malformation that can lead to renal failure, oligohydramnios, gastrointestinal bleeding or perforation, increased risk of necrotizing enterocolitis.

In studies in rats and mice treated with indomethacin at doses of 4 mg/kg/day in the last 3 days of pregnancy, there was a decrease in body weight in females and a small number of deaths of females and fetuses. An increase in the frequency of neuronal necrosis in the diencephalon in live-born fetuses has been noted. At a dose of 2.0 mg / kg / day, there was no increase in the frequency of neuronal necrosis compared with the control group. The introduction of 0.5 or 4.0 mg/kg/day in the first 3 days of life did not cause an increase in the frequency of neuronal necrosis.

Childbirth and childbirth. Studies in rats have shown that NSAIDs, as well as other drugs that inhibit the synthesis of PG, increase the number of cases of obstructed labor, delay the onset of labor and delivery, and reduce the number of surviving pups.

Indomethacin passes into breast milk, so breastfeeding should be discontinued during treatment or indomethacin should be avoided during breastfeeding.

Side effects of the substance Indomethacin

Systemic side effects

From the nervous system and sensory organs: headache, dizziness, vertigo, agitation, irritability, excessive fatigue, drowsiness, depression, peripheral neuropathy, taste disturbance, hearing loss, tinnitus, diplopia, blurred vision, corneal clouding, conjunctivitis.

From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): development (aggravation) of chronic heart failure, tachyarrhythmia, edematous syndrome, increased blood pressure, bleeding (from the gastrointestinal tract, gingival, uterine, hemorrhoidal), anemia (including autoimmune hemolytic and aplastic), leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, thrombocytopenic purpura.

From the digestive tract: NSAID gastropathy, nausea, vomiting, abdominal pain, heartburn, loss of appetite, diarrhea, liver dysfunction (increased liver transaminase activity, hyperbilirubinemia); with prolonged use in high doses - erosive and ulcerative lesions of the gastrointestinal tract.

From the genitourinary system: renal dysfunction, proteinuria, hematuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.

Allergic reactions: pruritus, rash, urticaria, exfoliative dermatitis, erythema nodosum, anaphylactic shock, bronchospasm, angioedema, toxic epidermal necrolysis (Lyell's syndrome).

Others: hyperglycemia, glucosuria, hyperkalemia, photosensitivity; aseptic meningitis (more often in patients with autoimmune diseases), increased sweating; local reactions with rectal use: burning, itching of the skin, heaviness in the anorectal region, exacerbation of hemorrhoids.

When applied to the skin: allergic reactions; itching and hyperemia of the skin, rash at the site of application, dry skin, burning; in isolated cases - exacerbation of psoriasis; with prolonged use - systemic manifestations.

When instilled in the eye: allergic reactions; with prolonged use - clouding of the cornea, conjunctivitis, systemic side effects.

Interaction

Reduces the diuretic effect of potassium-sparing, thiazide and loop diuretics. Increases (mutually) the risk of side effects (primarily gastrointestinal lesions) of other NSAIDs. Increases the plasma concentration of digoxin, methotrexate and Li + preparations, which can lead to an increase in their toxicity. Sharing with paracetamol increases the risk of nephrotoxicity. Ethanol, colchicine, glucocorticoids and corticotropin increase the risk of bleeding in the gastrointestinal tract. Enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs; enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (alteplase, streptokinase and urokinase) and increases the risk of bleeding. Against the background of the use of potassium-sparing diuretics, the risk of hyperkalemia increases; reduces the effectiveness of uricosuric and antihypertensive drugs (including beta-blockers); enhances the side effects of mineral and glucocorticoids, estrogen. Cyclosporine and gold preparations increase nephrotoxicity (by suppressing PG synthesis in the kidneys). Cefamandol, cefoperazone, cefotetan, valproic acid - increase the incidence of hypoprothrombinemia and the risk of bleeding. Antacids and cholestyramine reduce the absorption of indomethacin. Increases the toxicity of zidovudine (due to inhibition of metabolism), in newborns increases the risk of developing toxic effects of aminoglycosides (because it reduces renal clearance and increases blood concentration). Myelotoxic drugs increase the manifestations of hematotoxicity.

Overdose

Symptoms: nausea, vomiting, severe headache, dizziness, memory impairment, disorientation; in severe cases - paresthesia, numbness of the limbs and convulsions.

Treatment: symptomatic therapy. Hemodialysis is ineffective.

Routes of administration

Inside, in / m, rectally, cutaneously, conjunctivally.

Indomethacin Precautions

Particularly careful medical supervision is required when a history of allergic reactions to drugs of the “aspirin” series, the “aspirin” triad, peptic ulcer of the stomach and duodenum, as well as in violation of blood coagulation, hyperbilirubinemia, thrombocytopenia, epilepsy, parkinsonism, depression, in childhood and advanced age.