Indomethacin ointment prescription in Latin. Indomethacin (Indomethacin) Medicines Handbook. Candles Indomethacin, instructions for use

Indomethacin

Latin name

chemical name

1-(4-Chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid

Gross formula

C 19 H 16 ClNO 4

Pharmacological group

CAS code

Characteristic

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

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Inhibits cyclooxygenase (COX-1 and COX-2), reduces the synthesis of PG, causing the development of pain in the focus of inflammation, fever and increased 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 is in the form of unchanged substance and desmethyl-, desbenzoyl- and desmethyl-desbenzoyl-metabolites present in 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.

Indomethacin was not mutagenic in a number of in vitro bacterial tests (Ames test, E. Coli test with/without metabolic activation) and in a series of in vivo tests, including a test for sex-linked recessive lethal Drosophyla, a 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.

Application

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 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 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 cutaneous use: pregnancy (III trimester - for application to large surfaces), violation of the integrity of the skin, children under 1 year of age.

Application restrictions

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

In ophthalmology (eye drops): 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, which 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 liver 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 application: 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.

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, estrogens. 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.

Dosage and administration

Inside, in / m, rectally, cutaneously, conjunctivally. The dosage regimen is set individually depending on the indications, the severity of the disease and other factors.

Inside: adults are prescribed at an 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, the maximum daily dose is 200 mg . With prolonged use, the maximum daily dose should not 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 to oral or rectal administration. Rectally: after bowel emptying, 50 mg 1-3 times a day or 100 mg at bedtime; the maximum daily dose is 200 mg. Children over 14 years old - 1.5-2.5 mg / kg / day.

Skin: rub a thin layer into the skin over painful areas of the body (apply only to intact areas) 3-4 times a day.

Conjunctival: to inhibit intraoperative miosis, 1 drop is instilled into the conjunctival sac for 2 hours with an interval of 30 minutes (4 times) before surgery. For other indications - 1 drop 3-4 times a day.

In dentistry: inside, adults - 25-50 mg 3-4 times a day; locally - 10% ointment is rubbed into the skin (apply only to intact areas) 3-4 times a day.

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.

Year of last adjustment

Interactions with other active substances

Abciximab	Against the background of indomethacin, the effect is enhanced and the risk of hemorrhagic complications increases.
Algeldrate + Magnesium hydroxide	The combination of algeldrate + magnesium hydroxide slows down the absorption of indomethacin (the interval between doses should be at least 2 hours).
Acebutolol	Against the background of indomethacin, the antihypertensive effect is weakened.
Hydralazine	Against the background of indomethacin, which reduces the synthesis of prostaglandins in the kidneys with a delay in the body of sodium and fluid, the effect decreases.

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; inflammation caused by surgery; prevention and treatment of cystoid macular edema after cataract surgery; treatment and prevention of inflammation 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 diseases, 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.

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.

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

Side effects

Systemic side effects

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 flushing 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

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

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

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, carton 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. P 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% - bank (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, cardboard 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

Instructions for use:

Indomethacin is a non-steroidal anti-inflammatory drug with analgesic, antipyretic action.

Release form and composition

Dosage forms:

Enteric-coated tablets: round, biconvex, the color of the tablet core is white or white with a yellowish tint, the shells are from white to almost white (10 or 30 pcs. in blister packs made of aluminum or polyvinyl chloride, in a carton box 1, 2 , 3, 4, 5, 6, 8 or 10 packs, 10, 20, 30, 40, 50, 60 or 100 pieces in polymer cans, in a carton pack 1 can);
Rectal suppositories: they are torpedo-shaped, white with a yellow or creamy tint and have a slight specific smell (in a blister pack: 50 mg - 3 or 5 pcs., in a carton pack 2 packs; 6 pcs., in a carton pack 1 pack; 100 mg - 5 pieces, in a cardboard box 2 packs);
Ointment for external use 10%: from dark yellow to light yellow with a greenish tinge of color and a specific odor (15, 30 or 40 g in aluminum tubes, or 30 g in a polymer tube, in a cardboard box 1 tube; , 15, 20, 25, 30 or 40 g in glass jars, in a carton box 1 jar);
Gel for external use 5% or 10%: has a uniform yellow structure and a slight smell of alcohol (40 g each in aluminum tubes, 1 tube in a carton pack).

The active substance is indomethacin:

1 tablet - 25 mg;
1 suppository - 50 or 100 mg;
1 g of ointment - 100 mg;
1 g of gel - 50 or 100 mg.

Auxiliary components:

Tablets: potato starch, lactose monohydrate, microcrystalline cellulose, magnesium stearate, povidone;
Ointment: macrogol 1500, dimethyl sulfoxide, glycerol, macrogol 400;
Gel: carbomer, macrogol 400, propylene glycol, ethanol 96%, sodium benzoate.

Additionally, the tablets contain a film shell: polysorbate-80, cellacephate, titanium dioxide.

Indications for use

Systemic use: articular syndrome (including osteoarthritis, rheumatoid arthritis, gout, ankylosing spondylitis), pain in the spine, myalgia, neuralgia, inflammatory processes in soft tissues and joints as a result of injury, rheumatism, diffuse connective tissue diseases, dysmenorrhea; as part of complex therapy for prostatitis, adnexitis, cystitis, infectious and inflammatory diseases in otorhinolaryngology;
External use: articular syndrome with exacerbation of gout and rheumatism, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, pain in the spine, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, neuralgia, myalgia, inflammatory lesions of tendons and ligaments, sciatica, bursitis, lumbago; post-traumatic inflammation of soft tissues and joints; muscle pain of rheumatic and non-rheumatic origin;
Local application: inhibition of miosis during surgery, prevention of inflammatory processes after surgical operations on the anterior segment of the eye and for cataracts.

Contraindications

The use of all forms of Indomethacin is contraindicated:

Exacerbation of erosive and ulcerative lesions of the gastrointestinal tract (GIT);
Hypocoagulation and other disorders of hematopoiesis;
The period of pregnancy and breastfeeding;
Age up to 14 years;
Hypersensitivity to the components of the drug.

Tablets, suppositories and ointment are prohibited from prescribing to patients with the following diseases:

Aspirin triad;
Severe violations of the liver and / or kidneys;
Severe form of chronic heart failure;
Severe form of arterial hypertension;
Pancreatitis.

In addition, rectal application is contraindicated in patients with proctitis, with recent bleeding from the rectum, external - in violation of the integrity of the skin.

Indomethacin in the form of tablets, suppositories, ointments for patients with diseases of the gastrointestinal tract, kidneys, liver in history, epilepsy, heart failure, arterial hypertension, parkinsonism, immediately after major surgery, elderly patients;

Gel simultaneously with other non-steroidal anti-inflammatory drugs (NSAIDs), with bronchial asthma, allergic rhinitis, polyps on the nasal mucosa.

Method of application and dosage

The dosage form, dose and period of treatment is prescribed by the attending physician based on clinical indications and the patient's condition.

Tablets are taken orally, after meals. The initial dose for adults is 25 mg 2-3 times a day for 4 weeks. To achieve a therapeutic effect, an increase in dosage to 50 mg 3 times a day is allowed. The maximum daily dose is 200 mg, with long-term treatment no more than 75 mg.

Suppositories are used rectally at 50-100 mg 2 times a day, with maintenance therapy 1 time per day (at night). The maximum daily dose is 200 mg.

The ointment is applied externally 2 times a day.

The gel is applied in a thin layer on painful areas of the body, and rubbed into the skin with light movements. A single dose for adults corresponds to a strip of gel 4-5 cm long, for adolescents - 2-2.5 cm. The frequency of procedures for 5% gel is 3-4 times, for 10% - 2-3 times a day. Do not exceed the recommended dose of the drug.

Side effects

The use of tablets, suppositories, ointments can cause side effects:

From the digestive system: discomfort and pain in the abdomen, nausea, vomiting, constipation or diarrhea, anorexia, bleeding, erosive and ulcerative lesions and perforation of the gastrointestinal tract; rarely - stomatitis, intestinal strictures, flatulence, gastritis, jaundice, bleeding from the diverticulum or sigmoid colon, hepatitis;
From the side of the cardiovascular system: increased blood pressure (BP), edema, tachycardia, arrhythmia, chest pain, arterial hypotension, palpitation, hematuria, congestive heart failure;
From the nervous system: depression, dizziness, fatigue, headache; rarely - drowsiness, anxiety, convulsions, fainting, peripheral neuropathy, muscle weakness, involuntary muscle movements, sleep disturbances, paresthesia, mental disorders (psychotic episodes, depersonalization), parkinsonism, dysarthria;
From the hemopoietic system: rarely - petechiae or ecchymosis, leukopenia, purpura, thrombocytopenia, hemolytic and aplastic anemia, DIC;
Allergic reactions: rarely - urticaria, skin rash and itching, angiitis, erythema nodosum, Stevens-Johnson syndrome, exfoliative dermatitis, hair loss, erythema multiforme, acute respiratory distress, toxic epidermal necrolysis, a sharp decrease in blood pressure, bronchial asthma, anaphylactic reactions, dyspnea , angioedema, pulmonary edema;
From the sensory organs: rarely - diplopia, orbital and periorbital eye pain, impaired visual perception, hearing impairment, tinnitus, deafness;
From the urinary system: rarely - nephrotic syndrome, proteinuria, impaired renal function, interstitial nephritis, renal failure;
From the side of metabolism: rarely - glucosuria, hyperglycemia, hyperkalemia;
Others: rarely - hot flashes, vaginal bleeding, tension and enlargement of the mammary glands, increased sweating, epistaxis, gynecomastia;
Local reactions: with rectal use, tenesmus, irritation of the rectal mucosa, exacerbation of chronic colitis are possible; with external - redness, itching, rash at the site of application.

With prolonged use of the gel, local side effects may occur in the form of burning, redness, itching and rash, skin flushing, and the development of allergic reactions.

If signs of undesirable effects appear, you should consult your doctor.

special instructions

The drug should be used with caution if the patient has dyspeptic symptoms.

Only in emergency cases, Indomethacin is used if there is a history of data on allergic reactions to NSAIDs.

The use of the drug must be accompanied by systematic monitoring of the peripheral blood picture, liver and kidney function.

Ointment and gel are applied only to areas with intact integrity of the skin, they should not be allowed to enter the mucous membranes, including the eyes.

drug interaction

The drug reduces the effect of uricosuric, antihypertensive and diuretics (saluretics); increases the effect of antiplatelet agents, indirect anticoagulants, fibrinolytics; increases the development of side effects of estrogens, mineralocorticosteroids, other NSAIDs; contributes to the growth of the toxic effect of zidovudine.

Simultaneous use of probenecid may increase the concentration of indomethacin in the blood.

With the simultaneous use of Indomethacin:

Glucocorticosteroids, colchicine, diflunisal, ethanol - increase the likelihood of gastrointestinal complications and bleeding;
Gold preparations, paracetamol, cyclosporine - increase the nephrotoxic effect of indomethacin;

Terms and conditions of storage

Keep away from children. Keep:

Tablets and gel: in a place protected from light, at temperatures up to 25 ° C;
Suppositories: in a dry place, at temperatures up to 25 ° C;
Ointment: in a place protected from light, at a temperature of 5 to 30 ° C.

Shelf life: tablets - 3 years; suppositories, ointment, gel - 2 years.

Terms of dispensing from pharmacies

Tablets and suppositories are available by prescription, gel and ointment - without a prescription.

Synonym: Metindol. One of the most active anti-inflammatory drugs. It has a pronounced analgesic and antipyretic effect. It is a derivative of indolacetic acid.

The therapeutic effect of indomethacin is determined by its following pharmacological properties: it inhibits inflammation by limiting the production of ATP, inhibits the synthesis of prostaglandins, reduces the permeability of lysosomal membranes and capillaries. The drug is completely absorbed in the intestine, its maximum concentration is observed 2 hours after ingestion, the biological half-life is about 4 hours.

Indications for use: the active phase of rheumatism in all variants of its course (the best effect is observed in acute and subacute course), rheumatoid arthritis (the best results are observed in the early stages of the disease), all types of arthrosis, spondylosis, infectious-allergic myocarditis and arthritis, acute attacks of gouty disease.

Release form: in capsules and pills of 0.025 g (25 mg), in a package of 30 pieces. The drug is prescribed orally 3-4 times a day after meals at the rate of a daily dose for children of 2.5-3 mg per 1 kg of body weight. The initial daily dose is for children aged 3-7 years 50-75 mg (2-3 tablets), from 7 to 12 years old - 75-100 mg (3-4 tablets), over 12 years old - 100-125 mg (4 - 5 tablets). However, in the first 1 - 2 days of treatment, it is recommended to give the drug in smaller doses in order to find out its tolerance to a sick child.

The course of treatment averages 6-7 weeks (the course dose of indomethacin for children is 2200-4800 mg). If the drug is well tolerated, it can be administered continuously for many months. As complete remission occurs, the dose of indomethacin is reduced to maintenance.

Side effects: headache, dizziness, drowsiness, nausea, diarrhea, gastralgia, itchy rashes, sometimes fluid retention and increased blood pressure. Higher doses of the drug may have an ulcerogenic effect.

Contraindications: ulcerative lesions of the gastrointestinal tract, epilepsy, mental disorders, hypertension, heart failure. Do not prescribe indomethacin to children under 3 years of age, as well as to women during lactation and pregnancy.

Rp.: Indometacini 0.025
D.t. d. N. 30 in caps, gelat.
S. 1 capsule 3 times a day (after meals) for a child of 10 years.

"Drug Therapy in Pediatrics", S.Sh. Shamsiev