Indometacin

Индометацин Drug photo

The description is actual on 23.06.2016

  • Latin name: Indometacinum
  • ATH code: M02AA23
  • Active ingredient: Indometacin (Indomethacin)
  • Producer: Balkanfarm, JSC Sofarm (Bulgaria); Berlin-Hemi (Germany); JSC Biosintez, LLC Altfarm, JSC Akrikhin, LLC Ozon (Russia); CJSC Darnitsa, LLC Zdorovye (Ukraine)

Structure

The structure of all dosage forms of a remedy as active ingredient included indometacin (Indometacin) in different mass part: 25 mg for tablets and 50 mg or 100 mg for suppositories (candles), gel and ointment.

Additional ingredients of drugs can differ a little depending on the producer that the doctor appointing to the patient this or that medicine also has to consider.

Release form

The medicine Indometacin is made in shape:

  • peroral tablets No. 10-№300;
  • candles No. 6-№50;
  • gel on 40 grams;
  • ointments on 10-40 grams.

Pharmacological action

Anti-aggregation, anesthetizing, antiinflammatory, febrifugal.

Pharmacodynamics and pharmacokinetics

Remedy Indometacin (Sofarm; Berlin Hemi, Balkanfarm and so forth) is derivative indolacetic acid and treats drugs of NPVS group which are characterized by the febrifugal, antiinflammatory, anti-aggregation and anesthetizing action.

Efficiency of this remedy is connected with its inhibiting (oppressing) impact on TsOG enzyme (cyclooxygenase) which leads to suppression of metabolic transformations of arachidonic acid and decrease in synthesis of prostaglandins. Also one of their effects of drug braking of aggregation of thrombocytes is.

Parenteral and oral administration of Indometacin weakens expressiveness of a pain syndrome, in particular concerning joint pains, both in a condition of the movement, and at rest, reduces manifestations of a morning swelling of joints and their constraint, and also increases the volume of movements. Anti-inflammatory action develops after 5-7 days of treatment.

External use of this drug promotes elimination of pains, decrease in puffiness and weakening of an erythema, and also reduction of morning joint constraint and increase in a physical activity.

The tablets Indometacin at oral administration are quickly soaked up from bodies of a gastrointestinal tract. Serumal Cmax is noted after 120 minutes. After enterohepatic recirculation further metabolic transformations happen in a liver. In plasma not changed active ingredient and untied products of a metabolism – dezbenzoilny, dezmetilny, dezmetil-dezbenzoilny metabolites is defined. Average T1/2 proceeds about 4,5 hours. Excretion of 60% of drug, in the form of not changed substance and products of a metabolism, is carried out by kidneys and 33%, in the form of metabolites, intestines.

Candles rectal are characterized by fast absorption in a rectum. Bioavailability at such way of administration of drug equals 80-90%. About 90% of active ingredient contact serum proteins. T1/2 varies within 4-9 hours. Metabolic transformations happen in a liver. Kidneys remove about 70% of drug, by intestines about 30%.

Indications to use

Indications to use of Indometacin in the form of tablets and suppositories include:

Gel and ointment Indometacin it is shown to use at:

  • mialgiya;
  • the traumatic inflammatory processes proceeding in joints and soft tissues;
  • joint syndrome (including painful displays of gout, a pseudorheumatism, ankylosing spondylitis, osteoarthritis);
  • backbone pains;
  • neuralgia.

Contraindications

The tablets Indometacin (Sofarm, Balkanfarm and so forth), as well as candles Indometacin (Berlin Hemi, Sofarm and so forth) are contraindicated to appointment at:

In addition candles Indometacin 50/100 (Berlin Hemi, Sofarm and so forth) is forbidden to be applied at:

With care it is necessary to appoint both dosage forms of drug at:

Gel and ointment for topical administration are contraindicated at:

  • damages of integuments around carrying out application;
  • The III trimester of pregnancy (in case of putting drug on extensive body parts);
  • hypersensitivity;
  • aged till 1st year.

Outside dosage forms are appointed with care at:

  • any combination of bronchial asthma with polipozy a nose / okolonosovykh bosoms and intolerance of NPVS;
  • I and II trimesters of pregnancy;
  • aggravation of a peptic ulcer of a gastrointestinal tract;
  • feeding by a breast;
  • disturbances of blood coagulability;
  • till 6 years.

Side effects

Side effects at use of tablets or candles

Alimentary system:

  • meteorism;
  • nausea/vomiting;
  • gastrointestinal tract bleedings;
  • anorexia;
  • jaundice;
  • unpleasant or pain in a stomach;
  • gastritis;
  • lock/diarrhea;
  • perforation of a gastrointestinal tract;
  • gastrointestinal tract erosive cankers;
  • stomatitis;
  • intestines strictures;
  • bleeding from a diverticulum or a sigmoid gut;
  • hepatitis.

Nervous system:

Cardiovascular system:

System of a hemopoiesis:

  • petechias;
  • leukopenia;
  • ecchymomas;
  • thrombocytopenia;
  • DVS syndrome;
  • purpura;
  • aplastic/hemolitic anemia.

Urinary system:

  • disturbance of renal function;
  • nephrotic syndrome;
  • proteinuria;
  • intersticial nephrite;
  • renal failure.

Sense bodys:

  • deafness;
  • disorder of visual perception;
  • hearing disorder;
  • diplopia;
  • tinnit;
  • periorbital pains.

Metabolism:

  • hyperpotassemia;
  • glucosuria;
  • hyperglycemia.

Allergic manifestations:

Others:

  • gynecomastia;
  • vaginal bleeding;
  • hyperhidrosis;
  • inflow;
  • nasal bleeding;
  • intensity/increase in mammary glands.

In addition for suppositories

  • exacerbation of colitis;
  • irritation mucous rectum;
  • tenesmus;
  • exacerbation of hemorrhoids.

Side effects at use of gel or ointment

  • allergic phenomena;
  • itch/rash around application;
  • dryness/dermahemia;
  • burning sensation;
  • system manifestations (at long use);
  • exacerbation of psoriasis (in isolated cases).

Application instruction of Indometacin (Way and dosage)

Tablets Indometacin, application instruction

The dosing mode of drug in the form of tablets is set in an individual order taking into account expressiveness of negative symptoms of the diagnosed disease. A pill is taken orally directly after food or during its reception. As a rule, the initial daily dosage corresponds to 25 mg which 2-3 times are shown to accept at 24 o'clock. At unsatisfactory clinical performance increase of a daily dose twice follows (2-3 times on 50 mg). The maximum in days is allowed internal reception of 200 mg of drug. After achievement of satisfactory effect continue therapy for 4 weeks in a former or reduced dosage. In case of long treatment at most at 24 o'clock it is possible to accept 75 mg of this remedy.

For stopping of acute/serious conditions it is possible to use indometacin pricks in an initiation of treatment then to pass to use of tablets or suppositories. In case of an observed pain syndrome in organs of sight it is possible to appoint eye drops with similar active ingredient (for example, Indokollir).

Candles Indometacin, application instruction

Candles Indometacin (Altfarm, Sofarm and so forth) are intended for rectal (in a rectum) uses. Procedure of administration of suppositories should be carried out before going to bed after preliminary cleaning of intestines. Candles Indometacin (Berlin Hemi, Biosynthesis and so forth) needs to try to enter into a rectum as it is possible more deeply, for the purpose of the best absorption of drug. Usually at 24 o'clock appoint 3-times administration of suppositories on 50 mg or single introduction of candles on 100 mg. At the expressed pain syndrome (for example, a gout attack) allow rectal daily use of 200 mg of drug in suppositories (in addition to oral administration).

Gel and ointment Indometacin, application instruction

Gel and ointment Indometacin (Sofarm, Balkanfarm and so forth) are intended for application and rubbing in in the integuments which are directly over the place of a painful body part for what gel or ointment Indometacin (Sofarm, Quinacrine and so forth) apply with a thin layer on the unimpaired and previously cleared skin.

5% are shown to put outside means with frequency 3-4 times at 24 o'clock. Application of 10% drugs should carry out 2-3 times a day. One-time and maximum dosages of outside forms of drug are calculated proceeding from quantity (in centimeters) the squeezed-out gel or ointment from a tube. Adult patients can one-time use 4-5 cm of the squeezed-out drug, and as much as possible in days – 15-20 cm. Use twice of smaller dosages is shown to children.

Overdose

The negative symptomatology of overdose by Indometacin most often observed at use of peroral or rectal dosage forms is shown: nausea/vomiting, disorientation, severe headaches, memory disturbance, dizziness. In especially serious cases noted numbness of extremities, paresthesias, spasms.

The appointed treatment has to correspond to the monitored negative manifestations.

Interaction

The combined use of the Methotrexate, drugs of lithium and Digoxin increases their serumal concentration that can become the reason of strengthening of their toxicity.

In parallel the accepted etanolsoderzhashchy drugs, glucocorticoids, Colchicine and corticotropin increase possibility of bleedings of a gastrointestinal tract.

Joint appointment with the remedies including Paracetamol increases risk of nephrotoxicity.

Combinatory treatment with Insulin and other hypoglycemic drugs strengthens their action.

Simultaneous use with indirect antiagregant, anticoagulants and trombolitika strengthens their effects that increases a possibility of development of bleedings.

Jointly the accepted drugs of gold and Cyclosporine increase nephrotoxicity (most likely, due to oppression in kidneys of synthesis of prostaglandins).

Parallel reception with kaliysberegayushchy diuretics lowers their effects and, as a result, increases risk of forming of a hyperpotassemia.

The combined therapy with use of a tsefamandol, plikamitsin, tsefaperazon, valproic acid, a tsefotetan increases danger of developing of bleedings and increases the frequency of forming of prothrombinopenias.

The concomitant use of hypotensive and uricosuric remedies leads to reduction of their efficiency.

At combined use of estrogen, glucocorticoids and other NPVS increase in side effects inherent in them is observed.

Colestyraminum and antiacid means lower indometacin absorption.

Combinatory use with a zidovudine can become the reason of increase in its toxicity (because of oppression of a metabolism).

Parallel reception of miyelotoksichny medical drugs increases manifestations of their gematotoksichnost.

Terms of sale

Acquisition of tablets and suppositories will require the recipe in Latin. It is possible to buy gel and ointment of drug on free sale.

Storage conditions

All dosage forms of this remedy keep the properties at a temperature up to 25 °C.

Period of validity

3-5 years depending on a dosage form and the producer.

Special instructions

Careful use of indometacin is demanded by elderly persons, patients with heart failure, pathologies of a gastrointestinal tract, livers/kidneys, dyspepsia, epilepsy, an arterial hypertension, parkinsonism, and also patients after serious surgeries.

At all stage of carrying out treatment by peroral and rectal forms of drug it is necessary to watch a picture of blood and functionality of livers/kidneys.

Do not recommend parallel use with diflunizaly and other NPVS.

At the combined use with drugs of lithium it is necessary to take in attention to a possibility of emergence of symptomatology of its toxic action.

There is a great risk of development of complications from a gastrointestinal tract (bleeding, ulcer/erosive defeats and so forth) connected using drugs of NPVS group including tablets indometacin from what it is better to combine their reception with meal.

It is possible to appoint candles at prostatitis only in case of absence of damage of a rectum.

It is necessary to explain in accuracy to the patient how to apply candles in gynecology (for example, at a dysmenorrhea). Candles with indometacin in gynecology are appointed rektalno (in a rectum).

It is possible to apply gel and ointment only on mechanically unimpaired sites of integuments, and also to avoid hit of these dosage forms on mucous membranes and in eyes.

Analogs

Coincidence on the ATH code of the 4th level:

Analogs of Indometacin are provided by peroral, rectal and outside dosage forms of drugs with similar main action:

Zdravzona

  • Indometacin of a candle of 100 mg No. 10
  • Indometacin ointment of 10% 40 g
  • Indometacin of a candle of 50 mg No. 10
  • Indometacin 25 of mg No. 30 of a tablet / Sofarma/Sopharma of AD
  • Indometacin of a candle of 100 mg No. 10 Berlin-hemiberlin-Hemi AG

Drugstore of IFC

  • Indometacin ointment of 10% 40 g, Sopharma Jscbolgariya
  • Indometacin soup rekt. 50 mg No. 10, Berlin-Chemie/Menarini Groupgermaniya
  • Indometacin soup rekt. 100 mg No. 10, Berlin-Chemie/Menarini Groupgermaniya
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Apteka24

  • Indometatsinsopharma (Bulgaria)
  • Indometatsinzdorovye (Ukraine, Kharkiv)
  • Indometatsinsopharma (Bulgaria)
  • Indometatsinsopharma (Bulgaria)

Paniapteka

  • Indometacin of the tab. of 25 mg No. 30sofarma
  • Soup. indometacin 50 of mg No. 6
  • Indometacin of the tab. of 25 mg No. 30sofarma
  • Ointment indometacin of 10% 40 g

BIOSPHERE

  • Indometacin of 100 mg No. 6 supp.rekt.
  • Indometacin of 50 mg No. 6 supp.rekt.farmaprim SRL (Moldova)
  • Indometatsin-Sofarma of 25 mg No. 30 tabl.p.o.rastvor./kishechn.
  • Indometatsin-Sofarma of 10% 40 g ointment in a tuba
  • Indometacin of 10% 40 g ointment in tubeborisovsky ZMP (Belarus)
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Section: For joints Anesthetics
in more detail

Education: Graduated from the Vinnytsia national medical university of N. I. Pirogov, pharmaceutical faculty, the higher pharmaceutical education – the specialty "Pharmacist".

Experience: Work in Koneks and Bios-Media pharmacy chains as "Druggist". Work as "Pharmacist" in Avicenna pharmacy chain of the city of Vinnytsia.

PAY ATTENTION! Information on drugs on the website is help generalizing, collected from public sources and can form the basis for making decision on use of medicines it is not aware of treatment. Before medicine use Indometacin surely consult with the attending physician.