Indometacin-Altpharm, rectal suppositories 100mg, 10pcs

Composition

Active ingredient:

Indometacin 100 mg

Pharmacological action

Pharmacology:  

NSAIDs, a derivative of indolacetic acid; has anti-inflammatory, analgesic and antipyretic effects associated with the indiscriminate suppression of COX 1 and COX 2, which regulate Pg synthesis. It has an antiplatelet effect.

Pharmacokinetics:  

Absorption is fast. Bioavailability when taking conventional tablets, capsules-90-98%, when taking tablets of prolonged action for 12 hours,90% of the administered dose is absorbed, for rectal suppositories-80-90%. After oral use, TCmax – 2 hours, Cmax-0.69 mcg / ml.

Plasma protein binding is 90%. It is mainly metabolized 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%, and 30% in unchanged form, and the gastrointestinal tract-30%.

Penetrates into breast milk, when the mother uses 200 mg of the drug per day in the milk is determined from 0.5 to 2 mg. The drug is not removed during dialysis.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis, arthritis in Paget and Reiter’s disease, neuralgic amyotrophy (Personage-Turner disease), ankylosing spondylitis (Ankylosing spondylitis), gouty arthritis (with an acute attack of gout, fast-acting dosage forms are preferred), 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).

Algodismenorrhea; Bartter’s syndrome (secondary hyperaldosteronism); pericarditis (symptomatic treatment); childbirth (as an analgesic and tocolytic agent); pelvic inflammatory processes, including Adnexitis.

Non-blocking of the Botall bayou.

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

Febrile 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, and does not affect the progression of the disease.

Contraindications

• Individual hypersensitivity to Indometacin, aspirin or other NSAIDs (indications in the anamnesis of bronchospasm, urticaria or rhinitis caused by taking acetylsalicylic acid or other NSAIDs);
• peptic ulcer of the stomach and/or intestines in the acute phase;
• pregnancy and lactation;
• children (up to 14 years).
• hematopoietic disorders;
• severe liver and/or kidney dysfunction;
• severe forms of chronic heart failure, arterial hypertension, pancreatitis;
• for rectal use: proctitis, recent bleeding from the rectum.

Side effects

From the digestive system:  nausea, anorexia, vomiting, abdominal pain and discomfort, constipation or diarrhea, erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract; rarely-intestinal strictures, stomatitis, gastritis, flatulence, bleeding from the sigmoid colon or diverticula, jaundice, hepatitis.

From the central nervous system and peripheral nervous system: dizziness, headache, depression, fatigue; rarely-anxiety, fainting, drowsiness, seizures, peripheral neuropathy, muscle weakness, involuntary muscle movements, sleep disorders, mental disorders (depersonalization, psychotic episodes), paresthesia, dysarthria, parkinsonism.

From the cardiovascular system:  edema, increased blood pressure, tachycardia, chest pain, arrhythmia, palpitation, hypotension, congestive heart failure, hematuria.

Allergic reactions:  rarely-pruritus, urticaria, angiitis, erythema nodosum, skin rash, exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, hair loss, acute respiratory distress, sharp drop in blood pressure, anaphylactic reactions, angioedema, dyspnoea, bronchial asthma, pulmonary edema.

From the hematopoietic system:  rarely-leukopenia, petechiae or ecchymoses, purpura, aplastic and hemolytic anemia, thrombocytopenia, DIC syndrome.

From the side of the senses:  rarely – impaired visual clarity, diplopia, orbital and periorbital pain, tinnitus, hearing disorders, deafness.

From the urinary system:  rarely-proteinuria, nephrotic syndrome, interstitial nephritis, impaired renal function, renal failure.

From the side of metabolism:  rarely – hyperglycemia, glucosuria, hyperkalemia.

Other services:  rarely-vaginal bleeding, hot flashes, increased sweating, nosebleeds, enlarged and strained mammary glands, gynecomastia.

Local reactions:  at the site of intravenous use, in some cases – the formation of an infiltrate, abscess; with rectal use, irritation of the rectal mucosa, tenesmus, exacerbation of chronic colitis are possible.

For external use:  itching, redness, rash at the application site.

Interaction

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

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

Increases blood concentrations of lithium, methotrexate, and digoxin. Cyclosporine, gold preparations increase the nephrotoxicity of Indometacin. Cefamandol, cefoperazone, valproic acid-increase the risk of hypoprothrombinemia and the risk of bleeding. Potentiates the toxic effect of zidovudine.

How to take, course of use and dosage

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

Wash your hands, remove the suppository from the contour package by cutting it with scissors or opening it with your hands, pulling the edges of the contour package to different ends, and insert the suppository into the anus with the pointed end, as deep as possible.

For more convenient use of the suppository, it is recommended to bend down or sit down; you can enter it lying on your side.

Suppositories 50 mg for adults 1-3 times a day; children (older than 14 years) once a day.

Suppositories of 100 mg – 1 time a day;

During an attack of gout, up to 200 mg per day.

It is recommended to apply it at night.

Overdose

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

Treatment:  symptomatic therapy. Hemodialysis is ineffective.

Special instructions

It is used with caution in elderly patients, as well as in cases of liver, kidney, and gastrointestinal diseases in the anamnesis, with dyspeptic symptoms at the time of application, arterial hypertension, heart failure, immediately after serious surgical interventions, with Parkinsonism, and epilepsy.

If a history of allergic reactions is indicated, NSAIDs are used only in urgent cases.

During the treatment period, systematic monitoring of liver and kidney function, peripheral blood picture is necessary.

Concomitant use with acetylsalicylic acid and other NSAIDs is not recommended.

Indometacin should not be used simultaneously with diflunisalum.

When Indometacin is co-administered with lithium preparations, the possibility of symptoms of lithium toxicity should be borne in mind.

When applied topically, do not apply to the wound surface of the skin, and avoid contact with the eyes or mucous membranes.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, you should refrain from potentially dangerous activities related to the need for concentration and increased speed of psychomotor reactions.

Form of production

rectal suppositories

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Indometacin

Conditions of release from pharmacies

By prescription

Dosage form

rectal suppositories