Indometacin, pills 25 mg, 30 pcs.

Composition

Tablets coated with an enteric coating of white or almost white color, round, biconvex; on the break of the tablet, two layers are visible – yadoro white or white with a yellowish tinge of color and a film shell.

Auxiliary substances:

lactose monohydrate 41.6 mg,

potato starch 10 mg,

microcrystalline cellulose 16 mg,

povidone 2.5 mg,

magnesium stearate 0.9 mg.

Composition of the film shell:

cellacefate 2.2 mg, polysorbate-80 0.72 mg, titanium dioxide 1.08 mg

. Pharmacological action

Indometacin has anti-inflammatory, analgesic and antipyretic properties, as well as some antiplatelet effects.

Suppresses the activity of anti-inflammatory factors, reduces platelet aggregation. By inhibiting cyclooxygenase 1 and 2, it disrupts arachidonic acid metabolism, reduces the amount of prostaglandins (Pg) both in the inflammatory focus and in healthy tissues, and suppresses the exudative and proliferative phases of inflammation.

When applied externally, it causes a weakening or disappearance of rheumatic and non-rheumatic pain syndrome (including joint pain at rest and during movement, reduces morning stiffness and swelling of the joints, helps to increase the volume of movement; in inflammatory processes that occur after operations and injuries, quickly relieves both spontaneous pain and pain during movement, reduces inflammatory swelling at the wound site).

Indications

For system use: joint syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), spinal pain, neuralgia, myalgia, traumatic inflammation of soft tissues and joints, rheumatism, diffuse connective tissue diseases, dysmenorrhea. As an auxiliary agent for infectious and inflammatory diseases of ENT organs, adnexitis, prostatitis, cystitis.

For topical application: prevention of the inflammatory process during cataract surgery and in the anterior segment of the eye, inhibition of miosis during surgery.

Contraindications

Hypersensitivity to Indometacin, erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad”, hematopoietic disorders, severe liver and/or kidney function disorders, severe forms of chronic heart failure, arterial hypertension, pancreatitis, III trimester of pregnancy, children under 14 years of age; 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, convulsions, 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 sensory organs: rarely-impaired clarity of visual perception, 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: rarely-vaginal bleeding, hot flashes, increased sweating, nosebleeds, enlarged and strained mammary glands, gynecomastia. Local reactions: at the site of intravenous injection, 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.

How to take, course of administration and dosage

Inside, during or immediately after a meal, without chewing, with a sufficient amount 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 of age: 1.5-2.5 mg / kg / day, divided into 3-4 doses.

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.

Tablet Form of production

Storage conditions

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

Shelf life

5 years

Active ingredient

Indometacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Weight

Weight: 13 gr.