Indometacin, 10% ointment, 30g

Composition

Active ingredient:

Indometacin 10 g

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

Joint syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), spinal pain, neuralgia, myalgia, traumatic inflammation of soft tissues and joints.

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

When used concomitantly, Indometacin may reduce the effects of saluretics, beta-blockers, and enhance the effects of indirect anticoagulants.

With the simultaneous use of Indometacin and diflunizal, there is a risk of severe bleeding from the gastrointestinal tract.

When used concomitantly with probenecid, the concentration of Indometacin in blood plasma may increase. Indometacin can reduce the tubular secretion of methotrexate, which leads to an increase in its toxicity. Concomitant use with NSAIDs increases the toxicity of cyclosporine.

Indometacin at a dose of 50 mg 3 times / day increases the concentration of lithium in blood plasma and reduces the clearance of lithium from the body in patients with mental illnesses.

When Indometacin is co-administered with digoxin, it is possible to increase the concentration of digoxin in blood plasma and increase the half-life of digoxin.

How to take, course of use and dosage

Rub a thin layer into the skin of painful areas of the body 2-3 times a day. The total amount per day should not exceed 15 cm of ointment for adults and 7.5 cm for children over 14 years of age.

For topical use in ophthalmology, the dose, frequency and duration of use are determined individually.

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

ointment for external use

Storage conditions

Store in a dry place, protected from light, at temperatures below 25 °C.

Shelf life

5 years

Active ingredient

Indometacin

Dosage form

ointment