Indomethacin, 10% ointment 30 g

Indomethacin has anti-inflammatory, analgesic and antipyretic, as well as some antiaggregant action.

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

When used topically, it causes alleviation or disappearance of pain syndrome of rheumatic and non-rheumatic character (including In case of pain of the joints at rest and when moving, it reduces morning stiffness and swelling of the joints, increases the range of motion; in case of inflammatory processes after operations and injuries, it quickly relieves spontaneous pain as well as pain while moving, reduces inflammatory swelling of the wound area).

Indications

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

Active ingredient

Composition

Active ingredient:

Indomethacin 10 g

How to take, the 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 frequency and duration of application are determined individually.

Interaction

Concomitant use of indomethacin may reduce the effects of saluretics, beta-adrenoblockers; increase the effects of indirect anticoagulants.

In concomitant use of indomethacin and diflunisal there is a risk of severe bleeding from the gastrointestinal tract.

Concomitant use with probenecid may increase the plasma concentration of indomethacin.
Indomethacin may decrease the tubular secretion of methotrexate, which leads to increased toxicity.
Concomitant use with NSAIDs increases the toxicity of cyclosporine.

Indomethacin at a dose of 50 mg 3 times daily increases plasma lithium concentration and decreases clearance of lithium from the body in patients with psychiatric disorders.

Concomitant use of indomethacin with digoxin may increase the plasma concentration of digoxin and increase the elimination half-life of digoxin.

Special Instructions

With caution, use in elderly patients, as well as in patients with a history of liver, renal, GI diseases, dyspeptic symptoms at the time of use, arterial hypertension, heart failure, immediately after major surgical interventions, with parkinsonism, epilepsy.

When a history of allergic reactions to NSAIDs is indicated, use only in emergency cases.

During treatment, systematic monitoring of liver and renal function and peripheral blood counts is necessary.

The simultaneous use with acetylsalicylic acid and other NSAIDs is not recommended.

Indomethacin should not be used concomitantly with diflunisal.

In concomitant use of indomethacin with lithium preparations, be aware of the possibility of symptoms of lithium toxicity.

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

Impact on driving and operating machinery

At any time during treatment, avoid potentially hazardous activities requiring concentration and increased speed of psychomotor reactions.

Contraindications

Side effects

Digestive system disorders: nausea, anorexia, vomiting, abdominal pain and discomfort, constipation or diarrhea, erosive ulcerative lesions, bleeding and perforations of the gastrointestinal tract; rarely – intestinal strictures, stomatitis, gastritis, flatulence, bleeding from the sigmoid colon or from diverticulum, jaundice, hepatitis.

CNS and peripheral nervous system disorders:Dizziness, headache, depression, feeling of fatigue; rarely – anxiety, fainting, somnolence, seizures, peripheral neuropathy, muscle weakness, involuntary muscle movements, sleep disorders, mental disorders (depersonalization, psychotic episodes), paresthesias, dysarthria, parkinsonism.

Cardiovascular system disorders: edema, increased BP, tachycardia, chest pain, arrhythmia, palpitation, arterial hypotension, congestive heart failure, hematuria.

Allergic reactions: rare – itching, urticaria, angiitis, erythema nodosum, skin rash, exfoliative dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, hair loss, acute respiratory distress, severe BP drop, anaphylactic reactions, angioneurotic edema, dyspnea, bronchial asthma, pulmonary edema.

Hematopoietic system: rarely – leukopenia, petechiae or ecchymoses, purpura, aplastic and hemolytic anemia, thrombocytopenia, DIC syndrome.

Senses: rarely – visual disturbances, diplopia, orbital and periorbital pain, tinnitus, hearing disorders, deafness.

Urinary system disorders: rare – proteinuria, nephrotic syndrome, interstitial nephritis, renal failure.

Metabolism disorders: rare – hyperglycemia, glucosuria, hyperkalemia.

Other: rare – vaginal bleeding, hot flashes, increased sweating, nasal bleeding, enlargement and tightness of the mammary glands, gynecomastia.

Local reactions: in place of injection in some cases – infiltrate and abscess formation; with rectal administration irritation of rectal mucosa, tenesmus, exacerbation of chronic colitis is possible.

In external application: itching, redness, rash in the application area.

Overdose

Symptoms: nausea, vomiting, severe headache, dizziness, memory impairment, disorientation. In severe cases paresthesias, numbness of extremities, convulsions.

Treatment: symptomatic therapy. Hemodialysis is ineffective.

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