Indomethacin, 10% ointment 40 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, disrupts arachidonic acid metabolism, reduces the amount of prostaglandins (Pg) both in the focus of inflammation and in 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

• articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout),
• pain in the spine,

spinal pain,

• neuralgia,
• myalgia,
• traumatic inflammation of the soft tissues and joints.

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Active ingredient

Indomethacin

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

Indomethacin reduces the effectiveness of uricosuric drugs, hypotensive and diuretics (saluretics).

It enhances the effect of indirect anticoagulants, antiaggregants, fibrinolytics, the side effects of mineralocorticosteroids, estrogens, etc. NSAIDS.

Accelerates the hypoglycemic effect of sulfonylurea derivatives.

Combination with paracetamol increases the risk of nephrotoxic effects.

Ethanol, colchicine, glucocorticosteroids increase the risk of gastrointestinal complications accompanied by bleeding.

Enhances blood concentrations of lithium drugs, methotrexate, digoxin and penicillins (blockage of tubular secretion).

Cyclosporine , gold drugs increase nephrotoxicity of indomethacin.

Cefamandol , cefoperazone , valproic acid increase the risk of hypoprothrombinemia and the risk of bleeding.

Potentiates the toxic effects of zidovudine.

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 ointment should only be applied to intact areas of skin, avoid contact with eyes or mucous membranes.

Impact on driving and operating machinery

At the time of treatment, one should refrain from potentially hazardous activities requiring concentration and increased speed of psychomotor reactions.

Contraindications

• High sensitivity to sacubitril or valsartan or other excipients.
• Simultaneous use with angiotensin-converting enzyme inhibitors (ACEIs) and 36 hours after ACE withdrawal.
• An history of angioedema based on prior therapy with ACEIs or ARA II.
• Simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (rSFR <60 ml/min/1.73 m².
• Severe liver dysfunction (Child-Pugh class C), biliary cirrhosis, and cholestasis.
• Uperio is not recommended for use in children under 18 years of age due to lack of efficacy and safety data.
• Pregnancy, pregnancy planning and breastfeeding.
• Simultaneous use with other drugs containing ARA II, because the drug contains valine.

Cautions

• Severe renal impairment (RRF <30 ml/min/1.73 m²), including in patients on hemodialysis or undergoing hemodialysis (rGFR <15 ml/min/1.73 m²) due to lack of safety data in this category of patients;
• bilateral renal artery stenosis;
• hypovolemia that may be caused by diuretic therapy, low-salt diet, diarrhea, or vomiting;
• current use with statins, phosphodiesterase type 5 inhibitors;
• An history of angioedema due to lack of data on the use of the drug in this category of patients; patients of Negro race may be more at risk of angioedema.

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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.

Pregnancy use

Indomethacin is contraindicated in pregnancy, lactation and children under 14 years of age.

Similarities

Indomethacin 100 Berlin-Chemie, Indomethacin 50 Berlin-Chemie, Indomethacin, Indocollir, Metindol Retard