Name:
Indomethacin ointment dnar.prim.100mg in tubes 40g in pack No. 1
Description:
Ointment from light yellow to dark yellow in color with a specific smell of menthol, homogeneous consistency. Composition Each tube (40 g) contains – active substance – indomethacin – 4.0 g; excipients: dimethyl sulfoxide, urea, macrogol 400, macrogol 1500, propylene glycol, levomenthol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water. Pharmacotherapeutic groupNon-steroidal anti-inflammatory drugs for external use. Indomethacin. ATX code – M02AA23. Pharmacological properties Pharmacodynamics Indomethacin belongs to the group of non-steroidal anti-inflammatory drugs. Indomethacin has a strong inhibitory effect on the synthesis of prostaglandins by inhibiting the enzyme cyclooxygenase, which plays a significant role in inflammatory actions, pain and hyperthermia. It has an antipyretic effect and reversibly inhibits platelet aggregation. When applied topically, indomethacin has a direct anti-inflammatory and analgesic effect on inflamed tissues. Pharmacokinetics Ointment is well absorbed through the skin and accumulates in subcutaneous tissues at therapeutic concentrations, including joints and synovial fluid. It is excreted through the kidneys in the form of metabolites and in a small amount unchanged, including local application, and in a small amount is excreted through the biliary tract into the intestine. Indications for useadditional agent in the complex therapy of acute and chronic rheumatoid arthritis, osteoarthritis, osteoarthritis, ankylosing spondylitis, psoriatic arthritis, gouty arthritis; localized forms of extra-articular rheumatism of the musculoskeletal system: tendonitis, synovitis, tendovaginitis, inflammation of the fascia and articular ligaments, bursitis, local symptomatic treatment of inflammation, pain and swelling in post-traumatic lesions of the musculoskeletal system – sprains, dislocations, bruises. Contraindications Hypersensitivity to the active or any of the excipients of the drug. Hypersensitivity to aspirin (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs) with clinical manifestations of an asthmatic attack, urticaria or allergic rhinitis. Coagulopathy, leukopenia, thrombocytopenia. Ulcer of the stomach and duodenum in the acute stage. Children’s age up to 14 years. With caution Children’s age (up to 14 years), complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to ASA or other NSAIDs (including history), peptic ulcer of the stomach and duodenum (in the acute stage ), blood clotting disorders (including hemophilia, prolongation of bleeding time, tendency to bleed), pregnancy (I and II trimesters), lactation. Method of application and doses Method of application: topically, on the skin. Apply the ointment to the affected area 3-4 times a day, gently rubbing into the skin until complete resorption. The amount of ointment required for one application depends on the area of the lesion and is approximately 4-5 cm. Apply at least every 6 hours. The duration of treatment is 7-10 days. If there is no improvement in symptoms during this time, treatment should be reassessed. Children. Do not use under 14 years of age. Adverse reactions associated with the method of application: the likelihood of systemic side effects with topical application of indomethacin is negligible compared to the frequency of adverse reactions with oral administration. On the part of the immune system: rarely develops local edema and vesicular rash, and in some cases – angioedema and suffocation. From the gastrointestinal tract: when applied to a large surface of the skin, resorptive side reactions may occur, for example, disorders of the gastrointestinal tract (loss of appetite, nausea, vomiting, diarrhea, pain, hemorrhages and ulcers), increased levels of liver enzymes. On the part of the skin and subcutaneous tissues: sometimes with topical application in predisposed patients, burning at the site of application, redness, itching, rash, peeling, dry skin can be observed. In such cases, the use of the drug should be discontinued. PrecautionsSometimes taking NSAIDs can lead to damage to the gastrointestinal tract; deterioration of cardiac function in patients with cardiovascular insufficiency, impaired liver and kidney function. Despite the fact that after topical application to the skin, systemic resorption of indomethacin is minimal, patients with an active gastric or duodenal ulcer, with a history of kidney disease and heart failure, should be treated with ointment only after consulting a doctor. Treatment with the drug should be carried out with extreme caution and only after consulting a doctor in patients with manifestations of hypersensitivity to food and drugs or with allergic diseases – hay fever, bronchial asthma, nasal polyposis. There is cross-sensitivity to other NSAIDs, so patients with manifestations of hypersensitivity to any drugs from this group may have manifestations of hypersensitivity to indomethacin. With long-term treatment (more than 10 days), laboratory monitoring of the number of leukocytes and platelets is recommended. With simultaneous use with antibiotics, anticoagulant and hypoglycemic drugs, it is necessary to control the relevant laboratory parameters. It should be applied only to healthy, intact skin (in the absence of open wounds and damage). If rashes appear after topical application, treatment should be stopped immediately. Do not apply to mucous membranes and eyes. The composition of the drug contains dimethyl sulfoxide, propylene glycol, methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause skin irritation. Use during pregnancy or lactation Pregnancy No controlled clinical studies have been conducted in pregnant women, so the use of indomethacin is not recommended during pregnancy. Breast-feeding Penetrates in small amounts into breast milk, as a result of which it is not recommended for use in women during breast-feeding. The ability to influence the reaction rate when driving vehicles or operating other mechanisms Does not affect the ability to drive vehicles or work with other mechanisms. Interaction with other medicinal products With topical application of indomethacin, due to minimal resorption, interactions with other medicinal products are unlikely. The simultaneous use of indomethacin with another NSAID drug, including a selective COX-2 inhibitor, should be avoided due to an increased risk of adverse reactions. The simultaneous use of indomethacin with aspirin or corticosteroids increases the risk of gastrointestinal complications. Non-steroidal anti-inflammatory drugs can interact with drugs that lower blood pressure, although this possibility is extremely rare when applied topically. Overdose When applied topically, overdose is unlikely due to poor systemic resorption. Overdose phenomena (mainly from the digestive tract, hepatotoxicity) can be observed very rarely, only with prolonged application to large skin surfaces. It is necessary to monitor the leukocyte formula and the number of platelets in the blood. Symptoms of accidental ingestion: burning of the oral mucosa, salivation, nausea, vomiting. Treatment: washing the mouth and stomach, if necessary – symptomatic treatment. There is no specific antidote. Symptoms in case of contact with eyes, mucous membranes or open wounds: local irritation is observed – lacrimation, redness, burning, pain. Treatment: abundant washing of the affected area with distilled water or saline until the complaints decrease and disappear. Packaging: 40 g in aluminum tubes. Each tube with a leaflet in a pack of cardboard. Storage conditions At a temperature not higher than 25? Keep out of the reach of children. Shelf life 2 years. Do not use the medicine after the expiration date. Terms of dispensing from pharmaciesWithout a prescription. Buy Indomethacin ointment 40g №1 Price for Indomethacin ointment 40g №1 Instructions for use for Indomethacin ointment 40g №1
INN | INDOMETACIN |
---|---|
The code | 14 446 |
Barcode | 4 810 201 003 894 |
Dosage | 100mg/g 40g |
Active substance | Indomethacin |
Manufacturer | Borisov plant of medical preparations, Belarus |
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