Name:
Nise Gel gel for nar.prim. 10mg/1g in tubes 20g per pack. #1
Description:
White or almost white gel, free from visible inclusions. The main active ingredient Nimesulide Release form A tube containing 20 g of gel, made of PE / Ethylene acrylic acid / aluminum foil with a polypropylene cap, is packed in a cardboard box with instructions for use. Dosage 10mg/1g in tubes 20g per pack. №1 Pharmacodynamics The main effects of NICE GEL are due to the action of the components that make up its composition. Nimesulide? non-steroidal anti-inflammatory drug belonging to the class of sulfonamides. Selectively inhibits cyclooxygenase-2 (COX-2), thereby reducing the synthesis of prostaglandins (PG)? major mediators of inflammation and pain. Nimesulide inhibits the production of platelet activating factor, tumor necrosis factor alpha, the release of proteinases and histamine. Methyl salicylate? salicylic acid derivative? has a local anti-inflammatory and distracting effect. Menthol has an analgesic effect, which is accompanied by a feeling of cold. The analgesic effect of menthol is associated with the stimulation of cold receptors in the skin. Capsaicin has a local irritant effect, causes a local increase in blood flow and tissue hyperemia at the site of application, promotes the release of endogenous biologically active substances. Pharmacokinetics Nimesulide: according to international studies, the maximum concentration of nimesulide in blood plasma after a single topical application at a dose of 200 mg is observed 24 hours after application and reaches 9.77 ng / ml. Metabolized in the liver. No traces of the main metabolite of nimesulide? 4-hydroxynimesulide was not detected in plasma. With prolonged use, the concentration of nimesulide on day 8 in the blood plasma was 37.25 ± 13.25 ng / ml, which is 100 times less than when taken orally at an average daily dose (200 mg / day). Due to the insignificant systemic absorption, there are no data on the pharmacokinetics of the remaining active components when applied topically. Indications for use? as an aid in the complex therapy of diseases of the joints and soft tissues of an inflammatory nature (osteoarthritis, periarthritis, tendinitis, tendosynovitis), with pain in the lower back. ? stretching of muscles and ligaments. Dosage regimen and method of application For external use only. The gel (in an amount corresponding to a column length of 3 cm) is carefully applied in a thin layer to the painful area 3? 4 times a day or as directed by a physician. Rinse thoroughly and dry the area of skin before application. Apply a thin layer of gel to the appropriate area and the surrounding area, rub in with light movements. It is recommended to avoid wearing tight clothing. Wash hands with soap before and after the procedure. It is not recommended to use more than 1 tube per day (5 mg/kg). Usually the course of treatment lasts 7? 15 days. If necessary, repeated courses of treatment are recommended after 3? 5 days. Warnings and Precautions If local irritative reactions occur, the use of the drug should be suspended and appropriate remedial measures should be taken. Do not apply the gel to mucous membranes, eyes, damaged and infected areas of the skin, areas affected by skin diseases and open wounds. During application, an intense burning sensation may occur, which disappears within a few days. Do not touch sensitive areas of the skin during the procedure and before cleansing the hands from the remnants of the drug. The gel should be used with caution in patients at risk of developing adverse reactions caused by salicylates. It is not recommended to use this drug immediately before, during, or after activities that increase body and skin temperature (eg, hot water bathing, swimming, sunbathing, strenuous exercise), or in hot or humid weather. It is recommended to wait until the skin has cooled to normal temperature and normal sweating is restored. Do not use the drug before visiting the solarium or being under direct or indirect sunlight, it is not recommended to warm up the place of application of the gel. There have been reports of the development of skin burns after the use of topical agents containing methyl salicylate, capsaicin and menthol. Dosage and administration Externally. Before applying the gel, wash and dry the surface of the skin. Apply a gel column approximately 3 cm long in a uniform thin layer to the area of maximum soreness, without rubbing, 3-4 times / day. The amount of gel and the frequency of its application (no more than 4 times / day) may vary depending on the size of the treated area and the patient’s response. Do not use the gel for more than 10 days without consulting a doctor. Use during pregnancy and lactation is contraindicated in pregnancy and lactation. PrecautionsLiver failure; kidney failure; severe heart failure; arterial hypertension; type 2 diabetes; old age, childhood. Interaction with other drugs The drug causes flushing of the skin and reflexively enhances blood circulation in the subcutaneous tissue, thus, combined use with other drugs of local action can lead to increased absorption. The use of large amounts may increase the toxicity of methotrexate and reduce the therapeutic hypoglycemic agents. Do not use the drug with oral anticoagulants. The drug should not be used together with other drugs for topical use. It is not recommended to use the gel simultaneously with other non-steroidal anti-inflammatory drugs. Glucocorticosteroids and antirheumatic drugs (gold preparations, aminoquinolones) enhance the effect of the drug. Pharmaceutical information Contraindications Pregnancy and lactation. Dermatoses, epidermal lesions, skin infections in the area of application. Established hypersensitivity to nimesulide, and other components of the drug. Children under 18 years of age. It is recommended to use with caution in erosive and ulcerative lesions of the gastrointestinal tract, liver failure, renal failure (creatinine clearance less than 30 ml / min), congestive heart failure, arterial hypertension, “aspirin” asthma, type 2 diabetes mellitus (non-insulin dependent). Epilepsy, history of convulsions (including febrile). Application features Do not apply the gel around the eyes, on mucous membranes, on healthy areas of the body, on wound surfaces. Do not use for dermatitis. Do not touch sensitive skin areas with gel. The use of the gel with airtight dressings should be avoided. Wash your hands with soap and water after applying the gel. After complete rubbing of the drug, redness, burning sensation may occur. These symptoms usually disappear within a few days after the drug is discontinued. The drug should be used with caution in patients with an increased risk of side effects associated with taking salicylates. Use in pregnant and lactating women Nimesulide is not used in pregnant and lactating women. Studies confirming its efficacy and safety during pregnancy and lactation have not been conducted. There are no data on the effect on fetal development. Pediatric use Indications and recommendations for use in children are not known. The effect of use in drivers and workers associated with mechanisms Patients taking nimesulide orally should be warned about its side effects? dizziness. Use with caution while driving and working. Cases of dizziness after topical application of nimesulide have not been described. Mutagenicity and carcinogenicity In various studies, nimesulide turned out to be a non-mutagenic drug. There is also no data on the effect of the drug on the chromosomes of lymphocytes in vitro, and the interaction with H-thymidine of cultured human lymphocytes. Composition 1 g nimesulide 10 mg Excipients: N-methyl-2-pyrrolidone – 250 mg, propylene glycol – 100 mg, macrogol – 315.5 mg, isopropanol – 100 mg, purified water – 200 mg, carbomer 940 – 20 mg, butylhydroxyanisole – 0.2 mg , thiomersal – 0.1 mg, potassium dihydrogen phosphate – 0.2 mg, flavor (Narciss-938) – 4 mg. Overdose Cases of overdose with topical application have not been described. When applying more than 50 g to large areas of the skin, an overdose (systemic adverse reactions) may develop. It is recommended to see a doctor. There are no specific antidotes. Side effects Locally applied preparations of nimesulide are usually well tolerated. Observed side effects include moderate or severe local irritative reactions, hyperemia, rash, desquamation, itching and related reactions in the area of application of the drug, as a manifestation of hypersensitivity to the components of the drug. Capsaicin, which is part of the drug, at a concentration of 1% or more can cause neurotoxicity and thermal hyperalgesia, burning sensation, redness. In case of adverse reactions, it is necessary to stop using the drug and prescribe appropriate treatment. No systemic adverse reactions were observed with the use of the drug. Photosensitivity may develop. Mild changes in skin color and allergic reactions have also been reported. In rare cases, sensitive patients developed anaphylactic reactions, such as Quincke’s edema, vasomotor rhinitis, shortness of breath, bronchospasm. Storage conditions Store in a place protected from light at temperatures up to 25 ° C. Do not freeze. Keep out of the reach of children. Buy Nise gel 20g No. 1 Price for Nise gel 20g No. 1
INN | NIMESULID |
---|---|
The code | 19 326 |
Barcode | 8 901 148 211 551 |
Dosage | 10mg/1g 20g |
Active substance | Nimesulide |
Manufacturer | Dr. Reddy's Laboratories Ltd, India |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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