Product description Yellowish-orange non-woven patch with transparent adhesive and white cover paper, size 70mm×101mm. 1 patch: ketoprofen – 30 mg. The composition of the adhesive layer: acrylic adhesive solution (acrylacrylate, methyl acrylate, ethylhexyl acrylate); rubber adhesive solution (hydrocarbon resin ESCOREZ-1401, polyisobutene Himol 5H). Substrate composition: non-woven material (polyester). The composition of the protective film: cover paper (cellulose). 3 pcs. – Laminated paper bags. Pharmacological action Ketoprofen is one of the most powerful COX inhibitors. It also inhibits the activity of lipoxygenase and the synthesis of bradykinin. By stabilizing lysosomal membranes, ketoprofen prevents the release of enzymes that are involved in the inflammatory process. Ketoprofen, when applied topically, reduces soreness and swelling of tissues. Pharmacokinetics Absorption and distribution When applied topically, ketoprofen is absorbed extremely slowly, while its concentration in blood plasma is very low, and in adjacent affected tissues it is sufficient to reduce pain and inflammation. Plasma protein binding is 50-90%. Metabolism and excretion Ketoprofen is metabolized in the liver to form conjugates that are excreted primarily in the urine. T1 / 2 of ketoprofen from plasma ranges from 1-3 hours. Ketoprofen is characterized by slow excretion in the urine. Pharmacokinetics in special groups of patients In patients of the older age group, with severe renal and hepatic insufficiency, the metabolism of ketoprofen does not change. Indications for use For local treatment of pain and reduction of inflammation and swelling of tissues in uncomplicated injuries, incl. sports, sprains or ruptures of ligaments, tendinitis, bruises of muscles and ligaments. Dosage regimen In adults, the KetoPlastin patch is used by application to painful areas of the body 1 time / day. The frequency of applications and duration of therapy depends on the severity of the injury. The patch should not be used for more than 7 days. Multiple patches must not be used at the same time. There are no data on the need to change the dosage regimen in elderly patients with renal or hepatic insufficiency. How to use The patch is applied to clean, dry skin. After removing the protective film, stick the patch on the painful area of the body, leveling its surface. To remove the patch, it must first be moistened with warm water for several minutes. Use water to clean areas of the skin where the patch has been applied. Wash your hands after applying or removing the patch. After removing the patch, it should be folded in half and disposed of out of reach of children and pets. Side effects The most common adverse effects associated with topical application of ketoprofen are localized skin reactions that may spread beyond the site of application. Adverse effects are classified according to MedDRA by organs and systems. The frequency of occurrence is defined as follows: very often (≥1/10); often (≥1/100, <1/10); infrequently (≥1/1000, <1/100); rarely (≥1/10,000, <1/1000); very rarely (<1/10,000), including individual messages. From the immune system: hypersensitivity reactions may include non-specific reactions and anaphylaxis; very rarely - angioedema and anaphylaxis with systemic and local use of ketoprofen. From the skin and subcutaneous tissues: infrequently - itchy rash, erythema, itching, burning, eczema and mild short-term dermatitis; rarely - urticaria, rashes, photosensitivity reactions, rupture of blisters, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis and Stevens-Johnson syndrome; cases of more severe skin reactions, such as bullous and phlyctenular eczema, are described, which can intensify and spread; very rarely - severe contact dermatitis has been described in a patient due to poor hygiene and exposure to sunlight. A severe, prolonged, diffuse contact photoallergic reaction may occur. Ketoprofen may cause prolonged photosensitivity even after one application. Toxic epidermal necrolysis has been described. From the urinary system: very rarely - worsening of renal failure. Contraindications to the use of NSAID-induced asthma in history; hypersensitivity to thiaprofenic acid, fenofibrate, bezafibrate, ciprofibrate, oxybenzone, tk. possible cross-sensitivity with ketoprofen; open wounds, infected abrasions, burns, weeping dermatoses, eczema at the site of application of the patch; ulcerative colitis, exacerbation of peptic ulcer; decompensated heart, liver and kidney failure; pregnancy; breastfeeding period; exposure to direct sunlight (even in cloudy weather) and a visit to the solarium during treatment and 2 weeks after its completion; hypersensitivity or photosensitivity to ketoprofen or any other components of the drug, as well as sensitivity to octocrylene. The use of the drug in children is not recommended, since the safety of use has not been established. Application during pregnancy and lactation The use of the patch during pregnancy and during breastfeeding is contraindicated. Use in Hepatic Impairment The patch should be used with caution in patients with hepatic impairment. Use in Impaired Renal Function The patch should be used with caution in patients with renal insufficiency. Use in Elderly Patients NSAIDs should be used with extreme caution in elderly patients who are more likely to develop adverse reactions. Use in children Not recommended for use in children, tk. the safety of use in children has not been established. Special instructions The likelihood of developing systemic side effects with topical application of ketoprofen is negligible compared with the use of oral forms, but it is not excluded when the drug is used on relatively large areas of the skin for a long time. Topical application of ketoprofen may provoke hypersensitivity reactions, including an asthma attack, in sensitive individuals. To minimize the occurrence of adverse reactions, it is recommended to use the drug at the lowest effective dose for the shortest period necessary to control symptoms. The KetoPlastin patch is recommended to be used only on intact skin areas, avoiding contact with inflamed, damaged or infected skin. Avoid contact of the drug with eyes and mucous membranes. Do not use a patch with an occlusive dressing. If a skin rash occurs after applying the patch, the patient should immediately stop treatment and consult a doctor. Do not use KetoPlastin concomitantly with other topical NSAIDs. In case of severe pain syndrome, on the recommendation of a doctor, the simultaneous use of the KetoPlastin patch with other dosage forms of Ketoprofen (capsules, tablets, suppositories) is permissible. The maximum total daily dose of Ketoprofen should not exceed 200 mg. The patch should be used with caution in patients with renal, cardiac or hepatic insufficiency, with a history of peptic ulcer, inflammatory bowel disease or hemorrhagic diathesis. NSAIDs should be used with extreme caution in elderly patients who are more likely to develop adverse reactions. Patients should be warned against exposure to direct sunlight and tanning beds to reduce the risk of photosensitivity. During the application of the KetoPlastin patch and for 2 weeks after the end of treatment, skin areas that have been exposed to Ketoprofen must be protected with clothing to avoid exposure to UV radiation and photosensitivity. Influence on the ability to drive vehicles and control mechanisms Does not affect. Overdose Cases of overdose when using KetoPlastin are not described. Treatment: if ketoprofen is ingested, symptomatic therapy is carried out. Drug Interactions There are no data on interactions with other drugs when applied topically. Terms of dispensing from pharmacies The drug is dispensed by prescription. It is included in the list of medicines sold without a doctor's prescription, according to the Appendix to the Decree of the Ministry of Health of the Republic of Belarus dated April 10, 2019 No. 27. Storage conditions of the drug The drug should be stored in its original packaging, out of the reach of children, protected from moisture and light at a temperature not exceeding °C. Shelf life of the drug Shelf life - 3 years. Buy KetoPlastin patch 30mg №3 Price for KetoPlastin patch 30mg №3Instruction for use for KetoPlastin patch 30mg №3
INN | KETOPROFEN |
---|---|
The code | 131 621 |
Barcode | 8 806 538 028 040 |
Active substance | Ketoprofen |
Manufacturer | Sinil Pharmaceutical Co. Ltd., Republic of Korea, Cyprus |
Scope of application | Musculoskeletal system |
Indications Applications | For local treatment of pain and reduction of inflammation and swelling of tissues in uncomplicated injuries, incl. sports, sprains or ruptures of ligaments, tendonitis, bruises of muscles and ligaments |
Contraindications | NSAID-induced asthma in history; hypersensitivity to thiaprofenic acid, fenofibrate, bezafibrate, ciprofibrate, oxybenzone, tk. possible cross-sensitivity with ketoprofen; open wounds, infected abrasions, burns, weeping dermatoses, eczema at the site of application of the patch; ulcerative colitis, exacerbation of peptic ulcer; decompensated heart, liver and kidney failure; pregnancy; breastfeeding period; exposure to direct sunlight (even in cloudy weather) and a visit to the solarium during treatment and 2 weeks after its completion; hypersensitivity or photosensitivity to ketoprofen or any other components of the drug, as well as sensitivity to octocrylene. The use of the drug in children is not recommended, since the safety of use has not been established. |
Use during pregnancy and lactation | Forbidden to use |
Age category | 16+ |
Application Gender | Any |
Release Form | patch |
Composition Means | ketoprofen – 30 mg |
Importer | Closed joint-stock company "Unipharm", 223060, Minsk region, Novodvorsky s / council, 40-1, room. 36, area of the village of Bolshoye Stiklevo; LLC "LIGMATON", Republic of Belarus, Minsk region, Minsk district, Senitsky s / s, 68/3-3, Senitsa district., 223056; Trade private unitary enterprise "Kapsipharm", 223016 Minsk district, Novodvorsky s / s, 6-18 |
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