Name:
Ketoprofen gel dnar.prim.25mg in tubes 30g in pack â„–1
Description:
Colorless transparent or almost transparent gel, homogeneous in consistency with a fragrant odor. Air bubbles are allowed. The main active ingredient Ketoprofen Form of release gel Dosage 2.5% 30 g Pharmacological properties Pharmacodynamics With the appropriate composition of excipients, ketoprofen reaches the inflammation zone through the skin, thus providing the possibility of local treatment of lesions of the joints, tendons, ligaments and muscles, accompanied by pain. Pharmacokinetics After oral administration of a single dose of ketoprofen, its maximum concentration in the blood is reached within 2 hours. The half-life of ketoprofen from plasma ranges from 1 to 3 hours. Plasma protein binding is 60-90%. Excretion occurs mainly in the urine, in the form associated with glucuronic acid; approximately 90% of the administered dose is excreted within 24 hours. Absorption of the drug administered through the skin, on the contrary, is very slow. Even with the introduction of 50 to 150 mg of ketoprofen through the skin, the concentration of the active substance in the blood plasma after 5-8 hours is 0.08-0.15 μg / ml. Indications for use Topical treatment for pain in muscles, bones or joints of rheumatic or traumatic origin: for example, bruises, sprains, muscle strains, neck stiffness, lumbago. Dosage and administration Ketoprofen gel should be applied topically. It is applied to the affected area 1-3 times a day. The recommended duration of treatment is no more than 7 days. For better absorption, the application of the gel should be accompanied by light rubbing. With one application, a strip of gel 5-10 cm long (2 g) is applied. Use during pregnancy and lactation In the first and second trimester In a study on mice and rats, teratogenic or embryotoxic effects were not observed. A small embryotoxic effect was noted in a rabbit study, probably related to maternal toxicity. Since studies on the safety of ketoprofen in pregnant women have not been conducted, its use in the first and second trimester of pregnancy should be avoided. In the third trimester of pregnancy All prostaglandin synthesis inhibitors, including ketoprofen, cause toxic damage to the cardiopulmonary system and kidneys in the fetus. At the end of pregnancy, both the mother and the child may experience prolonged bleeding time. In this regard, ketoprofen is contraindicated in the third trimester of pregnancy. Application during lactation There are no data on the transition of ketoprofen into mother’s milk. Ketoprofen is not recommended for use in nursing mothers. Precautions The gel should be used with caution in patients with cardiac, hepatic or renal insufficiency. Isolated cases of systemic side effects associated with kidney damage have been reported. Topical application of large amounts of the drug can lead to systemic effects such as hypersensitivity or asthma. If a rash occurs, treatment with the drug should be discontinued. During the period of treatment with the drug, as well as in the next 2 weeks, direct sunlight, including solariums, should be avoided. The recommended duration of treatment should not be exceeded, as the risk of developing contact dermatitis and photosensitivity reactions increases over time. Wash your hands thoroughly after each use of the medicine. With the development of any skin reactions, including those associated with the concomitant use of products containing octocrylene, treatment with the gel should be stopped immediately. In order to avoid the development of skin photosensitivity, it is recommended to protect the areas to which the drug is applied with clothing – during treatment and for two weeks after its termination. The use of the gel should not be combined with the wearing of an occlusive dressing. The gel should not come into contact with mucous membranes or eyes. The gel should not be applied to areas of the skin where there are signs of damage, such as eczema, acne, infection or open wounds. Patients with asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis have an increased risk of allergic reactions to aspirin and/or NSAIDs compared to the general population. Use in the elderly When prescribing the drug to elderly patients, dose adjustment is not required. Use in children The safety and efficacy of Ketoprofen Gel in children has not been established. Interaction with other drugs There have been no reports of the interaction of Ketoprofen gel with other drugs. Interactions with other medicinal products are unlikely because of the local application of the concentration of the drug in the blood is low. However, it is recommended to conduct regular examination of patients taking coumarin drugs. Contraindications Ketoprofen is contraindicated in the following cases: hypersensitivity to ketoprofen and/or to any of the excipients of the drug; any history of photosensitivity reactions; known hypersensitivity reactions, such as asthma symptoms, allergic rhinitis or urticaria, which occurred during the use of ketoprofen, fenofibrate, thiaprofenic acid , acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); a history of skin manifestations of allergies when using ketoprofen, thiaprofenic acid, fenofibrate, UV blockers or perfume products; exposure to sunlight (even diffused light) or UV radiation in a solarium during gel treatment and within 2 weeks after its termination; ketoprofen is contraindicated in patients with hypersensitivity to any of the excipients of the drug; the gel should not be used on skin areas damaged and altered by a pathological process, for example , eczema, acne, various dermatoses, open wounds or infectious lesions, as well as on the area around the eyes; third trimester of pregnancy (see. section “Precautions”) Composition 1 g of gel contains: active ingredient: ketoprofen – 25 mg; excipients: carbomer 980, ethyl alcohol 96%, lavender oil, macrogol 400, diethanolamine, purified water. Overdose When applied topically, overdose is unlikely. If the gel is accidentally swallowed, systemic side effects may develop, the severity of which depends on the amount of the drug swallowed. However, with the development of overdose phenomena, symptomatic and supportive treatment should be carried out, corresponding to the treatment for overdose of anti-inflammatory drugs. Side effects Like all medicines, Ketoprofen can cause side effects, although not everybody gets them. Localized skin reactions have been reported, which may subsequently extend beyond the site of drug application. Rare events include cases of more pronounced reactions, such as bullous or phlyctenular eczema, which can spread and become generalized. The frequency and severity of these effects are significantly reduced by limiting exposure to sunlight (even diffused light) or UV exposure in a solarium during gel treatment and for 2 weeks after its cessation. Other side effects of anti-inflammatory drugs (hypersensitivity, disorders of the gastrointestinal tract and kidneys) depend on the penetration of the active ingredient through the skin and, therefore, on the amount of gel applied, the surface area treated, the integrity of the skin, the duration of treatment and the use of occlusive dressings. Since entering the market, the following side effects have been reported. They are listed by organs and organ systems and classified according to the frequency of occurrence: very often (?1/10); often (? 1/100 to <1/10); infrequently (? 1/1000 to <1/100); rarely (?1/10,000 to <1/1000); very rarely (<1/10,000); the frequency is unknown (it is impossible to determine the frequency from the available data). Immune system disorders Frequency unknown: anaphylactic reactions, hypersensitivity reactions, angioedema. Gastrointestinal disorders Very rare: peptic ulcer, gastrointestinal bleeding, diarrhoea. Skin and subcutaneous fat disorders Uncommon: erythema, itching, eczema, burning sensation. Rare: photosensitivity reactions, urticaria. Cases of more severe skin reactions, such as bullous or phlyctenular eczema, are described, which can spread and become generalized. Very rare: contact dermatitis. Frequency unknown: bullous dermatitis. Renal and urinary disorders Very rare: acute renal failure, worsening of renal failure. Elderly patients are more susceptible to adverse reactions to non-steroidal anti-inflammatory drugs. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Buy Ketoprofen gel 25mg/g 30g Price for Ketoprofen gel 25mg/g 30g
INN | KETOPROFEN |
---|---|
The code | 14 324 |
Barcode | 4 810 201 005 119 |
Dosage | 25mg/g 30g |
Active substance | Ketoprofen |
Manufacturer | Borisovsky ZMP, Belarus |
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