Each sheet (10cm x 7cm) contains: Ketoprofen 30 mg.
Pharmacotherapeutic group: Antiinflammatory preparations, non-steroids for topical use.
Pharmacology: Pharmacodynamics: Mechanism of action: Ketoprofen is an inhibitor of both the cyclo-oxygenase and lipoxygenase pathways. In addition, ketoprofen is a powerful inhibitor of bradykinin (a chemical mediator of pain and inflammation).
Pharmacodynamic effects: Inhibition of prostaglandin synthesis provides for potent anti-inflammatory, analgesic and antipyretic effects. Lipoxygenase inhibitors appear to attenuate cell-mediated inflammation and thus retard the progression of tissue destruction in inflamed joints. Ketoprofen stabilises the lysosomal membranes against osmotic damage and prevents the release of lysosomal enzymes that mediate tissue destruction in inflammatory reactions.
Pharmacokinetics: Absorption: Ketoprofen can be applied topically in effective concentrations, but with very low plasma concentrations of drug. Therapeutic levels in the affected tissues provide relief from pain and inflammation.
Distribution: Ketoprofen is 95-99% bound to plasma proteins. Significant levels of ketoprofen have been found in tonsillar tissue and in the synovial fluid following systemic administration.
Biotransformation: Ketoprofen is extensively metabolised: approximately 60-80% of the product administered systemically is found in the form of metabolites in the urine.
Elimination: Elimination is rapid and takes place essentially via the renal route: 50% of the product administered systemically is excreted in the urine within 6 hours.
Ketoprofen is used to relieve mild to moderate pain.
Remove the nonwoven fabric and then apply to the affected part twice daily.
Patients with hypersensitivity to any ingredients of this product.
Patients with aspirin asthma (asthmatic attack due to NSAIDs) or patients with a history thereof (It may cause asthmatic attack).
History of hypersensitivity to the following drugs: Tiaprofenic Acid, Fenofibrate, Bezafibrate, Ciprifibrate, Oxybenzone (It may cause cross-hypersensitivity).
Pregnant woman of the last trimester.
Pediatrics below 18 years or age.
The medicine should be administered with care in the following patients: 1) Patients with bronchial asthma (It may cause asthmatic attack; 2) Undergoing therapy; 3) Pregnant woman and Nursing mothers. (Safety has not been established. Therefore, massive or broad application over prolonged period should be avoided.)
General caution: 1) Avoid outdoor activities regardless of weather during use of this drug and until 2 weeks after using the preparation. Also, cover the applied site of this drug with clothes, sunglass, cap or sun-block. Because white or thin clothes can penetrate ultra-violet, wear colored clothes. (Photosensitivity due to ultraviolet has been reported.)
2) The treatment using an anti-inflammatory and analgesic drug is not a casual therapy but a symptomatic therapy.
Caution in application: 1) Do not use to the eye or mucosa.
2) When this product is used to affected part with injury, eczema or exanthema, it can occur feeling of skin contraction or smarting pain. Therefore caution in use is required.
3) Do not use for tinea pedis or dermatophytosis, etc.
4) Do not use for occlusive dressing.
Use in Pregnancy & Lactation: 1) The contraction of fetus artery is reported in the study of terminal stage pregnant rats that this product was orally administered.
2) It is reported that the renal failure and continuous fetal circulation of a fetus occurred by administration (oral, injection, rectal infusion) of this product in late pregnancy.
3) The prolonged use of this product with large dose or to wide affected parts should be avoided in pregnant or some who may be pregnant and some in lactation as its safety during pregnancy and lactation has not yet been established.
4) In rat with this drug during late pregnancy, premature closure of the ductus arteriosus has been reported. In oral administration during late pregnancy (oral, injection, rectal infusion). Persistent fetal circulation (PFC) and fetus renal failure have been reported.
Use in Children: The safety of this product in children has not been established.
Use in Pregnancy & Lactation: 1) The contraction of fetus artery is reported in the study of terminal stage pregnant rats that this product was orally administered.
2) It is reported that the renal failure and continuous fetal circulation of a fetus occurred by administration (oral, injection, rectal infusion) of this product in late pregnancy.
3)The prolonged use of this product with large dose or to wide affected parts should be avoided in pregnant or some who may be pregnant and some in lactation as its safety during pregnancy and lactation has not yet been established.
4) In rat with this drug during late pregnancy, premature closure of the ductus arteriosus has been reported. In oral administration during late pregnancy (oral, injection, rectal infusion). Persistent fetal circulation (PFC) and fetus renal failure have been reported.
In the following cases, discontinue using this drug immediately and consult physician, pharmacist or dentist with the enclosed paper: 1) Rarely anaphylactoid reaction (similarity of hypersensitivity such as urticaria, dyspnea, facial edema) may occur. In the occurrence of such symptoms, therapy should be discontinued.
2) May cause asthmatic attack. In the occurrence of initial symptom such as dry rale, strider, dyspnea, therapy should be discontinued. Asthmatic attack occur within hours after application.
3) Bleberosion, contact dermatitis such as irritation and swelling, dry skin and pigmentation may occur. Photosensitivity may occur with sunlight. Exanthem can be expanded systemically. In such severe case, therapy should be discontinued.
4) If any improvement is not shown after one month of therapy, it is discontinued and patients consult physician or pharmacist.
Store below 30°C.
Shelf Life: 36 months.
M02AA10 - ketoprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
KefenTech plaster 30 mg
20 × 7's
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