Flamax capsules 50 mg 25 pcs.
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Active ingredients
Ketoprofen
Composition
1 caps ketoprofen 50 mg. Excipients: lactose monohydrate - 84 mg, microcrystalline cellulose - 90.
Pharmacological effect
NSAID, a derivative of propionic acid. It has analgesic, anti-inflammatory and antipyretic effects, inhibits platelet aggregation. By acting on the cyclooxygenase and lipoxygenase metabolism of arachidonic acid, ketoprofen inhibits the synthesis of prostaglandins, leukotrienes and thromboxanes. The analgesic effect is due to both central and peripheral mechanisms.
Pharmacokinetics
Absorption: After taking the drug inside the Cmax of dexketoprofen in human serum, an average of 30 minutes (15-60 minutes) is achieved. Simultaneous ingestion slows down the absorption of the drug. The values of AUC after single and repeated doses are similar, which indicates the lack of cumulation of the drug. After i / m administration of dexketoprofen, Cmax in the serum is reached on average after 20 minutes (10-45 minutes). AUC after a single injection in a dose of 25-50 mg is proportional to the dose, as with the / m, and with a / in the introduction. The corresponding pharmacokinetic parameters are similar after a single and repeated intramuscular or intravenous administration, which indicates the absence of drug accumulation. Distribution: Dexketoprofen is characterized by a high level of plasma protein binding - 99%. The average value of Vd is less than 0.25 l / kg, the half-time is about 0.35 hours. Metabolism and excretion: Dexketoprofen metabolism mainly occurs by conjugation with glucuronic acid, followed by excretion by the kidneys. T1 / 2 of dexketoprofen trometamol is about 1-2.7 hours. Pharmacokinetics in special clinical situations: In elderly people, an increase in the duration of T1 / 2 is observed (both after a single dose and after repeated intramuscular or intravenous administration) to an average of 48 % and a decrease in the total clearance of the drug.
Indications
Inflammatory and degenerative diseases of the musculoskeletal system: - rheumatoid arthritis - psoriatic arthritis - ankylosing spondylitis (ankylosing spondylitis) - gouty arthritis (with an acute attack of gout, fast-acting dosage forms are preferred) - osteoarthritis.Pain syndrome: - myalgia, ossalgia, arthralgia - neuralgia - tendonitis, bursitis - radiculitis - adnexitis - otitis media - headache - toothache - for oncological diseases - post-traumatic and postoperative pain syndrome, accompanied by inflammation - algodismenorrhea.
Contraindications
- a history of bronchial asthma caused by ketoprofen, other NSAIDs or acetylsalicylic acid - recurrent gastric ulcer and duodenal ulcer - peptic ulcer - severe hepatic failure - severe renal failure - circulatory failure - gastrointestinal, gastrointestinal, gastrointestinal failure bleeding) - hemophilia and other bleeding disorders - ulcerative colitis, Crohn's disease, diverticulitis - pregnancy - varnish period ation (breastfeeding) - Children under 15 years old - Hypersensitivity to ketoprofen or to any component of the drug. Caution should be given to the drug for anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, liver and kidney (because the drug is mainly excreted by the kidneys) deficiency, diabetes, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, ischemic heart disease, blood diseases (including leukopenia), stomatitis, in childhood (over 15), in old age.
Use during pregnancy and lactation
The use of ketoprofena is contraindicated during pregnancy and lactation.
Dosage and administration
The drug is taken orally during the meal. With rheumatic diseases - 1 caps. in the morning, 1 caps. - in the afternoon and 2 caps. - in the evening or 1 caps. 4 times / day Perhaps the combined use of dosage forms. In the treatment of pain syndrome and algodimenorrhea, the dose, if necessary, is 50 mg of ketoprofen every 6-8 hours. The dose to patients with renal insufficiency is reduced to 33-50%, in elderly patients the dose is adapted to age. The maximum daily dose is 300 mg. Flamax forte Assign an adult on 1 tab. 2-3 times / day (every 8 hours). The maximum daily dose is 300 mg.
Side effects
Nervous system disorders: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy. On the part of the senses: noise or tinnitus, blurred vision, conjunctivitis, dryness of the mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, vertigo. Since the cardiovascular system: increased blood pressure, tachycardia. On the part of the respiratory system: hemoptysis, dyspnea, bronchospasm, rhinitis, laryngeal edema, nose bleeding, shortness of breath. On the part of the digestive system: NSAID-gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, loss of appetite, diarrhea), stomatitis; change in taste, ulceration and perforation of the mucous membrane of the gastrointestinal tract, gingival, gastrointestinal, hemorrhoidal bleeding; increased activity of hepatic transaminases with serum, hepatitis. From the side of blood-forming organs: rarely - agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia. On the part of the urinary system: edema syndrome, cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria. On the part of the skin: skin rash, alopecia and eczema, exudative erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), photodermatitis. Allergic reactions: skin rash (including erythematous, urticaria), itchy skin, rhinitis, angioedema, exfoliative dermatitis, anaphylactic shock. Other: increased sweating, myalgia, muscle twitching, thirst, vaginal bleeding.
Overdose
Symptoms: drowsiness, nausea, vomiting, abdominal pain, bleeding, liver and kidney dysfunction may occur. Treatment: symptomatic treatment, gastric lavage and / or activated carbon and / or other sorbents. There is no specific antidote.
Interaction with other drugs
Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of glucocorticoids and mineralocorticoids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics. Simultaneous use with other NSAIDs, GCS, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, to an increased risk of developing renal dysfunction.Simultaneous use with oral anticoagulants, heparin, thrombolytic agents, antiplatelet agents, cefoperazone, cefamundol, and cefotetan increases the risk of bleeding. Ketoprofen enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is needed). The inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Simultaneous use with sodium valproate causes a violation of platelet aggregation. Increases plasma concentration of verapamil and nifedipine, lithium preparations, methotrexate. Antacids and colestyramine reduce ketoprofen absorption. Myelotoxic drugs increase the hematotoxicity of the drug.
special instructions
With simultaneous use of ketoprofen and warfarin, as well as coumarin anticoagulants or lithium salts, patients should be under strict medical supervision. Care must be taken when prescribing the drug to patients with peptic ulcers of the gastrointestinal tract in history, renal or hepatic insufficiency. During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys. In case of impaired renal function and liver (increased activity of ALT is the most sensitive indicator of NSAID-induced liver dysfunction), a dose reduction and careful observation is necessary. If necessary, determine the 17-ketosteroids drug should be canceled 48 hours before the study. Like the rest of the drugs in this group, it can mask signs of an infectious disease. With the development of violations of the organs of sight is necessary to consult an ophthalmologist. Impact on the ability to drive vehicles and control mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and psychomotor speed.