Flamax 0.05 ml 2 ml N10 ampoule solution intravenous in oil
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Active ingredients
Ketoprofen
Release form
Solution
Composition
Solution for intravenous and intramuscular administration, composition (1 amp. (2 ml)): active substance: ketoprofen - 100 mg; excipients: propylene glycol - 800 mg; ethanol (95% ethyl alcohol based on 100% substance) - 200 mg; benzyl alcohol - 40 mg; Sodium hydroxide 1M solution - to pH 6.5–7.5; water for injection - up to 2 ml
Pharmacological effect
anti-inflammatory, antipyretic, antiplatelet, analgesic
Pharmacokinetics
Distribution; Up to 99% of ketoprofen binds to plasma proteins, mainly albumin. Cmax in plasma is reached quickly due to low Vd (0.1–0.2 l / kg). Css ketoprofen is achieved 24 hours after the start of its regular intake. Ketoprofen penetrates well into the synovial fluid and connective tissue. A significant concentration in the synovial fluid is reached already 15 minutes after a single intramuscular injection of 100 mg of ketoprofen. Although the concentrations of ketoprofen in synovial fluid are somewhat lower than in plasma, they are more stable (lasting up to 30 hours), as a result of which pain syndrome and stiffness of joints are reduced for a long time. In a significant amount does not penetrate through the BBB .; Metabolism; Ketoprofen is mainly metabolized in the liver, where it undergoes glucuronidation to form esters with glucuronic acid, mainly excreted by the kidneys. It has the effect of first passing through the liver .; Derivation; Excreted mainly by the kidneys. Withdrawal with feces is less than 1%. T1 / 2 ketoprofen ranges from 1.6 to 1.9 hours. It does not accumulate.
Indications
Symptomatic treatment of pain and inflammation of various genesis of moderate intensity: inflammatory and degenerative diseases of the musculoskeletal system - rheumatoid, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (Bechterew's disease), gouty arthritis, rheumatic soft tissue lesions, osteoarthrosis, peripheral and peripherals. H. and with radicular syndrome); ; lumbago, sciatica, neuralgia; ;migraine; ; algomenorrhea, inflammatory processes of the pelvic organs, including adnexitis; ; post-traumatic pain syndrome, accompanied by inflammation; ; postoperative pain; ;toothache; ; pain syndrome in cancer .; The progression of the disease is not affected.
Contraindications
hypersensitivity (includingother NSAIDs or auxiliary components); ; erosive and ulcerative lesions of the gastrointestinal tract in the acute phase; ; bleeding from the digestive tract; ; inflammatory bowel disease in the acute phase (ulcerative colitis, Crohn's disease); ; severe liver failure or liver disease in the acute period; ; severe renal failure (Cl creatinine less than 30 ml / min); progressive kidney disease; hyperkalemia; ; complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history); ; hematopoietic disorder, hemostasis disorders (including hemophilia); ; period after coronary artery bypass surgery; ; pregnancy (III trimester); ; lactation period; ; age up to 15 years .; With care: bronchial asthma; the presence of factors that increase the toxicity of the gastrointestinal tract - alcoholism and cholecystitis, chronic heart failure, edematous syndrome; arterial hypertension, impaired renal function, cholestasis, sepsis, simultaneous use with other NSAIDs, old age (over 65), pregnancy (I – II trimester); coronary heart disease; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease; smoking; chronic renal failure (Cl creatinine 30–60 ml / min); anamnestic data on the development of ulcerative lesions of the gastrointestinal tract; confirmed presence of Helicobacter pylori infection; long-term use of NSAIDs; severe somatic diseases; Concomitant therapy with the following drugs - anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline), GCS (including Prednisone To reduce the risk of adverse events from the gastrointestinal tract, use the minimum effective dose of the shortest possible course.
Use during pregnancy and lactation
With the simultaneous use of the drug Flamax and warfarin or lithium preparations, patients should be under the strict supervision of a physician .; Care must be taken when prescribing the drug to patients with gastrointestinal ulcers in history, kidney or liver failure,as well as receiving coumarin anticoagulants .; Like other drugs in this group, it can mask the symptoms of infectious diseases .; During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys .; If necessary, determine the 17-ketosteroids drug should be canceled 48 hours before the study .; In violation of the liver, kidney, you need a dose reduction and careful observation.; To reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used with the shortest possible course (see “
Dosage and administration
”) .; Influence on ability to drive vehicles and work with 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 reactions.Dosage and administration
In / in, in / m .; V / m introduction: 100 mg (1 amp.) 1-2 times a day .; In / in the infusion of the drug should be carried out only in a hospital. The average infusion time is 0.5–1 h, the maximum is no more than 48 hours, and the dose of the drug should not exceed 300 mg. A short intravenous infusion: 100–200 mg (1–2 amp.) Of the drug diluted in 100 ml of 0.9% sodium chloride solution, injected within 0.5–1 h. Re-administration after 8 hours is possible; Prolonged intravenous infusion: 100–200 mg (1–2 amp.) Of the preparation diluted in 500 ml of solution for infusions (0.9% sodium chloride solution, lactated Ringer’s solution, 5% dextrose solution) is administered within 8 h ; Perhaps re-introduction after 8 h. Combined use; Flamax can be combined with centrally acting analgesics; It can be mixed with morphine in one bottle. It is impossible to mix in one bottle with tramadol due to precipitation. Parenteral administration of Flamax can be combined with the use of oral forms (pills, capsules) or rectal suppositories, and the total daily dose should be increased to 300 mg or reduced to 100 mg depending on the nature of the disease and the patient's condition .; The minimum effective dose should be used with the shortest possible short course (see “Special Instructions”).
Side effects
With the simultaneous appointment of the drug Flamax and loop diuretics nephrotoxic effect of both drugs is enhanced. Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of GCS and mineralocorticosteroids, 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, an increase in the risk of developing renal dysfunction .; Simultaneous use with oral anticoagulants, heparin, thrombolytic agents, antiplatelet agents, cefoperazone, cefamundol, and cefotetan increases the risk of bleeding. Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is required) .; Inductors of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites .; Combined use with sodium valproate leads to a decrease in platelet aggregation .; Increases plasma concentration of verapamil and nifedipine, lithium preparations, methotrexate .; Antacids and colestyramine reduce absorption .; Enhances the hematotoxicity of myelotoxic drugs .; In order to avoid sedimentation, Flamax and Tramadol should not be mixed in one vial .; If the patient is taking other drugs, he should consult a doctor.
Overdose
On the part of the digestive system: abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, loss of appetite, diarrhea), stomatitis, abnormal liver function, changes in taste. With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, gingival, gastrointestinal, hemorrhoidal bleeding .; Nervous system disorders: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, confusion or loss of consciousness, memory impairment, migraine, peripheral neuropathy .; From the sensory organs: noise or tinnitus, blurred vision, conjunctivitis, dryness of the mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss,vertigo .; From the side of the cardiovascular system: increased blood pressure, tachycardia .; On the part of the blood-forming organs: agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia .; On the part of the urinary system: edema syndrome, cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria .; Allergic reactions: skin rash (including erythematous, urticaria), itchy skin, rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock .; Other: increased sweating, hemoptysis, epistaxis, myalgia, muscle twitching, shortness of breath, thirst, photosensitization; with prolonged use in large doses - vaginal bleeding .; If the patient has developed any of the side effects indicated in the instructions, you should consult a doctor as soon as possible. If any of the side effects indicated in the instructions are aggravated or the patient has noticed any other side effects that are not indicated in the instructions, you should inform your doctor.
Interaction with other drugs
Precautionary measures
special instructions
Cases of overdose are not described .; Symptoms: dizziness, vomiting, headache, shortness of breath, abdominal pain, bleeding, liver and kidney dysfunction are possible .; Treatment: symptomatic.