Flamax ampoules 50 mg / ml, 2 ml, 10 pcs. (Ketoprofen)

Latin name

Flamax

Release form

Solution for intravenous and intramuscular administration.



packaging 10 pcs

Indications

Inflammatory and degenerative diseases of the musculoskeletal system, including rheumatoid arthritis, nonspecific spondylitis (ankylosing and psoriatic spondylitis), gouty arthritis, pseudogout, osteoarthritis, extra-articular rheumatism (tendovaginitis, bursitis, capsulitis). Relief of pain syndrome of various origins, including postoperative, post-traumatic pain, sciatica, myalgia, sciatica, bruises and muscle strains, renal colic, pain syndromes in dental, gynecological, neurological, oncological practice. Symptomatic treatment of acute pain syndrome in inflammatory diseases of the musculoskeletal system (only for i / m administration). Primary dysmenorrhea.

Contraindications

“Aspirin” asthma, gastric and duodenal ulcer (exacerbation), ulcerative colitis (exacerbation), Crohn's disease, diverticulitis, peptic ulcer, disorders of the blood coagulation system (including hemophilia, hepatic insufficiency), children and adolescents under 18 years of age, pregnancy (III trimester).

Special instructions

When using FlamaxВ® and warfarin or lithium preparations at the same time, patients should be under strict medical supervision. Caution must be exercised when prescribing the drug to patients with a history of gastrointestinal ulcer, renal or hepatic insufficiency, as well as 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 it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

In case of impaired liver and kidney function, a dose reduction and careful monitoring are necessary.

To reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used with the lowest possible short course.

Influence on the ability to drive vehicles and control mechanisms

During the treatment period, care must be taken when driving vehicles and engaging in other potentially dangerous activities, requiring increased concentration of attention and speed of psychomotor reactions.

Composition

1 ampoule (2 ml) contains ketoprofen 100 mg

excipients: propylene glycol ethanol (95% ethyl alcohol based on 100% substance) benzyl alcohol sodium hydroxide water for injection

Dosage and administration of

V / m introduction: 100 mg (1 amp. ) 1-2 times a day.

IV infusion of Flamax should be carried out only in a hospital setting.

Short intravenous infusion: 100-200 mg (1-2 amp.) of the drug, diluted in 100 ml of 0.9% sodium chloride solution, is administered within 0.5-1 hours. Repeated administration after 8 hours is possible.

Continuous IV infusion: 100-200 mg (1-2 amp.) Of the drug, diluted in 500 ml of infusion solution (0.9% sodium chloride solution, lactate-containing Ringer's solution, 5% dextrose solution), is administered for 8 hours.

Perhaps repeated administration after 8 hours.

The maximum dose is 200 mg / day.

Use the smallest effective dose with the smallest possible short course.

Side effects of

In clinical trials, the following side effects were noted (possibly associated with the use of ketoprofen): From the digestive tract: dyspepsia (11%) 3–9% - nausea, abdominal pain, diarrhea / constipation, flatulence> 1% - anorexia, vomiting, stomatitis On the part of the nervous system and sensory organs: 3–9% - headache, agitation (including insomnia, nervousness, unusual dreams)> 1% - dizziness, depression of the central nervous system (including drowsiness , malaise), tinnitus, visual impairment On the part of the cardiovascular systems and blood (hematopoiesis, hemostasis): From the respiratory system:> 1% - dyspnea, hemoptysis, nosebleeds, pharyngitis, rhinitis, bronchospasm, laryngeal edema.

From the genitourinary system: 3–9% - impaired renal function (edema, increase in blood urea nitrogen)> 1% - symptoms and signs of urinary tract irritation From the skin:> 1% - rash, alopecia, eczema, pruritis, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Drug Interactions

With the simultaneous use of Flamax® and “loop” diuretics, the nephrotoxic effect of both drugs is enhanced. Reduces the effectiveness of uricosuric drugs, enhances the action of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of glucocorticosteroids and mineralocorticosteroids, estrogen reduces the effectiveness of antihypertensive drugs and diuretics.

Concomitant use with other NSAIDs, glucocorticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, to an increased risk of impaired renal function. Concomitant use with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefaperazone, cefamandol and cefotetan increases the risk of bleeding.

Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation required). Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Co-administration with sodium valproate results in decreased platelet aggregation.

Increases the plasma concentration of verapamil and nifedipine, lithium preparations, methotrexate.

Antacids and colestyramine decrease absorption.

Enhances hematotoxicity of myelotoxic drugs.

To avoid sediment, do not mix Flamax and tramadol in one bottle.

Overdose

Overdose has not been reported.

Symptoms: dizziness, vomiting, headache, shortness of breath, abdominal pain, bleeding, liver and kidney dysfunction may occur.

Treatment: symptomatic.

Storage Conditions

In a dark place at a temperature not exceeding 25 ° C.

Shelf life

3 years.

The active substance

Ketopr fan

Terms and conditions

prescription

Dosage form

injection for injection

Possible Product Names

FLAMAX 0.05 / ML 2ML N10 AMP R-V / V / M

Flamax 50 mg / ml 2 ml No. 10 amp

Flamax 50mg / ml r d / vv / vm / vvv. 2 ml Amp.t / s X10 B (R)

Flamax ampoules 50 mg / ml, 2 ml, 10 pcs.

FLAMAX RR I / O and I / O 50MG / ML 2ML No. 10



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