Flamax, 50 mg/ml 2 ml 10 pcs

Pharmgroup:

NSAIDs.

Pharmic action:

Flamax is a non-steroidal anti-inflammatory drug, a propionic acid derivative.
It has analgesic, anti-inflammatory and antipyretic effects, inhibits platelet aggregation.
By affecting cyclooxygenase and lipooxygenase link of arachidonic acid metabolism, ketoprofen inhibits the synthesis of prostaglandins, leukotrienes and thromboxanes.

The analgesic effect is due to both central and peripheral mechanisms.
It has anti-bradykinin activity, stabilizes lysosomal membranes.

Pharmacokinetics:

Distribution.

Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly to albumin. The maximum concentration of the drug in plasma (Cmax) is reached quickly due to the low volume of distribution (0.1-0.2 l/kg). The equilibrium concentration of ketoprofen is reached 24 hours after the start of its regular administration. Ketoprofen penetrates well into the synovial fluid and connective tissues.

Significant levels of concentrations in synovial fluid are reached as early as 15 minutes after a single intramuscular injection of 100 mg of ketoprofen. Although ketoprofen concentrations in synovial fluid are somewhat lower than in plasma, they are more stable (persisting for up to 30 hours), resulting in long-term reduction of pain and joint stiffness.

Metabolism, excretion.

Ketoprofen is mainly metabolized in the liver, where it undergoes glucuronization to form glucuronic acid esters, excreted mainly by the kidneys. Excretion with feces is less than 1%. The half-life of ketoprofen varies from 1.6 to 1.9 hours. It does not cumulate.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system:

– rheumatoid arthritis;
– seronegative arthritis: ankylosing spondylitis (Bechterew’s disease), psoriatic arthritis, reactive arthritis (Reiter’s syndrome);
– gout, pseudopodagra;
– osteoarthritis.

Pain syndrome:

– tendinitis, bursitis, myalgia, neuralgia, radiculitis;
– migraine;
– posttraumatic and postoperative pain syndrome;
– pain syndrome in cancer;
– algodysmenorrhea.

Flamax is intended for symptomatic therapy, to reduce pain and inflammation at the time of use, has no effect on the progression of the disease.

Active ingredient

Composition

1 ampoule (2 ml) contains ketoprofen 100 mg;

excipients:

propylene glycol;

ethanol (ethyl alcohol 95% in terms of 100% substance);

benzyl alcohol;

Sodium hydroxide;

Injectable water.

How to take, the dosage

Intravenous infusion: 100 mg (1 ampoule) 1-2 times a day.

Intravenous infusion of Flamax should be performed only in a hospital setting.

Short intravenous infusion: 100-200 mg (1-2 ampoules) of the drug diluted in 100 ml of 0.9% sodium chloride solution is infused for 0.5-1 hour. It is possible to administer it again after 8 hours.

Continuous intravenous infusion: 100-200 mg (1-2 ampoules) 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 within 8 hours.

The maximum dose is 200 mg/day.

The lowest effective dose should be used for the shortest possible course.

Interaction

When concomitant use of Flamax® and “loop” diuretics the nephrotoxic effect of both drugs is increased. Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiaggregants, fibrinolytics, ethanol, the side effects of glucocorticosteroids and mineralocorticosteroids, estrogens; reduces the effectiveness of hypotensive drugs and diuretics.

Simultaneous use with other NSAIDs, glucocorticosteroids, ethanol, corticotropin may lead to ulceration and gastrointestinal bleeding, increased risk of renal dysfunction. Concomitant use with oral anticoagulants, heparin, thrombolytics, antiaggregants, cefaperazone, cefamandole and cefotetan increases the risk of bleeding.

Induces hypoglycemic effect of insulin and oral hypoglycemic drugs (recalculation of the dose is necessary). Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase production of hydroxylated active metabolites.
Co-use with sodium valproate decreases platelet aggregation.

Increases plasma concentrations of verapamil and nifedipine, lithium drugs, methotrexate.
Antacids and colestyramine decrease absorption.

It increases hematotoxicity of myelotoxic drugs.

To avoid sedimentation, Flamax and tramadol should not be mixed in the same bottle.

Special Instructions

When concomitant use of Flamax® and warfarin or lithium preparations, patients should be under close medical supervision. Caution should be exercised when prescribing the drug to patients with a history of gastrointestinal ulcers, renal or hepatic insufficiency, as well as those receiving coumarin anticoagulants. Like other drugs of this group, it may mask the symptoms of infectious diseases.

The peripheral blood count and the functional status of the liver and kidneys should be monitored during treatment.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Dose reduction and close monitoring are necessary if liver and renal function are impaired.

In order to reduce the risk of gastrointestinal adverse events, the lowest effective dose should be used for the shortest possible course.

Impact on driving and operating machinery

At the time of treatment, caution should be exercised when driving motor vehicles and engaging in other potentially hazardous activities that require increased concentration and quick psychomotor reactions.

Contraindications

“Aspirin” asthma, gastric and duodenal ulcer (acute condition), ulcerative colitis (acute condition), Crohn’s disease, diverticulitis, peptic ulcer, coagulation disorders (including hemophilia), renal and liver failure, childhood and adolescence under 18 years, pregnancy (III trimester).

Side effects

The following side effects (possibly related to the use of ketoprofen) have been reported in clinical trials:

Gastrointestinal organs: dyspepsia (11%); 3-9% – nausea, abdominal pain, diarrhea/ constipation, flatulence; >1% – anorexia, vomiting, stomatitis;

Nervous system and sensory organs: 3-9% – headache, agitation (incl.ч. Insomnia, nervousness, unusual dreams); >1% – dizziness, CNS depression (incl. sleepiness, malaise), tinnitus, visual disturbances;

Cardiovascular system and blood (hematopoiesis, hemostasis):

Respiratory system disorders: >1% – dyspnea, hemoptysis, nasal bleeding, pharyngitis, rhinitis, bronchospasm, laryngeal edema.

Urinary system disorders: 3-9% – renal dysfunction (edema, increased blood urea nitrogen); >1% – symptoms and signs of urinary tract irritation;

Skin disorders: >1% – rash, alopecia, eczema, pruritis, urticaria, bullous rash, exfoliative dermatitis, photosensitization, skin color changes, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Overdose

No cases of overdose have been described.

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

Treatment: symptomatic.

Similarities