Flamax, 50 mg/ml 2 ml 5 pcs

Pharmgroup:

NSAIDs.

Pharmic action:

Flamax is a nonsteroidal anti-inflammatory drug, a propionic acid derivative.

It has analgesic, anti-inflammatory and antipyretic effects, inhibits platelet aggregation.

Empacting on cyclooxygenase and lipooxygenase link of arachidonic acid metabolism, ketoprofen inhibits the synthesis of prostaglandins, leukotrienes and thromboxanes.
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. Maximal concentration of the drug in plasma (Cmax) is reached quickly due to low volume of distribution (0.1-0.2 l/kg). The equilibrium concentration of ketoprofen is reached 24 hours after the beginning of its regular use.

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 the concentration of ketoprofen in synovial fluid is somewhat lower than in plasma, it is more stable (lasts up to 30 hours), resulting in long-term reduction of pain and stiffness in joints.

Metabolism, excretion. Ketoprofen is mainly metabolized in the liver, where it undergoes glucuronization with the formation of esters with glucuronic acid, excreted mainly by the kidneys. Excretion with feces is less than 1%.

The elimination 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, pseudogout;
osteoarthritis.

Pain syndrome:

tendinitis, bursitis, myalgia, neuralgia, radiculitis;
migraine;
post-traumatic and postoperative pain syndrome;
pain syndrome in cancer;
algodismenorrhea.

Flamax is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

Pharmacological effect

Pharmaceutical group:

NSAIDs.

Pharmaceutical action:

Flamax is a non-steroidal anti-inflammatory drug, a derivative of propionic acid.

It has an analgesic, anti-inflammatory and antipyretic effect, suppresses platelet aggregation.

By acting on the cyclooxygenase and lipoxygenase components 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 and stabilizes lysosomal membranes.

Pharmacokinetics

Distribution.
Up to 99% of absorbed ketoprofen is bound to plasma proteins, mainly albumin. The maximum concentration of the drug in plasma (Cmax) is achieved quickly due to the low volume of distribution (0.1-0.2 l/kg). The equilibrium concentration of ketoprofen is achieved 24 hours after the start of its regular use.

Ketoprofen penetrates well into synovial fluid and connective tissue. Significant concentration levels in the synovial fluid are achieved within 15 minutes after a single intramuscular injection of 100 mg of ketoprofen. Although the concentrations of ketoprofen in synovial fluid are slightly lower than in plasma, they are more stable (lasting up to 30 hours), resulting in a long-term reduction in pain and joint stiffness.

Metabolism, excretion. Ketoprofen is mainly metabolized in the liver, where it undergoes glucuronidation to form esters with glucuronic acid, which are excreted mainly by the kidneys. Excretion in feces is less than 1%.

The half-life of ketoprofen ranges from 1.6 to 1.9 hours. Does not cumulate.

Special instructions

If you are hypersensitive to ketoprofen or other components of the drug, you must consult your doctor before taking it.

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

When using ketoprofen and warfarin simultaneously, as well as coumarin anticoagulants or lithium salts, patients should be under strict medical supervision.

Caution must be exercised when prescribing the drug to patients with a history of peptic ulcers of the gastrointestinal tract, renal or liver failure. During treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary. If renal and liver function are impaired (increased ALT activity is the most sensitive indicator of NSAID-induced liver dysfunction), dose reduction and careful monitoring are necessary.

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

Like other drugs in this group, it can mask signs of an infectious disease.

Impact on the ability to drive vehicles and operate machinery

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

Active ingredient

Ketoprofen

Composition

1 amp. (2 ml) contains ketoprofen 100 mg;

excipients:

propylene glycol;

ethanol (ethyl alcohol 95% calculated as 100% substance);

benzyl alcohol;

sodium hydroxide;

water for injections.

Pregnancy

Flamax is contraindicated during pregnancy, breastfeeding and children under 15 years of age (for tablets).

Contraindications

“aspirin” asthma,
peptic ulcer of the stomach and duodenum (exacerbation),
ulcerative colitis (exacerbation),
Crohn’s disease, diverticulitis,
peptic ulcer,
disorders of the blood coagulation system (including hemophilia),
renal and liver failure.

Side Effects

From the gastrointestinal tract: dyspepsia (11%); 3–9% – nausea, abdominal pain, diarrhea/constipation, flatulence; >1% – anorexia, vomiting, stomatitis; From the nervous system and sensory organs: 3–9% – headache, agitation (including insomnia, nervousness, unusual dreams); >1% – dizziness, central nervous system depression (including drowsiness, malaise), ringing in the ears, blurred vision; From the cardiovascular system 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, increased 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.

From the senses: noise or ringing in the ears, blurred vision, conjunctivitis, dry mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, vertigo.

From the cardiovascular system: increased blood pressure, tachycardia.

From the hematopoietic organs: agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia.

From the urinary system: edema syndrome, cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria.

Allergic reactions: skin rash (including erythematous, urticaria), skin itching, rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock.

Other: increased sweating, hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity; with long-term use in large doses – vaginal bleeding.

Interaction

Flamax can be combined with centrally acting analgesics; can be mixed with morphine in one vial. It should not be mixed in the same vial with tramadol due to sedimentation.

Parenteral administration of the drug Flamax can be combined with the use of oral forms (tablets, capsules) or rectal suppositories, and the total daily dose can be increased to 300 mg or reduced to 100 mg, depending on the nature of the disease and the patient’s condition.

With the simultaneous use of Flamax and loop diuretics, the nephrotoxic effect of both drugs is enhanced.

Ketoprofen reduces the effectiveness of uricosuric drugs.

Enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of glucocorticosteroids and mineralocorticosteroids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.

Simultaneous use with other NSAIDs, corticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, increasing the risk of developing renal dysfunction.

Concomitant use with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandole and cefotetan increases the risk of bleeding.

Ketoprofen enhances the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

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 leads to a decrease in platelet aggregation.

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

Antacids and cholestyramine reduce the absorption of ketoprofen.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Overdose

Cases of overdose have not been described.

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

Treatment: symptomatic.

Storage conditions

In a place protected from light, at a temperature not exceeding 25°C.

Shelf life

3 years.

Manufacturer

PharmFirma Sotex, Russia