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:

Pain syndrome:

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;

water for injection.

How to take, the dosage

The drug is intended for intravenous and intravenous administration.

Introduction: 100 mg (1 ampoule) 1-2 times/day.

Intravenous infusion of the drug should be carried out only under hospital conditions. The average infusion time is 0.5-1 h, the maximum time is 48 hours; at that the drug dose should not exceed 300 mg.

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

Interaction

Flamax can be combined with centrally acting analgesics; can be mixed with morphine in the same vial. Do not mix in the same vial with tramadol due to precipitation.

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

The nephrotoxic effect of both drugs is increased when Flamax and loop diuretics are used concomitantly.

Ketoprofen reduces the effectiveness of uricosuric drugs.

It enhances the effects of anticoagulants, antiaggregants, fibrinolytics, ethanol, the side effects of glucocorticosteroids and mineralocorticosteroids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.

Simultaneous use with other NSAIDs, GCS, ethanol, corticotropin may lead to ulceration and gastrointestinal bleeding, increased risk of renal dysfunction.

Simultaneous use with oral anticoagulants, heparin, thrombolytics, antiaggregants, cefoperazone, cefamandole and cefotetan increases the risk of bleeding.

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

The inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase production of hydroxylated active metabolites.

Concomitant use with sodium valproate leads to decreased platelet aggregation.

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

Antacids and colestiramine reduce absorption of ketoprofen.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special Instructions

In case of hypersensitivity to ketoprofen or other components of the drug, always consult a physician before taking.

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

Patients should be under close medical supervision when concomitant use of ketoprofen and warfarin and coumarin anticoagulants or lithium salts.

Caution should be exercised when prescribing the drug in patients with a history of gastrointestinal ulcers, renal or hepatic insufficiency. During the treatment it is necessary to monitor peripheral blood count and functional state of liver and kidneys. In patients with impaired renal and hepatic function (increased ALT activity is the most sensitive indicator of NSAID-induced hepatic dysfunction) the dose should be reduced and closely monitored.

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 infectious disease.

Impact on driving and operating machinery

When using the drug, caution must be exercised while driving motor vehicles and engaging in other potentially hazardous activities that require increased concentration and quick psychomotor reactions.

Contraindications

Side effects

Gastrointestinal system: dyspepsia (11%); 3-9% – nausea, abdominal pain, diarrhea/ constipation, flatulence; >1% – anorexia, vomiting, stomatitis; Nervous system and sensory organs: 3-9% – headache, agitation (incl. Insomnia, nervousness, unusual dreams); >1% – dizziness, CNS depression (including drowsiness, malaise), tinnitus, visual disturbances; Cardiovascular system and blood (hematopoiesis, hemostasis): Respiratory system: >1% – dyspnea, hemoptysis, nasal bleeding, pharyngitis, rhinitis, bronchospasm, laryngeal edema.

Urogenital 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.

Senses: tinnitus or ringing in the ears, blurred vision, conjunctivitis, dry mucous membrane of the eye, eye pain, conjunctival hyperemia, decreased hearing, vertigo.

Systemic system disorders: increase in blood pressure and tachycardia.

Hematopoietic disorders: agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia.

Urinary system disorders: 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.

Others: increased sweating, hemoptysis, nasal bleeding, myalgia, muscle twitching, shortness of breath, thirst, photosensitization; with prolonged use in high doses – vaginal bleeding.

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.

Pregnancy use

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

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