Flamax, 50mg/ml ampoules, 2ml, 5pcs

Composition

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

excipients:

propylene glycol;

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

benzyl alcohol;

sodium hydroxide;

water for injection.

Pharmacological action

Pharmaceutical Group:

NSAIDs.

Pharmaceutical action:  

Flamax is a nonsteroidal anti-inflammatory drug derived from propionic acid.

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

Ketoprofen acts on the cyclooxygenase and lipoxygenase components of arachidonic acid metabolism and inhibits the synthesis of prostaglandins, leukotrienes, and thromboxanes. The analgesic effect is caused by both central and peripheral mechanisms. It has anti-radikinin activity, stabilizes lysosomal membranes.

Pharmacokinetics

Distribution. Up to 99% of absorbed ketoprofen binds to plasma proteins, mainly 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 steady-state concentration of ketoprofen is reached 24 hours after the start of its regular intake.

Ketoprofen penetrates well into synovial fluid and connective tissues. Significant levels of synovial fluid concentrations are reached as early as 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 (they last up to 30 hours), as a result of which pain and joint stiffness are reduced for a long time.

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

The half-life of ketoprofen ranges from 1.6 to 1.9 hours. It doesn’t accumulate.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system:

• rheumatoid arthritis;
• seronegative arthritis: ankylosing spondylitis (Ankylosing spondylitis), psoriatic arthritis, reactive arthritis (Reiter’s syndrome);
• gout, pseudogout;
• osteoarthritis.

Pain syndrome:

• tendinitis, bursitis, myalgia, neuralgia, sciatica;
• 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.

Use during pregnancy and lactation

Flamax is contraindicated in pregnancy, lactation 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,
• blood coagulation disorders (including hemophilia),
• kidney and liver failure.

Side effects

Gastrointestinal disorders: 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), tinnitus, visual impairment; Cardiovascular and blood disorders (hematopoiesis, hemostasis):  From the respiratory system: > 1% — dyspnoea, 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; Skin disorders: >1% – rash, alopecia, eczema, pruritis, urticaria, bullous rash, exfoliative dermatitis, photosensitization, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

From the side of the senses:  tinnitus or ringing, blurred vision, conjunctivitis, dry eye mucosa, eye pain, conjunctival hyperemia, hearing loss, vertigo.

From the CCC side:  raising Blood pressure, tachycardia.

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

From the urinary system:  edematous 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 services:  increased sweating, hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitization; with prolonged use in large doses — vaginal bleeding.

Interaction

Flamax can be combined with central-acting analgesics; it can be mixed with morphine in a single bottle. Do not mix in the same bottle with tramadol because of precipitation.

Parenteral use of Flamax can be combined with the use of oral forms (tablets, capsules) or rectal suppositories, while 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.

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

Concomitant use with other NSAIDs, corticosteroids, ethanol, and corticotropin may lead to ulceration and gastrointestinal bleeding, and increase the risk of developing impaired renal function.

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

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

Antacids and colestyramine reduce the absorption of ketoprofen.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

How to take, course of use and dosage

The drug is intended for intravenous and intramuscular use.

I / M introduction:  100 mg (1 ampoule) 1-2 times / day.

Intravenous infusion of the drug should be performed only in a hospital setting. The average infusion time is 0.5-1 h, the maximum-no more than 48 hours, while the dose of the drug should not exceed 300 mg.

Short-term 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. Repeated use is possible after 8 hours.

Prolonged intravenous infusion:  100-200 mg (1-2 ampoules) of the drug diluted in 500 ml of an infusion solution (0.9% sodium chloride solution, Ringer’s solution,5% dextrose solution) for 8 hours. Repeated use is possible after 8 hours.

The minimum effective dose should be used in the shortest possible course.

Overdose

Cases of overdose are not described.

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

Treatment: symptomatic.

Special instructions

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

To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.

Patients with concomitant use of ketoprofen and warfarin, as well as coumarin anticoagulants or lithium salts, should be under strict medical supervision.

Caution should be exercised when prescribing the drug to patients with a history of gastrointestinal ulcers, renal or hepatic insufficiency. During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. In patients with impaired renal and hepatic function (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 of this group, it can mask the signs of an infectious disease.

Influence on the ability to drive motor vehicles and manage mechanisms

During treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Solution for intravenous and intramuscular use

Storage conditions

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

Shelf

life is 3 years.

Active ingredient

Ketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Children over 15 years of age, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Children as prescribed by a doctor, For adults

Indications

Myositis, Swelling after injuries and operations, Osteochondrosis, Bruises, Lumbago, Sciatica, Trigeminal Neuralgia, Arthritis, Bursitis, Osteoarthritis, Gout, Osteoarthritis, Rheumatoid Arthritis