Ketoprofen | Flamax ampoules 50 mg / ml, 2 ml, 5 pcs.

Release form

Solution For intravenous and intramuscular administration



packaging 5 pcs

Indications

For the symptomatic treatment of pain and inflammation of various genesis of moderate intensity (does not affect the progression of the disease): inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis, ankylosing spondylitis, under ankylosing spondylitis) soft tissue damage, osteoarthritis of the peripheral joints and spine (including with radicular syndrome)

lumbago, sciatica

neuralgia

migraine

algodismenorea

inflammatory processes of the pelvic organs, including adnexitis

post-traumatic pain syndrome, accompanied by inflammation

postoperative pain

toothache

pain syndrome in cancer.

Contraindications

hypersensitivity (including other NSAIDs or auxiliary components)

erosive and ulcerative lesions of the gastrointestinal tract in the exacerbation phase of

bleeding from the gastrointestinal tract

inflammatory bowel disease in the exacerbation phase (non-acute liver disease) period

severe renal failure (Clcreatinin less than 30 ml / min)

progressive kidney disease

hyperkalemia

complete or incomplete combination bronchial asthma recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history)

impaired hematopoiesis, hemostasis (including hemophilia)

period after coronary artery bypass grafting

age up to 15 years.

With caution: bronchial asthma, factors that increase toxicity to the gastrointestinal tract - alcoholism and cholecystitis, chronic heart failure, edematous syndrome, hypertension, impaired renal function, cholestasis, sepsis, simultaneous use with other NSAIDs, old age (over 65), pregnancy (I – II trimester) coronary heart disease cerebrovascular disease dyslipidemia / hyperlipidemia diabetes mellitus peripheral artery disease smoking chronic renal failure (creatinine Cl 30–60 ml / min) history of gastrointestinal ulcer development evidence of Helicobacter pylori infection long-term use severe somatic diseases concomitant therapy with the following drugs - anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, cl pidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline), corticosteroids (including prednisolone). To reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used with the minimum possible short course.

Use during pregnancy and lactation

The use of the drug Flamax in the third trimester of pregnancy and when breast-feeding is contraindicated (you should refuse feeding for the period of use of the drug). Use in the I and II trimesters of pregnancy is allowed if the potential benefit to the mother outweighs the potential risk to the fetus.

Composition

1 amp. (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

Dosage and administration of

Intramuscular administration: 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 within 8 hours.

It is possible to re-enter 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 (incl. drowsiness, malaise), tinnitus, visual impairment

From the side of cardiovascular distant 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.

On the part of the sensory organs: noise or ringing in the ears, blurred visual perception, conjunctivitis, dry eyes, eye pain, conjunctival hyperemia, hearing loss, vertigo.

From the CCC: increased blood pressure, tachycardia.

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

From the urinary system: edematous syndrome, cystitis, urethritis, impaired renal function, 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, photosensitization with prolonged use in large doses - vaginal bleeding.

Drug Interaction

With the 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, estrogens reduces the effectiveness of antihypertensive drugs and diuretics.

Concurrent use with other NSAIDs, glucocorticosteroids, ethanol, corticotropin can lead to ulcer formation and gastrointestinal bleeding, to increase the risk of kidney dysfunction. Concomitant use with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefaperazone, cefamandol and cefotethan increases the risk of bleeding.

Increases hypoglycemic action of insulin and oral hypoglycemic drugs (dose adjustment is required). Inductors 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 plasma concentration of verapamil and nifedipine, lithium drugs, methotrexate.

Antacids and cholestyramine reduce absorption.

Increases the hematotoxicity of myelotoxic drugs.

Do not mix Flamax and tramadol in one vial to avoid sediment.

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 the dark place at a temperature of no higher than 25 РC.

Expiration

3 years.

Deystvuyuschee substances

Ketoprofen

Terms of delivery p1frod sf150 pharmacy from

pharmacies Prescription

dosage form

dosage form

injection