Fleksen of an ampoule

General characteristics. Structure:

Active agent: ketoprofen of 100 mg (in the form of sodium salt of 108 mg).
Excipients: glycine – 85 mg.
Solvent:
Each ampoule with solvent contains: benzyl alcohol – 0,0625 ml and water for injections – to 2,5 ml.
Description:
Lyophilisate for preparation of solution for intramuscular introduction: white or almost white homogeneous mass.
Solvent: transparent colourless solution, free from foreign particles.

Pharmacological properties:

FLEKSEN renders antiinflammatory, analgeziruyushchy and febrifugal, anti-aggregation actions. Suppresses activity of the cyclooxygenases 1 and 2 regulating synthesis of prostaglandins. Analgeziruyushchy action is caused, both central, and peripheral by mechanisms. Has antibradikininovy activity, stabilizes lizosomalny membranes.

Pharmacokinetics. At intramuscular introduction time of achievement of the maximum concentration in plasma
blood are made by 15-30 min. Bioavailability – more than 90%. Contacts proteins of a blood plasma for 99%. Equilibrium concentration in plasma is reached in 24 h after the beginning of regular use. Therapeutic concentration in synovial fluid remains 6-8 h. It is metabolized in a liver by a glyukuronirovaniye. Also 1-8% by means of intestines are removed, mainly, by kidneys. The elimination half-life makes 1,6 – 1,9 h. Does not kumulirut.

Indications to use:

Short-term symptomatic treatment of an acute pain syndrome at inflammatory processes of various origin: the osteoarthrosis ankylosing a spondylitis, gouty arthritis, a bad attack of gout, a pseudorheumatism, psoriasis arthritis; the bursitis, tendosinovit; ischialgia, mialgiya, neuralgia, dorsalgiya, radiculitis; bruises and muscle strain; adnexitis, otitis; head and dentagra; bolevoysindry at oncological diseases; posttraumatic and postoperative pain syndrome; альгодисменорея.

Route of administration and doses:

Lyophilisate is dissolved the enclosed solvent and the received solution is entered deeply into a muscle. Intramuscular injections appoint for removal of an acute pain syndrome 100 mg 1-2 times a day. Duration of parenteral therapy is usually short-term and makes several days. After achievement of necessary effect to the patient appoint capsules or suppositories.
The maximum daily dose of drug should not exceed 300 mg.

Features of use:

At simultaneous use of ketoprofen and warfarin, and also coumarinic anticoagulants or salts of lithium patients have to be under strict observation of the doctor. It is necessary to be careful at purpose of drug the patient with ulcer diseases of digestive tract in the anamnesis, a renal and liver failure. During treatment control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary. At a renal failure and a liver (increase in activity of ALT is the liver dysfunction NPVP-indutsirovannoy indicator) the dose decline and careful observation of the doctor is necessary. In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research.
To avoid reception of alcoholic drinks!
At development of disturbances from organs of sight consultation of the ophthalmologist is necessary.
During treatment it is necessary to be careful when driving motor transport and occupations other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the alimentary system: NPVP-gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, meteorism, loss of appetite, diarrhea), stomatitis; taste change, ulceration and perforation of a mucous membrane of digestive tract, gingival, gastrointestinal, hemorrhoidal bleeding; increase in activity of "hepatic" transaminases in blood serum, hepatitis.
From a nervous system: headache, dizziness, sleeplessness, excitement, nervousness, drowsiness, depression, adynamy, confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy.
From sense bodys: noise or a ring in ears, a sight illegibility, conjunctivitis, dryness of a mucous membrane of an eye, eye pain, a conjunctiva hyperemia, decrease in hearing, вертиго.
From cardiovascular system: increase in arterial pressure, tachycardia.
3 From bodies of a hemopoiesis: seldom – an agranulocytosis, anemia, hemolitic anemia, thrombocytopenia, a leukopenia.
From an urinary system: edematous syndrome, cystitis, urethritis, renal failure, intersticial nephrite, nephrotic syndrome, hamaturia.
From a respiratory organs: диспноэ, bronchospasm, rhinitis, throat hypostasis, nasal bleeding, pneumorrhagia, asthma.
From integuments: alopecia, eczema, mnogoformny exudative erythema, including Stephens-Johnson's syndrome, toxic epidermal necrolysis (Lyell's disease), photodermatitis.
Allergic reactions: skin rash (including erythematic, small tortoiseshell), skin itch, Quincke's disease, exfoliative dermatitis, acute anaphylaxis.
Others: sweating strengthening, a mialgiya, muscular twitchings, thirst, vaginal bleeding, pain and reddening in the place of an injection.

Interaction with other medicines:

Reduces efficiency of uricosuric medicines, strengthens effect of anticoagulants, antiagregant, fibrinolitik, ethanol, side effects of glucocorticosteroids and mineralokortikosteroid, estrogen; reduces efficiency of hypotensive medicines and diuretics. Joint reception with other NPVP, glucocorticosteroids, ethanol, corticotropin can lead to formation of ulcers and development of gastrointestinal bleedings, to increase in risk of development of disturbances of functions of kidneys. Co-administration with peroral anticoagulants, heparin,
trombolitikam, antiagregant, tsefoperazony, tsefamandoly and tsefotetany the risk of development of bleedings raises. Increases hypoglycemic effect of insulin and peroral hypoglycemic medicines (recalculation of a dose is necessary). Inductors of a microsomal oxidation in a liver (Phenytoinum, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase products of hydroxylated active metabolites. Joint appointment with Valproatum of sodium causes disturbance of aggregation of thrombocytes.
Increases concentration in plasma of verapamil and nifedipine, drugs of lithium, a methotrexate.
Antacids and Colestyraminum reduce absorption.
Myelotoxic medicines strengthen manifestations of a gematotoksichnost of drug.
Pharmaceutical it is incompatible with solution of a tramadol.

Contraindications:

· individual hypersensitivity to ketoprofen, acetylsalicylic acid or other NPVP (including instructions in the anamnesis on the bronchospasm, urticaria or rhinitis caused by reception of acetylsalicylic acid);
· digestive tract diseases in an aggravation phase;
· gastrointestinal bleedings and perforation in the anamnesis;
· the expressed renal failures and a liver;
· disturbances from blood (a leukopenia, thrombocytopenia, disturbances of hemocoagulation, hemophilia);
· stopping of a pain syndrome just before or right after operational treatment of cardiovascular system;
· the expressed heart failure;
· pregnancy and feeding by a breast;
· children's age (up to 18 years).

With care:
It is necessary to use with care drug at patients: with abnormal liver functions and/or kidneys, gastrointestinal diseases in the anamnesis; bronchial asthma, rhinitis, small tortoiseshell, polyps mucous nose; hypertensia and/or with cardiac osudisty diseases, cerebrovascular diseases; diseases of blood, anemia; alcoholism, alcoholic cirrhosis, a hyperbilirubinemia, diabetes, dehydration, smoking, sepsis and at patients of advanced age.

Overdose:

Symptoms: emergence of drowsiness, nausea, vomiting, abdominal pains, bleedings, abnormal liver functions and kidneys is possible.
Symptomatic treatment: there is no specific antidote.

Storage conditions:

To store at a temperature not above 25ºС. To store in the place, unavailable to children. Period of validity 3 years. Drug should not be used after a period of validity!

Issue conditions:

According to the recipe

Packaging:

Lyophilisate for preparation of solution for intramuscular introduction. On 100 mg of drug in ampoules of dark glass type 1 with rings for an otlom. Solution of benzyl alcohol of 2,5% (solvent). On 2,5 ml in glass ampoules from colourless neutral glass type 1 with rings for an otlom. On 6 ampoules with lyophilisate and 6 ampoules with solvent for intramuscular introduction on 2.5 ml laid in one or two plastic pallets together with the application instruction in a cardboard box.