Фламакс форте®

General characteristics. Structure:

Active veshchestva:100 ketoprofen mg;
excipients: lactoses monohydrate, starch rice, croscarmellose sodium, povidone, cellulose microcrystallic, magnesium stearate, sodium lauryl sulfate, silicon dioxide colloid, gipromelloza, macrogoal 6000, talc, titanium dioxide, diamond blue.

Description: tablets are round, biconvex, coated blue color

Chemical name: (2RS) – 2 – (3 – benzoilfenit) propionic acid.

Pharmacological properties:

Pharmacodynamics. Non-steroidal anti-inflammatory drug (NPVP), derivative propionic acid. 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. Absorption – bystry, bioavailability – 90%. To 99% of the absorbed ketoprofen contacts proteins of plasma, it is preferential with albumine. The maximum concentration of drug in plasma (Cmax) is reached quickly (in 0,5-2 h after intake) because of the low volume of distribution (0,1-0,2 l/kg). Equilibrium concentration (Css) of ketoprofen in plasma is reached in 24 h after the beginning of its regular reception. Ketoprofen well gets into synovial fluid and connecting fabrics.

The maximum concentration in synovial fluid makes 30% of concentration in serum, and in 4-6 hours after reception exceeds it. Ketoprofen gets through a blood-brain barrier. It is almost completely metabolized in a liver by a glyukuronirovaniye, has effect of "the first passing" through a liver. It is removed by kidneys (mainly) and intestines (1-8%). An elimination half-life of ketoprofen (T1/2) – 1,6-1,9 h. At elderly the elimination half-life increases to 3-5 h, at patients with a renal failure (clearance of creatinine of 20-60 ml/min.) makes about 3,5 h. Does not kumulirut.

Indications to use:

Inflammatory and degenerative diseases of a musculoskeletal system: rhematoid, psoriasis arthritis, Bekhterev's disease (an ankylosing spondylarthritis), gouty arthritis (at a bad attack of gout high-speed dosage forms are preferable), an osteoarthrosis.

Pain syndrome: a mialgiya, an ossalgiya, neuralgia, a tendinitis, an arthralgia, a bursitis, radiculitis, an adnexitis, otitis, head and a dentagra, at oncological diseases, the posttraumatic and postoperative pain syndrome which is followed by an inflammation. Algodismenorey.

Route of administration and doses:

Inside, during meal. The adult on 1 tablet 2-3 times a day (each 8 hours).

The maximum daily dose – 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 or 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 most sensitive NPVP-indutsirovannoy indicator of dysfunction of a liver) the dose decline and careful observation is necessary.

In need of definition of 17 ketosteroids drug should be cancelled for 48 h prior to a research.

As well as other drugs of this group, can mask symptoms of an infectious disease.

At development of disturbances from organs of sight consultation of the ophthalmologist is necessary.

At the termination of therapy the gradual dose decline is recommended.

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 with 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.
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: pneumorrhagia, диспноэ, bronchospasm, rhinitis, throat hypostasis, nasal bleeding, asthma.
From integuments: skin rash, alopecia and 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, rhinitis, Quincke's disease, exfoliative dermatitis, acute anaphylaxis.
Others: sweating strengthening, mialgiya, muscular twitchings, thirst, vaginal bleeding.

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, trombolitika, antiagregant, tsefaperazony, tsefamandoly and tsefotetany increases risk of development of bleedings.

Increases hypoglycemic effect of insulin and peroral hypoglycemic HP (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 HP strengthen manifestations of a gematotoksichnost of drug.

Contraindications:

Hypersensitivity to ketoprofen or to any component of drug;
the bronchial asthma in the anamnesis caused by ketoprofen, other non-steroidal anti-inflammatory drugs or acetylsalicylic acid;
recurrent peptic ulcer of a stomach and duodenum;
round ulcer;
the expressed liver failure;
the expressed renal failure;
insufficiency of the blood circulatory system;
gastrointestinal, cerebrovascular and other bleedings (or suspicion of bleeding);
pregnancy and period of feeding by a breast;
children's age;
hemophilia and other disturbances of a blood coagulation;
ulcer colitis, disease Krone, diverticulitis.

With care

Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis, hyperbilirubinemia, hepatic and renal (since drug is mainly removed by kidneys) insufficiency, a diabetes mellitus, dehydration, sepsis, HSN, hypostases, arterial hypertension, coronary heart disease, blood diseases (including a leukopenia), stomatitis, advanced age.

Pregnancy and lactation

Use of drug is contraindicated at pregnancy and in the period of a lactation.

Overdose:

Symptoms: emergence of drowsiness, nausea, vomiting, abdominal pains, bleedings, abnormal liver functions and kidneys is possible.

Symptomatic treatment: gastric lavage and/or absorbent carbon and/or other sorbents. There is no specific antidote.

Storage conditions:

Period of validity: 3 years. Not to apply after the termination of the period of validity specified on packaging. To store in the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, the film coated, containing 100 mg of ketoprofen. On 10 tablets in the blister. On 2 blisters together with the application instruction in a cardboard pack.