Фламакс®

General characteristics. Structure:

Active agent ketoprofen - 100 mg
Excipients: propylene glycol, ethanol (alcohol), benzyl alcohol, 1M sodium hydroxide solution, water for injections.

Description: the transparent colourless or slightly painted liquid.

Pharmacological properties:

Pharmacodynamics. Non-steroidal anti-inflammatory drug, derivative propionic acid. Has analgeziruyushchy, antiinflammatory and febrifugal effect, suppresses aggregation of thrombocytes. Influencing a cyclooxygenase and lipooksigenazny link of metabolism of arachidonic acid, ketoprofen inhibits synthesis of prostaglandins, leukotrienes and thromboxanes. Analgeziruyushchy action is caused both central, and peripheral by mechanisms. Has antibradikininovy activity, stabilizes lizosomalny membranes.
 
Pharmacokinetics. Distribution. 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 because of the low volume of distribution (0,1-0,2 l/kg). Equilibrium concentration of ketoprofen is reached in 24 hours after the beginning of its regular reception. Ketoprofen well gets into synovial fluid and connecting fabrics. Significant levels of concentration in synovial fluid are reached in 15 minutes after single intramuscular introduction of 100 mg of ketoprofen. Though concentration of ketoprofen in synovial fluid are slightly lower, than in plasma, they are stabler (remain till 30 o'clock) therefore the pain syndrome and constraint of joints decreases by a long time.

Metabolism, removal. Ketoprofen is generally metabolized in a liver where it is exposed to a glyukuronization with formation of the esters with glucuronic acid removed mainly by kidneys. Removal with a fecal masses makes less than 1%. The elimination half-life of ketoprofen fluctuates from 1,6 to 1,9 hours. Does not kumulirut.

Indications to use:

For a symptomatic treatment of pains and inflammation of various genesis of moderate intensity:
- Inflammatory and degenerative diseases of a musculoskeletal system: the rhematoid, psoriasis, juvenile chronic arthritis ankylosing a spondylitis (Bekhterev's disease), gouty arthritis, rheumatic defeat of soft tissues, an osteoarthrosis of peripheral joints and a backbone (including with a radicular syndrome);
- lumbago, sciatica, neuralgia;
- migraine;
- альгодисменорея, inflammatory processes of an inflammation of bodies of a small pelvis, in т.ч an adnexitis;
- the posttraumatic pain syndrome which is followed by an inflammation;
- postoperative pain;
- dentagra;
- a pain syndrome at oncological diseases.

Does not influence progressing of a disease.

Route of administration and doses:

Intravenously, intramusculary.

Intramuscular introduction: on 100 mg (1 ampoule) 1-2 times a day.

Intravenous infusional administration of drug has to be carried out only in the conditions of a hospital. The average time of infusion makes 0,5-1 hours. Perhaps repeated introduction in 8 hours.

Short intravenous infusion: 100 - 200 mg (1-2 ampoules) of the drug divorced in 100 ml of 0,9% of solution of sodium of chloride are entered within 0,5-1 hours. Perhaps repeated introduction in 8 hours.

Long intravenous infusion: 100 - 200 mg (1-2 ampoules) of the drug divorced in 500 ml of solution for infusions (0,9% chloride sodium solution, Ringer's solution, 5% dextrose solution), within 8 hours. Perhaps repeated introduction in 8 hours.

The combined use

 Фламакс® it is possible to combine with analgetics of the central action, it can be mixed with morphine rolled into one. It is impossible to mix rolled into one with tramadoly because of loss of a deposit.
Parenteral administration of ketoprofen can be combined using peroral forms (a tablet, the capsule) or rectal suppositories, at the same time the maximum daily dose can be increased to 300 mg or is reduced to 100 mg depending on the nature of a disease and a condition of the patient.

 It is necessary to use a minimal effective dose minimum possible short course (see the section "Special Instructions").

Features of use:

At simultaneous use of ketoprofen and warfarin or drugs 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, and also receiving coumarinic anticoagulants. As well as other drugs of this group, can mask symptoms of infectious diseases.
During treatment control of a picture of peripheral blood and a functional condition of a liver and kidneys is necessary.
In need of definition of 17 ketosteroids drug should be cancelled in 48 hours prior to a research.
At an abnormal liver function, kidneys the dose decline and careful observation is necessary.
For decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimal effective dose minimum possible short course (see the section "Route of Administration and Doses")

Influence on ability to drive the car and to work with mechanisms

During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From the alimentary system: abdominal pain, dyspepsia (nausea, vomiting, heartburn, meteorism, loss of appetite, diarrhea), stomatitis, abnormal liver function, taste change. At prolonged use in high doses - an ulceration of a mucous membrane of digestive tract, gingival, gastrointestinal, hemorrhoidal bleeding;
From a nervous system: headache, dizziness, sleeplessness, excitement, nervousness, drowsiness, depression, adynamy, confusion or loss of consciousness, memory disturbance, migraine, peripheral neuropathy.
From sense bodys: noise or a ring in ears, an illegibility of visual perception, conjunctivitis, dryness of a mucous membrane of an eye, eye pain, a conjunctiva hyperemia, decrease in hearing, вертиго.
With the party of cardiovascular system: increase in arterial pressure, tachycardia.
From bodies кроветворения:агранулоцитоз, anemia, hemolitic anemia, thrombocytopenia, leukopenia.
From an urinary system: edematous syndrome, cystitis, urethritis, renal failure, intersticial nephrite, nephrotic syndrome, hamaturia.
Allergic reactions: skin rash (including erythematic, small tortoiseshell), skin itch, rhinitis, Quincke's disease, bronchospasm, exfoliative dermatitis, acute anaphylaxis.
Others: sweating strengthening, pneumorrhagia, nasal bleeding, mialgiya, muscular twitchings, asthma, thirst, photosensitization; at prolonged use in high doses — vaginal bleeding.

If at you any of the side effects specified in the instruction developed, as soon as possible see a doctor
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

At simultaneous use of Flamaks® and "loopback" diuretics nephrotoxic effect of both drugs amplifies. Reduces efficiency of uricosuric drugs, strengthens effect of anticoagulants, antiagregant, fibrinolitik, ethanol, side effects of glucocorticosteroids and mineralokortikosteroid, estrogen; reduces efficiency of hypotensive drugs and diuretics.
Simultaneous use 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.
Simultaneous use with peroral anticoagulants, heparin, trombolitika, antiagregant, tsefoperazony, tsefamandoly and tsefotetany increases risk of development of bleedings.
Increases hypoglycemic effect of insulin and peroral hypoglycemic medicinal средст (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.
Combined use with Valproatum of sodium leads to decrease in aggregation of thrombocytes.
Increases concentration in plasma of verapamil and nifedipine, drugs of lithium, a methotrexate.
Antacids and Colestyraminum reduce absorption.
Strengthens a gematotoksichnost of miyelotoksichny medicines.
In order to avoid formation of a deposit it is not necessary to mix rolled into one Flamaks® and трамадол.
If you accept other drugs, it is necessary to consult with the doctor.

Contraindications:

Hypersensitivity (including to other non-steroidal anti-inflammatory drugs or auxiliary components);
erosive cankers of the digestive tract (DT) (in an aggravation phase);
bleedings from digestive tract, inflammatory diseases of intestines in an aggravation phase (nonspecific ulcer colitis, a disease Krone);
heavy liver failure or diseases of a liver during the acute period;
heavy renal failure (clearance of creatinine (CC) less than 30 ml/min.);
the progressing diseases of kidneys
hyperpotassemia
full or incomplete combination of bronchial asthma, retsidiviruyeshchy a polypose of a nose and okolonosovy bosoms and intolerance of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (in т.ч in the anamnesis);
hemopoiesis disturbance, disturbance of a hemostasis (including hemophilia);
pregnancy (III trimester)
lactation period
children's age (up to 15 years);
the period after aortocoronary shunting;

If you have a hypersensitivity to ketoprofen or other components of drug, before reception surely consult with the doctor.

With care

Bronchial asthma, existence of the factors increasing toxicity concerning a GIT: alcoholism and cholecystitis, chronic heart failure, edematous syndrome; arterial hypertension, a renal failure, a cholestasia, sepsis, simultaneous use with other NPVP, advanced age (65 years are more senior), pregnancy (the I-II trimester).
Ischemic disease of a serd, cerebrovascular diseases, дислипидемия / lipidemia, diabetes mellitus, diseases of peripheral arteries, smoking, chronic renal failure (clearance of creatinine of 30-60 ml/min.).
Anamnestic data on development of a canker of digestive tract in the anamnesis, the confirmed fact of existence of an infection Helicobacter pylori, prolonged use of NPVP, heavy somatopathies, the accompanying therapy by the following drugs:
anticoagulants (for example, warfarin);
antiagregant (for example, acetylsalicylic acid, klopidogret);
selective serotonin reuptake inhibitors (for example, to tsitalopra, fluoxetine, пароксетин, sertraline).
peroral glucocorticosteroids (for example, Prednisolonum);

For decrease in risk of development of the undesirable phenomena from a GIT it is necessary to use a minimal effective dose minimum possible short course.

Use at pregnancy and during breastfeeding

Use of Flamaks® in the III trimester of pregnancy and when feeding by a breast contraindicated (it is necessary to refuse feeding by a breast for drug use).
Use in I and II trimesters of pregnancy is allowed if the potential advantage for mother exceeds potential risk for a fruit.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity: 5 years. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Solution for intravenous and intramuscular administration, 50 mg/ml.
On 2 ml of an ampoule of light-protective glass type I with a color ring of a break or with a color point and a notch. One, two or three color rings and/or a two-dimensional barcode, and/or the alphanumeric coding or without additional color rings, a two-dimensional barcode, the alphanumeric coding in addition apply on ampoules.
On 5 ampoules place in a blister strip packaging.
1 or 2 blister strip packagings together with the application instruction in a pack from the card.