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Dekstanol 50 mg / 2 ml 6’s solution for injection in ampoules

$5.80

7a0d8e78e658

Description

Trade name
of DEKSTANOL

the International unlicensed

name Deksketoprofen Lekarstvennaya a form
Solution for injections, 50 mg / 2 ml

Structure
One ampoule contains
active agent – a deksketoprofen trometamol 73.80 mg (it is equivalent to a deksketoprofen of 50 mg),
excipients: sodium chloride, sodium hydroxide, alcohol of 96%, water for injections

the Description
Transparent, colourless solution.

Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs.
Derivatives of propionic acid. Deksketoprofen
the ATX M01AE17 Code

the Pharmacological

Pharmacokinetics Peak Plasma Concentration properties (26.4+5.4 mkg/ml) is reached in 4-5 minutes after intravenous infusion, through 20 minutes – after an intramuscular injection and remains within 2 hours.
The bioavailability is 90% and increases consistently with increase in a dose of drug. Deksketoprofen for 99% contacts proteins of blood plasma, mainly albumin fraction. The volume of distribution is 0.25 l/kg.
In synovial fluid the concentration of a deksketoprofen reaches 50% of plasma concentration (1.5 mkg/ml), is brought out of synovial fluid slowly – within 24 hours.
Is exposed to metabolism in a liver where it conjugates with glucuronic acid. About 80% of a deksketoprofen are allocated with urine, mainly in the form of a conjugate with glucuronic acid. Less than 10% are removed in not changed view with a stake. Elimination half-life of a deksketoprofen varies from 1 to 2.7 hours. At patients with a renal failure deksketoprofen it is removed more slowly, and its elimination half-life lasts for 1 hour.

DEKSTANOL pharmacodynamics, solution for injections, possesses the anti-inflammatory, anesthetizing and febrifugal action and enters into group of non-steroidal anti-inflammatory drugs.
The mechanism of effect of drug is connected with decrease in prostaglandinovy synthesis by inhibition of biosynthesis of prostaglandins and leukotrienes due to suppression of activity of enzyme of cyclooxygenase (cyclooxygenase-1 and cyclooxygenase-2) which catalyzes synthesis of prostaglandins from arachidonic acid. Ketoprofen stabilizes a liposomal membrane, renders the braking effect on synthesis of leukotriene and has antibradikininovy activity.
The clinical trials conducted on several painful models showed analgeziruyushchy action deksketoprofen a trometamola. During the researches, analgeziruyushchy effect of drug was fast, and the peak of analgeziruyushchy effect was shown within the first 45 minutes. Duration of analgesic effect after introduction of 50 mg of a deksketoprofen usually is 8 hours.

Indications
– stopping of a pain syndrome (posttraumatic, postoperative, in renal colic), pain in metastases in a bone at patients with oncological diseases
– symptomatic treatment of acute and chronic inflammatory diseases of a musculoskeletal appatar (including: pseudorheumatism, seronegative spondylarthrites (ankylosing spondylarthritis, reactive arthritis), gout, pseudogout, osteoarthrosis, extraarticular rheumatism (tendinitis, bursitis, capsulitis of a shoulder joint).

A route of administration and doses
For intravenous and intramuscular administration.
Adults:
Contents of one ampoule of Dekstanol (2 ml) are entered by a slow injection deeply into a muscle by each 8-12 hours. If necessary, administration of drug can be carried out each 6 hours. The general dose should not exceed 150 mg a day.
Dekstanol is appointed to the short period of treatment and is limited only to the acute symptomatic period (no more than two days). Patients whenever possible have to pass to oral analgetics.
The recommended daily dose of Dekstanol for intravenous injections makes 100 – 150 mg and should not exceed 150 mg. For intravenous injection it is necessary to dissolve contents of one ampoule (2 ml) of Dekstanol in 100 ml of solution of sodium of chloride and to enter within 10-30 minutes each 8-12 hours. Solution has to be prepared in sterile conditions, is protected from hit of direct sunshine because of photosensitivity of drug and applied right after preparation.

Side effects
Often:
– nausea and/or vomiting
– pains in the injection site of drug, local reactions in the field of an injection, including inflammation, bruises or bleedings
Sometimes:
– anemia
– insomnia
– headaches, dizzinesses, drowsiness
– illegibility of sight
– hypotension, hyperaemia
– abdominal pain, diarrhea, dyspepsia, a konstipation, a hematemesis, dryness in an oral cavity
– dermatitis, a skin itching, rash, the increased sweating
– a hyperthermia, fatigue, pains, a fever
Seldom:
– a laryngeal edema
– a hyperglycemia, a hypoglycemia, a gipertriglitseridemiya, anorexia
– paresthesia, faints
– a ring in ears
– disturbance of warm activity (extrasystole, tachycardia)
– disturbance of activity of a cardiovascular system (hypertensia, thrombophlebitis)
– disturbances from the respiratory system, bodies of a thorax and mediastinum (bradipnoe)
– a round ulcer, bleeding of a round ulcer, a perforation of a round ulcer, a stomacace, exacerbations of colitis and Crohn’s disease
– hepatitis, a bilious attack
– allergic rash, eels
– muscle tension, constraint in joints, muscular spasms, dorsodynias
– an acute renal failure, a polyuria, pains in kidneys, a ketonuria, a proteinuria
– disturbance of a menstrual cycle, prostatic disturbances
– a shiver and peripheral hypostasis
– disturbance of functional trials of a liver
is Very rare:
– a neutropenia, thrombocytopenia, a purpura, aplastic and hemolytic anemia, an agranulocytosis, a marrow hypoplasia
– reaction of an anaphylaxis, including an acute anaphylaxis
– a bronchospasm, breath difficulty
– pancreatitis, gastritis
– hepatocellular damages
– Stephens’s syndrome – Johnson, a toxic necrolysis (Lyell’s disease), a Quincke’s edema, a face edema, photosensitivity
– nephrite or a nephrotic syndrome
– a myocardial infarction or a stroke, increase in risk of developing arterial thrombosis

of the Contraindication
– hypersensitivity to a deksketoprofen and salicylates or auxiliary components of drug
– a peptic ulcer of a stomach and duodenum in an aggravation phase
– gastrointestinal bleedings or other forms of active bleedings
– heavy abnormal liver functions and kidneys (clearance of creatinine & lt, 50ml/mines)
– inflammatory bowel diseases in an aggravation phase, Crohn’s disease
– hemorrhagic diathesis and other disturbances of fibrillation
– bronchial asthma
– pregnancy and the period of a lactation
– heart failure
– children’s age up to 18 years

Medicinal interactions
the Following means: it is not recommended to apply together with Dekstanol.
– other NPVS, including salicylates in high doses (& gt, 3 g/days): at combined use of two and more NPVS the risk of developing an ulcer and gastrointestinal bleeding owing to mutually amplifying effect of these drugs,
– anticoagulants increases: Dekstanol strengthens effect of anticoagulants, for example, of warfarin, owing to high extent of linking of a deksketoprofen with proteins of plasma and also suppression of function of thrombocytes and damage mucous a stomach and a duodenum. If combined use is necessary, it has to take place under careful observation of the doctor and control of laboratory indicators,
– heparins: the risk of bleedings increases (because of suppression of function of thrombocytes and damage mucous a stomach and a duodenum). If combined use is necessary, it has to take place under careful observation of the doctor and control of laboratory indicators,
– corticosteroids: risk of developing an ulcer and gastrointestinal bleeding increases,
– lithium: Dekstanol increases concentration of lithium in blood that can lead to intoxication (decrease in removal of lithium kidneys). Therefore at the beginning of use of a deksketoprofen, at dose adjustment and drug withdrawal the control of concentration of lithium is necessary,
– a methotrexate in high doses (15 mg a week or above): due to reduction of renal clearance of a methotrexate against the background of use of anti-inflammatory drugs, in general, its toxic impact on the system of blood amplifies,
– derivatives of hydantoin and a sulfanomida: strengthening of toxic properties of these substances is possible.
Joint appointment of Dekstanol and the following medicines demands care:
– diuretics, AKF inhibitors, antibacterial aminoglycosides and antagonists of receptors of angiotensin II: Deksketoprofen weakens effect of diuretics and other antihypertensives. At some patients with a renal failure (for example, in dehydration or at elderly patients with disturbance of renal function) use of the means having overwhelming effect on cyclooxygenase together with APF inhibitors, antagonists of receptors of angiotensin II or antibiotics-aminoglikozidnogo of a row can aggravate a state that, as a rule, has reversible character. When assigning a deksketoprofen along with diuretic it is extremely necessary to make sure that the patient receives enough liquid and also to control function of kidneys in an initiation of treatment,
– a methotrexate in low doses, less than 15 mg a week: due to reduction of renal clearance of a methotrexate against the background of use of anti-inflammatory drugs its toxic action on the system of blood in general amplifies. In the first weeks of combined use it is necessary to do blood test weekly. Even in an insignificant renal failure and also at patients of advanced age the treatment should be carried out under strict observation of the doctor,
– pentoksifillin: the risk of bleedings increases. It is necessary to strengthen control and more often to check a bleeding time,
– a zidovudine: there is a risk of strengthening of toxic impact on erythrocytes due to influence on reticulocytes that after the first week of use Dekstanol can lead to heavy anemia. Within one-two weeks after the beginning of use Dekstanol it is necessary to make the general blood test and to check the maintenance of reticulocytes,
– sulphonylurea drugs: NPVS are capable to strengthen hypoglycemic effect of drugs of sulphonylurea due to substitution them in connections with proteins of plasma.
It is necessary to consider possible interactions when using the following means:
– beta-blockers: Dekstanol is capable to weaken their hypotensive action due to suppression of synthesis of prostaglandins,
– cyclosporine and takrolimus: strengthening of nephrotoxicity due to impact of a deksketoprofen on renal prostaglandins is possible. At combination therapy it is necessary to control function of kidneys,
– thrombolytic means: the risk of bleedings increases,
– anti-units and the selective serotonin reuptake inhibitors (SSRI): the risk of gastrointestinal bleedings increases,
– probenetsid: increase in concentration of a deksketoprofen in plasma is possible that is probably caused by suppression of canalicular secretion and conjugation of drug with glucuronic acid and demands dose adjustment of a deksketoprofen,
– cardiac glycosides: Dekstanol is capable to increase concentration of glycosides in plasma,
– mifepristone: there is a theoretical risk of change of efficiency of mifepristone under the influence of inhibitors prostaglandin-sintetazy: Dekstanol it is not necessary to apply within 8-12 days after prescribing of mifepristone,
– antibiotics of a hinolonovy row: results of researches on animals showed that use of derivatives of a hinolon in high doses in combination with Dekstanol increases risk of developing spasms.

The special
instructions Safety of Use for Children and Teenagers it is not confirmed.
To take at patients with allergic reactions in the anamnesis with caution.
To avoid use of the drug Dekstanol in combination with other NPVS, including selection inhibitors of cyclooxygenase-2.
Side effects can be reduced to a minimum due to use of the smallest effective dose during the minimum time necessary for improvement of a state.
Dekstanol it is impossible to mix in solution for infusions with promethazine and pentazocine. Destanol it is impossible to mix in small volumes (for example in the syringe) with solutions of a dopamine, promethazine of pentazocine, pethidine and a hydrocortisone as the white deposit is formed.
Gastrointestinal bleeding, formation or perforation of an ulcer, in certain cases from the death, were reported at therapy by all NPVS at different stages of treatment, irrespective of existence of symptoms harbingers or existence in the anamnesis of serious pathology from a GIT. At development of gastrointestinal bleeding against the background of Dekstanol’s use, drug should be cancelled.
The risk of gastrointestinal bleeding, education or perforation of an ulcer increases with increase in a dose of NPVS at patients with the ulcer in the anamnesis which is especially complicated by bleeding or a parforation and also at elderly patients.
Patients of advanced age: at patients of advanced age the frequency of emergence of side effects of non-steroidal anti-inflammatory drugs, especially such as gastrointestinal bleeding and perforation of the ulcer which can pose a threat for life is increased. Treatment of these patients should be begun with the smallest possible dose.
Before an initiation of treatment of a deksketoprofen trometomoly – as well as in cases of others NPVS-should interview the patient regarding presence of an esophagitis, gastritis and/or a peptic ulcer in the anamnesis and to be convinced that these diseases are completely curable. At patients with existence is symptoms or pathology from housing and public utilities and with gastrointestinal diseases in the anamnesis it is necessary to carry out control regarding disturbances from a digestive tract, especially regarding gastrointestinal bleeding.
Dekstanol it is necessary to appoint with care the patient with gastrointestinal diseases in the anamnesis (ulcer colitis, Crohn’s disease) as there is a risk of exacerbation of these diseases.
For these patients and also patients who need the accompanying treatment by aspirin in low doses or in intake of other drugs increasing risk of emergence of disturbances from digestive tract it is necessary to consider the possibility of use of combination therapy with drugs protectors, for example, mizoprostoly or inhibitors of proton pumps.
Patients, especially advanced age at which in the anamnesis side effects from a GIT took place have to report about all unusual symptoms connected with digestive system (in particular about gastrointestinal bleedings), especially at the initial stages of treatment.
It is necessary to appoint with care drug to the patients who are at the same time accepting means which can increase risk of developing of an ulcer or bleeding, such as oral corticosteroids, anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors or antiagregant, for example aspirin.
As well as other not selection NPVS, Dekstanol can inhibit aggregation of thrombocytes and extend a bleeding time in connection with inhibition of synthesis of prostaglandins. Therefore, use of a deksketoprofen of a trometomol for the patients receiving other medicines affecting blood clotting, such as warfarin or other drugs of a coumarinic row or heparins is not recommended.
As all NPVS, drug it is capable to increase concentration of urea nitrogen and creatinine in blood plasma. It is similar other inhibitor of synthesis of prostaglandins, its use can be followed by the side effects from kidneys leading to a glomerulonephritis, interstitial nephrite, papillary necrosis, a nephrotic syndrome and an acute renal failure.
It is similar to other NPVS, drug can cause temporary and insignificant increase in some hepatic indicators and also the significant increase in activity of nuclear heating plant and ALT. At the corresponding increase in the specified indicators the therapy should be stopped.
Dekstanol it is necessary to appoint with care at the patients suffering from hemopoiesis disturbances, a system lupus erythematosus or the mixed collagenoses.
As well as other NPVS, deksketoprofen can mask symptoms of infectious diseases. It is necessary
to be careful at patients from the liver broken by function and/or kidneys and also at patients with a hypertension and/or heart failure in the anamnesis. At such patients the use of NPVS can lead to deterioration in renal function, a liquid delay in an organism and to hypostases. Also it is necessary to be careful at the patients receiving therapy by diuretics and patients with risk have hypovolemia as at such patients the risk of toxic effects of drug on kidneys is increased. The extra care should be observed at patients with heart diseases in the anamnesis, in particular in the presence of episodes of heart failure in the past as drug can lead to aggravation of heart failure.
Elderly patients suffer from disturbances from kidneys, a cardiovascular system or a liver more often.
Use of NPVS, in rare instances, was connected with serious skin reactions, sometimes with a lethal outcome, including such reactions as eksofoliativny dermatitis, Stephens-Johnson’s syndrome and a toxic necrolysis of epidermis. Risk of development of these states the greatest in an initial phase of therapy, in most cases the beginning of reactions took place within the first month of treatment. At the first symptoms of skin rash, defeats mucous or other instructions on hypersensitivity, Dekstanol it is necessary to cancel immediately.
As well as other NPVS, the deksketoprofena trometamol can render negative effects on female fertility and, therefore, use of drug it is not recommended at the women trying to become pregnant. At women with problems concerning conception and the women undergoing inspections concerning disturbances of fertility it is necessary to consider the possibility of cancellation of a deksketoprofen of a trometomol.
At patients with a hypertension and/or stagnant heart failure easy to average degree in the anamnesis it is necessary to make careful observation and consultations as use Dekstanol can be connected with a liquid delay in an organism and development of hypostases.
According to results of clinical trials and epidemiological data, use of some NPVS, especially in high doses and for a long time, can be followed by some increase in risk of arterial thromboses (for example, a myocardial infarction or a stroke). Given for an exception of such danger at use of a deksketoprofen of a trometomol it is not enough.
In uncontrollable arterial hypertension, stagnant heart failure, coronary heart disease, diseases of peripheral arteries and/or vessels of a brain of a deksketoprofen trometomol it is necessary to appoint only after careful assessment of a condition of the patient. The same concerns patients with risk factors of cardiovascular diseases (for example, hypertensia, a lipidemia, diabetes, smoking) before long-term treatment.
Period of pregnancy and feeding by a breast.
Use of the drug Dekstanol is contraindicated in the III trimester of pregnancy and during feeding by a breast. Oppression of synthesis of prostaglandins can negatively influence a course of pregnancy and/or fetation. According to results of epidemiological researches at use of the drugs suppressing synthesis of prostaglandins in the early stages of pregnancy the risk of an abortion, emergence at a fruit of heart disease and not fusion of an anterior abdominal wall increases. Absolute risk of development of anomalies of a cardiovascular system increased with & lt, 1% up to about 1.5%.
Consider that the danger of emergence of such phenomena increases with increase in a dose of drug and duration of therapy. Purpose of a deksketoprofen of a trometamol in I and II trimester of pregnancy is possible only at emergency. When assigning a deksketoprofen of a trometamol the women planning pregnancy, or I and II trimester of pregnancy need to apply a minimal effective dose throughout whenever possible shortest time of treatment.
In the III trimester all inhibitors of synthesis of prostaglandins cause the following:
Risks for a fruit:
• a cardiopulmonary toxic syndrome (with an obliteration of an arterial channel and pulmonary hypertensia),
• a renal failure which can progress to a renal failure with development of an oligogidroamnion.
Risks for mother and the child at the end of pregnancy:
• lengthening of a bleeding time (effect of oppression of aggregation of thrombocytes) that is possible even at an application condition in low doses,
• delay of reductions of a uterus with the corresponding delay of childbirth and long childbirth.
There are no data on penetration of a deksketoprofen into breast milk.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Against the background of use of the drug Dekstanol are possible dizziness and drowsiness therefore weak or moderate influence on ability to control of vehicles and work with other mechanisms is not excluded. Therefore patients have to consider it and objectively estimate the ability to performance of such works.

Overdose
Symptoms of overdose of drug are not known. The overdose by similar drugs is expressed in gastrointestinal (vomiting, lack of appetite, pain in a stomach) and neurologic (drowsiness, dizziness, a disorientation, a headache) disturbances.
Treatment: at accidental overdose or reception of too high dose it is necessary to begin immediately symptomatic treatment according to a condition of the patient. At reception more 5mg/kg the adult or the child it is necessary to give within an hour inside activated carbon.
Deksketoprofena trometamol leaves from an organism by means of dialysis.

The form of release and packing
On 2 ml of drug place in an ampoule from dark glass with the line for a break. Apply the text on an ampoule with method of an intaglio printing the fast fixed paint.
On 6 ampoules together with the instruction for medical use in the state and Russian languages place in a pack from cardboard with the hologram of firm – producer.

To Store storage conditions at a temperature not above 25 °C, in the place protected from light.
To store out of children’s reach!

2 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

the Ilach Dolum Sanai Idol Producer ve A.Sh. Tidzharet, Turkey

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