Producer: JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan
Code of automatic telephone exchange: M01AE17
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 36,9 mg of a deksketoprofen of a trometamol that is equivalent to 25 mg of a deksketoprofen respectively.
Excipients: cellulose microcrystallic PH 101, cellulose microcrystallic PH 102, starch corn undried, sodium of starch glikolit type A, a glitserol дибегенат (Kompritol 888 ATO).
Structure of a cover Kollikoat IR white II: copolymer of polyvinyl alcohol and polyethyleneglycol, silicon dioxide colloid, коповидон (Kolidon VA 64), titanium dioxide (E171), kaolin, sodium lauryl sulfate.
Pharmacodynamics. Dekstanol possesses antiinflammatory, analgeziruyushchy and febrifugal action. The mechanism of effect of drug is based on oppression of synthesis of prostaglandins owing to cyclooxygenase suppression. After intake analgeziruyushchy action ДЕКСТАНОЛа comes in 30 min. after administration of drug, duration of action makes from 4 to 6 h.
Pharmacokinetics. After oral administration of a deksketoprofen трометамол Cmax at the person is reached on average in 30 minutes. Time of distribution makes 0,35 hours and an elimination half-life 1,65 hours. Linkng with proteins of plasma - 99%. The average volume of distribution makes less than 0,25 l/kg. The main part of drug is removed by kidneys in the form of metabolites (after a glyukuronirovaniye).
Indications to use:
Pain syndrome of easy and average intensity at the following diseases and states:
Route of administration and doses:
Depending on a look and intensity of pain, the recommended single dose makes 1/2 tablets of Dekstanol (12,5 mg) from 1 to 6 times a day with intervals between receptions of 4-6 hours or on 1 tablet (25 mg) from 1 to 3 times a day every 8 hours.
The maximum daily dose makes 3 tablets of drug (75 mg).
At patients with an abnormal liver function from easy to moderate severity or with slightly reduced function of kidneys, at elderly people administration of drug should be begun in lower doses - no more than 2 tablets DEKSTANOLA (50 mg) a day.
At acute pains it is necessary to take a pill a minimum in 30 minutes prior to food.
Drug Dekstanol is not intended for prolonged use: duration of reception should not exceed 3-5 days.
Features of use:
It is necessary to be careful at purpose of drug to patients of advanced age, patients with allergic reactions, with general diseases of connecting fabric and to patients with hemopoiesis disturbance. Administration of drug can mask symptoms of infectious diseases.
In case of side effects, and also in the absence of clinical effect within 3-5 days of treatment, it is necessary to report about it to the attending physician.
Features of influence of medicine on ability to manage the vehicle or potentially dangerous mechanisms
As Dekstanol can cause decline in the ability to concentration of attention, it is necessary to appoint with care drug to the patients who are engaged in potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.
• anemia, including aplastic and hemolitic, purpura, agranulocytosis, marrow hypoplasia; very seldom – a neutropenia, thrombocytopenia;
• nausea, vomiting; infrequently - dyspepsia, heartburn, abdominal pains, diarrhea, a lock, a hematemesis, dryness of a mucous membrane of an oral cavity;
• digestive tract erosive cankers, including bleedings and perforation, an anreksiya, increase in activity of pechenochy transaminases (alaninaminotranspherase and aspartate aminotransferase), jaundice; very seldom – an abnormal liver function;
• headache, dizziness, sleeplessness, drowsiness; seldom – paresthesias;
• illegibility of visual perception, sonitus;
• decrease or increase in the ABP, feeling of heat, hyperemia of integuments, premature ventricular contraction, tachycardia, peripheral hypostases, thrombophlebitis of superficial veins;
• брадипноэ; very seldom - a bronchospasm;
• polyuria, renal colic; very seldom – nephrite, a nephrotic syndrome;
• dysfunction of a prostate;
• a spasm of muscles, difficulty of movements in joints;
• dermatitis, rash, perspiration; small tortoiseshell, eels; very seldom – Stephens-Johnson's syndrome, a Lyell's disease, a Quincke's disease, allergic dermatitis, a photosensitization;
• hyper - or a hypoglycemia, a gipertriglitseridemiya;
• ketonuria, proteinuria;
• allergic reactions: acute anaphylaxis, face edema.
Interaction with other medicines:
• with other NPVP, including salicylates in high doses (> 3 g/days): increases risk of developing of gastrointestinal bleedings and ulcers, owing to an action synergism;
• with anticoagulants: strengthens effect of anticoagulants (in case of need simultaneous use – careful control of laboratory indicators of blood);
• with corticosteroids: increases risk of development of an ulcer and bleeding in a GIT;
• with lithium drugs: increases concentration of lithium in a blood plasma which can reach the toxic level therefore lithium level in blood should be controlled at appointment, change of a dose or cancellation of a deksketoprofen;
• with a methotrexate: increase gematoligichesky toxicity of a methotrexate in connection with decrease in its renal clearance. It is necessary to carry out weekly control of a picture of blood in the first weeks of the combined treatment. In the presence even insignificant renal failures, and also at elderly people careful control is necessary;
• with derivatives of hydantoin and streptocides: expressiveness of their toxic manifestations can increase;
• with diuretics, APF inhibitors, antagonists of receptors of angiotensin II and blockers of β-adrenoceptors:::::::::: reduce efficiency of diuretic and other anti-hypertensive means;
• with pentoksifilliny: increase risk of development of bleedings, active clinical monitoring and frequent control of a bleeding time is necessary;
• with a zidovudine: in 1 week after the beginning of a combination therapy manifestation of toxic action of a zidovudine on reticulocytes which can lead to development of heavy anemia is possible. It is necessary to carry out calculation of blood cells and reticulocytes in 1–2 weeks from the beginning of the combined treatment;
• with sulphonylurea drugs: increase in gipoglikemiziruyushchy action in connection with ability to force out them from places of linkng with proteins of a blood plasma;
• with cyclosporine and takrolimusy: декскетопрофен can increase their nephrotoxicity. When carrying out a combination therapy it is necessary to control function of kidneys;
• with thrombolytic drugs: increase risk of development of bleedings;
• antiagregantny means and selective serotonin reuptake inhibitors: increase risk of development of gastrointestinal bleeding;
• with probenetsidy: concentration of a deksketoprofen in a blood plasma can increase that can be caused by the inhibiting influence on canalicular secretion and/or conjugation with glucuronic acid that demands dose adjustment of a deksketoprofen;
• with cardiac glycosides: increase their concentration in blood serum;
• from hinolona: increase risk of development of spasms.
• hypersensitivity to a deksketoprofen or other non-steroidal anti-inflammatory drugs;
• peptic ulcer of a stomach and duodenum (including gastrointestinal bleedings and tendency to them);
• active bleedings of various genesis, the raised bleeding;
• concomitant use of anticoagulants;
• disease Krone, nonspecific ulcer colitis;
• bronchial asthma (including in the anamnesis), recuring polyposes of a nose and okolonosovy bosoms, intolerance of acetylsalicylic acid;
• heavy heart failure;
• heavy renal failure (clearance of creatinine less than 30 ml/min.);
• active diseases of a liver, heavy abnormal liver function;
• the period after performing aortocoronary shunting;
• the confirmed hyperpotassemia;
• inflammatory diseases of intestines;
• children's and teenage age up to 18 years;
• pregnancy and period of a lactation.
Symptoms: strengthening of side effects.
Treatment: gastric lavage, purpose of absorbent carbon, symptomatic therapy.
To store at a temperature not over 25 ºС, in the dry, protected from light place. Period of storage 2 years.
According to the recipe
On 10 tablets place in a blister strip packaging from a film of opaque PVH/PE/PVDH and printing aluminum foil.
On 1, 2 or 3 planimetric packagings together with the instruction on a medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer.