Flowed
Producer: Synmedic Laboratories (Sinmedik Laboratoriz) India
Code of automatic telephone exchange: M01AE14
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 200 mg, 300 mg or 400 mg of a deksibuprofen
Excipients: microcrystallic cellulose, silicon dioxide colloid anhydrous, talc, calcium of a kroskarmeloz, gipromeloz, titanium dioxide (Е 171).
Non-steroidal anti-inflammatory drug with febrifugal and analgeziruyushchy action.
Pharmacological properties:
Pharmacodynamics. Effect of drug is based on braking of products of prostaglandins that is shown by ability of inhibition of synthesis of leukotrienes, decrease in inflammatory hypostasis due to action on polymorphonuclear leukocytes and decrease in formation of nitrogen oxide, mitochondrial oxidation of fatty acids.
Pharmacokinetics. Absorption of drug happens in a small intestine. The maximum concentration of drug in blood is observed 2 hours later after administration of drug inside. Removal of a deksibuprofen from synovial fluid is carried out slowly therefore the stable concentration independent of concentration of drug in plasma is maintained.
Metabolism of drug happens in a liver then inactive metabolites are removed to 90% by kidneys, is partially allocated with bile in an intestines gleam.
The elimination half-life of drug makes 1,8-3,5 hours, linkng with proteins of plasma about 99%. Use of a deksibuprofen together with food extends time of development of the maximum concentration in blood from 2,1 to 2,8 hours and reducing the maximum plasma concentration from 20,6 to 18,1 mkg/ml, but does not exert impact on extent of absorption.
Indications to use:
Symptomatic therapy of a pain syndrome with weak and moderate intensity of a different origin, including pains in a back, in joints and muscles, a dentagra, rheumatic pain, a dysmenorrhea.
Route of administration and doses:
Doses of drug and the mode of its use are appointed individually, considering intensity of expressiveness of a pain syndrome. To adult patients Zotek appoint on 1-2 tablets to one reception that corresponds to 200-400 mg of a deksibuprofen, three times a day after meal. The initial dose corresponding to 200 mg of a deksibuprofen is recommended. The dose of drug corresponds to 600-900 mg of a deksibuprofen, divided into three receptions within a day. The highest daily dose corresponds to 1200 mg, and the highest single dose – 400 mg. The highest single dose – 300 mg, the highest daily – 900 mg is applied to treatment of a dysmenorrhea. It is necessary to accept drug during food.
Drug is shown for symptomatic removal of a pain syndrome, but if symptoms of a disease are left without changes more than 3 days, are followed by rise in temperature, a headache or other symptoms, specification of the diagnosis and additional change of the scheme of treatment is required.
To people of old age at the beginning of therapy appoint the minimum doses. Increase a daily dose only after good tolerance of drug is established.
To people with moderate disturbance of functions of a liver and kidneys appoint with care and begin reception with the minimum doses.
Features of use:
Those patients who have in the anamnesis of a disease of a stomach and intestines need to use drug carefully. These patients demands careful inspection and observation.
At purpose of drug patients with disturbances from the blood circulatory system, with persistent arterial hypertension, a liver and renal failure, including at simultaneous treatment by diuretic drugs need to mean possible risk of a delay of liquid and a renal failure. Such patients are recommended to accept drug in the minimum dosage and to regularly control work of kidneys.
Extra care is demanded by drug use by people of advanced age.
Care at drug use by patients, suffering system lupus erythematosus and other diseases of connecting fabric as at these patients tendency to development of disturbances from the central nervous system is observed and development of renal complications is necessary.
It is necessary to check renal and hepatic function at the patients accepting дексибупрофен for an appreciable length of time.
At single or short-term use drug Zotek does not exert impact on speed of response and ability of control of motor transport or other difficult mechanisms. During long reception the possibility of development of such undesirable reaction as dizziness which can influence speed of response in time driving or other mechanisms is not excluded.
Do not apply in pediatric practice.
For the first five months of pregnancy use of drug is not recommended. Use of a deksibuprofen in case of a certain need taking into account risk and advantage for the smallest dose and in a short period is admissible. Use of a deksibuprofen is absolutely contraindicated since the beginning of the 6th month of pregnancy.
Drug is not recommended for use by women, planning pregnancy.
Deksibuprofen easily gets into breast milk therefore during a lactation purpose of a deksibuprofen is contraindicated. In case of need treatments by drug chest feeding need to be stopped.
Side effects:
At administration of drug Zotek from a GIT emergence of dyspepsia, diarrhea, nausea, vomiting, an abdominal pain is possible, and at long reception formation of stomach ulcer and a duodenum, with the subsequent bleedings from digestive tract is possible. Development of a stomacace, in rare instances – gastrointestinal perforation, a meteorism, locks, an esophagitis, ezofagalny strictures, an aggravation of a diverticulitis, nonspecific hemorrhagic and ulcer colitis, a disease Krone is in addition possible.
From skin development of complications in the form of emergence of rash, a small tortoiseshell, an itch, a hyperemia, including an allergic, multiformny erythema, an epidermal necrolysis, baldness, emergence of reaction of photosensitivity, Stephens-Johnson's syndrome, acute toxic epidermal necrolysis (scalded skin syndrome) and an allergic vasculitis is possible.
Reaction of hypersensitivity is shown by emergence of fever, headache, rhinitis, a bronchospasm, bronchial asthma, tachycardia, arterial hypotension, shock, anaphylactic reaction, a Quincke's disease, system lupus erythematosus, other kollagenoz.
From the central nervous system emergence of dizziness, fatigue, drowsiness or sleeplessness, concern, visual hallucinations, psychotic reactions, irritability, a depression, a disorientation, doubling in eyes, a ring or a sonitus, aseptic meningitis is possible.
From system of blood: increase in a blood clotting time, in rare instances development of thrombocytopenia, leukopenia, granulocytopenia, pancytopenia, agranulocytosis, aplastic anemia, hemolitic anemia.
From system of heart and vessels increase in arterial pressure and development of symptoms of acute and chronic heart failure is possible, especially it concerns patients of advanced age. At patients with arterial hypertension or with an impaired renal function liquid removal disturbance is possible.
From an urinary system – development of intersticial nephrite, a nephrotic syndrome. Accepting experience of use of NPVP in attention, emergence of symptoms of a renal and liver failure cannot be excluded.
Seldom or never perhaps increased sweating.
Interaction with other medicines:
Not to apply NPVP combination as there can be a damage of renal fabric with risk of development of symptoms of an acute renal failure.
It is necessary to apply with care NPVP with other drugs increasing risk of development of gastrointestinal bleedings, perforation and deterioration in renal function.
Use Zotek with any other drug inhibiting cyclooxygenase and synthesis of prostaglandins can break fertility and is not recommended to the women wishing to become pregnant.
At interaction of a deksibuprofen to the tableted anticoagulants, acetylsalicylic acid there can be an increase in time of turning of blood and decrease in aggregation of thrombocytes.
The methotrexate appointed in a dose is less than 15 mg/kg, demands purpose of blood test and control of function of kidneys for the first weeks, especially it concerns patients of advanced age. Metatreksat who is appointed in a dose of 15 mg, kg and more has to be used in a day after a dezibuprofen. Because of increase in concentration in plasma as a result of decrease in its removal by kidneys, toxicity of a methotrexate therefore simultaneous use of a deksibuprofen is not recommended increases.
NPVP can cause increase in concentration of level of lithium in a blood plasma, reducing its removal by kidneys. The combination of drugs of lithium with Zotek is not recommended.
Especially carefully it is necessary to combine with non-steroidal anti-inflammatory drugs including with Zotek, hypotensive drugs as efficiency of beta adrenoblockers as a result decreases.
Simultaneous use of drug with APF inhibitors or with antagonists of receptors of angiotensin II can reduce hypotensive action of antagonists of receptors of angiotensin II and APF inhibitors, and also to cause development of symptoms of an acute renal failure, especially it concerns the patients having a renal failure in the anamnesis or elderly people.
Cyclosporine, такролимус at co-administration can strengthen risk of nephrotoxicity because of reduced synthesis in kidneys of prostaglandins. It is necessary to control function of kidneys, especially at patients of advanced age.
Koritkosteroida at simultaneous use with Zotek can promote increase in probability of gastrointestinal bleedings.
Use Zotek with cardiac glycoside digoxin causes increase in concentration and toxicity of digoxin in a blood plasma.
Flowed can replace фентоин at linkng with proteins, perhaps, leading to increase in its concentration in blood and toxicity. Therefore control of concentration of a fentoin in blood is recommended.
Diuretics, including thiazide, tiazidopodobny, loopback and kaliysberegayushchy, at parallel use with nonsteroid antiinflammatory to drugs increase risk of development of a renal failure and secondary decrease in renal blood circulation.
The drugs increasing potassium concentration at simultaneous use with deksibuprofeny lead to increase in potassium concentration and demand control of potassium concentration in blood.
Trombolitiki, тиклопидин, antithrombocytic means at simultaneous use with non-steroidal anti-inflammatory drugs can increase antithrombocytic effect.
Contraindications:
Drug Zotek is contraindicated at hypersensitivity to a deksibuprofen or to other NPVP and other components which are a part of drug that is shown in the form of an attack of bronchial asthma, a bronchospasm, an acute inflammation of a nasal cavity or emergence of nasal polyps, development of a small tortoiseshell and a Quincke's disease in the anamnesis is also considered.
Flowed do not apply at bronchial asthma, gastrointestinal bleedings, bleedings of other localization or disturbances of coagulability of blood, and also hemorrhagic diathesis and others narusheny coagulation or during performing anticoagulating therapy.
At erosive cankers of a digestive tract in an aggravation phase, nonspecific ulcer colitis in a phase of an aggravation, a disease Krone in an aggravation phase drug is contraindicated.
Flowed do not apply at heavy abnormal liver functions and kidneys, a leukopenia, thrombocytopenia, malignant arterial hypertension, heart failure, diseases of an optic nerve, disturbance of color perception.
Overdose:
Symptoms of overdose are dizziness, a condition of an oglushennost, an abdominal cavity pain, nausea, vomiting, a condition of drowsiness, a headache, a nystagmus, a ring in ears, the ataxy, gastrointestinal bleeding, a lowering of arterial pressure, decrease in temperature, development of a metabolic acidosis, disturbance of work of kidneys, is in exceptional cases possible a loss of consciousness.
The specific antidote is not known, the symptomatic treatment of overdose is shown.
Within the first hour after administration of drug it is possible to carry out a gastric lavage by water. Appoint enterosorbents. Gemodaliz at this overdose is inefficient as extent of linkng of drug with proteins is high.
Storage conditions:
To store in original packaging, in unavailable to children, the dry place, at a temperature no more than 25 degrees Celsius.
Issue conditions:
Without recipe
Packaging:
The blister on 10 tablets. On 1 and 10 blisters in cardboard packaging.