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Description
The instruction for medical use of Askoril Torgovoye medicine a name Askoril Mezhdunarodnoye the unlicensed name Is not present the Dosage form of the Tablet Structure One Tablet contains active agents: salbutamol sulfate (it is equivalent to salbutamol) – 2 mg of Bromhexine a hydrochloride – 8 mg of a gvayfenezin – 100 mg excipients: calcium hydrophosphate anhydrous, starch corn, methylparahydroxybenzoate, propilparagidroksibenzoat, the talc purified silicon dioxide colloidal, magnesium stearate, water purified. The description of the Tablet of white color, round shape, with a flat surface, with risky on one party. Pharmacotherapeutic group Drugs for treatment of obstructive respiratory diseases. Sympathomimetics for system use. Sympathomimetics in a combination with other drugs for treatment of obstructive respiratory diseases. The ATX R03CK code the Pharmacological Pharmacokinetics Salbutamol properties is soaked up in digestive tract. The bioavailability is 50-85%. Meal does not influence bioavailability. After intake, the maximum concentration of salbutamol in blood plasma is reached in 1 – 4 hour. Linking with proteins of plasma makes 10% and the volume of distribution (Vd) 156 ± 38 liters. It is metabolized in a liver to ether 4-o-sulfate. Elimination half-life of T ½ – 3-6.5 hours. It is removed with urine (64% of-98%) and with bile. Bromhexine is well soaked up in digestive tract. The maximum concentration in blood plasma (Cmax) is observed in 1 hour after intake. Ambroxol is metabolized in a liver in an active metabolite. Elimination half-life (T ½) makes 6.5 hours. It is removed mainly with urine in the form of metabolites, the insignificant amount of Bromhexine is removed in not changed look. Gvayfenezin is well soaked up in digestive tract. It is metabolized in a liver. Т½ – 1 hour. It is removed with urine in the form of inactive metabolites. A pharmacodynamics Askoril – the combined drug with bronkhodilatiruyushchy, mucolytic and expectorant action. Salbutamol — selection agonist β2-адренорецепторов, stimulates β2-адренорецепторы bronchial tubes, blood vessels and myometrium, has broncholitic effect, stops a bronchospasm. Bromhexine has mucolytic and expectorant effect. Increases a serous component of a bronchial secret, reduces viscosity of a phlegm, stimulates activity of a ciliary epithelium and production of pulmonary surfactant. Gvayfenezin – expectorant, reduces adhesive properties of a phlegm, stimulates secretory cells mucous bronchial tubes, reduces viscosity of a phlegm, activates the tsiliarny device of bronchial tubes. Indications For symptomatic treatment of the productive cough which is followed by a bronchospasm. Route of administration and doses Inside. To adults and children 12 years are more senior appoint on 1 tablet 2 times a day. Children at the age of 6-12 years: on 1/2 2 times a day. Course of treatment of 7-10 days. Side effects – a headache, dizziness – the increased nervous irritability, nervousness, a shiver – a sleep disorder, drowsiness, a tremor, spasms – nausea, vomiting, diarrhea – coloring of urine in pink color – exacerbation of a peptic ulcer of a stomach and duodenum – pain in epigastriums – collapse, a bronchospasm – a hypopotassemia – a cardiopalmus – the complicated urination – an urolithiasis – allergic reactions (rash, urticaria), a laryngeal edema – discomfort in a breast – increase in arterial blood pressure, stenocardia – dryness in a mouth or irritation – disturbance of taste – increase in level of hepatic tests of the Contraindication – hypersensitivity to drug components – pregnancy, the lactation period – simultaneous use of antibechics, non-selective blockers of β-adrenoceptors, MAO inhibitors – tachycardia, arrhythmias – myocarditis, heart diseases – diabetes dekompensirovanny – a thyrotoxicosis – glaucoma – gastric bleeding – arterial hypertension – a liver or renal failure – a peptic ulcer of a stomach, duodenum in an aggravation stage – children’s age till 6th years (risk of suffocation) Medicinal interactions Others a beta 2-adrenomimetichesky means and theophylline strengthen effect of salbutamol and increase the probability of emergence of side effects. Askoril do not appoint along with the drugs containing codeine and other antibechics since it complicates an otkhozhdeniye of the diluted phlegm. The Bromhexine which is a part of drug promotes penetration of antibiotics (erythromycin, cefalexin, Oxytetracyclinum) into pulmonary fabric. It is not recommended to use drug along with such non-selective blockers of beta adrenoceptors as propranolol. The salbutamol which is a part of the drug Askoril is not recommended to patients who receive monoaminooxidase inhibitors. Diuretics and drugs of glucocorticosteroids enhance gipokaliyemi-chesky effect of salbutamol. The concomitant use with Askoril of a tablet alkaline drink is not recommended. The special instructions Salbutamol as all sympathomimetic amines, it has to be used with care at patients with convulsive disorders, a hyperthyroidism, diabetes and at patients with hypersensitivity to sympathomimetic amines. Salbutamol as all other β-adrenergic agonists, can cause cardiovascular changes in some patients: pulse rates, arterial blood pressure, change of the electrocardiogram: alignment of a wave of T, lengthening of an interval of QT and decrease in a segment of ST. Therefore salbutamol has to be used with care at patients with cardiovascular disturbances, especially with coronary insufficiency, cardiac arrhythmias and an arterial hypertension. The aggravation of symptoms of the patient with bronchial asthma observed at Askoril’s reception within 1 hour or in several days (destabilization of asthma) – demands revaluation of treatment and possible therapy by corticosteroids. Salbutamol can cause a paradoxical bronchospasm, Askoril’s reception it is necessary to stop and begin alternative therapy. Allergic reactions can arise after salbutamol use: exceptional cases of an urticaria, a Quincke’s edema, rash, a bronchospasm, a laryngeal edema, it is rare: a multiformny erythema and Stephens-Johnson’s syndrome at children. The precaution at use of a gvayfenezin at treatment of the cough accompanied with a large amount of slime, the constant or chronic cough connected with smoking, asthma, chronic bronchitis, or emphysema is necessary. Gvayfenezin paints urine in pink color. Bromhexine has to be used with care at patients with a gastric or duodenal ulcer. Co-administration of Askoril with the drugs containing codeine and other antibechics complicates an otkhozhdeniye of the diluted phlegm. It is better for feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms during administration of drug to refrain from control of motor transport and other activity demanding exact coordination, speed of reaction and concentration of attention. Overdose Symptoms: strengthening of manifestation of side effects is possible. Treatment: symptomatic. The form of release and packing On 10 tablets place in planimetric bezjyacheykovy packing from aluminum foil. On 2 planimetric bezjyacheykovy packs together with the instruction for medical use in the state and Russian languages put in a pack from cardboard. Storage conditions In the dry, protected from light place at a temperature not above 25 °C. 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 Name and the country of the organization – Glenmark Pharmasyyutikalz Ltd producer, India Viledzh Kishanpura, Buddy – Nalagarkh Road, Tekhsil Buddy, Distt. Solana (HP)-173205 Name and country of the owner of the registration certificate of Glenmark Pharmasyyutikalz Ltd, India
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