APPLICATION INSTRUCTION
SALBUTAMOL NEO

PHARMACOLOGICAL GROUP: Selective beta 2 (β2) adrenomimetic –bronchodilator.
GENERIC NAME: Salbutamol.
DRUG FORM: Syrup.
COMPOSITION:
Salbutamol sulphate – 2mg/5ml.
Aiding substances: Sodium benzoate, citric acid, sugar, orange aromatizer, distilled water.
PHARMACOLOGICAL OPERATION:
Pharmacodynamics: Salbutamol represents beta-adrenomimetic primary influence on β2 adrenoreceptors (being localized in bronchi, myometrium and blood vessels).
“Salbutamol Neo” with selective stimulation of bronchial β2 adrenoreceptors, causes relaxation of smooth muscles and expansion of bronchi, stops bronchospasm, increases the vital capacity of lungs. Renders weakly expressed positive chrono- and inotropic action on a myocardium. Expands coronary vessels, practically doesn’t reduce arterial pressure. Lowers, myometrium tone and contractility (tocolytic operation).
Pharmacokinetics: Salbutamol is quickly absorbed from the gastrointestinal tract. Maximum concentration in blood serum is reached approximately in 2 hours.
The preparation metabolizes in the liver and is excreted in the form of metabolites. Salbutamol sulfate doesn’t break up by lungs’ catechol-0-methyltransferase, by this reason it has long-term action.
INDICATION:IT IS USED IN COMPLEX THERAPY, AS AN AID MEAN:
· Smooth muscles’ spasm at time of bronchial asthma;
· Chronic spastic bronchitis;
· Lungs emphysema;
CONTRAINDICATIONS: Hypersensitivity towards components of the preparation, myocardic infarct.
ADMINISTRATION AND DOSAGE RULE: For oral intake.
For adults and children up to 12 years: 10 ml syrup (4 mg salbutamol) 3-4 times a day.
For children from 2 to 6 years: 2.5-5 ml syrup (1-2 mg salbutamol) 3-4 times a day.
For children from 6 to 12 years: 5 ml syrup (2 mg salbutamol) 3-4 times a day.
5 ml syrup is equal to 1 teaspoon.
SIDE EFFECTS: From the side of central nervous system: trembling (hand fingers), tension, nervousness, increased excitability, dizziness, headache, sleep disorder.
From the side of cardiovascular system: tachycardia, arrhythmia, blood vessel peripheral expansion, myocardial ischemia, heart insufficiency, cardiopathy.
From the side of gastrointestinal tract: nausea, vomitting, mouth dryness, loss of appetite.
Rarely may develop bronchospasm (paradoxic or caused hypersensitivity towards Salbutamol), pharyngitis, urination difficulty, sweating, increase of glucose, free fatty acids content in blood, development of physical and psychical drug dependence.
PREGNANCY AND LACTATION PERIOD: Usage the preparation at time of pregnancy and lactation period is recommended only when possible benefit for mother exceeds potential risk for the foetus. Salbutamol can inhibite uterus contractility function, so usage the preparation at time of delivery is permitted only in case of absolute necessity.
In case of nessessity of “Salbutamol Neo” at lactation period, breast feeding should be stopped.
CAUTION: Bescause of sympathetic system’s strong excitability, Salbutamol should be carefully prescribed patints with cardiovascular system diseases: heart ischemic disease, heart insufficiency, heart rhythm disorder, hypertension.
Also, Salbutamol should be carefully prescribed patints with hyperthyroidism, epilepsy, diabetes mellitus and glaucoma.
Increase of Salbutamol dosage and siquence without doctor’s consultation is forbidden, in order to avoid overdose and undesirable side effects caused by hyperdosage.
INFLUENCE ON VEHICLE AND MECHANISMS MANAGEMENT: Preparation doesn’t influence on vehicle and mechanisms management.
INTERACTION WITH OTHER MEDICINES OR OTHER SORT INTERACTION: Simultaneous usage of the preparation together with other adrenomimetic means is forbidden, because it may cause undesirable effect from the side of cardiovascular system, e.g. tachycardia and strong heartbeat. In special cases, after doctor’s consultation, usage of inhalation beta-adrenomimetic means is permitted.
Antidepressant means and MAO inhibitors can reinforce Salbutamol’s influence on the cardiovascular system.
PACKAGE: Primary packing: 100 ml syrup in polymeric bottle.
Secondary packing: 1 bottle is located in a cardboard box with leaflet.
SHELF-LIFE: 2 years.
In case of visual defects and expiry of validity date, the preparation can not be used.
STORAGE CONDITIONS: Store at 15-25ºC temperature, in a dark place and keep away from children.
ISSUE: II group of a pharmaceutical product, issued with prescription form #3.
MANUFACTURER: Ltd ,,Neopharmi”.

12th km, David Agmashenebeli alley, Tbilisi, Georgia.
Tel/Fax: +995 (032) 259-57-90; 259-64-46