Romhexin neo (8mg) - №50 Tab
Expectorant drug
Pharmacological group: Mucolytic action expectorant drug.
Drug form: Ttablets.
Characteristics: White covered pills
International name: Bromhexinum. (N – (2-amino–3,5 dibromobenzene)–N- Methylcyclohexylamine hydrochloride).
Composition:
Active substance: Bromhexin hydrochloride – 8mg;
Aiding substances: lactose monohydrate, corn starch, microcrystalline cellulose, glucose, polyvinylpyrrolidone, manganese carbonate, calcium or magnesium stearate, saccharose, talcum, yellow pigment, titanium dioxide, aerosyl.
Pharmacological operation:
Pharmacodynamics: Bromhexin reveals mucolytic (secretory) and expectorate action. Mucolytic effect is related to mucopolysaccharide fiber depolymerization and secretion mucus liquefaction.
Except that, Bromhexin stimulates endogenous surfactant output, that is necessary for alveols’ proper operation. Surfactant is a muco-polysaccharide nature surface-active substance, which is synthesized in alveols’ cells. Biosynthesis of surfactant is disordered at time of various diseases of bronchus and lungs. It causes alveols’ cells stability decrease and weakening.
Preparation has also weak anti-cough action.
Pharmacokinetics: After peroral intake Bromhexin is almost entirely absorbed in gastrointestinal tract and is excreted with urine basically unchanged form. Metabolizes in the liver, arises active metabolite – ambroxol, which has similar effect of Bromhexin on the organism. Bio-penetration of the preparation is about 80%. Maximal concentration in blood is reached in an hour. Half-value period makes up 4-5 hours. Bromhexin reaches in hematoencephalic and placental barrier, gets in the mother's milk.
Indication:
• Respiratory tracts and lungs’ diseases, followed by viscous sputum formation: acute and chronic bronchitis, bronchial asthma, pneumonia, laryngitis, pharyngitis, tracheitis, tracheobronchitis, pulmonary tuberculosis and etc.
• Productive cough treatment;
Order of intake and dosage: Peroral intake
If there isn’t other prescription, the preparation should be intake with the following drug dosage regimen:
Children from 6 to 14 years old, also patients less than 50 kg. 1 pill 3 times in a day
Adults and adolescents over 14 years 1-2 pills 3 times in a day
Pill should be intake with sufficient amount of water.
Direction:
Pay attention to intake sufficient amount of water, because increase of liquid supply helps therapy and
desired swelling of secretion in bronchus.
Treatment duration depends on disease current. Preparation shouldn’t be intake more than 4-5 days without doctor’s consultation. Course of treatment may be extended up to 4 weeks.
In case of liver and kidney functions severe disorder, dosage reduction is necessary.
In the case of dose omission, it should be intake according to primary scheme.
Contraindication:
Hypersensitivity toward components including in the preparation.
Side effects:
• From the side of digestion system: dyspepsia in the form of nausea and vomiting, pain in epigastrium, also exacerbation of stomach and duodenum ulcer, bleeding from intestine;
• From the side of central system: dizziness, headache;
• Allergic reactions: itch, rash, nettle-rash, angionervous swollen.
Special indications:
Intake of Bromhexin neo isn’t recommended together with cough reflex blocking preparations that are used for dry cough treatment. Their simultaneous usage arise danger of secretion congestion in the respiratory tracts, which reinforces inflammatory process. Combined intake is possible only interchange of the following preparations: expectorant preparations (Lazolvan, Mucaltin) are intake during a day, but anti-cough preparations - once at bedtime.
Pregnancy and lactation period:Preparation may be used at time of pregnancy and lactation period, only with the consent of doctor, when expected benefit for mother exceeds potential risk of the fetus.
Influence on driving motor transport and mechanisms:
Preparation intake doesn’t influence on vehicle and mechanism management.
Interaction with other preparations:
The preparation may be prescribed in combination with bronchodilators and antibacterial preparations. It shouldn’t be intake together with cough depressant drugs (codeine include). It is possible to intake combined, in the day-time - expectorant and in the evening – alternately with anti-cough preparations (for perfect sleep).
Bromhexin neo is incompatible with alkaline solutions.
Overdose:
In case of excessive doses side effects are not dangerous. In case of heavy cases there may be necessary blood flow control. Treatment is symptomatic.
Caution:
The drug is prescribed with caution during pregnancy and lactation period, children’s age.
Package:
Primary packing: 10 tablets in polyvinylchloride blister.
Secondary packing: 5 blister are located in a cardboard box.
Validity: 2 years.
In case of visual defects and expiry of validity date, the preparation can not be used.
Storage conditions: Store on 15-25ºC temperature in a dark, dry place and keep away from children.
Issue: III group of a pharmaceutical product - issued without prescription.
