50 mg/1 mg per 5 mL SYRUP
EXPECTORANT/SELECTIVE
BETA-2-ADRENORECEPTOR AGONIST

 

FORMULATION:
Each 5 mL (1 teaspoonful) contains:
Guaifenesin…………..........................................….............……….50 mg
Salbutamol (as sulfate) …………..............................................……1 mg

PRODUCT DESCRIPTION:
Guaifenesin + Salbutamol 50 mg/1 mg per 5 mL Syrup (Bronchoprime) is clear bluish violet colored syrup with a sweet grape fruit taste.

PHARMACODYNAMICS:
Guaifenesin possesses mucolytic properties. Mucolytics are agents that alter the structure of mucus to decrease its viscosity and therefore facilitate its removal by ciliary action or expectoration. Although
mucolytics have been shown to affect sputum viscosity and structure, and patients have reported alleviation of their symptoms, no consistent improvement has been demonstrated in lung function. Guaifenesin is reported to reduce viscosity of tenacious sputum and is used as an expectorant. Salbutamol is a direct acting sympathomimetic agent with predominantly beta-adrenergic activity and selective action on beta 2 receptors. It is used as a bronchodilator. It has more prolonged action than isoprenalin and as a predominantly beta 2 stimulant, has a bronchodilating action relatively more prominent than its effect on the heart. An additional beneficial effect of salbutamol is its action on the
uterus as a relaxant, the uterine muscles as we all know contract under beta adrenergic stimulation. Thus it has gained popularity among obstetricians for controlling premature labor. However, a relative
contraindication to its used is among pregnant patients with vaginal bleeding because it may cause pulmonary edema.

PHARMACOKINETICS:
Guaifenesin rapidly well absorbed from the gastrointestinal tract. Guaifenesin has a plasma half life of approximately 1 hour and is rapidly metabolized and excreted in urine.Salbutamol is readily absorbed
from the gastrointestinal tract after given by oral administration. Salbutamol’s onset of action is within 30 minutes peaks in 2 to 3 hours and persists for 6 hours after a dose; Salbutamol has a half-life of 4 to 6
hours. It is metabolized in the liver and converted to the inactive Salbutamol 4’-O-sulfate (phenolic sulfate) which is also excreted primarily in the urine. Salbutamol and its metabolites are excreted via urine and feces. After oral administration, Salbutamol is excreted within 72 hours mainly as a major metabolite, and 4-5% is excreted via feces. Salbutamol is bound to plasma proteins to the extent of 10%, after oral
administration, it is absorbed in the gastrointestinal tract and undergoes to first pass metabolism to phenolic sulfate. Both the conjugate and the drug are excreted primarily in the urine. The bioavailability of salbutamol is about 50% when given by oral administration.

INDICATIONS:
Respiratory disorders complicated by bronchospasm and excessive secretion of tenacious mucus,
bronchial asthma, chronic bronchitis and emphysema.