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Terbutaline Sulphate + Guaiphenesin + Bromhexine Hydrochloride + Menthol

SUSPENSION PRESENTATION:
Each 5 ml contains:
Terbutaline Sulphate             12.5 mg
Guaiphenesin                         50mg
Bromhexine Hydrochloride     4 mg
Menthol                                 2.5 mg

Terbutaline Sulphate + Guaiphenesin + Bromhexine Hydrochloride + Menthol Suspension:
Terbutaline Sulphate is a selective beta2 -adrenergic agonist which predominantly stimulates beta2-receptors, thus producing relaxation of bronchial smooth muscle. Guaiphenesin, by increasing respiratory tract fluid, reduces the viscosity of tenacious secretions and acts as an expectorant. Bromhexine HCl is intended to support the body's mechanisms for clearing mucus from the respiratory tract. It is secretolytic, increasing the production of serous mucus in the respiratory tract and makes the phlegm thinner and less viscous Menthol is also classified as a expectorant.

RATIONALE OF COMBINATION
Terbutaline sulphate relaxes bronchial muscles and Guaiphenesin along with Menthol acts as a expectorant reducing the viscosity and helps to loosens mucus in your lungs. Whereas,
Bromohexine HCl contributes to a secretomotoric effect by helping the cilia transport the phlegm out of the lungs. Thereby relieving the patient of acute or chronic cough and other bronchospastic disorders.

• Cough associated with Acute and Chronic Bronchitis
• Asthmatic Bronchitis
• Emphysema, Active and Passive Smoking
• Pulmonary TB
• Other Bronchospastic Disorders

Terbutaline Sulphate:
Terbutaline is a selective beta2 - adrenergic causing bronchodilation; increase in mucociliary clearance; suppression of oedema and anti-allergic effects.

Guaiphenesin:
Guaiphenesin is thought to exert its pharmacological action by stimulating receptors in the gastric mucosa. This increases the output from secretory glands of the gastrointestinal system and reflexly increases the flow of fluids from glands lining the respiratory tract. The result is an increase in volume and decrease in viscosity of bronchial secretions.

Bromohexien HCl:
Bromhexine is intended to support the body's mechanisms for clearing mucus from the respiratory tract. It is secretolytic, increasing the production of serous mucus in the respiratory tract and makes the phlegm thinner and less viscous. This contributes to a secretomotoric effect by helping the cilia transport the phlegm out of the lungs. For this reason it is often added to cough syrups.

Terbutaline Sulphate:
Absorption: Approximately 30-50% if administered orally and well absorbed subcutaneously.
Route of Elimination: About 90% of the drug was excreted in the urine at 96 hours after subcutaneous administration, with about 60% of this being unchanged drug. It appears that the sulfate conjugate is a major metabolite of terbutaline and urinary excretion is the primary route of elimination.
Half Life: 5.5-5.9 hours.

Guaiphenesin:
Absorption: Rapidly absorbed from the GI tract.
Metabolism: Rapidly hydrolyzed (60% within seven hours) and then excreted in the urine.
Half Life: 1 hour.

Bromohexine Hydrochloride:
Absorption: Bromohexine hydrochloride is rapidly absorbed from the gastrointestinal tract.
Distribution: It is widely distributed to body tissues and is highly bound to plasma proteins.
Metabolism: It undergoes extensive first-pass metabolism in the liver.
Route of Elimination: About 85 to 90% of a dose is excreted in the urine mainly as metabolites.
Half Life: It has a terminal elimination half-life of up to about 12 hours.

• Beta-blocking agents (including eye drops); especially the non-selective ones such as propranolol, may partially or totally inhibit the effect of beta-stimulants. Therefore terbutaline preparations and non-selective beta-blockers should not normally be administered concurrently. Terbutaline should be used with caution in patients receiving other sympathomimetics.
  
• Hypokalaemia may result from beta2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics.

• Increased heart rate
• Palpitations
• Dizziness
• Headache
• Drownsiness
• Vomitting/Nausea
• Gastrointestinal discomfort.

Hypersensitivity to any of the components of the formulation. It should not be used in patients with pre- existing ischaemic heart disease or those patients with significant risk factors for ischaemic heart disease.

• As for all β2-agonists, caution should be observed in patients with thyrotoxicosis and in patients with severe cardiovascular disorder, such as ischemic heart disease, tachyarrhythmias or severe heart failure.
• Due to the hyperglycemic effects of β2-agonists, additional blood glucose controls are recommended initially in diabetic patients.
No teratogenic effects have been observed in patients or animals. However, caution is recommended during the first trimester of pregnancy.