Presentation

Windel 2 tablet: Each tablet contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol.

Windel syrup: Each 5 ml contains Salbutamol Sulphate BP equivalent to 2 mg Salbutamol.

Windel respirator solution: Each 1 ml solution contains Salbutamol Sulphate BP equivalent to Sulbutamol 5 mg. Windel nebuliser solution: Each ampoule contains 3 ml isotonic, clear solution for inhalation of Salbutamol Sulphate BP equivalent to Salbutamol 2.5 mg.

Windel DS nebuliser solution: Each ampoule contains 2.5 ml isotonic, clear solution for inhalation of Salbutamol Sulphate BP equivalent to Salbutamol 5 mg.

Windel 0.5 injection: Each ampoule contains 1 ml sterile isotonic solution for injection of Salbutamol Sulphate BP equivalent to Salbutamol 0.5 mg.

Windel 5 IV infusion: Each ampoule contains 5 ml sterile isotonic solution for intravenous infusion of Salbutamol Sulphate BP equivalent to Salbutamol 5 mg.

Description

Salbutamol is a synthetic sympathomimetic agent with predominant beta-2 adrenergic activity. Salbutamol produces bronchodilatation through stimulation of beta-2-adrenergic receptors in bronchial smooth muscles, thereby causing relaxation of bronchial muscle fibres. This action is manifested by an improvement in pulmonary function as demonstrated by spirometric measurements.

Indications

Salbutamol is indicated as a bronchodilator for use in –

Asthma, Chronic Bronchitis, Emphysema and other conditions associated with airways obstruction.

Dosage & Administration

Children

2 – 6 years: 2.5 ml syrup, 3-4 times daily

6-12 years: 5 ml syrup, 3-4 times daily

Over 12 years: 5-10 ml syrup, 3-4 times daily (2-4 mg tablet, 3-4 times daily)

Adults

2-4 mg tablet, 3-4 times daily. Maximum single dose is 8 mg tablet.

Windel Respirator Solution

To be used with a suitable nebuliser device under the direction of a physician. The solution must not be injected or ingested.

Method 1 – Intermittent Administration:

Adults (and the elderly): 0.5 ml – 1.0 ml salbutamol up to four times a day. Up to 40mg per day can be given under strict medical direction in hospital. 0.5 – 1ml solution should be diluted to final volume of 2 – 4 ml with sterile normal saline solution. It will take time about 10 minutes.

Salbutmol respiratory solution may be used undiluted for intermittent administration. For this 2.0 ml of the solution is placed in the nebuliser and the patient allowed to inhale until bronchodilation is achieved. This usually takes 3-5 minutes.

Children under 12 years of age: 0.5 ml of the solution diluted to 2.0 – 4.0 ml with normal saline. Some children may however require higher doses of up to 1.0 ml of the solution. Intermittent treatment may be repeated four times a day.

Method 2- Continuous administration:

1 – 2 ml solution is diluted to made up to 100 ml with normal saline solution. The diluted solution is administered by a suitable nebuliser devise. When there is risk of anoxia through hypoventilation, oxygen should be added to the inspired air.

Windel nebuliser solution

To be used with a suitable nebuliser device under the direction of a physician. The solution must not be injected or ingested.

Adults & Elderly: 2.5 mg to 5 mg Salbutamol up to 4 times a day. Up to 40 mg/day may be given under strict medical direction in hospital.

Children under 12 years: 2.5 mg up to 4 times a day. Higher dose up to 5 mg four times a day may be used if required.

Side Effects

Salbutamol may cause fine tremor of skeletal muscles (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilatation have been reported after large doses.

Precautions

Salbutamol should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension and aneurysms. Hypokalaemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmia. Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or closed-angle glaucoma, and in those receiving antihypertensive therapy.

Use in Pregnancy & Lactation

In pregnancy

The drug should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus.

In lactation

It is not known whether this drug is excreted in human milk. Because of the potential of tumorigenecity shown for Salbutamol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Over Dose

The symptoms with overdosage are angina, headache, nausea, vomiting, tremor etc. The preferred antidote for overdosage with Salbutamol is a cardio-selective beta-blocking agent but beta-blocking drugs should be used with caution in patients with a history of bronchospasm.

Commercial Pack

Windel 2 tablet: Each box containing 20 blister strips of 10 tablets.

Windel 4 tablet: Each box containing 20 blister strips of 10 tablets.

Windel syrup: Each amber glass bottle contains 100 ml syrup.

Windel Respirator solution: Each bottle contains 20 ml solution.

Windel nebuliser solution: Each box contains 10 ampoules in blister packs.