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VENTISAL L

LEVOSALBUTAMOL SULPHATE INN


NAME STRENGTH PACK SIZE DOSAGE FORM
VENTISAL L 1 MG/ 5 ML 1 MG/ 5 ML 100 ML SYRUP
VENTISAL L 2 MG 2 MG 100 S TABLET
VENTISAL L 1 MG/ 5 ML 1 MG/ 5 ML 50 ML SYRUP

Ventisal-L Tablet: Each tablet contains Levosalbutamol Sulphate INN equivalent to Levosalbutamol 2 mg. Ventisal-L Syrup: Each 5 ml syrup contains Levosalbutamol Sulphate INN equivalent to Levosalbutamol 1 mg.

Ventisal-L (Levosalbutamol) is a single isomer b2 agonist that differs from racemic salbutamol by elimination of (S)-salbutamol. Levosalbutamol is an effective bronchodilator whose primary mechanism of action is unimpeded by (S)-salbutamol. Thus, when compared with racemic salbutamol, clinically comparable bronchodilation can be achieved with doses that substantially lessen beta-mediated side effects.

Levosalbutamol (Ventisal-L) is indicated for the treatment & prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway diseases.

• Adults and adolescents above 12 years: 1-2 mg (5-10 ml), three times daily. • Children (6-11 years): 1mg (5 ml), three times daily.

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to this compound or any of the components of this formulation.

Particular caution is advised in acute severe asthma as this effect may be potentiated by hypoxia and by concomitant treatment with xanthine derivatives, steroids and diuretics. Serum potassium levels should be monitored in such situations. Oral Levosalbutamol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias or hypertension.

Potentially serious hypokalemia may result from b2 agonist therapy. This effect may be potentiated by hypoxia. Other side effects such as palpitation, fine tremors of the skeletal muscle (particularly the hand) and muscle cramps may occur. The other likely side effects are gastrointestinal disturbances such as nausea, vomiting, burning substernal or epigastric pain and diarrhoea. In some cases nervousness, headache, dizziness, fatigue and sleeplessness may occur.

The drug should be used during pregnancy only if the expected benefit to the mother is greater than any possible risk to the fetus or the infant. In Lactation: It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when oral Levosalbutamol is administered to a nursing woman.

Other short-acting sympathomimetic bronchodilators or epinephrine should be used with caution with Levosalbutamol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

The expected symptoms with overdose are those of excessive beta-adrenergic stimulation symptoms listed under side effects. In the event of serious poisoning, the stomach should be emptied and, if necessary, a beta-blocker administered with caution in patients with a history of bronchospasm.

Keep all medicines out of reach of children. Store in a cool and dry place, protected from light.

Ventisal-L Tablet: Each box containing 10X10’s tablets in blister strips. Ventisal-L Syrup: Each bottle contains 50 ml syrup with a plastic spoon. Ventisal-L Syrup: Each bottle contains 100 ml syrup with a plastic spoon.