ASMOLEX-L

Levosalbutamol

Description:

Asmolex-L (L-Salbutamol) is a single isomer β-2 agonist that differs from racemic salbutamol by elimination of S-salbutamol. Asmolex-L 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.

Composition:

Asmolex-L 1 mg Tablet: Each tablet contains Levosalbutamol sulphate INN equivalent to Levosalbutamol 1 mg.

Asmolex-L 2 mg Tablet: Each tablet contains Levosalbutamol sulphate INN equivalent to Levosalbutamol 2 mg.

Asmolex-L Syrup: Each 5 ml contains Levosalbutamol sulphate INN equivalent to Levosalbutamol 1 mg.

Indications:

Asmolex-L is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Dosage and Administration:

Tablet

Adults and children above 12 years: 1-2 mg three times daily.

Children (6 -11 years): 1 mg three times daily.

Syrup

Adults and children above 12 years: 5-10 ml three times daily.

Children (6 -11 years): 5 ml three times daily.

Contraindications:

Hypersensitivity to any of the components of the formulation.

Precautions:

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. Levosalbutamol can be used with caution after myocardial infarction.

Side effects:

Potentially serious hypokalaemia may result from β-2 agonist therapy. This effect may be potentiated by hypoxia. 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.

Drug Interactions:

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. Diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists. Hence, caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics. It reduces serum digoxin levels in patients who are currently receiving digoxin & Levosalbutamol. Levosalbutamol should be administered with extreme caution to patients being treated with MAOI or TCA.

Use in special groups:

Pregnancy

Use of oral Levosalbutamol in pregnant women should be considered only if the expected benefit to the mother is greater than any possible risk to the foetus or the infant.

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.

Storage:

Keep in a cool and dry place, away from light. Keep out of the reach of children.

Packing:

Asmolex-L 1 mg Tablet: Each box contains 10X10’s Tablets in blister pack.

Asmolex-L 2 mg Tablet: Each box contains 5X10’s Tablets in blister pack.

Asmolex-L Syrup: Each bottle contains 100 ml Syrup.