Purisal (Syrup--50 and 100 ml / tablet---1 and 2 mg)

Presentation

Purisal 1: Each tablet contains Levosalbutamol Sulphate INN equivalent to Levosalbutamol 1 mg.

Purisal 2: Each tablet contains Levosalbutamol Sulphate INN equivalent to Levosalbutamol 2 mg.

Purisal syrup: Each 5 ml syrup contains Levosalbutamol Sulphate INN equivalent to Levosalbutamol 1 mg.

 Indications

Levosalbutamol 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.

Therapeutic Class

Short-acting selective β2-adrenoceptor stimulants

Pharmacology

L-Salbutamol is a single isomer ß-2 agonist that differs from racemic salbutamol by elimination of S-salbutamol. L-Salbutamol 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.

Dosage & 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.

                            

Interaction

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.

Contraindications

Hypersensitivity to any of the components of the formulation.

Side Effects

Potentially serious side effects like hypokalamia may result from ß-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.

Pregnancy & Lactation

Use in 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.

Use 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.

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.

Overdose Effects

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under side effects e.g., tachycardia, nervousness, headache, tremor, nausea, dizziness, fatigue and sleeplessness. Hypokalaemia also may occur. Treatment consists of discontinuation of oral Levosalbutamol together with appropriate symptomatic therapy. 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.

Storage Conditions

Store at cool and dry place. Protected from light and moisture. Keep out of the reach of children.

 Pack Size & Price:

Purisal 1 tablet: Each box containing 10 blister strips of 10 tablets.
Purisal 2 tablet: Each box containing 10 blister strips of 10 tablets.
Purisal 50 ml syrup: Each amber glass bottle contains 50 ml syrup.
Purisal 100 ml syrup: Each amber glass bottle contains 100 ml syrup

Incepta Pharmaceuticals Limited