Brodil Levo 1mg

Tablet
Levosalbutamol (Oral)
ACI Pharmaceuticals

Other Strength:
- Brodil 2mg
- Brodil 4mg
- Brodil Levo 2mg

Alternative:
- SALMOLIN-L 1mg
- Purisal 1mg
- Levostar® 1mg
- Lebrod 1mg



Brodil Levo
Description
Brodil®Levo is the preparation of Levosalbutamol. Levosalbutamol is a single isomer ß2-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.

Indications and Uses
Brodil®Levo are indicated for the treatment of prevention or bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Dosage and Administration
Brodil®Levo1mg & 2 mg Tablets
Adults and adolescents above 12 years:1-2 mg three times daily.

Brodil®Levo Syrup
Adults: 5-10 ml three times daily.Children (6-11 Years): 5 ml three times daily.Children (2-5 Years): 2.5 ml
three times daily.

Contraindications
Brodil®Levo is contraindicated in patients with a history of hypersensitivity to any of the components of the formulation.

Precautions
Potentially serious hypokalemia may result from ß2-agonist therapy. 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.Levosalbutamol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias or hypertension.

Side effects
The most frequent side effects are 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.

Pregnancy & Lactation
Use of oral levosalbutamol in pregnant or nursing mothers should be considered only if the expected benefit to the mother is greater than any possible risk to the foetus or the infant.It is not known whether levosalbutamol is excreted in human milk. Caution should be exercised when oral levosalbutamol is administered to a nursing woman.

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.Beta-blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists such as levosalbutamol, but may also producesevere bronchospasm in asthmatic patients.Diuretics: 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.Digoxin: Digoxin levels were demonstrated after single-dose intravenous and oral administration of racemic salbutalmol, hence it is advisable to carefully evaluate theserum digoxin levels in patients who are currently receiving digoxin and levosalbutamol.Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Levosalbutamol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of suchagents, because the action of levosalbutamol on the vascular system may bepotentiated.

Overdosage
The expected symptoms with overdosge are 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.

Pharmaceutical Precautions
Store in a cool & dry place. Protect from light & moisture.

Presentation
Brodil®Levo 1 mg tablets: Each tablet contains Levosalbutamol 1 mg as Sulphate INN.
Brodil®Levo 2 mg tablets: Each tablet contains Levosalbutamol 2 mg as Sulphate INN.
Brodil®Levo Syrup: Each 5 ml contains Levosalbutamol 1 mg as Sulphate INN.

Package quantities
Brodil®Levo 1 mg tablets: Carton of 100 tablets in blister.
Brodil®Levo 2 mg tablets: Carton of 100 tablets in blister.
Brodil®Levo Syrup: Bottle of 100 ml & 50 ml.

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