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Levodilツョ
Levosalbutamol
Levodil<sup>ツョ</sup>

Levodilテつョ 1 tablet: Each tablet contains Levosalbutamol Sulphate INN equivalent to 1 mg Levosalbutamol. Levodilテつョ 2 tablet: Each tablet contains Levosalbutamol Sulphate INN equivalent to 2 mg Levosalbutamol. Levodilテつョ syrup: Each 5 ml syrup contains Levosalbutamol Sulphate INN equivalent to 1 mg Levosalbutamol.

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Pharmacology/Description

Levosalbutamol is a single isomer beta 2 -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.

Indication

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.

Dosage And Administration

Levodilテつョ1 & Levodilテつョ2 tablets: Adults and adolescents above 12 years: 1-2 mg three times daily. Children (6 -11 years): 1 mg three times daily. Levodilテつョ syrup: Adults: 5-10 ml three times daily. Children (6-11 years): 5 ml three times daily.

Side Effects

Potentially serious hypokalaemia may result from beta 2 -agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma, with monitoring of serum potassium levels. 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.

Contraindications

Hypersensitivity to any of the components of the formulation.

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 produce severe bronchospasm in asthmatic patients. However, under certain circumstances, e.g. as prophylaxis after myocardial infarction, use of beta-adrenergic blocking agents could be considered, although they should be administered with caution. Diuretics: The ECG changes and/or hypokalaemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists. Hence, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. Digoxin: Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of racemic salbutamol, hence it is advisable to carefully evaluate the serum 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 such agents, because the action of Levosalbutamol on the vascular system may be potentiated.

Precautions

Potentially serious hypokalemia may result from beta 2- agonist therapy. Levosalbutamol, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and/or symptoms. Although such effects are uncommon after administration of Levosalbutamol at recommended doses, if they occur, the drug may need to be discontinued. Oral Levosalbutamol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias or hypertension. Use in Pregnancy: Use of oral Levosalbutamol in a pregnant woman should be considered only if the expected benefit to the mother is greater than any possible risk to the foetus. 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.

Over Dosage

The expected symptoms with over dosage 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.

Pharmaceutical Precautions

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

Commercial Pack

Levodilテつョ 1 tablet: Each box contains 10 X10 tablets in blister pack. Levodilテつョ 2 tablet: Each box contains 10 X10 tablets in blister pack. Levodilテつョ syrup : Each bottle contains 100 ml syrup.