Levotol

Uses

• • Acute and chronic diseases of respiratory tracts associated with viscid mucus including acute and chronic bronchitis
• • Productive cough
• • Inflammatory diseases of Rhinopharyngeal tract (e.g. Laryngitis, Pharyngitis, Sinusitis and Rhinitis) associated with viscid mucus
• • Asthmatic bronchitis, Bronchial asthma with difficult departure of mucus
• • Bronchiectasis
• • Chronic pneumonia.

Levosalbutamol tablet is used for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Levosalbutamol Nebuliser Solution or Inhaler is used for the treatment or prevention of bronchospasm in adults, adolescents, and children with reversible obstructive airway disease.

Levotol is also used to associated treatment for these conditions: Airway secretion clearance therapyBronchospasm

How Levotol works

Ambroxol is a mucolytic agent. Excessive Nitric oxide (NO) is associated with inflammatory and some other disturbances of airways function. NO enhances the activation of soluble guanylate cyclase and cGMP accumulation. Ambroxol has been shown to inhibit the NO-dependent activation of soluble guanylate cyclase. It is also possible that the inhibition of NO-dependent activation of soluble guanylate cyclase can suppress the excessive mucus secretion, therefore it lowers the phlegm viscosity and improves the mucociliary transport of bronchial secretions.

β2 adrenergic receptors on airway smooth muscle are Gs coupled and their activation by levosalbutamol leads to activation of adenylate cyclase and to an increase in the intracellular concentration of 3',5'-cyclic adenosine monophosphate (cyclic AMP). Increased cyclic AMP activates protein kinase A which itself inhibits the phosphorylation of myosin produces lower intracellular ionic calcium concentrations, inducing muscle relaxation. Increased cyclic AMP concentrations are also associated with the inhibition of the release of mediators from mast cells in the airways, potentially contributing to its benefit in asthma attacks.

Dosage

Levotol dosage

Average daily dose (preferably after meal):Pediatric Drops:

• 0-6 months: 0.5 ml 2 times a day
• 6-12 months: 1 ml 2 times a day
• 1-2 years: 1.25 ml 2 times a day

Syrup:

• 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
• 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
• 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.

Sustained release capsule:

• Adult and children over 12 years old: 1 capsule once daily

Specific application features: Ambroxol may be prescribed to patients suffering from diabetes mellitus.

Levosalbutamol 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.

Levosalbutamol Nebuliser Solution-

This Nebuliser Solutionis supplied in unit-dose ampoules and requires no dilution before administration by nebulization.

• Children (6 months-11 years): The recommended dosage is 0.31 mg administered three times a day, by nebulization. Routine dosing should not exceed 0.63 mg three times a day.
• Adults and Adolescents above 12 years old: The recommended starting dosage is 0.63 mg administered three to four times a day, every 6 to 8 hours, by nebulization.
• Patients 12 years of age and older with more severe asthma or patients who do not respond adequately: 0.63 mg of Levosalbutamol Nebuliser Solution may benefit from a dosage of 1.25 mg three times a day.

Levosalbutamol Inhaler-

You should take your Levosalbutamol Inhaler as needed for an asthma attack at any time of day, with or without food, by taking 1-2 puffs up to 4 times daily and no more than 8 puffs in 24 hours. If you are using your Levosalbutamol Inhaler more than 3-4 times a week this may indicate that your asthma is not well controlled and you may need to review your medication. You can also use your Levosalbutamol Inhaler to prevent allergy or exercise induced asthma by taking 2 puffs 15 minutes before exercise or exposure to a known allergen.

Side Effects

Gastrointestinal side-effects like epigastric pain, gastric fullness may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema may occur.

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.

Precaution

Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.

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.

Levosalbutamol Hydrochloride, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Levosalbutamol Nebuliser Solution or Inhaler must not be injected.

Interaction

Ambroxol has no interaction with cardioactive glycosides, corticosteroids, bronchodilators, diuretics and antibiotics (normally used in the treatment of bronchopulmonary affections). But Ambroxol should not be taken simultaneously with antitussives (e.g. Codeine) because mucus, which has been liquefied by Ambroxol, might not be expectorated.

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.

Elimination Route

Rapid and almost complete.

Inhalation delivers the medication directly into the airways and lungs, thereby minimizing side effects because of reduced systemic absorption of the inhaled medications.

Half Life

7-12 hours

3.3 - 4 hours

Elimination Route

excreted into the urine.

Pregnancy & Breastfeeding use

Pregnancy: Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use during pregnancy, especially in the 1st trimester.

Lactation: Safety during lactation has not been established.

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.

Pregnancy: There are no adequate and well-controlled studies of Levosalbutamol Nebuliser Solution in pregnant women. Levosalbutamol Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when Levosalbutamol Nebuliser Solution is administered to a nursing woman.

Contraindication

Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Levosalbutamol Nebuliser Solution is contraindicated in patients with a history of hypersensitivity to Levosalbutamol Hydrochloride or racemic salbutamol.

Acute Overdose

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 Condition

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

Innovators Monograph

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