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Levosalbutamol | Prescribing Information

Levosalbutamol, also known as levalbuterol, is a short-acting β2 adrenergic receptor agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Evidence is inconclusive regarding the efficacy of levosalbutamol versus salbutamol or salbutamol-levosalbutamol combinations, though levosalbutamol is believed to have a better safety profile due to its more selective binding to β2 receptors (primarily in the lungs) versus β1 (primarily in the heart muscle).

The drug is the (R)-(−)-enantiomer of its prototype drug salbutamol. It is available in some countries in generic formulations from pharmaceutical companies including Cipla, Teva, and Dey, among others.

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.

Pharmacology

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.

Dosage & Administration

Tablet

  • Adults and adolescents above 12 years: 1-2 mg three times daily.
  • Children (6 -11 years): 1 mg three times daily.

Syrup

  • Adults: 5-10 ml three times daily.
  • Children (6-11 years): 5 ml three times daily.

Nebuliser Solution: This Nebuliser Solution is 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.

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.

Following simple steps can help to use Inhaler effectively (According to “National Asthma Guidelines for Medical Practitioners” published by Asthma Association):

  • Take off the cap.
  • Shake the inhaler (at least six times) vigorously before each use.
  • If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
  • Breathe out as full as comfortably possible & hold the inhaler upright.
  • Place the actuator into the mouth between the teeth and close the lips around the mouthpiece.
  • While breathing deeply and slowly through the mouth, press down firmly and fully on the canister to release medicine.
  • Remove the inhaler from the mouth. Continue holding your breath for at least 10 seconds or as long as it is comfortable.
  • If the doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
  • After use, replace the cap on the mouthpiece. After each treatment, rinse the mouth with water.
  • Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around the mouthpiece, or you may not be breathing in as you press the can. This indicates a failure of the technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove the canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

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 will be used with caution to avoid deleterious cardiovascular effects.

Contraindications

Levosalbutamol is contraindicated in patients with a history of hypersensitivity to levosalbutamol or any of its components.

Side Effects

Hypocalcaemia, palpitation, fine tremors of the skeletal muscle, and muscle cramps may occur. The other likely side effects are nausea, vomiting, burning substernal or epigastric pain, and diarrhea.

Pregnancy & Lactation

The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 & Warnings

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.

Overdose Effects

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and the symptoms listed under side effects. 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 in a cool & dry place below 30°C.
  • Protect from light & moisture.
  • Keep out of reach of children.

References:

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