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Product Information

Overview of Ventolin

Ventolin (salbutamol) is a selective beta2 adrenoceptor agonist indicated for the treatment or prevention of bronchospasm. It provides short- acting (four hours) bronchodilation in reversible airways obstruction due to asthma, chronic bronchitis and emphysema.1

Why Ventolin?

When inhaled, Ventolin provides quick relief 1-2 of asthma symptoms.

  • Inhaled reliever therapy provides more rapid bronchodilation and fewer side-effects than oral reliever therapy in asthma.3
  • Therapeutic efficacy has been established in numerous clinical trials.2
  • The use of a metered-dose inhaler (MDI) has a lower propensity to cause systemic side effects than oral medication.1-2

Dosage

Multiple delivery systems* provide solutions for all patients.1

Population Device Recommended Dosage
Relief of acute bronchospasm
Adults Inhaler** Evohaler 100 or 200 μg
Diskus 200 μg as required
Children Inhaler Evohaler

100 μg(may be increased to 200 μg if required)

Diskus 200 μg as required
Prevention of allergen-or-exercise-induced bronchospasm
Adults Inhaler** Evohaler 200 μg before challenge or exertion
Diskus 200 μg before challenge or exertion
Children Inhaler** Evohaler 100 μg before challenge or exertion (may be increased to 200 μg if required)
Diskus 200 μg before challenge or exertion
 

*Inhaler, Evohaler, Diskus:

On demand use of Ventolin should not exceed four times daily. Reliance on such supplementary use or a sudden increase in dose indicates deteriorating asthma control.1

 

** Inhaler, Evohaler:

In patients who find co-ordination of a pressurised metered dose inhaler difficult, a spacer may be used with Ventolin inhaler or Evohaler.

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Succinct safety information

Contraindications1

  • Salbutamol inhaled formulations are contraindicated in patients with a history of hypersensitivity to any of their components.
  • Non-i.v. formulations of salbutamol must not be used to arrest uncomplicated premature labour or threatened abortion.

Diskus

  • Salbutamol dry powder inhaler formulations are contraindicated in patients with severe milk-protein allergy or who have a history of hypersensitivity to salbutamol or any of its formulation components.

Warnings and Precautions1

  • Increasing use of short-acting bronchodilators indicates deterioration of asthma control.
  • Sudden and progressive deterioration in asthma control is potentially life-threatening and consideration should be given to starting or increasing corticosteroid therapy.
  • Salbutamol should be administered cautiously to patients with thyrotoxicosis.
  • Nebules and Respirator solution must only be used by inhalation, to be breathed in through the mouth, and must not be injected or swallowed.

Side effects1

Common adverse reactions (≥1/100 to <1/10):

  • Tremor, headache, tachycardia.

Pregnancy and lactation1

Pregnancy:

  • Rare cases of various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with salbutamol. Some of the mothers were taking multiple medications during their pregnancies.
  • No consistent pattern of defects can be discerned, and baseline rate for congenital anomalies is 2 to 3%; a relationship with salbutamol use cannot be established.

Lactation:

Salbutamol is probably excreted in human breast milk. Therefore, use by breast-feeding mothers is not recommended unless the expected benefits outweigh any potential risk.

 

 

References:

  1. Ventolin Discus Summary of Product Characteristics Last Accessed December 2018 www.medicines.ie
  2. Ventolin Evohaler Summary of Product Characteristics Last Accessed December 2018 www.medicines.ie
  3. Price AH, Clissold SP. Salbutamol in the 1980s. A reappraisal of its clinical efficacy. Drugs. 1989; 38(I):77-122.
  4. Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2015. Available from: http://www.ginasthma.org/. Accessed on January 12, 2016.

 

Adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971 medsafety@hpra.ie . Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Ventolin is a registered trademark of the GSK group of companies.