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Drug Details

VENTMAX SR

• Drug Class Description
  Selective ß2 - agonist
• Generic Name
  Salbutamol
• Presentation
  Modified release capsules, hard. Ventmax SR 4mg: Size 4 capsules with opaque grey cap and opaque pale green body, containing creamy white spherical microgranules, with '4 mg' printed in black ink. Ventmax SR 8mg: Size 3 capsules with opaque white cap and body, containing creamy white spherical microgranules, with '8 mg' printed in black ink.
• Description
  Each capsule contains salbutamol sulphate 4.80mg (equivalent to 4mg of salbutamol base). Each capsule contains salbutamol sulphate 9.60mg (equivalent to 8mg of salbutamol base).
• Indications
  

  Continuous symptomatic treatment of asthma and other types of reversible obstructive airways disease: - in patients requiring daily administration of quick-acting beta2 agonists with a short duration of action; - and/or with nocturnal symptoms.

  N.B.: in asthma, the treatment with Ventmax SR should be combined with an anti-inflammatory treatment, such as inhaled corticosteroids.

• Adult Dosage
  

  Route of administration

  Oral use.

  Posology

  Twice-daily administration of Ventmax SR capsules procures a bronchodilator effect which is maintained for about 12 hours after each dose.

  Adults: The recommended dose is one 8mg capsule twice daily.

• Child Dosage
  

  In children aged 3 to 12 years, the recommended dose is one 4mg capsule twice daily.

• Elderly Dosage
  

  It is not necessary to adjust the dose.

• Contra Indications
  

  Hypersensitivity to the active substance or any of the excipients.

• Special Precautions
  

  Warnings:

  Athletes should be advised that this product contains an active substance which may produce a positive dope test reaction.

  Precautions for use:

  In asthma, Ventmax SR is a maintenance treatment reserved, like all long-acting beta₂ agonists, for patients who are not completely controlled by the anti-inflammatory treatments with which it is prescribed concomitantly.

  Ventmax SR can be combined on demand with other symptomatic treatments (bronchodilators). If paroxysmal dyspnoea should occur in spite of an adequately followed treatment, it is recommended that a short-acting beta₂ agonist bronchodilator be used to treat such symptoms.

  If a patient's consumption of quick and short-acting beta₂ agonists should increase rapidly within a few days, this may be indicative (especially if the peak flow values fall and/or become very irregular), of decompensation of the asthmatic disease, with a possibility of development of a status asthmaticus, and calls for a consultation to re-evaluate the patient's condition. Such decompensation should be treated preferably in a specialised centre. In such circumstances consideration should be given to increased anti-inflammatory therapy, for example by increasing the patient's dose of inhaled corticosteroids, or by a course of oral corticosteroids.

  Ventmax should be given with caution to patients with hyperthyroidism/thyrotoxicosis, cardiovascular disease, arrhythmias and hypertension.

  Potentially serious hypokalaemia may result from beta₂ agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by hypoxia or by concomitant treatment with steroids, diuretics and xanthine derivatives such as theophylline. It is recommended that serum potassium levels are monitored in these circumstances.

  In common with other beta₂ agonists, salbutamol can cause an increase in blood glucose levels. In diabetic patients this may cause the development of ketoacidosis especially when beta₂ agonists are administered intravenously. Therefore, salbutamol should be used with caution in patients with diabetes.

• Interactions
  

  Potentially serious hypokalaemia may result from beta₂ agonist therapy. Particular caution is advised in severe asthma as this effect may be potentiated by concomitant treatment with steroids, diuretics and xanthine derivatives such as theophylline. It is recommended that serum potassium levels are monitored in these circumstances.

  Non-cardioselective beta-adrenoceptor blocking agents such as propranolol antagonise the effects of salbutamol.

  The adverse metabolic effects of high doses of salbutamol, such as increased blood glucose levels, may be exacerbated by concomitant administration of high doses of corticosteroids.

• Adverse Drug Reactions
  

  Potentially serious hypokalaemia may result from beta₂ agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma, with monitoring of serum potassium levels.

  Like all beta-stimulants, oral salbutamol can produce muscular tremor, predominantly of the extremities, possibly with associated tenseness. Such tremor seems to be rare in children. Tachycardia (with or without peripheral voasodilation) may occur at high doses. Other cardiac effects which have been reported, usually in susceptible patients, are arrythmias, including atrial fibrillation, supraventricular tachycardia and extrasystoles.

  Digestive disorders (nausea and vomiting) and headaches have been reported. Very rarely muscle cramps have been reported. Hypersensitivity reactions, including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely.

  As with other beta₂ agonists, hyperactivity has rarely been reported in children.