Venteze 2 mg & 4 mg (Tablet & Syrub)

VENTEZE is indicated as a bronchodilator:

• in the treatment of bronchospasm associated with bronchial asthma.
• emphysema.
• chronic obstructive bronchitis.

Posology

VENTEZE-2 and VENTEZE 4 tablets

Adults

The usual dose is 2 mg to 4 mg three or four times daily.

VENTEZE Syrup

Adults: 5 ml to 10 ml (1 to 2 measuresful) three to four times daily. Some patients may require dosages of up to 20 ml.

Special populations

Elderly population

Elderly patients should be given the lower dose initially.

Paediatric

The safety and efficacy of VENTEZE in children aged younger than 2 years has not yet been established.

VENTEZE-2 and VENTEZE 4 tablets

Children: 2 to 6 years : 1 mg to 2 mg three or four times daily.

6 to 12 years : 2 mg three or four times daily.

Over 12 years : Adult dose.

VENTEZE Syrup

Children: 2 to 6 years : 2,5 ml to 5 ml (u00bd to 1 measureful) three to four times daily.

Over 6 years : 5 ml (1 measureful) three to four times daily.

Method of administration

For oral administration.

VENTEZE is contraindicated in:

• Patients with hypersensitivity to salbutamol or to any of the other excipients of VENTEZE (see section 6.1).
• Concurrent use with beta-blocking medicines.
• Hyperthyroidism.
• Cardiac disease.
• Prevention of premature labour associated with toxaemia of pregnancy or ante partum haemorrhage.
• Threatened abortion during first and second trimesters of pregnancy.
• Concurrent use with monoamine oxidase inhibitors (MAOIs) (see section 4.5).

Tolerance may develop in asthmatic patients given VENTEZE. If tolerance develops, and the patient's condition worsens, alternative or additional therapy should be instituted. The dosage of VENTEZE should not be increased in these cases.

VENTEZE should be avoided or used with care in patients undergoing anaesthesia with any halogenated anaesthetics.

Bronchodilators should not be the only or main treatment in patients with severe or unstable asthma. Increasing use of bronchodilators indicates deterioration of asthma control. If patients find that short acting relief bronchodilator treatment becomes less medical attention must be sought.

VENTEZE causes peripheral vasodilation which may result in reflex tachycardia and increased cardiac output. VENTEZE should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension or aneurysms.

Hyperthyroidism

VENTEZE should only be administered cautiously to patients suffering from thyrotoxicosis after careful evaluation of the benefits and risks of treatment (see section 4.3).

Constant monitoring of potassium levels in patients with severe asthma is essential, potentially serious hypokalaemia may result from beta-2 agonist therapy. Hypokalaemia associated with high doses of VENTEZE may result in increased susceptibility to digoxin-induced cardiac dysrhythmias.

In common with other u03b2 -adrenoceptor agonists, VENTEZE can induce reversible metabolic changes such as increased blood glucose levels.

Diabetes

Administration of beta agonists is associated with a rise of blood glucose. Therefore blood glucose and lactate levels should be monitored in diabetics and diabetic treatment adjusted accordingly to meet the needs of the diabetic during tocolysis. Diabetic patients may be unable to compensate for the increase in blood glucose and the development of ketoacidosis has been reported. Concurrent administration of corticosteroids can exaggerate this effect.

Cardiovascular effects may be seen with sympathomimetic medications, including VENTEZE. Patients with underlying severe heart disease (e.g. ischaemic heart disease, dysrhythmia or severe heart failure) who are receiving VENTEZE should be warned to seek medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin.

Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with closed-angle glaucoma, and in those receiving antihypertensive therapy. It is important to avoid excessive doses as this is thought to be linked to sudden death probably due to the induction of ventricular dysrhythmias.

Salbutamol may be restricted in certain sports as it is considered to be a member of the prohibited group, Beta-2 agonists; competitors should check with the appropriate sports authorities.

The effects of VENTEZE are antagonised by propranolol and other u03b2 -adrenoceptor blocking medicines. An increased risk of dysrhythmias may occur if patients are receiving digoxin, quinidine, or tricyclic antidepressants. The effects of VENTEZE may be altered by reserpine or methyldopa. Interaction with alpha-and beta-blocking medicines may occur. VENTEZE may interact with monoamine oxidase inhibitors, and should not be given to patients receiving such treatment or within 14 days after stopping treatment (see section 4.3).

Halogenated anaesthetics

Owing to the additional antihypertensive effect, there is increased uterine inertia with risk of haemorrhage; in addition, serious ventricular rhythm disorders due to increased cardiac reactivity, have been reported on interaction with halogenated anaesthetics. Treatment should be discontinued, whenever possible, at least 6 hours before any scheduled anaesthesia with halogenated anaesthetics (see section 4.4).

Anti-diabetics

The use of VENTEZE and other beta-agonists are associated with a rise of blood glucose which may be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted.

Potassium depleting medicine

Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting medicine known to exacerbate the risk of hypokalaemia, such as diuretics, digoxin, methyl xanthines (e.g. theophylline) and corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia.

Pregnancy

VENTEZE should only be used during pregnancy if it is considered essential by the physician.

Breastfeeding

As VENTEZE is probably secreted in breast milk its use in nursing mothers requires careful consideration.

Fertility

No data available.

Patients should not drive, use machinery or perform any tasks that require concentration until they are certain that VENTEZE does not adversely affect their ability to do so safely (see section 4.8).

a) Tabulated list of adverse reactions

System organ class

Frequent

Less frequent

• Immune system disorders
• Hypersensitivity reactions including paradoxical bronchospasm, angioedema, urticaria, hypotension, and collapse
• Metabolism and nutrition disorders
• Decreased appetite, altered metabolism, lactic acidosis, hypokalaemia
• Psychiatric disorders
• Anxiety, restlessness, insomnia, confusion, irritability, psychotic states, nervous tension
• Nervous system disorders
• Tremor of skeletal muscle (particularly in the hands), headache
• Myoclonus
• Cardiac disorders
• Palpitations, tachycardia, cardiac dysrhythmias, myocardial ischaemia
• Vascular disorders
• Peripheral vasodilatation
• Respiratory, thoracic and mediastinal disorders
• Dyspnoea, pulmonary oedema
• Gastrointestinal disorders
• Nausea, vomiting, hypersalivation
• Musculoskeletal and connective tissue disorders
• Muscle cramps
• Renal and urinary disorders
• Difficulty in micturition, urinary retention
• General disorders and administrative site conditions
• Asthenia, increased sweating

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088

See sections 4.4 and 4.8.

Symptoms

Fine tremor of skeletal muscles, tachycardia, palpitations, hyperactivity, peripheral vasodilatation and metabolic effects including hypokalaemia. Hypokalaemia may occur following overdose with VENTEZE. Serum potassium levels should be monitored. Lactic acidosis has been reported in association with high therapeutic doses as well as overdoses of short-acting beta-agonist therapy, therefore monitoring for elevated serum lactate and consequent metabolic acidosis (particularly if there is persistence or worsening of tachypnea despite resolution of other signs of bronchospasm such as wheezing) may be indicated in the setting of overdose. Nausea, vomiting and hyperglycaemia have been reported, predominantly in children and when VENTEZE overdose has been taken via the oral route.

Treatment

The preferred antidote for overdosage with VENTEZE is a cardioselective beta blocking medicine, but beta blocking medicines should be used with caution in patients with a history of bronchospasm.