INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo VENTEZE®-2 TABLETS
VENTEZE®-4 TABLETS
VENTEZE®SYRUP

SYRUP-SUGAR FREE FORMULA
SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form)

VENTEZE®-2 TABLETS
VENTEZE®-4 TABLETS
VENTEZE®SYRUP

COMPOSITION:
VENTEZE-2 TABLETS contain 2,4 mg Salbutamol sulphate equivalent to 2 mg
Salbutamol.
VENTEZE-4 TABLETS contain 4,8 mg Salbutamol sulphate equivalent to 4 mg Salbutamol.
VENTEZE SYRUP: each 5 mL of the syrup contains: 2,4 mg Salbutamol sulphate equivalent to 2 mg of Salbutamol.
Preserved with Sodium Benzoate 0,2% m/v.

PHARMACOLOGICAL CLASSIFICATION:
A 10.2 Bronchodilators.

PHARMACOLOGICAL ACTION:
Salbutamol is a beta-adrenergic stimulant which has a selective action on bronchial beta-adreno-receptors.

INDICATIONS:
Venteze is indicated as a bronchodilator in the treatment of bronchospasm associated with bronchial asthma, emphysema and chronic bronchitis.

CONTRA-INDICATIONS:
Venteze should not be taken together with beta-blocking agents.
Hyperthyroidism and cardiac disease.
Safety in pregnant and lactating women has not been established.
Venteze is not indicated for the prevention of premature labour associated with toxaemia of pregnancy or ante partum haemorrhage, nor should it be used for threatened abortion during the first and second trimesters of pregnancy.
Venteze may interact with mono-amine oxidase inhibitors, and should not be given to patients receiving such treatment or within 14 days after stopping treatment.

WARNING:
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.

DOSAGE AND DIRECTIONS FOR USE:
Venteze-2 and Venteze-4 Tablets
Adults:
The usual dose is 2 to 4 mg three or four times daily.
Elderly patients should be given the lower dose initially.
Children: 2-6 years: 1 to 2 mg three or four times daily.
        6-12 years: 2 mg three or four times daily.
Over 12 years: Adult dose.
Syrup
Children: 2-6 years:
2,5 to 5 mL (½ to 1 medicine measure) three to four times daily.
Over 6 years: 5 mL (1 medicine measure) three to four times daily.
Adults: 5 - 10 mL (1 - 2 medicine measures) three to four times daily.
Some patients may require dosages of up to 20 mL.
Elderly patients should be given the lower dose initially.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Venteze may cause fine tremor of skeletal muscle (particularly the hands), palpitations and muscle cramps. Tachycardia, tenseness, headaches and peripheral vasodilation have been reported after large doses. Anxiety, fever, restlessness, insomnia confusion, irritability, weakness, psychotic states, decreased appetite, nausea and vomiting may occur due to the central effects of Venteze.
Difficulty in micturition and urinary retention, dyspnoea, altered metabolism, sweating and hypersalivation may occur.

SPECIAL PRECAUTIONS:
Venteze should be used with caution in patients with hyperthyroidism, cardiovascular disease, occlusive vascular disorders, hypertension or aneurysms.
Hypokalaemia associated with high doses of salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmias.
Tachyphylaxis with resistance may occur with prolonged use of high dosage. Care is necessary when treating patients with diabetes mellitus or 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 arrhythmias.

INTER-ACTIONS:
The adverse effects of high doses of Venteze may be exacerbated by concomitant administration of high doses of corticosteroids.
The effects of Venteze are antagonised by propranolol and other ß-adrenoceptor blocking agents and enhanced by aminophylline or other xanthines.
An increased risk of arrhythmias may occur if patients are receiving cardiac glycosides, quinidine or tricyclic antidepressants. Interaction with alpha-and beta-blocking agents may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Fine tremor of skeletal muscles, tachycardia, palpitations and peripheral vasodilation. Treatment is symptomatic and supportive.

IDENTIFICATION:
Venteze-2 and Venteze-4 tablets:
Flat bisected lilac tablets with bevelled edges, engraved with mortar and pestle on one side.
The 2 mg tablet has a diameter of 6,5 mm.
The 4 mg tablet has a diameter of 8,8 mm.
Syrup: A clear light orange liquid with an orange odour and taste.

PRESENTATION:
Venteze-2 and Venteze-4 tablets:
Packs of 100 and 500 tablets.
Syrup: Bottles of 100 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Tablets: 2 mg –M/10.2/14.
  4 mg –M/10.2/15.
Syrup: 2 mg/5 mL –T/10.2/84.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
27/11/1985.
                G905
                A&S PRINTERS

Current: July 2003
Source: Community Pharmacy

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