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

Logo IPRADOL AEROSOL - DISCONTINUED
IPRADOL TABLETS - DISCONTINUED
IPRADOL INHALANT SOLUTION - DISCONTINUED
IPRADOL SYRUP - DISCONTINUED

SCHEDULING STATUS:
IPRADOL AEROSOL         S2
IPRADOL TABLETS         S2
IPRADOL INHALANT SOLUTION         S3
IPRADOL SYRUP         S2

PROPRIETARY NAME
(and dosage form):

IPRADOL AEROSOL - DISCONTINUED
IPRADOL TABLETS - DISCONTINUED
IPRADOL INHALANT SOLUTION - DISCONTINUED
IPRADOL SYRUP - DISCONTINUED

COMPOSITION:
AEROSOL
Each aerosol contains 0,1 mg
hexoprenaline sulphate per measured dose.

TABLETS
Each tablet contains 0,5 mg hexoprenaline sulphate.

INHALANT SOLUTION
Each mL of solution contains 0,25 mg hexoprenaline hydrochloride (i.e. 0,025% m/v).

SYRUP
Each 5 mL contains 0,125 mg hexoprenaline hydrochloride.
Contains Ethanol 100%        6,720% v/v
Preservatives:
Methyl hydroxybenzoate 0,077% m/v
Propyl hydroxybenzoate 0,039% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.2 Bronchodilators

PHARMACOLOGICAL ACTION:
IPRADOL exhibits a long acting bronchospasmolytic effect. In therapeutic doses, heart rate and blood pressure are only slightly affected. IPRADOL eliminates functional bronchostenosis by the relaxation of bronchial spasm and in long term treatment IPRADOL causes a decrease of pathological hypersecretory changes of the bronchial mucosa. IPRADOL provokes an improved ventilation of the alveoli, a decrease of obstructive reversible pulmonary emphysema and thus a decrease of respiratory action, which finally normalises the respiratory gas values and the blood count.

INDICATIONS:
IPRADOL is a stimulant of the beta receptors in the bronchi and thus a bronchodilator. IPRADOL is effective for the relief of bronchospasm caused by allergic asthma, acute, sub-acute and chronic bronchitis and emphysema.

CONTRA-INDICATIONS:
IPRADOL should be used with caution in patients with cardiac disease and hyperthyroidism.
Should not be taken together with beta-blocking agents .
IPRADOL 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. If tolerance develops, and the patient's condition worsens, alternative or additional therapy should be instituted. The dosage of IPRADOL should not be increased in these cases.
IPRADOL should be avoided or used with care in patients undergoing anaesthesia with any halogenated anaesthetics.

DOSAGE AND DIRECTIONS FOR USE:
IPRADOL AEROSOL
Contains 0,1 mg hexoprenaline sulphate per measured dose (the aerosol is metered to provide 300 doses). Take 1-2 puffs per breath and then hold the breath for 1-3 seconds. The drug should not be taken more than 6 times per day. When no relief is obtained after 1 or 2 doses, the drug should be discontinued.

IPRADOL TABLETS: ADULTS
0,5 mg hexoprenaline sulphate per tablet (sublingual).
Take half to one tablet 3 times daily. Take the tablets half an hour before meals. This method of application is especially suitable for long term treatment.

IPRADOL TABLETS: CHILDREN
0,5 mg hexoprenaline sulphate per tablet (sublingual).
Children 6-10 years        ½-1 tablet 1-3 times daily.
Take the tablets half an hour before meals.

IPRADOL INHALANT SOLUTION
IPRADOL inhalant solution should not be used more than 30 days after opening.
Inhalant Solution 0,025% m/v for therapy using apparatus operated by compressed air:
Treatment of attack and as a cure
Time of treatment:
Not more than 10 minutes (15-20 breaths per minute)
Treatment can be combined with antihistamine therapy, antibiotics, antiphlogistics and mucolytic agents. The mixture must always be prepared fresh.
For inhalation with air humidifiers for e.g. in the plastic tent, 1 mL IPRADOL inhalant solution 0,025% m/v per hour in 25 mL water.

IPRADOL SYRUP: INFANTS AND CHILDREN
Each 5 mL syrup contains 0,125 mg hexoprenaline hydrochloride.
Infants 3-6 months: 5 mL 1-2 times daily.
Infants 6-12 months: 5 mL 1-3 times daily.
Children 1-3 years: 5 mL to 10 mL 1-3 times daily.
Children 3-6 years: 10 mL 1-3 times daily.
Exceeding the recommended dose will not give a better therapeutic result.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side Effects:
IPRADOL, being a sympathomimetic, may cause a slight tremor.
Tremor and palpitations with tachycardia and muscle cramps, tenseness and headaches may occur. Peripheral vasodilation may occur.
Anxiety, fever, restlessness, insomnia, confusion, irritability, weakness, psychotic states, decreased appetite, nausea and vomiting may occur.
Difficulty in micturition and urinary retention, dyspnoea, altered metabolism, sweating and hypersalivation may occur.
The concomitant use of other sympathomimetic agents should be carefully controlled. It is of no benefit to the patient to exceed doses as recommended and prescribed.
Special Precautions:
When a patient presents a pulse rate of more than 120 beats per minute, IPRADOL (or any other beta stimulant) should not be used. Patients with organic heart disease, hyperthyroidism, occlusive vascular disorders, hypertension or diabetes should only use IPRADOL on the advice of a doctor.
If no relief from the conditions is obtained after two dosages of IPRADOL and palpitations are prominent, use of the drug should be stopped. It would also be advisable at this stage to contact a doctor.
Hypokalaemia associated with high doses may result in increased susceptibility to digitalis-induced cardiac arrhythmias.
The adverse effects of high doses of IPRADOL may be exacerbated by concomitant administration of high doses of corticosteroids.
The effects of IPRADOL may be antagonised by propranolol and other beta 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.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of overdosage immediately stop IPRADOL treatment and administer a beta-blocker e.g. propranalol, in an adequate dosage.
Tachycardia may be diminished by a beta-blocker. Beta-blockers should not be used in asthmatics because of the risks of increasing bronchoconstriction.

IDENTIFICATION:
AEROSOL:                A finely-divided aerosol spray.
TABLETS:                A white, flat bevelled edged tablet, scored on one side with "Hl" engraved on the same side and "CE" embossed on the other side.
INHALANT SOLUTION: A clear, colourless solution free from suspended particles.
SYRUP: A clear colourless syrup.

PRESENTATION:
AEROSOL:                Aerosol containing 300 metered doses.
TABLETS:                Securitainers of 100.
INHALANT SOLUTION: Bottles of 50 mL.
SYRUP:                Bottles of 100 mL.

STORAGE INSTRUCTIONS:
Store below 25°C in air-tight containers, protected from light.
KEEP OUT OF REACH OF CHILDREN.
Aerosol: Container under pressure - do not puncture or burn. Keep away from direct heat or open flame.

APPLICATION/REGISTRATION NUMBERS:
IPRADOL AEROSOL:         G515 (Act 101/1965)
IPRADOL TABLETS:         G516 (Act 101/1965)
IPRADOL INHALANT SOLUTION:         G514 (Act 101/1965)
IPRADOL SYRUP:         F/10.2/51

NAME AND BUSINESS ADDRESS OF APPLICANT:
CONTINENTAL ETHICALS (PTY) LTD
17 EASTERN SERVICE ROAD
EASTGATE EXT 8
SANDTON

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
26/03/1996

Discontinued products
Updated: October 2006
Source: Pharmaceutical Industry

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