COMPOSITION: Each ampoule of 2 mL contains 5 micrograms hexoprenaline sulphate.
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 Hypersensitivity to any of the ingredients. Safety in pregnancy and lactation has not been established. IPRADOL should be used with great care in patients with cardiovascular disease such as ischeamic heart disease, arrhythmia or tachycardia, occlusive vascular disorders including arteriosclerosis, hypertension or aneurysms. Care is also required in patients with hyperthyroidism.
IPRADOL 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.
IPRADOL should be avoided or used with care in patients undergoing anaesthesia with cyclopropane, halothane, or other halogenated anaesthetics as they may induce venticular fibrillation.
WARNING DO NOT USE THE INJECTION IF CLOUDY OR IF A PRECIPITATE HAS FORMED.
Tolerance may develop in asthma 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 may cause an increase in blood pressure and special care in advisable in patients receiving antihypertensive therapy.
Care is also required with IPRADOL is administered to patients with diabetes mellitus or closed-angle glaucoma.
DOSAGE AND DIRECTION FOR USE IPRADOL INJECTION 5µG HEXOPRENALINE SULPHATE PER 2mL AMPOULE (Parenterally) DO NOT EXCEED THE RECOMMENDED DOSE
Acute attack of bronchial asthma 1 - 2 x (2 mL) ampoules I.V. (Injection should be administered slowly over a period of approximately 5 minutes). Severe Dyspnoea 1 to 1½(2 mL) ampoules to a maximum dose of 2 ampoules. Status Asthmaticus 1 x 2 mL ampoules 3 - 4 times within 24 hours if required. Ampoules: Infants and children 5 micrograms hexopremaline sulphate per 2 mL parenterally. Infants 3 - 6 months: 1 microgram i.v. 1 - 3 times daily. Infants 6 - 12 months: 2 micrograms i.v. 1 - 3 times daily. Children 1 - 3 years: 2 - 3 micrograms i.v. 1 - 3 times daily. Children 3 - 10 years: 3 - 4 micrograms i.v. 1 - 3 times daily.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects IPRADOL, being a sympathomimetic, may cause a slight tremor.
Central effects include feat: anxiety, restlessness, tremor, insomnia, confusion, irritability and psychotic states: Appetite may also be reduced and nausea and vomiting may occur.
Peripheral vasodilation may occur.
Effects on the cardiovascular system are complex. Vasoconstriction with resultant hypertension may occur.
There may also be a resultant bradycardia.
Difficulty in micturition and urinary retention, dyspnoea, weakness, altered metabolism, sweating and hypersalivation may occur. Headache is also common. 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 condition 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.
The adverse metabolic effects of high doses of IPRADOL may be exacerbated by the concomitant administration of high doses of corticosteroids. The effects of IPRADOL may be antagonised by propranolol and other beta adrenoseptor blocking agents and enhanced by aminophyline or other xanthines.
An increased risk of arrhythmias may occur if patients are receiving cardiac glycosides, quinidine or tricyclic antidepressants.
Hypokalaemia may occur. Hypokalaemia associated with high doses may result in increase susceptibility to digitalis-induced cardiac arrhythmias.
High dosages may increase the risk of serious side effects, including cardiac dysthythmias. this risk is further aggravated if administered with other medicines that cause hypokalaemia and cardiac dysthythmias or in the presence of hypoxia and acidosis. The maximum dose should not be exceeded.
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. propranolol, 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.
A clear colourless solution packed in clear glass ampoules.
PRESENTATION AMPOULESAmpoules of 2 mL in containers of 10's. STORAGE INSTRUCTIONS Store below 25°C
KEEP OUT OF REACH OF CHILDREN.
G517 (ACT 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Pharmacare Limited
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 16/03/1973
printech pe 4871840
Updated on this site: October 2006
Source: Pharmaceutical Industry