General ORCIPRENALINE should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be life threatening. 1 Dosing Considerations). g. salbutamol). In acute tests, orciprenaline sulfate has been shown to have minimal effect on blood pressure and pulse.
The drug should be used with care, however, in asthmatic or emphysematous patients who also have systemic hypertension, coronary artery disease, acute and recurring congestive heart failure, diabetes mellitus, glaucoma or hyperthyroidism or in patients sensitive to sympathomimetic amines.
Cardiovascular Beta-adrenergic agonists may have clinically significant cardiac effects. Orciprenaline is a non-selective beta-adrenergic agonist and may have more cardiac side effects than more selective beta2-adrenergic agonists. Care should be taken with patients suffering from cardiovascular disorders, especially coronary insufficiency, myocardial insufficiency, cardiac arrhythmias, recent myocardial infarction, severe organic heart and/or other vascular disorders, hypertension, hyperthyroidism phaeochromocytoma or Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Syrup 2 mg/mL Artificial grape flavour, edetate disodium, glycerin, hydroxyethyl cellulose, methylparaben, propylparaben, purified water, and sorbitol.
ORCIPRENALINE Product Monograph Page 7 of 21 diabetes mellitus. Endocrine and Metabolism Potentially serious hypokalemia may result from 2–agonist therapy, mainly from parenteral and nebulized administration. Particular caution is advised in acute severe asthma as this may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics; the adverse effects of hypokalemia on cardiac rhythm may be exacerbated by hypoxia.
It is recommended that serum potassium levels be monitored in such situations. Hypokalemia will increase the susceptibility of digitalis–treated patients to cardiac arrhythmias. If therapy does not produce a significant improvement or if the patient’s condition gets worse, medical advice must be sought in order to determine a new plan of treatment.
In the case of acute or rapidly worsening dyspnea, a doctor should be consulted immediately. Immune Hypersensitivity Immediate hypersensitivity reactions may occur after administration of orciprenaline sulfate. Care should be taken in patients who are unusually responsive to sympathomimetic amines.
Respiratory Deterioration of asthma Increasing use of ß2–agonists to control symptoms of bronchial obstruction, especially administration on a regular basis or in high amounts, indicates deterioration of asthma control. Under these conditions, the patient’s therapy plan has to be revised.
It is inadequate simply to increase the use of bronchodilators under these circumstances, in particular over extended periods of time (see 4. DOSAGE AND ADMINISTRATION). Paradoxical Bronchospasm Paradoxical bronchospasm may occur with inhaled medications and is characterized by an immediate increase in wheezing after the dose.
This should be treated immediately with an alternative presentation or a different fast-acting inhaled bronchodilator to relieve acute asthmatic symptoms. The use of the preparation should be discontinued immediately and alternate therapy instituted.
The cause of this refractory state is unknown. It is advisable that in such instances the use of the preparation be discontinued immediately and alternate therapy instituted since, in the reported cases, the patients. Fatalities have been reported following excessive use of isoproterenol inhalation preparations and t he exact cause is unknown.
Cardiac arrest was noted in several instances. 1 Pregnant Women ORCIPRENALINE should not be administered to pregnant women or to women of childbearing potential unless in the opinion of the physician the expected benefits outweigh the possible risks to the fetus.
Clinical evidence presently available from the use of ORCIPRENALINE in pregnancy is limited. 2 mg/kg) have resulted in malformed offspring in some experiments, but not in others. Studies in the rat, mouse and rhesus monkey have shown no adverse effects on the developing fetus.
, ORCIPRENALINE Product Monograph Page 8 of 21 ephedrine and phenylephrine, produced teratogenic effects in the rabbit when given orally at high doses as did isoproterenol given subcutaneously at low doses. The significance of these findings is not known.
There is no well documented experience in pregnant women. Orciprenaline sulfate should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus. Use in labour and delivery Beta–agonists should be used with caution before and during childbirth in view of their inhibiting effect on uterine contractions.
Orciprenaline is contraindicated as a tocolytic in patients at risk of premature labour or threatened abortion. 2 Breast-feeding It is not known whether orciprenaline sulfate is excreted in human milk; therefore, orciprenaline sulfate should be used during nursing only if the potential benefit justifies the possible risk to the newborn.
3 Pediatrics Pediatrics (< 4 years of age): The safety and efficacy in children below the age of 4 years have not been established. 4 Geriatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
As with other beta-agonists, special caution should be observed when using Orciprenaline in elderly […]