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Acute bronchospasm: inhaled medicines, including the drug, may cause paradoxical bronchospasm. If this occurs, stop treatment and consider other treatments. In the case of acute, rapidly worsening dyspnoea (difficulty in breathing), should consult a physician immediately.
Hypersensitivity reactions: Immediate hypersensitivity reactions may occur after administration of ipratropium as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
Special risk patients: The drug should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction, particularly if they are receiving an anticholinergic by another route.
Ocular Effects: There have been isolated reports of ocular complications (ie, difficulty in accommodation, Burning eyes, mydriasis, temporary blurred vision, ocular pain, conjunctival or corneal congestion associated with visual halos or colored images, or precipitation or worsening of angle-closure glaucoma) when orally inhaled ipratropium bromide either alone or in combination with an adrenergic beta2-agonist was sprayed into the eyes. Thus, patients must be instructed in the correct administration of the drug. Eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist's advice sought immediately.
Cardiovascular effects: Fenoterol likes all the other sympathomimetic drugs can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Even there is a rare case of myocardial ischemia associated with beta-agonist.
The drug should be used with caution in patients with underlying severe heart disease including ischemic heart disease, arrhythmia or severe heart failure.
Hypokalemia: the administration of fenoterol and overdose of beta2-agonist may decrease serum potassium concentration possibly through intracellular shunting. The decrease is dose-related and usually transient.
Prolonged Use: The drug should be used just on asthmatic attack in bronchial asthma and may be regular used in mild Chronic Obstructive Pulmonary Disease. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Bronchial obstruction deterioration: Increasing use of inhaled, beta-2 agonists is a marker of deteriorating bronchial obstruction; be alert to such changes and advise patients to be alert to such changes. A patient's condition may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient's inhaled, beta-2 agonist becomes less effective, the patient needs more inhalations than usual, or the patient develops a significant decrease in lung function, this may be a marker of destabilization of the disease. In this setting, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for adding an additional inhaled corticosteroid, or initiating systemic corticosteroids.
Concomitant administration: The drug should be used with caution when concomitant administration with other sympathomimetic bronchodilators.
Patient with underlying diseases: The drug should be used with caution in patient with diabetes mellitus, recent myocardial infarction, severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma.
Carcinogenesis: In 2-year oral carcinogenicity studies in rats and mice ipratropium at oral dosages up to 6 mg/kg/day (approximately 240 and 120 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis for the HFA aerosol) showed no carcinogenic activity. Studies to evaluate the carcinogenic, tumorigenic, or mutagenic potential of fenoterol have not been done.
There is no evidence from human data that use of these medications may cause problems.
Mutagenesis: Results of various mutagenicity studies with ipratropium (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative.
Fertility impairment: Fertility of male or female rats at oral dosages up to 50 mg/kg/day (approximately 2,000 times the maximum recommended human daily inhalation dosage on mg/m2 basis for HFA aerosol) was unaffected by ipratropium administration. At an oral dose of 500 mg/kg (approximately 20,000 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis), ipratropium inhalation HFA aerosol formulation produced a decrease in the conception rate.
Product Interchangeability: Between CFC-containing and HFA-containing formulations have been interchangeable for all purposes with having no consequences of the safety or the efficacy.
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, tremor, accommodation disorder, mydriasis and blurred vision, which may occur in some instances, must be taken into account.
Use in Children: the safety and efficacy of orally inhaled ipratropium HFA aerosol in pediatric patients have not been established, although the drug has been used in such patients (generally in children with asthma) with any unusual risk. Appropriate studies on the relationship of age to the effects of fenoterol have not been performed in the pediatric population and also the safety and efficacy of fenoterol in fixed combination with ipratropium bromide for oral inhalation in children have not been established.
Safety and efficacy of orally inhaled ipratropium in pediatric patients have not been established although the drug has been used in such patients (generally in children with asthma) with any unusual risk. Appropriate studies of on the relationship of age to the effects of fenoterol have not been performed in the pediatric population.
Therefore, Aerobidol inhaler should only be used on medical advice and under the supervision of an adult.
Use in the Elderly: 57% of the total number of subjects in clinical studies of ipratropium HFA inhalation aerosol were 65 years of age or older. No overall differences in safety or efficacy were observed between these subjects and younger subjects. Although not clearly proven, airway responsiveness to these medications may change with age. Additionally, older patients may also be more sensitive to the side effects of beta 2-agonists, including tremor and tachycardia, especially those with preexisting ischemic heart disease. Appropriate studies on the relationship of age to the effects of fenoterol have not been performed in the geriatric population. However, no geriatric specific problems have been documented to date.
Appropriate studies on the relationship of age to the effects of fenoterol have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date. When the total number of patients studied in clinical trials of ipratropium HFA inhalation aerosol is considered, 57% were 65 years of age or older. No overall differences in efficacy or safety were observed between geriatric and younger patients in these studies.
