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20 ml x 0.25 mg/ml
The dosage should be adapted to the individual requirements of the patient; patients should also be kept under medical supervision during treatment. It is advisable not to greatly exceed the recommended daily dose during both acute and maintenance treatment. If therapy does not produce a significant improvement or if the patient’s condition worsens, medical advice must be sought in order to determine a new regimen of therapy. In the case of acute or rapidly worsening dyspnea, a doctor should be consulted immediately. Ipratropium bromide Respirator Solution is not recommended for use in children under 3 years of age. Note: Ipratropium bromide and disodium cromoglycate inhalation solutions should not be simultaneously administered in the same nebulizer as precipitation may occur. Ipratropium bromide Respirator Solution may be administered from an intermittent positive pressure ventilator or from suitable nebulizers. The recommended dosage is as follows:
Adults: 0.1 – 0.5 mg (0.4 – 2.0 ml = 8-40 drops) up to 4 times daily.
Children: 6-12 Years: 0.25 mg (20 drops, i.e., 1 ml) 3 to 4 times daily.
3-6 Years: 0.1-0.25 mg (8-20 drops, i.e.: 0.4-1.0 ml) 3 to 4 times daily.
N.B. For ease of administration, the dose may need to be diluted in order to obtain a final volume suitable for the nebulizer being used. If dilution is necessary, only normal saline should be used.
For the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema. Ipratropium bromide Respirator Solution is of particular benefit in relieving acute bronchospasm when used concomitantly with inhaled beta agonists.
Hypersensitivity to the drug, to atropine and its derivatives. Hypersensitivity to any other ingredient of the preparation.
Ipratropium bromide is not indicated for the initial treatment of acute episodes of bronchospasm where rapid response is required. If dyspnoea suddenly worsens during inhalation of the product (paradoxical bronchospasm), treatment should be stopped immediately and the treatment plan reviewed.
Preclinical Data: Local and systemic tolerability of ipratropium bromide has been investigated extensively in several species and with different administration routes. The acute inhaled, oral and intravenous toxicity has been investigated in several rodent and non-rodent species.
Use in Pediatrics: Ipratropium bromide Respirator Solution is not recommended for use in children under 3 years of age. Note: Immediate hypersensitivity reactions may occur after administration of Ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal edema, and anaphylaxis. Ipratropium bromide should be used with caution in patients predisposed to narrow-angle glaucoma, or with pre-exisiting outflow tract obstructions (e.g, with prostatic hyperplasia, or bladder-neck obstruction). Patients should be reminded that Ipratropium bromide is not intended for occasional use, but rather, in order to be maximally effective, must be used consistently as prescribed throughout the course of therapy.
Ocular complications: There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular pressure, angle-closure glaucoma, eye pain) when aerosolized ipratropium bromide either alone or in combination with an adrenergic 2 -agonist, has escaped into the eyes. Thus patients must be instructed in the correct administration of Ipratropium bromide. 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 angle-closure glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately. Patients must be instructed in the correct administration of Ipratropium bromide inhalation solution. Care must be taken not to allow the solution or mist into the eyes. It is recommended that the nebulized solution be administered via a mouth piece. If this is not available and a nebulizer mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes. Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances. The patient should be instructed to seek medical advice should a reduced response become apparent. Because of occasional reports of bronchospasm associated with the use of this drug, due to the preservative (benzalkonium chloride) and the stabilizer (sodium edetate), it is recommended that the patient be subject to medical supervision during the first week of treatment.
See prescribing information for full details.
Headache, dizziness, Cough, irritation in the throat, Dry mouth, disturbed gastrointestinal motility, nausea.
See prescribing information for full details.
Additive effect has been reported when ipratropium bromide is used in patients treated with beta-2-adrenergic stimulants and xanthine preparations. The therapeutic and adverse effects of Ipratropium bromide may become more pronounced if other anticholinergic medications, such as those containing pirenzepine, are given concomitantly. The risk of acute glaucoma in patients with a history of narrow-angle glaucoma may be increased when nebulized ipratropium bromide and beta sympathomimetics are administered simultaneously.
Pregnancy and Lactation
Pregnancy: The safety of ipratropium during human pregnancy has not been established. The benefits of using ipratropium bromide during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.
Lactation: It is not known whether ipratropium is secreted into breast milk. Although lipid-insoluble quaternary cations pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to an important extent, when administered by inhalation. However, because many drugs are secreted into breast milk, caution should be exercised when ipratropium bromide is administered to nursing mothers.
No symptoms specific to overdose have been encountered to date. In view of the wide therapeutic range and topical route of administration of ipratropium bromide inhalation, however, no serious anticholinergic symptoms are to be expected. Mild systemic anticholinergic effects such as dry mouth, ocular accommodation disturbances and increase in heart rate are possible.
Pharmaceutical Precautions: Store below 25°C. Do not freeze. Once the bottle has been opened, the contents should not be kept for longer than one month. A fresh solution should be prepared before each usage and any residual diluted solution should be discarded.