A bronchodilator in the maintenance therapy of bronchoconstriction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and bronchial asthma.
Composition:
1 ml (20 drops) of inhalation fluid contains 250 μg of anhydrous ipratropium bromide; the preparation contains benzalkonium chloride. 1 dose of spray contains 20 μg of anhydrous ipratropium bromide; the preparation contains anhydrous ethanol (8.415 mg / dose).
Action:
Anticholinergic drug that widens the bronchi. Ipratropium bromide as an antagonist of acetylcholine, a neurotransmitter released from the vagus nerve, inhibits reflexes conducted through the vagus nerve and prevents the increase of intracellular concentration of cGMP caused by the action of acetylcholine on muscarinic receptors in bronchial smooth muscles. Enlargement of the bronchi following inhalation of the drug is mainly a result of local action, not a result of general action. In patients with bronchoconstriction in COPD, significant improvement in lung function occurs within 15 min, maximal improvement occurs after 1-2 h, action persists for 6 h. Total systemic bioavailability of ipratropium bromide after inhalation (part of the dose deposited in the lungs and the part passing to the gastrointestinal tract) is 7-28%.
Contraindications:
Hypersensitivity to atropine or its derivatives or other components of the preparation.
Precautions:
Caution should be exercised when using the product in patients with prostatic hyperplasia, narrowing of the bladder neck, predisposition to narrow-angle glaucoma. Patients with cystic fibrosis may be more susceptible to gastrointestinal motility disorders. If an aerosol containing ipratropium bromide or ipratropium bromide enters the eye in combination with a β-receptor agonist2 may occur: mydriasis, increased intraocular pressure, narrow-angle glaucoma, eye pain - special care should be taken to prevent the preparation from getting into the eye, especially in patients predisposed to glaucoma. The liquid sprayed from the nebulizer should be administered through the mouthpiece; if the mask is used, it must be well-fitted. Eye pain or discomfort, blurred vision, seeing a rainbow rim around the light source, or altered color vision coexisting with redness of the eyes following conjunctival hyperaemia and corneal edema may be signs of acute narrow-angle glaucoma - if any of these symptoms occur initiate treatment with droplets that constrict the pupil of the eye and consult a specialist immediately. The inhalable liquid formulation contains benzalkonium chloride and disodium edetate, which may cause bronchospasm in patients with hypersensitivity to the airways. Due to limited data on the use of the drug in children, the preparation should be used in this age group under strict medical supervision.
Pregnancy and lactation:
The safety of using the drug during pregnancy has not been established. It should be considered whether the therapeutic benefit of using it during a confirmed or suspected pregnancy outweighs the potential risk to the fetus. Preclinical studies did not show embryotoxic or teratogenic effects of the drug administered in inhaled or intranasal form at doses much in excess of those recommended for human use. It is not known whether the drug is excreted in human milk. Caution should be exercised when using the product during breastfeeding.
Inhalation. Dosage should be adjusted to the individual needs of the patient.Fluid for inhalation. Adults and adolescents> 14 years: 2 ml (40 drops = 0.5 mg) 3-4 times a day. Children 6-14 years: 1 ml (20 drops = 0.25 mg) 3-4 times a day. Children <6 years: 0.4-1 ml (8-20 drops = 0.1-0.25 mg) 3-4 times a day. The recommended dose should be diluted with 0.9% NaCl solution to a volume of 3-4 ml, spray with the inhaler and inhaled until the solution is consumed. Prepare the solution immediately before use. Dose> 2 mg / day (adults and children> 14 years) or> 1 mg / day (children <14 years) should be administered under the supervision of a physician. The inhalation fluid can be administered using any commercially available nebulizer. If an oxygen wall installation is available, a flow of 6-8 l / min should be used. It can be used together with inhalations of mucus secretion and thinning agents (eg Mucosolvan inhomogeneous liquid from a nebulizer). Do not use ipratropium bromide and disodium cromoglycate in the same sprayer (it may precipitate).aerosol. Adults and children> 6 years: 2 doses (spray) 4 times a day. The maximum daily dose is 12 sprays.
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