Index of drugs

As a bronchodilator in the maintenance treatment of bronchoconstriction in chronic obstructive pulmonary disease.

1 ml of nebuliser solution contains 250 μg of ipratropium bromide.

Anticholinergic bronchodilator. Ipratropium bromide inhibits reflexes conducted through the vagus nerve, by acting antagonistically to acetylcholine - a relay released from the vagus nerve. The bronchial dilation following inhalation of the preparation is caused by local drug concentration sufficient to cause anticholinergic action on the bronchial smooth muscle; it is not the result of the systemic action of the drug. After inhalation, 10-30% of the dose is delivered to the lungs. Most of the dose is swallowed and passes through the digestive tract. As a result of a very low degree of absorption from the gastrointestinal tract, the bioavailability of the ingested dose is approximately 2%. Part of the dose that has entered the lungs quickly penetrates into the bloodstream (within minutes). The absolute systemic bioavailability of ipratropium bromide (part of the dose absorbed from the lungs and from the gastrointestinal tract) after inhalation of the nebuliser solution is 7-28%. The drug minimally (less than 20%) is bound to plasma proteins. T_0,5 in the final phase of elimination is about 1.6 hours. Approx. 60% of the public dose is excreted via metabolism, probably in the liver. The main metabolites found in the urine are considered inactive. Approx. 40% of the public dose is excreted in the urine.

Hypersensitivity to ipratropium bromide or to any of the excipients. Hypersensitivity to atropine or its derivatives.

The nebulizer solution should be used under the supervision of a physician, especially at the beginning of treatment. Due to the risk of paradoxical bronchospasm at the beginning of treatment, treatment should be started in the hospital. Patients should be monitored closely during the first week of treatment. The patient should contact a doctor if the treatment is not improving. In patients requiring long-term treatment with bronchodilators, regular examinations should be performed to check health. Anticholinergic agents should be used with caution in patients with or with the risk of glaucoma, prostatic hyperplasia and if the bladder neck is obstructed. Anticholinergics may cause urinary retention in patients with prostate hyperplasia. In patients with cystic fibrosis, there is an increased tendency to gastrointestinal motility disorders - these patients should be cautious. There are few reports of ocular side effects (eg mydriasis, increased intraocular pressure, narrow-angle glaucoma, and eye pain) after ibratropium bromide has entered the eyes during nebulization. Eye pain or discomfort, blurred vision, seeing a colored border around the light sources, or altered color vision with redness of the eyes following conjunctival and corneal hyperaemia may be signs of acute narrow-angle glaucoma. If any of these symptoms occur, initiate treatment with eye constricting pupils and seek specialist advice immediately. Do not let the solution get into your eyes. It is recommended to use the solution for nebulization through the mouthpiece. If the drug can not be administered through the mouthpiece and the nebulizer is equipped with a mask, it must adhere exactly to the face. Eye protection is particularly important in patients with a predisposition to glaucoma.

Ipratropium bromide should not be used during pregnancy, especially during the first trimester. It should be considered whether the expected therapeutic benefit to the mother resulting from the use of the preparation outweighs the potential risk to the fetus.Preclinical animal studies did not show embryotoxic or teratogenic ipratropium bromide after inhalation or intranasal administration at doses significantly greater than those recommended for human use. It is not known whether ipratropium bromide passes into breast milk. It is unlikely that ipratropium bromide can enter into the body of a newborn in a significant amount. Do not give the drug to women who are breastfeeding.

Common: pain and dizziness, cough, local irritation, inhalation-induced bronchoconstriction, dry mouth, vomiting, gastrointestinal motility disorders (constipation, diarrhea). Uncommon: urticaria, disturbances in eye accommodation, narrow-angle glaucoma, tachycardia, rash, pruritus. Rare: anaphylactic reaction, angioneurotic edema of the tongue, lips and face, increased intraocular pressure, eye pain, mydriasis, palpitation, supraventricular tachycardia, atrial fibrillation, laryngeal spasm, nausea, urinary retention (risk of urinary retention is increased in patients with neck constriction bladder).

Inhalation. Dosage should be determined individually for each patient. Adults (including the elderly) and adolescents over 14 years: 0.4-2.0 ml of solution (100-500 μg) 3 to 4 times daily. Children from 3 to 14 years of age: 0.4-1.0 ml of solution (100-250 μg) 3 to 4 times a day. Due to the limited amount of data on the use of the preparation in children under 14 years of age, the recommended doses should be used under the supervision of a physician. The preparation can be administered using commercially available nebulizers. It may be necessary to dilute the dose of the nebuliser solution to obtain a volume suitable for the type of nebulizer (usually 2-4 ml). If dilution is necessary, use 0.9% sterile sodium chloride solution for this purpose. Follow the instructions of the nebulizer manufacturer.