Atrovent solution for inhalation of 0,025% bottle dropper 20ml

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Active ingredients

Ipratropium bromide

Release form

Solution

Composition

Ipratropium bromide monohydrate 261 mcg, in terms of ipratropium bromide 250 mcg. Additional substances: benzalkonium chloride - 100 mcg, disodium edetate dihydrate - 500 mcg, sodium chloride - 8.8 mg, hydrochloric acid 1N (before pH 3.4) - 659 mg, and then 959 mcg, 8.8 mg, sodium chloride, 8.8 mg, hydrochloric acid 1N (up to pH 3.4), 659 mcg, sodium chloride - 8.8 mg, hydrochloric acid 1N up to 1 ml. 20 ml - dark glass bottles with a polyethylene dropper and a screw-on polypropylene lid with first opening control (1) - packs of cardboard.

Pharmacological effect

Bronchodilator. It blocks the m-cholinergic receptors of the smooth muscles of the tracheobronchial tree and suppresses reflex bronchoconstriction. Having a structural similarity with the acetylcholine molecule, it is a competitive antagonist. Anti-cholinergics prevent an increase in the intracellular concentration of calcium ions, which occurs due to the interaction of acetylcholine with muscarinic receptors located in the smooth muscles of the bronchi. Calcium ions are released through mediators, which include ITP ( inositol triphosphate) and DAG (diacylglycerol). Effectively prevents bronchospasm resulting from inhaling cigarette smoke. , Cold air, the action of various drugs, but also eliminates bronchospasm associated with the effect of the vagus nerve. With inhalation use has almost no resorptive effect. Bronchodilation, which occurs after inhalation of the drug Atrovent ;, is mainly a consequence of local and specific effects of the drug on the lungs, and not the result of its systemic effects. In controlled 85-90-day studies conducted in patients with bronchospasm caused by COPD, chronic bronchitis and emphysema, a significant improvement in lung function was observed for 15 minutes, reached a maximum after 1-2 hours and lasted up to 4-6 hours.

Pharmacokinetics

The therapeutic effect of the drug Atrovent; is a consequence of its local action in the respiratory tract. The development of bronchodilation is not parallel to pharmacokinetic parameters. Absorption After inhalation, the lungs usually receive (depending on the dosage form and method of inhalation) 10-30% of the administered dose of the drug.Most of the dose is swallowed and enters the gastrointestinal tract. The part of the drug dose that enters the lungs quickly reaches the systemic blood flow (within a few minutes). The total renal excretion (within 24 hours) of the parent compound makes up approximately 46% of the dose administered w / v, less than 1% of the dose administered orally and approximately 3-13% inhalation dose of the drug. Based on these data, it is calculated that the total systemic bioavailability of ipratropium bromide, administered orally and by inhalation, is 2% and 7-28%, respectively. Distribution The kinetic parameters describing the distribution of ipratropium bromide were calculated on the basis of its plasma concentrations after intravenous administration. There is a rapid biphasic decrease in plasma concentration. The apparent Vd in the equilibrium state is approximately 176 liters (about 2.4 liters / kg). The drug binds to plasma proteins to a minimal extent (less than 20%). Ipratropium bromide, which is a quaternary ammonium compound, does not penetrate through BBB. Metabolism After / in the administration, approximately 60% of the dose is metabolized by oxidation, mainly in the liver. Excretion of T1 / 2 in the terminal phase is approximately 1.6 h. The total clearance of ipratropium bromide is 2.3 ml / min, and the renal clearance is 0.9 l / min. The total renal excretion (within 6 days) of the isotope-labeled dose (including the parent compound and all metabolites) was 72.1% after IV administration, 9.3% after oral administration, and 3.2% after inhalation use. The total isotope-labeled dose excreted through the intestine was 6.3% after iv administration, 88.5% after oral administration, and 69.4% after inhalation. Thus, the excretion of the isotope-labeled dose after IV injection is carried out mainly through the kidneys. T1 / 2 of the original compound and metabolites is 3.6 hours. The main metabolites excreted in the urine are weakly associated with muscarinic receptors and are considered inactive.

Indications

- COPD (including chronic obstructive bronchitis, pulmonary emphysema); - bronchial asthma of mild to moderate severity.

Contraindications

- Hypersensitivity to atropine and its derivatives; - Hypersensitivity to ipratropium bromide and other components of the drug. With caution, you should prescribe the drug for angle-closure glaucoma, obstruction of the urinary tract, prostatic hyperplasia, during the period of breastfeeding, children under 6 years of age.

Precautionary measures

During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.

Use during pregnancy and lactation

The safety of Atrovent; during pregnancy in humans is not installed. When prescribing the drug during a possible or confirmed pregnancy, consider the ratio of the estimated benefit of the drug and the potential risk to the fetus. In preclinical studies, no embryotoxic or teratogenic effect of the drug after its inhalation use was found in doses significantly higher than the doses recommended in humans. whether ipratropium bromide is excreted in breast milk. However, it is unlikely that ipratropium bromide, especially when administered by inhalation, can be delivered with milk to the child’s body in substantial quantities. But during the use of the drug Atrovent; breastfeeding mothers should be careful. Clinical data on the effect of ipratropium bromide on fertility are not available. During the use of ipratropium bromide in preclinical studies, no adverse effect on fertility was found.

Dosage and administration

Note that 20 drops = 1 ml, 1 drop = 12.5 mcg ipratropium anhydrous bromide. The dosing mode is selected individually. During treatment, patients should be under medical supervision. The recommended daily dose should not be exceeded during emergency and maintenance therapy. If treatment does not lead to significant improvement or if the patient's condition worsens, consult a physician to develop a new treatment plan.In case of sudden or rapid increase in shortness of breath, the patient should immediately consult with a physician. For maintenance treatment, adults (including elderly patients) and children over 12 years old are prescribed 2 ml (40 drops = 500 μg) 3-4 times / day . The maximum daily dose is 8 ml (2 mg). Children should be treated under medical supervision. Children aged 6 to 12 years old are prescribed 1 ml (20 drops = 250 μg) 3-4 times / day. The maximum daily dose is 4 ml (1 mg). Children under the age of 6 years old are prescribed 0.4–1 ml (8–20 drops = 100–250 μg) 3–4 times / day. The maximum daily dose is 4 ml (1 mg). For the treatment of acute bronchospasm, adults (including elderly patients) and children over 12 years old are prescribed 2 ml (40 drops = 500 mcg); repeated appointments are possible until the patient’s condition is stabilized. The interval between injections is set individually by the attending physician. Atrovent; can be used simultaneously with inhaled beta2-adrenomimetikami. Treatment of children should be carried out under medical supervision. Children aged 6 to 12 years old should be prescribed 1 ml (20 drops = 250 μg); children under 6 years old - at 0.4-1 ml (8-20 drops = 100-250 mcg). Possible re-appointment to stabilize the patient's condition. The interval between injections is set individually by the attending physician. Atrovent; can be used simultaneously with inhaled beta2-adrenomimetikami. Children under the age of 6 years old appoint 0.4-1 ml (8-20 drops = 100-250 μg) 3-4 times / day. Possible re-appointment to stabilize the patient's condition. The interval between injections is set individually by the attending physician. Atrovent; can be used simultaneously with inhaled beta2-adrenomimetikami. Rules of use of the drug The recommended dose of the drug should be diluted with a 0.9% solution of sodium chloride to reach a drug volume of 3-4 ml, pour into a nebulizer and make inhalation. The drug should be diluted with a 0.9% solution of sodium chloride each time immediately before use. The solution remaining after inhalation is poured. Dosing may depend on the method of inhalation and the type of nebulizer. The duration of inhalation can be controlled by the consumption of diluted volume. Atrovent; can be used using various nebulizers available commercially. When using a centralized oxygen system, the solution is best applied at a flow rate of 6-8 l / min.

Side effects

Many of the listed undesirable effects may be due to the anticholinergic properties of the drug Atrovent;As with any inhalation therapy, when using the drug Atrovent; possibly local irritation. Adverse reactions were determined on the basis of data obtained in clinical studies and during pharmacological supervision of the use of the drug after its registration. The most frequent side effects reported in clinical studies were headache, pharynx irritation, cough, dryness. mouth, gastrointestinal dysmotility (including constipation, diarrhea and vomiting), nausea and dizziness. Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema, Rapivnitsa. From the nervous system: headache, dizziness. From the organ of vision: blurred vision, mydriasis, increased intraocular pressure, glaucoma, pain in the eyes, the appearance of aureole around objects, hyperemia of the conjunctiva, corneal edema, impaired accommodation. On the side of the heart vascular system: palpitations, supraventricular tachycardia, atrial fibrillation, increased heart rate. On the respiratory system: irritation of the pharyngeal mucosa, cough, bronchospasm, paradoxical bronchospasm, laryngo spasm, swelling and dryness of the pharyngeal mucosa. On the part of the digestive system: dry mouth, nausea, gastrointestinal motility, diarrhea, constipation, vomiting, stomatitis, swelling of the oral mucosa. From the urinary system: urinary retention. From the skin and subcutaneous tissue: rash, itching.

Overdose

Symptoms: specific symptoms of overdose have been identified. Considering the breadth of therapeutic action and the local method of using Atrovent ;, the appearance of any serious anticholinergic symptoms is unlikely. There may be minor manifestations of systemic anticholinergic action (including dry mouth, blurred vision, increased heart rate). Treatment: conducting symptomatic therapy.

Interaction with other drugs

Long-term combined inhalation of the drug Atrovent; with other anticholinergic drugs has not been studied, so long-term combined use is not recommended. Beta-adrenergic drugs and xanthine derivatives can enhance the bronchodilator effect of Atrovent; in the case of simultaneoususe with nebulizer ipratropium bromide and beta adrenergic agonists in patients with angle-closure glaucoma in history, the risk of developing acute glaucoma may increase. Atrovent; the solution for inhalation should not be administered simultaneously with the inhalation solution of cromoglycic acid, given the possibility of precipitation. The anti-cholinergic effect is enhanced when used simultaneously with anti-Parkinsonian drugs, quinidine, tricyclic antidepressants.

special instructions

Atrovent; can be used for combined inhalation simultaneously with Ambroxol (solution for inhalation), Bromhexine (solution for inhalation) and Berotek (solution for inhalation). Hypersensitivity After using Atrovent; immediate-type hypersensitivity reactions may occur, as indicated by rare cases of rash, urticaria, angioedema, oropharyngeal edema, bronchospasm, and anaphylaxis. Paradoxical bronchospasmotherapy; In the case of paradoxical bronchospasm use of the drug Atrovent; it should be immediately discontinued and alternative therapy should be prescribed. Complications of the eye in patients who are predisposed to the development of angle-closure glaucoma. Separate reports of eye complications (including the development of mydriasis, increased intraocular pressure, development of angle-closure glaucoma, pain in the eyes) are known in cases where inhaled ipratropium bromide (used separately or in combination with a beta2-adrenoreceptor agonist) gets into the eyes. Symptoms of acute angle-closure glaucoma can be pain or discomfort in the eyes, blurred vision, the appearance of aureole in objects and colored spots red eyes combined with red eyes due to injection of the conjunctival vessels and corneal edema. If any combination of these symptoms develops, the use of eye drops to reduce intraocular pressure is indicated, and a specialist should be consulted immediately. Patients should be instructed on the correct use of Atrovent; care should be taken to prevent the solution from getting into the eyes. It is recommended that the solution used with a nebulizer should be applied through a mouthpiece.If the mouthpiece is missing and the nebulizer mask is used, it should be applied properly. Patients predisposed to the development of glaucoma should be warned about the need to protect the eyes. Effect on urinary tractWith caution should be used Atrovent; in patients with an existing obstruction of the urinary tract (for example, prostatic hyperplasia or bladder neck obstruction). Disorders of gastrointestinal motility in patients with cystic fibrosis may be susceptible to gastrointestinal motility disorders. contains benzalkonium chloride preservative, and disodium edetate stabilizer dihydrate. During inhalation, these components can cause bronchospasm in sensitive patients with hyperreactivity of the respiratory tract. The patient should be informed that if inhalation is not effective enough or the condition has worsened, consult a doctor to change the treatment plan. In the case of sudden onset and rapid progression of dyspnea, the patient should also immediately consult a doctor. The effect on the ability to drive vehicles and control mechanisms The effect of the drug on the ability to control vehicles and use mechanisms was not specifically studied. However, patients need to be informed that during treatment with Atrovent; possible development of such adverse events as dizziness, disturbance of accommodation, mydriasis, blurred vision. Therefore, caution should be recommended when driving or using machinery.

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