Atrovent N aerosol 20mcg dose 200dose 10ml
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Active ingredients
Ipratropium bromide
Release form
Spray
Composition
Ipratropium bromide monohydrate 21 mcg, which corresponds to an ipratropium bromide anhydrous 20 mcg; Excipients: absolute ethanol - 8.415 mg, purified water - 281 mcg, citric acid - 2 mcg, tetrafluoroethane (HFA 134a, propellant) - 47.381 mg.
Pharmacological effect
Bronchodilating drug, blocker of m-cholinergic receptors. 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, is its competitive antagonist. Anticholinergics prevent an increase in the intracellular concentration of calcium ions, which occurs due to the interaction of acetylcholine with m-cholinergic receptors located in the smooth muscles of the bronchi .; The release of calcium ions occurs through secondary mediators (mediators), which include inositol triphosphate (ITP) and diacylglycerol (DAG). Effectively prevents narrowing of the bronchi, resulting from inhalation of cigarette smoke, cold air, the actions of various bronchoconstrictors, and also eliminates bronchospasm associated with the influence of the vagus nerve .; With inhalation use has almost no resorptive effect. Bronchodilation, occurring after inhalation of the drug Atrovent; H is mainly a consequence of the 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 pulmonary emphysema, a significant improvement in lung function was observed for 15 minutes, reached a maximum after 1-2 hours and persisted up to 4-6 hours; In patients with asthma, a significant improvement in the function of external respiration is observed in 51% of patients.
Pharmacokinetics
The therapeutic effect of the drug Atrovent; H is the result of its local action in the respiratory tract. The development of bronchodilation is not parallel to the pharmacokinetic parameters .; Absorption; After inhalation, usually 10-30% of the dose is administered to the lungs (depending on the dosage form and method of inhalation).Most of the dose is swallowed and enters the gastrointestinal tract. Part of the dose of the drug that entered the lungs quickly reaches the systemic blood flow (within a few minutes) .; The overall systemic bioavailability of ipratropium bromide, when taken orally and inhalation, is 2% and 7-28%, respectively; Distribution; Plasma protein binding is minimal (less than 20%) .; The kinetic parameters describing the distribution of ipratropium bromide were calculated on the basis of its concentration in plasma after i / v administration. There is a rapid biphasic decrease in plasma concentration. The apparent Vd in the equilibrium state is approximately 176 liters (approximately 2.4 liters / kg) .; Ipratropium bromide, which is a quaternary amine, does not penetrate through the BBB .; Metabolism and excretion; Total renal excretion (within 24 hours) of the unchanged substance is approximately 46% of the intravenous dose, less than 1% of the dose when taken orally, and about 3-13% of the inhalation dose of the drug .; T1 / 2 in the terminal phase is approximately 1.6 h. The total clearance of ipratropium bromide is 2.3 l / min, and the renal clearance is 0.9 l / min. After i.v. administration, approximately 60% of the dose is metabolized by oxidation, mainly in the liver .; The total renal excretion (within 6 days) with the isotope-labeled dose (including the unchanged substance 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 by the kidneys. The T1 / 2 of the parent compound and metabolites is 3.6 h. The major 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 and moderate severity (especially with concomitant diseases of the cardiovascular system).
Contraindications
- I trimester of pregnancy; - hypersensitivity to atropine and its derivatives; - Hypersensitivity to ipratropium bromide and other components of the drug.
Use during pregnancy and lactation
The safety of the drug Atrovent; H during pregnancy in humans is not installed .; When prescribing a drug for a possible or confirmed pregnancy, consider the ratio of the intended benefits of prescribing the drug to the mother and the possible risk to the fetus .; Use of the drug Atrovent is contraindicated; H in the first trimester of pregnancy .; Appointment of the drug in the II and III trimesters of pregnancy is possible only if the intended benefit of therapy for the mother outweighs the possible risk to the fetus .; In preclinical studies, no embryotoxic or teratogenic effect of the drug was found after its inhalation use in doses significantly higher than the doses recommended in humans .; It is not known 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; Care should be taken when breastfeeding mothers .; 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
Dosing regimen set individually. During treatment, patients should be under medical supervision. Do not exceed the recommended daily dose during emergency and maintenance therapy .; If the treatment does not lead to a significant improvement or the patient’s condition worsens, consult a physician to change the treatment plan. In the case of sudden or rapid increase in shortness of breath (difficulty breathing), you should immediately consult a doctor. The following doses are recommended (unless another dosing regimen is prescribed) .; Adults and children over 6 years old are prescribed 2 inhalation doses (injections) 4 times / day. Since The need to increase the dose indicates the possible need for additional methods of treatment, as a rule, should not be used during the day more than 12 inhalation doses .; Atrovent Solution may be indicated for the treatment of sudden exacerbations of chronic obstructive pulmonary disease; for inhalation .; In childrenAtrovent; H should be used only on prescription and under the supervision of adults (due to insufficient information) .; Terms of use of the drug; Before the first use of the inhaler, you should press the bottom of the cylinder 2 times .; Before each use, you must observe the following rules: 1. Remove the protective cap .; 2. Take a deep breath .; 3. Hold the inhaler tightly around the mouthpiece with your lips. The arrow and the bottom of the container must be directed upwards .; 4. Making the maximum deep breath, simultaneously sharply press the bottom of the balloon until the release of a single inhalation dose. Hold your breath for a few seconds, then take the mouthpiece out of your mouth and exhale slowly. Repeat steps to obtain a second inhalation dose .; 5. After using the inhaler, put on the protective cap .; 6. If the aerosol inhaler has not been used for more than 3 days, then before use, press the valve once; The cylinder is not transparent, therefore it is impossible to determine by eye when it becomes empty. The inhaler contains 200 inhalation doses. After all doses have been used, the balloon may appear to still contain a small amount of fluid. However, inhaler in such cases should be replaced, since it may contain an insufficient amount of the drug .; The amount of the drug in your inhaler can be checked in the following ways: - shake the bottle, it will show if there is any liquid in it; - remove the plastic mouthpiece from the bottle and place the bottle in a container with water. The contents of the container can be assessed depending on its position in the water .; The inhaler should be cleaned at least once a week. It is important to keep the mouthpiece of the inhaler clean to prevent the ingestion of a drug that can block the release of the aerosol .; During cleaning, first remove the protective cap and remove the balloon from the inhaler. Pass a stream of warm water through the inhaler, make sure that the preparation and / or visible dirt are removed .; After cleaning, shake the inhaler and allow it to air dry without using heating devices. Once the mouthpiece has dried, insert the balloon into the inhaler and put on the protective cap .; The plastic mouthpiece was designed specifically for use of Atrovent metered-dose aerosol; H and serves for accurate dosing of the drug. This mouthpiece should not be used with other metered aerosols.It is also impossible to use Atrovent dosage aerosol; H with other mouthpieces .; The aerosol in the cylinder is under pressure .; The cylinder must not be opened or stored at temperatures above 50 ° C.
Side effects
Many of the listed undesirable effects may be due to the anticholinergic properties of the drug Atrovent; N. Atrovent; H, like any inhalation therapy, can cause local irritation. Adverse drug reactions were determined on the basis of data obtained in clinical studies and during pharmacological supervision over the use of the drug after its registration .; The most frequent side effects reported in clinical studies were headache, pharyngeal irritation, cough, dry mouth, gastrointestinal dysmotility (including constipation, diarrhea and vomiting), nausea and dizziness .; On the part of the immune system: hypersensitivity, anaphylactic reaction .; Of the nervous system: headache, dizziness .; On the part of the organ of vision: blurred vision, mydriasis, increased intraocular pressure, glaucoma, pain in the eyes, the appearance of a halo around objects, conjunctival hyperemia, corneal edema, accommodation disturbances .; From the side of the heart: feeling of palpitations, supraventricular tachycardia, atrial fibrillation, increase in heart rate .; On the part of the respiratory system: irritation of the pharynx, cough, bronchospasm, paradoxical bronchospasm, laryngospasm, pharyngeal edema, dry pharynx .; On the part of the digestive system: dry mouth, nausea, gastrointestinal motility disorders, diarrhea, constipation, vomiting, stomatitis, swelling of the oral cavity .; Skin and subcutaneous tissue: rash, itching, angioedema, urticaria .; On the part of the urinary system: urinary retention.
Overdose
Symptoms: specific symptoms of overdose have been identified. Given the breadth of therapeutic action and local method of use of the drug Atrovent; H, the occurrence of any serious anticholinergic symptoms is unlikely. There may be minor manifestations of systemic anticholinergic action (including dry mouth, visual impairment, increased heart rate) .; Treatment: symptomatic treatment.
Interaction with other drugs
Long-term combined inhalation of the drug Atrovent; H has not been studied with other anticholinergic drugs, therefore long-term combined use is not recommended .; Beta-adrenergic agents and xanthine derivatives can enhance the bronchodilator effect of Atrovent; N .; Anticholinergic effect increases with simultaneous use of anti-Parkinsonian drugs, quinidine, tricyclic antidepressants.
special instructions
Hypersensitivity; After applying the drug Atrovent; H, immediate-type hypersensitivity reactions may occur, as indicated by rare cases of rash, urticaria, angioedema, oropharyngeal edema, bronchospasm and anaphylaxis .; Paradoxical bronchospasm; Atrovent; H, like other inhaled drugs, can cause paradoxical bronchospasm, which can be life-threatening. In the case of paradoxical bronchospasm use of the drug Atrovent; H should be stopped immediately and an alternative therapy prescribed .; Eye complications; Atrovent should be used with caution; H in patients prone to the development of angle-closure glaucoma .; There are separate reports of eye complications (including the development of mydriasis, increased intraocular pressure, development of angle-closure glaucoma, pain in the eyes) in cases where ipratropium inhaled bromide (used alone or in combination with an beta2-adrenoreceptor agonist) caught in 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 before the eyes, combined with red eyes due to injection of conjunctival vessels and corneal edema. If any combination of these symptoms develops, the use of eye drops, reducing intraocular pressure, and an immediate consultation with a specialist are indicated .; Patients should be instructed on the correct use of the drug Atrovent; N .; Care should be taken to prevent the ingress of aerosol into the eyes. Since the aerosol is released from the can only when it is pressed by the patient and comes from the mouthpiece into the oral cavity,the risk of eye contact is small; Effect on urinary tract; Atrovent should be used with caution; H in patients with existing urinary tract obstruction (for example, prostatic hyperplasia or bladder neck obstruction) .; Dysmotility of the gastrointestinal tract; Patients with cystic fibrosis may be susceptible to disorders of motility of the gastrointestinal tract .; Patients should use Atrovent correctly; H aerosol for inhalation dosed. The patient should be informed that if inhalations are not sufficiently effective 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 influence of the drug on the ability to drive vehicles and use mechanisms was not specifically studied. However, patients need to be informed that during treatment with Atrovent; H may develop such adverse events as dizziness, disturbance of accommodation, mydriasis, blurred vision. Therefore, caution should be recommended when driving or using machinery.