Release form, composition and packing
Solution for inhalation transparent, colorless or nearly colorless, practically free from particles.
1 ml ipratropium bromide monohydrate 261 mg, calculated on the anhydrous ipratropium bromide 250 mcg. Excipients: benzalkonium chloride, disodium edetate, sodium chloride, hydrochloric acid, purified water.
Clinico-pharmacological group: bronchodilator medication - m-cholinergic receptor blocker.
Pharmacological action
Bronchodilator drug. Blocks of m-cholinergic receptors of smooth muscles of the bronchi (predominantly at the level of large and medium bronchi) and inhibits reflex bronchoconstriction. Having structural similarity to acetylcholine, a molecule is its competitive antagonist. Warns bronchospasm, resulting from inhalation of cigarette smoke, cold air, the action of various drugs, and also eliminates bronchospasm associated with the influence of the vagus nerve.
In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema), improved external respiration (forced expiratory volume in first second / FEV 1 / and the mean volume velocity of forced vydoha25-75% increase by 15% or more) states in 15 minutes after administration. The maximum effect is achieved in 1-2 hours and lasts most of the patients up to 6 hours after injection of ipratropium bromide. 40% of patients with asthma showed a significant improvement in lung (FEV1 increased by 15% or more).
Inhalation application has almost no resorptive effect, while only 10% reaches the small bronchi and alveoli, and the rest settles in the throat or mouth and swallowed.
Pharmacokinetics
Suction
Absorption of the drug is low. Practically not absorbed from the gastrointestinal tract.
Distribution
Poorly soluble in fat and slightly penetrates through biological membranes. Not accumulates.
Metabolism
Metabolized to form eight inactive or weakly active metabolites of anticholinergics. Excretion in unchanged form is displayed through the intestines. Metabolites are excreted in the urine.
Statement
chronic obstructive pulmonary disease (including chronic obstructive bronchitis, emphysema);
Bronchial asthma is mild to moderate severity.
Dosing regimen
Keep in mind that 20 drops = 1 ml, 1 drop = 12.5 mcg ipratropium bromide anhydrous. For maintenance treatment for adults (including elderly patients) and children over 12 years are designated by 2 ml (40 drops = 500 mg) 3-4 times a day. The maximum daily dose - 8 ml (2 mg).
Treatment of children should be under medical supervision. Children aged 6 to 12 years are designated by 1 ml (20 drops = 250 mg) 3-4 times a day. The maximum daily dose - 4 mL (1 mg).
Children under 6 years are designated by 0.4-1 ml (8-20 drops = 100-250 mg) 3-4 times a day. The maximum daily dose - 4 mL (1 mg). For the treatment of acute bronchospasm adults (including elderly patients) and children over 12 years are designated by 2 ml (40 drops = 500 mg).
Treatment of children should be under medical supervision.
Children from 6 to 12 years are designated by 1 ml (20 drops = 250 mg) for children under 6 years - to 0.4-1 ml (8-20 drops = 100-250 mg). Possibility of reappointment to the stabilization of the patient. The interval between injections is set individually by the attending doctor. The simultaneous use of beta 2-agonists.
Rules of the drug
The recommended dose should be diluted with saline to achieve the volume of 3-4 ml of the drug, to fill in the nebulizer and make inhalation. The drug should be diluted with saline before each use. Remaining after inhalation solution is poured.
Dosing may depend on the method of inhalation and type of nebulizer. The duration of inhalation can be controlled by spending diluted volume. Atrovent can be applied using different nebulizers available for purchase. When using a centralized oxygen system solution is best applied at a flow rate of 6.8 l / min.
Side effect
The most frequent adverse events: headache, dry mouth, gastrointestinal dysmotility (nausea, vomiting, diarrhea, constipation). Effects associated with anticholinergic effect of the drug: supraventricular tachycardia, palpitations, atrial fibrillation, disturbance of accommodation, urinary retention (due to low systemic absorption of the drug are rare and are reversible). In patients with obstructive lesions of the urinary tract increases the risk of urinary retention.
From the respiratory system: Possible coughing, local irritation, rarely - paradoxical bronchospasm.
From the organ of vision: in some cases when the product enters the eyes observed mydriasis, accommodation paresis, increased intraocular pressure (particularly in patients with angle-closure glaucoma).
Pain in the eye or discomfort, blurry vision, ghosting and color spots before his eyes, combined with conjunctival and corneal hyperemia may be symptoms of an attack angle-closure glaucoma. Allergic reactions: possible skin rash, angioedema tongue, lips, face, laryngospasm, erythema multiforme, urticaria, anaphylactic reaction.
Contraindications
I trimester of pregnancy;
Hypersensitivity to atropine and its derivatives;
hypersensitivity to ipratropium bromide and other ingredients.
Precautions should be prescribed drug in angle-closure glaucoma, obstructive urinary tract (including prostate enlargement), breast feeding, children under the age of 6 years.
Pregnancy and lactation
Safety of Atrovent in pregnancy in humans has not been established.
Contraindicated the use of Atrovent in I trimester of pregnancy. Of the drug in the II and III trimester of pregnancy is only possible if the intended use of therapy to the mother justifies the potential risk to the fetus. Is not known whether ipratropium bromide in breast milk. Although insoluble in lipids quaternary cations pass into the breast milk, it is unlikely that Atrovent will have significant effect inhalation use.
However, it should be prescribed with care medicine during breastfeeding.
Use in renal impairment
Be wary of obstruction in the urinary tract.
Cautions
Not recommended to prescribe a drug for emergency relief of bronchial asthma attack (since the bronchodilator effect develops later than the beta-agonists). In patients with cystic fibrosis increased risk of slowing down the digestive tract motility. It is not recommended to allow a significant excess of recommended doses as the treatment of acute bronchospasm, and supportive care.
The patient should be informed that, if inhaled or not effective enough deteriorated condition, you should consult your doctor to change the treatment plan. Atrovent can be used for combined inhalation concurrently with Lazolvanom (solution for inhalation) and berotek (solution for inhalation). The product contains an antibacterial preservative benzalkonium chloride, disodium edetate and the stabilizer, which can cause narrowing of the bronchi. Patients should be able to correctly apply the Atrovent. Should not allow solution into the eye.
Patients are predisposed to glaucoma, it should be warned about the need to protect your eyes from getting the drug. In case of any symptom of an attack angle-closure glaucoma should appoint a drop, causing narrowing of the pupil, and immediately contact an ophthalmologist. For inhalation is recommended nebulizers with a tip to the mouth. When you use the nebulizer with a mask to be applied a mask of appropriate size.
Overdose
Symptoms: The specific symptoms of overdose is not revealed. Given the breadth of therapeutic action and the local way of Atrovent, the emergence of any serious anticholinergic symptoms are unlikely. Minor systemic manifestations of anticholinergic action (including dry mouth, accommodation disturbances, increased heart rate).
Treatment: symptomatic therapy of conduct.
Drug Interactions
With the simultaneous application of beta2-adrenoceptor agonists and xanthine derivatives potentiate the bronchodilator effect of Atrovent. While the application Atrovent with antiparkinsonian means, quinidine, tricyclic antidepressants increased anticholinergic effect of the drug.
While the application Atrovent with other anticholinergic drugs indicated an additive effect.
While using Atrovent with inhaled beta2-adrenomimetikami patients with angle-closure glaucoma increases the risk of an acute attack of glaucoma. Atrovent should not be administered concurrently with inhaled disodium cromoglycate solution, given the possibility of precipitation.
Conditions and terms of
The drug should be stored in a place inaccessible to children at or above 30 ° C. Do not freeze. Shelf life - 5 years.
Solution for inhalation transparent, colorless or nearly colorless, practically free from particles.
1 ml ipratropium bromide monohydrate 261 mg, calculated on the anhydrous ipratropium bromide 250 mcg. Excipients: benzalkonium chloride, disodium edetate, sodium chloride, hydrochloric acid, purified water.
Clinico-pharmacological group: bronchodilator medication - m-cholinergic receptor blocker.
Pharmacological action
Bronchodilator drug. Blocks of m-cholinergic receptors of smooth muscles of the bronchi (predominantly at the level of large and medium bronchi) and inhibits reflex bronchoconstriction. Having structural similarity to acetylcholine, a molecule is its competitive antagonist. Warns bronchospasm, resulting from inhalation of cigarette smoke, cold air, the action of various drugs, and also eliminates bronchospasm associated with the influence of the vagus nerve.
In patients with bronchospasm associated with COPD (chronic bronchitis and emphysema), improved external respiration (forced expiratory volume in first second / FEV 1 / and the mean volume velocity of forced vydoha25-75% increase by 15% or more) states in 15 minutes after administration. The maximum effect is achieved in 1-2 hours and lasts most of the patients up to 6 hours after injection of ipratropium bromide. 40% of patients with asthma showed a significant improvement in lung (FEV1 increased by 15% or more).
Inhalation application has almost no resorptive effect, while only 10% reaches the small bronchi and alveoli, and the rest settles in the throat or mouth and swallowed.
Pharmacokinetics
Suction
Absorption of the drug is low. Practically not absorbed from the gastrointestinal tract.
Distribution
Poorly soluble in fat and slightly penetrates through biological membranes. Not accumulates.
Metabolism
Metabolized to form eight inactive or weakly active metabolites of anticholinergics. Excretion in unchanged form is displayed through the intestines. Metabolites are excreted in the urine.
Statement
chronic obstructive pulmonary disease (including chronic obstructive bronchitis, emphysema);
Bronchial asthma is mild to moderate severity.
Dosing regimen
Keep in mind that 20 drops = 1 ml, 1 drop = 12.5 mcg ipratropium bromide anhydrous. For maintenance treatment for adults (including elderly patients) and children over 12 years are designated by 2 ml (40 drops = 500 mg) 3-4 times a day. The maximum daily dose - 8 ml (2 mg).
Treatment of children should be under medical supervision. Children aged 6 to 12 years are designated by 1 ml (20 drops = 250 mg) 3-4 times a day. The maximum daily dose - 4 mL (1 mg).
Children under 6 years are designated by 0.4-1 ml (8-20 drops = 100-250 mg) 3-4 times a day. The maximum daily dose - 4 mL (1 mg). For the treatment of acute bronchospasm adults (including elderly patients) and children over 12 years are designated by 2 ml (40 drops = 500 mg).
Treatment of children should be under medical supervision.
Children from 6 to 12 years are designated by 1 ml (20 drops = 250 mg) for children under 6 years - to 0.4-1 ml (8-20 drops = 100-250 mg). Possibility of reappointment to the stabilization of the patient. The interval between injections is set individually by the attending doctor. The simultaneous use of beta 2-agonists.
Rules of the drug
The recommended dose should be diluted with saline to achieve the volume of 3-4 ml of the drug, to fill in the nebulizer and make inhalation. The drug should be diluted with saline before each use. Remaining after inhalation solution is poured.
Dosing may depend on the method of inhalation and type of nebulizer. The duration of inhalation can be controlled by spending diluted volume. Atrovent can be applied using different nebulizers available for purchase. When using a centralized oxygen system solution is best applied at a flow rate of 6.8 l / min.
Side effect
The most frequent adverse events: headache, dry mouth, gastrointestinal dysmotility (nausea, vomiting, diarrhea, constipation). Effects associated with anticholinergic effect of the drug: supraventricular tachycardia, palpitations, atrial fibrillation, disturbance of accommodation, urinary retention (due to low systemic absorption of the drug are rare and are reversible). In patients with obstructive lesions of the urinary tract increases the risk of urinary retention.
From the respiratory system: Possible coughing, local irritation, rarely - paradoxical bronchospasm.
From the organ of vision: in some cases when the product enters the eyes observed mydriasis, accommodation paresis, increased intraocular pressure (particularly in patients with angle-closure glaucoma).
Pain in the eye or discomfort, blurry vision, ghosting and color spots before his eyes, combined with conjunctival and corneal hyperemia may be symptoms of an attack angle-closure glaucoma. Allergic reactions: possible skin rash, angioedema tongue, lips, face, laryngospasm, erythema multiforme, urticaria, anaphylactic reaction.
Contraindications
I trimester of pregnancy;
Hypersensitivity to atropine and its derivatives;
hypersensitivity to ipratropium bromide and other ingredients.
Precautions should be prescribed drug in angle-closure glaucoma, obstructive urinary tract (including prostate enlargement), breast feeding, children under the age of 6 years.
Pregnancy and lactation
Safety of Atrovent in pregnancy in humans has not been established.
Contraindicated the use of Atrovent in I trimester of pregnancy. Of the drug in the II and III trimester of pregnancy is only possible if the intended use of therapy to the mother justifies the potential risk to the fetus. Is not known whether ipratropium bromide in breast milk. Although insoluble in lipids quaternary cations pass into the breast milk, it is unlikely that Atrovent will have significant effect inhalation use.
However, it should be prescribed with care medicine during breastfeeding.
Use in renal impairment
Be wary of obstruction in the urinary tract.
Cautions
Not recommended to prescribe a drug for emergency relief of bronchial asthma attack (since the bronchodilator effect develops later than the beta-agonists). In patients with cystic fibrosis increased risk of slowing down the digestive tract motility. It is not recommended to allow a significant excess of recommended doses as the treatment of acute bronchospasm, and supportive care.
The patient should be informed that, if inhaled or not effective enough deteriorated condition, you should consult your doctor to change the treatment plan. Atrovent can be used for combined inhalation concurrently with Lazolvanom (solution for inhalation) and berotek (solution for inhalation). The product contains an antibacterial preservative benzalkonium chloride, disodium edetate and the stabilizer, which can cause narrowing of the bronchi. Patients should be able to correctly apply the Atrovent. Should not allow solution into the eye.
Patients are predisposed to glaucoma, it should be warned about the need to protect your eyes from getting the drug. In case of any symptom of an attack angle-closure glaucoma should appoint a drop, causing narrowing of the pupil, and immediately contact an ophthalmologist. For inhalation is recommended nebulizers with a tip to the mouth. When you use the nebulizer with a mask to be applied a mask of appropriate size.
Overdose
Symptoms: The specific symptoms of overdose is not revealed. Given the breadth of therapeutic action and the local way of Atrovent, the emergence of any serious anticholinergic symptoms are unlikely. Minor systemic manifestations of anticholinergic action (including dry mouth, accommodation disturbances, increased heart rate).
Treatment: symptomatic therapy of conduct.
Drug Interactions
With the simultaneous application of beta2-adrenoceptor agonists and xanthine derivatives potentiate the bronchodilator effect of Atrovent. While the application Atrovent with antiparkinsonian means, quinidine, tricyclic antidepressants increased anticholinergic effect of the drug.
While the application Atrovent with other anticholinergic drugs indicated an additive effect.
While using Atrovent with inhaled beta2-adrenomimetikami patients with angle-closure glaucoma increases the risk of an acute attack of glaucoma. Atrovent should not be administered concurrently with inhaled disodium cromoglycate solution, given the possibility of precipitation.
Conditions and terms of
The drug should be stored in a place inaccessible to children at or above 30 ° C. Do not freeze. Shelf life - 5 years.
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