Acute overdosage by intranasal administration is unlikely since ipratropium bromide is not well absorbed systemically after intranasal or oral administration. Following administration of a 20 mg oral dose (equivalent to ingesting more than two bottles of Atrovent® (ipratropium bromide) Nasal Spray 0.06%) to 10 male volunteers, no change in heart rate or blood pressure was noted. Following a 2 mg intravenous infusion over 15 minutes to the same 10 male volunteers, plasma ipratropium concentrations of 22-45 ng/mL were observed (>100 times the concentrations observed following intranasal administration). Following intravenous infusion these 10 volunteers had a mean increase of heart rate of 50 bpm and less than 20 mmHg change in systolic or diastolic blood pressure at the time of peak ipratropium levels.
No symptoms specific to overdosage have been encountered. In view of the wide therapeutic window and topical administration of Атровент, no serious anticholinergic symptoms are to be expected. As with other anticholinergics, dry mouth, visual accommodation disturbances and tachycardia would be the expected symptoms and signs of overdose.
Атровентasal Spray 0.06% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients.
Атровент UDVs are contraindicated in patients with known hypersensitivity to atropine or its derivatives (such as the active substance ipratropium bromide) or to any other component of the product.
Not applicable.
Adverse reaction information on Атровентasal Spray 0.06% in patients with the common cold was derived from two multicenter, vehicle-controlled clinical trials involving 1,276 patients (195 patients on Атровентasal Spray 0.03%, 352 patients on Атровентasal Spray 0.06%, 189 patients on Атровентasal Spray 0.12%, 351 patients on vehicle and 189 patients receiving no treatment).
Table 1 shows adverse events reported for patients who received Атровентasal Spray 0.06% at the recommended dose of 84 mcg per nostril, or vehicle, administered three or four times daily, where the incidence is 1% or greater in the ATROVENT group and higher in the ATROVENT group than in the vehicle group.
Table 1 % of Patients with Common Cold Reporting Events1
| Atrovent® (ipratropium bromide) Nasal Spray 0.06% | Vehicle Control | |
| No. of Patients | 352 | 351 |
| Epistaxis2 | 8.2% | 2.3% |
| Nasal Dryness | 4.8% | 2.8% |
| Dry Mouth/Throat | 1.4% | 0.3% |
| Nasal Congestion | 1.1% | 0.0% |
| 1 This table includes adverse events for which the incidence was 1% or greater in the ATROVENT group and higher in the ATROVENT group than in the vehicle group. 2 Epistaxis reported by 5.4% of ATROVENT patients and 1.4% of vehicle patients, blood-tinged nasal mucus by 2.8% of ATROVENT patients and 0.9% of vehicle patients. |
Атровентasal Spray 0.06% was well tolerated by most patients. The most frequently reported adverse events were transient episodes of nasal dryness or epistaxis. The majority of these adverse events (96%) were mild or moderate in nature, none was considered serious, and none resulted in hospitalization. No patient required treatment for nasal dryness, and only three patients (<1%) required treatment for epistaxis, which consisted of local application of pressure or a moisturizing agent (e.g., petroleum jelly). No patient receiving ATROVENT
Nasal Spray 0.06% was discontinued from the trial due to either nasal dryness or bleeding. Adverse events reported by less than 1% of the patients receiving Атровентasal Spray 0.06% during the controlled clinical trials that are potentially related to ATROVENT's local effects or systemic anticholinergic effects include: taste perversion, nasal burning, conjunctivitis, coughing, dizziness, hoarseness, palpitation, pharyngitis, tachycardia, thirst, tinnitus, and blurred vision. No controlled trial was conducted to address the relative incidence of adverse events for three times daily versus four times daily therapy.
Nasal adverse events seen in the clinical trial with seasonal allergic rhinitis (SAR) patients (see Table 2) were similar to those seen in the common cold trials. Additional events were reported at a higher rate in the SAR trial due in part to the longer duration of the trial and the inclusion of Upper Respiratory Tract Infection (URI) as an adverse event. In common cold trials, URI was the disease under study and not an adverse event.
Table 2 % of Patients with SAR Reporting Events1
| Atrovent® (ipratropium bromide) Nasal Spray 0.06% | Vehicle Control | |
| No. of Patients | 218 | 211 |
| Epistaxis2 | 6.0% | 3.3% |
| Pharyngitis | 5.0% | 3.8% |
| URI | 5.0% | 3.3% |
| Nasal Dryness | 4.6% | 0.9% |
| Headache | 4.1% | 0.5% |
| Dry Mouth/Throat | 4.1% | 0.0% |
| Taste Perversion | 3.7% | 1.4% |
| Sinusitis | 2.8% | 2.8% |
| Pain | 1.8% | 0.9% |
| Diarrhea | 1.8% | 0.5% |
| 1 This table includes adverse events for which the incidence was 1% or greater in the ATROVENT group and higher in the ATROVENT group than in the vehicle group. 2 Epistaxis reported by 3.7% of ATROVENT patients and 2.4% of vehicle patients, blood-tinged nasal mucus by 2.3% of ATROVENT patients and 1.9% of vehicle patients. |
There were no reports of allergic-type reactions in the controlled clinical common cold and SAR trials.
Post-Marketing ExperienceAllergic-type reactions such as skin rash, angioedema, including that of the throat, tongue, lips and face, generalized urticaria (including giant urticaria), laryngospasm, and anaphylactic reactions have been reported with Атровентasal Spray 0.06% and for other ipratropium bromide-containing products, with positive rechallenge in some cases.
Additional side effects identified from the published literature and/or post-marketing surveillance on the use of ipratropium bromide-containing products (singly or in combination with albuterol), include: urinary retention, prostatic disorders, mydriasis, cases of precipitation or worsening of narrow-angle glaucoma, acute eye pain, ocular irritation, wheezing, dryness of the oropharynx, tachycardia, edema, gastrointestinal distress (diarrhea, nausea, vomiting), bowel obstruction, constipation, nasal discomfort, throat irritation, hypersensitivity, accommodation disorder, intraocular pressure increased, glaucoma, halo vision, conjunctival hyperaemia, corneal edema, heart rate increased, bronchospasm, pharyngeal edema, gastrointestinal motility disorder, mouth edema, stomatitis, and pruritus.
After oral inhalation of ipratropium bromide in patients suffering from COPD/Asthma supraventricular tachycardia and atrial fibrillation have been reported.
Many of the listed undesirable effects can be assigned to the anticholinergic properties of Атровент. As with all inhalation therapy Атровент may show symptoms of local irritation. Adverse drug reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the drug.
The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastro-intestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.
Frequencies
| Very common | > 1/10 |
| Common | > 1/100 < 1/10 |
| Uncommon | > 1/1,000< 1/100 |
| Rare | > 1/10,000 < 1/1,000 |
| Very rare | < 1/10,000 |
| Immune system disorder | |
| Hypersensitivity | Uncommon |
| Anaphylactic reaction | Uncommon |
| Angioedema of tongue, lips & face | Uncommon |
| Nervous system disorders | |
| Headache | Common |
| Dizziness | Common |
| Eye disorders | |
| Blurred vision | Uncommon |
| Mydriasis (1) | Uncommon |
| Intraocular pressure increased (1) | Uncommon |
| Glaucoma (1) | Uncommon |
| Eye pain (1) | Uncommon |
| Halo vision | Uncommon |
| Conjunctival hyperaemia | Uncommon |
| Corneal oedema | Uncommon |
| Accommodation disorder | Rare |
| Cardiac Disorders | |
| Palpitations | Uncommon |
| Supraventricular tachycardia | Uncommon |
| Atrial fibrillation | Rare |
| Heart rate increased | Rare |
| Respiratory, Thoracic and Mediastinal Disorders | |
| Throat irritation | Common |
| Cough | Common |
| Bronchospasm | Uncommon |
| Paradoxical bronchospasm(2) | Uncommon |
| Laryngospasm | Uncommon |
| Pharyngeal oedema | Uncommon |
| Dry throat | Uncommon |
| Gastro-intestinal Disorders | |
| Dry mouth | Common |
| Nausea | Common |
| Gastro-intestinal motility disorder | Common |
| e.g. Diarrhoea | Uncommon |
| Constipation | Uncommon |
| Vomiting | Uncommon |
| Stomatitis | Uncommon |
| Skin and subcutaneous tissue disorders | |
| Rash | Uncommon |
| Pruritus | Uncommon |
| Urticaria | Rare |
| Renal and Urinary Disorders | |
| Urinary retention(3) | Uncommon |
(2) As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. Атровент UDVs should be discontinued immediately, the patient assessed and, if necessary, alterative treatment instituted.
(3) the risk of urinary retention may be increased in patients with pre-existing urinary outflow tract obstruction.
Reporting of suspected adverse reactions
Reporting suspected adverse reaction after authorisation of the medicinal product is important. It allows continued monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The toxicity of ipratropium bromide has been investigated extensively in the following types of studies: acute, subchronic and chronic toxicity, carcinogenicity, reproductive toxicity and mutagenicity via oral, intravenous, subcutaneous, intranasal and/or inhalation routes. Based on these toxicity studies, the probability of systemic anticholinergic side effects decreases in the following order:
intravenous > subcutaneous > oral > inhalation > intranasal.
Pre-clinically, ipratropium bromide was found to be well-tolerated. Two-year carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to approximately 1,200 times the maximum recommended human daily dose for intranasal ipratropium. Results of various mutagenicity tests were negative.
Studies to investigate the possible influence of ipratropium bromide on fertility, embryo-fetotoxicity, and peri-/postnatal development have been performed on mice, rats and rabbits. High oral levels, i.e. 1000 mg/kg/day in the rat and 125 mg/kg/day in the rabbit were maternotoxic for both species and embryo-/fetotoxic in the rat, where the fetal weight was reduced. Treatment-related malformations were not observed. The highest, technically feasible doses for inhalation of the pressurised inhalation, solution, 1.5 mg/kg/day (human equivalent dose of 0.24 mg/kg/day) in rats and 1.8 mg/kg/day (human equivalent dose of 0.576 mg/kg/day) in rabbits, showed no adverse effects on reproduction.
These doses are 6- and 14-fold the maximum recommended human daily dose (MRHDD) of 2 mg or 0.04 mg/kg (based on a body weight of 50 kg).
Атровентasal Spray 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. Атровентasal Spray 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. The safety and effectiveness of the use of Atrovent® (ipratropium bromide) Nasal Spray 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established.
Атровент UDVs are indicated for treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD).
Атровент UDVs are indicated, when used concomitantly with inhaled beta2-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma.
Pharmacotherapeutic group: Anticholinergics
ATC Code: R03BB01
Атровент is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In nonclinical studies, it appears to inhibit vagally mediated reflexes by antagonising the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increase in intracellular concentration of Ca++ which is caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. Ca++ release is mediated by the second messenger system consisting of IP3 (inositol triphosphate) and DAG (diacylglycerol).
The bronchodilation following inhalation of Атровент is induced by local drug concentrations sufficient for anticholinergic efficacy at the bronchial smooth muscle and not by systemic drug concentrations.
In clinical trials using metered dose inhalers in patients with reversible bronchospasm associated with chronic obstructive pulmonary disease significant improvements in pulmonary function (FEV1 increases of 15% or more) occurred within 15 minutes, reached a peak in 1-2 hours, and persisted for approximately 4 hours.
Preclinical and clinical evidence suggest no deleterious effect of Атровент on airway mucous secretion, mucociliary clearance or gas exchange.
The bronchodilator effect of Атровент in the treatment of acute bronchospasm associated with asthma has been shown in studies in adults and children > 6 years of age. In most of these studies Атровент was administered in combination with an inhaled beta2-agonist.
Ipratropium bromide is poorly absorbed into the systemic circulation following oral administration (2-3%). Less than 20% of an 84 mcg per nostril dose was absorbed from the nasal mucosa of normal volunteers, induced-cold adult volunteers, naturally acquired common cold pediatric patients, or perennial rhinitis adult patients.
DistributionIpratropium bromide is minimally bound (0 to 9% in vitro) to plasma albumin and α1-acid glycoprotein. Its blood/plasma concentration ratio was estimated to be about 0.89. Studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier.
MetabolismIpratropium bromide is partially metabolized to ester hydrolysis products, tropic acid, and tropane. These metabolites appear to be inactive based on in vitro receptor affinity studies using rat brain tissue homogenates.
EliminationAfter intravenous administration of 2 mg ipratropium bromide to 10 healthy volunteers, the terminal half-life of ipratropium bromide was approximately 1.6 hours. The total body clearance and renal clearance were estimated to be 2,505 and 1,019 mL/min, respectively. The amount of the total dose excreted unchanged in the urine (Ae) within 24 hours was approximately one-half of the administered dose.
PediatricsFollowing administration of 84 mcg of ipratropium bromide per nostril three times a day in patients 5-18 years old (n=42) with a naturally acquired common cold, the mean amount of the total dose excreted unchanged in the urine of 7.8% was comparable to 84 mcg per nostril four times a day in an adult induced common cold population (n=22) of 7.3 to 8.1%. Plasma ipratropium concentrations were relatively low (ranging from undetectable up to 0.62 ng/mL). No correlation of the amount of the total dose excreted unchanged in the urine (Ae) with age or gender was observed in the pediatric population.
Absorption
The therapeutic effect of Атровент is produced by a local action in the airways. Time courses of bronchodilation and systemic pharmacokinetics do not run in parallel.
Following inhalation, 10 to 30% of a dose is generally deposited in the lungs, depending on the formulation, device and inhalation technique. The major part of the dose is swallowed and passes through the gastro-intestinal tract.
The portion of the dose deposited in the lungs reaches the circulation rapidly (within minutes).
Cumulative renal excretion (0-24 hrs) of the parent compound is approximated to 46% of an intravenously administered dose, below 1% of an oral dose and approximately 3 to 13% of an inhaled dose. Based on these data the total systemic bioavailability of oral and inhaled doses of ipratropium bromide is estimated at 2% and 7 to 28% respectively.
Taking this into account, swallowed dose portions of ipratropium bromide do not contribute significantly to systemic exposure.
Distribution
The drug is minimally (less than 20%) bound to plasma proteins. Nonclinical data indicate that the quaternary amine ipratropium does not cross the placental or the blood-brain barrier.
Biotransformation
After intravenous administration approximately 60% of the dose is metabolised, mainly by conjugation (40%), whereas after inhalation about 77% of the systemically available dose is metabolised by ester hydrolysis (41%) and conjugation (36%).
The known metabolites, which are formed by hydrolysis, dehydration or elimination of the hydroxy-methyl group in the tropic acid moiety, show very little or no affinity for the muscarinic receptor and have to be regarded as ineffective
Elimination
Ipratropium has a mean total clearance of 2.3 L/min and a renal clearance of 0.9 L/min.
In an excretion balance study cumulative renal excretion (6 days) of drug-related radioactivity (including parent compound and all metabolites) accounted for 72.1% after intravenous administration, 9.3% after oral administration and 3.2% after inhalation. Total radioactivity excreted via the faeces was 6.3% following intravenous application, 88.5% following oral dosing and 69.4% after inhalation. Regarding the excretion of drug-related radioactivity after intravenous administration, the main excretion occurs via the kidneys. The half-life for elimination of drug-related radioactivity (parent compound and metabolites) is 3.2 hours.
Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
PRECAUTIONS GeneralPatients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma, mydriasis, increased intraocular pressure, acute eye pain or discomfort, visual halos or colored images in association with red eyes from conjunctival and corneal congestion may result if ATROVENT Nasal Spray 0.03% comes into direct contact with the eyes. Patients should be instructed to avoid spraying Атровентasal Spray (ipratropium bromide nasal spray) 0.03% in or around their eyes. Patients who experience eye pain, blurred vision, excessive nasal dryness, or episodes of nasal bleeding should be instructed to contact their doctor. To ensure proper dosing, patients should be advised not to alter the size of the nasal spray opening. Patients should be reminded to carefully read and follow the accompanying Patient's Instructions for Use.
Carcinogenesis, Mutagenesis, Impairment of FertilityTwo-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic activity at doses up to 6 mg/kg. This dose corresponds in rats and mice to approximately 190 and 95 times the maximum recommended daily intranasal dose in adults, respectively, and approximately 110 and 55 times the maximum recommended daily intranasal dose in children, respectively, on a mg/m² basis. Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test, and chromosome aberration of bone marrow in Chinese hamsters) were negative.
Fertility of male or female rats at oral doses up to 50 mg/kg (approximately 1,600 times the maximum recommended daily intranasal dose in adults on a mg/m² basis) was unaffected by ipratropium bromide administration. At an oral dose of 500 mg/kg (approximately 16,000 times the maximum recommended daily intranasal dose in adults on a mg/m² basis), ipratropium bromide produced a decrease in the conception rate.
Pregnancy Teratogenic Effects: Pregnancy Category B.Oral reproduction studies were performed at doses of 10 mg/kg in mice, 1000 mg/kg in rats and 125 mg/kg in rabbits. These doses correspond, in each species, respectively, to approximately 160, 32,000, and 8,000 times the maximum recommended daily intranasal dose in adults on a mg/m² basis. Inhalation reproduction studies were conducted in rats and rabbits at doses of 1.5 and 1.8 mg/kg, respectively, (approximately 50 and 120 times, respectively, the maximum recommended daily intranasal dose in adults on a mg/m² basis). These studies demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. At oral doses 90 mg/kg and above in rats (approximately 2,900 times the maximum recommended daily intranasal dose in adults on a mg/m² basis) embryotoxicity was observed as increased resorption. This effect is not considered relevant to human use due to the large doses at which it was observed and the difference in route of administration. However, no adequate or well controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, Atrovent® (ipratropium bromide) Nasal Spray 0.03% should be used during pregnancy only if clearly needed.
Nursing MothersIt is known that some ipratropium bromide is systemically absorbed following nasal administration; however the portion which may be excreted in human milk is unknown. Although lipid-insoluble quaternary cations pass into breast milk, the minimal systemic absorption makes it unlikely that ipratropium bromide would reach the infant in an amount sufficient to cause a clinical effect. However, because many drugs are excreted in human milk, caution should be exercised when Атровентasal Spray (ipratropium bromide nasal spray) 0.03% is administered to a nursing mother.
Pediatric UseThe safety of Atrovent® (ipratropium bromide) Nasal Spray 0.03% at a dose of two sprays (42 mcg) per nostril two or three times daily (total dose 168 to 252 mcg/day) has been demonstrated in 77 pediatric patients 6-12 years of age in placebo-controlled, 4-week trials and in 55 pediatric patients in active-controlled, 6 month trials. The effectiveness of Атровентasal Spray (ipratropium bromide nasal spray) 0.03% for the treatment of rhinorrhea associated with allergic and nonallergic perennial rhinitis in this pediatric age group is based on an extrapolation of the demonstrated efficacy of Атровентasal Spray (ipratropium bromide nasal spray) 0.03% in adults with these conditions and the likelihood that the disease course, pathophysiology, and the drug's effects are substantially similar to that of the adults. The recommended dose for the pediatric population is based on within and cross-study comparisons of the efficacy of Атровентasal Spray 0.03% in adults and pediatric patients and on its safety profile in both adults and pediatric patients. The safety and effectiveness of Атровентasal Spray 0.03% in patients under 6 years of age have not been established.
Use of the nebuliser solution should be subject to close medical supervision during initial dosing.
Hypersensitivity
Immediate hypersensitivity reactions following the use of Атровент have been demonstrated by cases of urticaria, angioedema, rash, bronchospasm, oropharyngeal oedema and anaphylaxis.
Paradoxical bronchospasm
As with other inhalation therapy, inhalation induced bronchoconstriction may occur with an immediate increase in wheezing after dosing. This should be treated straight away with a fast acting inhaled bronchodilator. Атровент UDVs should be discontinued immediately, the patient assessed and, if necessary, alternative treatment instituted.
Ocular complications
Caution is advocated in the use of anticholinergic agents in patients predisposed to or with narrow-angle glaucoma.
There have been isolated reports of ocular complications (i.e. mydriasis, increased intra-ocular pressure, narrow-angle glaucoma, eye pain) when aerosolised ipratropium bromide, either alone or in combination with an adrenergic beta2-agonist, has come into contact with the eyes during nebuliser therapy.
Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop, treatment with miotic drops should be initiated and specialist advice sought immediately.
Patients must be instructed in the correct administration of Атровент UDVs. Care must be taken not to allow the solution or mist to enter the eyes. It is recommended that the nebulised solution is administered via a mouthpiece. If this is not available and a nebuliser mask is used, it must fit properly. Patients who may be predisposed to glaucoma should be warned specifically to protect their eyes.
Renal and urinary effects
Атровент UDVs should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-outflow obstruction).
Gastro-intestinal motility disturbances
As patients with cystic fibrosis may be prone to gastro-intestinal motility disturbances, Атровент, as with other anticholinergics, should be used with caution in these patients.
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as dizziness, accommodation disorder, mydriasis and blurred vision during treatment with Атровент. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
The recommended dose of Атровентasal Spray 0.06% is two sprays (84 mcg) per nostril three or four times daily (total dose 504 to 672 mcg/day) in adults and children age 12 years and older. Optimum dosage varies with response of the individual patient. The recommended dose of Атровентasal Spray 0.06% for children age 5-11 years is two sprays (84 mcg) per nostril three times daily (total dose of 504 mcg/day).
The safety and effectiveness of the use of Атровентasal Spray 0.06% beyond four days in patients with the common cold have not been established.
For Symptomatic Relief of Rhinorrhea Associated with Seasonal Allergic RhinitisThe recommended dose of Атровентasal Spray 0.06% is two sprays (84 mcg) per nostril four times daily (total dose 672 mcg/day) in adults and children age 5 years and older.
The safety and effectiveness of the use of Атровентasal Spray 0.06% beyond three weeks in patients with seasonal allergic rhinitis have not been established.
Initial pump priming requires seven sprays of the pump. If used regularly as recommended, no further priming is required. If not used for more than 24 hours, the pump will require two sprays, or if not used for more than seven days, the pump will require seven sprays to reprime. Avoid spraying into eyes.
The dosage should be adapted to the individual needs of the patient. In children aged 12 years and under, only Атровент 250 UDVs, 1 ml should be used. The following doses are recommended:
Adults (including the elderly) and adolescents > 12 years of age:
250 - 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or 1 vial of 500 micrograms in 2 ml) 3 to 4 times daily.
For treatment of acute bronchospasm, 500 micrograms.
Repeated doses can be administered until the patient is stable. The time interval between the doses may be determined by the physician.
It is advisable not to exceed the recommended daily dose during either acute or maintenance treatment. Daily doses exceeding 2 mg in adults and adolescents > 12 years of age should only be given under medical supervision.
Children 6 - 12 years of age:
250 micrograms (i.e. one vial of 250 micrograms in 1ml) up to a total daily dose of 1mg (4 vials).
The time interval between doses may be determined by the physician.
Children 0 - 5 years of age (for treatment of acute asthma only):
125 - 250 micrograms (i.e. half to one vial of 250 micrograms in 1 ml) up to a total daily dose of 1 mg (4 vials).
Ipratropium bromide should be administered no more frequently than 6 hourly in children under 5 years of age.
For acute bronchospasm, repeated doses may be administered until the patient is stable.
If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be sought. The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a physician should be consulted immediately.
Атровент UDVs may be combined with a short-acting beta2-agonist in the same nebuliser chamber, for simultaneous administration where co-administration is required. The solution should be used as soon as possible after mixing and any unused solution should be discarded.
Атровент UDVs can be administered using a range of commercially available nebulising devices. The dose of nebuliser solution may need to be diluted in order to obtain a final volume suitable for the particular nebuliser being used (usually 2 - 4 mL); if dilution is necessary use only sterile sodium chloride 0.9% solution.
Атровент UDVs and disodium cromoglycate inhalation solutions that contain the preservative benzalkonium chloride should not be administered simultaneously in the same nebuliser as precipitation may occur.
The unit dose vials are intended only for inhalation with suitable nebulising devices and should not be taken orally or administered parenterally.
Please refer to the patient information leaflet for instructions on use with a nebuliser.
None.
