ATROVENT UDV Ipratropium Bromide 500mcg / 2mL Solution for Inhalation 2mL 1's
RXDRUG-DRP-7890-1pc
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Features
Brand
Atrovent UDV
Full Details
Dosage Strength
500 mcg / 2 mL
Drug Ingredients
- Ipratropium
Drug Packaging
Solution for Inhalation 1's
Generic Name
Ipratropium Bromide
Dosage Form
Solution for Inhalation
Registration Number
DRP-7890
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Ipratropium bromide (ATROVENT) 500 mcg unit dose vials are indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Ipratropium bromide (ATROVENT) 500 mcg unit dose vials are indicated, when used concomitantly with inhaled beta-agonists in the treatment of acute bronchospasm associated with chronic obstructive pulmonary disease including chronic bronchitis and asthma.
Ipratropium bromide (ATROVENT) 500 mcg unit dose vials are indicated, when used concomitantly with inhaled beta-agonists in the treatment of acute bronchospasm associated with chronic obstructive pulmonary disease including chronic bronchitis and asthma.
Dosage/Direction for Use
The dosage should be adapted to the individual requirements and the patients should be kept under medical supervision during treatment. It is advisable not to exceed the recommended daily dose during either acute or maintenance treatment.
If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be sought in order to determine a new plan of treatment. The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a physician should be consulted immediately.
Dosage: The following dosages are recommended: Maintenance treatment: Adults (including elderly) and adolescents over 12 years of age: 1 unit dose vial (UDV) 3 to 4 times daily.
Acute attacks: Adults (including elderly) and adolescents over 12 years of age: 1 unit dose vial (UDV); repeated doses can be administered until the patient is stable.
The time interval between the doses may be determined by the physician.
Ipratropium bromide (ATROVENT) can be administered combined with an inhaled beta-agonist.
Daily doses exceeding 2 mg ipratropium bromide anhydrous in adults and adolescents >12 years of age should be given under medical supervision.
If therapy does not produce a significant improvement or if the patient's condition gets worse, medical advice must be sought in order to determine a new plan of treatment. The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a physician should be consulted immediately.
Dosage: The following dosages are recommended: Maintenance treatment: Adults (including elderly) and adolescents over 12 years of age: 1 unit dose vial (UDV) 3 to 4 times daily.
Acute attacks: Adults (including elderly) and adolescents over 12 years of age: 1 unit dose vial (UDV); repeated doses can be administered until the patient is stable.
The time interval between the doses may be determined by the physician.
Ipratropium bromide (ATROVENT) can be administered combined with an inhaled beta-agonist.
Daily doses exceeding 2 mg ipratropium bromide anhydrous in adults and adolescents >12 years of age should be given under medical supervision.
Overdosage
No symptoms specific to overdose have been encountered. In view of the wide therapeutic range and topical administration of Ipratropium bromide (ATROVENT), no serious anticholinergic symptoms are to be expected. Minor systemic manifestations of anticholinergic action, including dry mouth, visual accommodation disorder and increase of heart rate may occur.
Contraindications
Ipratropium bromide (ATROVENT) is 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.
Special Precautions
Hypersensitivity: Immediate hypersensitivity reactions may occur after administration of Ipratropium bromide (ATROVENT), as demonstrated by rare cases of rash, urticaria, angioedema, oropharyngeal oedema bronchospasm and anaphylaxis.
Paradoxical bronchospasm: As with other inhaled medicines Ipratropium bromide (ATROVENT) may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Ipratropium bromide (ATROVENT) should be discontinued immediately and substituted with an alternative therapy.
Ocular complications: Ipratropium bromide (ATROVENT) should be used with caution in patients predisposed to narrow-angle glaucoma. There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular 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.
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 should be sought immediately.
Patients must be instructed in the correct administration of Ipratropium bromide (ATROVENT) nebulizer solution.
Care must be taken not to allow the solution or mist into the eyes. It is recommended that the nebulised solution is administered via a mouth piece. 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.
Gastro-intestinal motility disturbances: Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Effects on ability to drive and use machines: 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 Ipratropium bromide (ATROVENT). Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
Renal and urinary effects: Ipratropium bromide (ATROVENT) should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-neck obstruction).
Paradoxical bronchospasm: As with other inhaled medicines Ipratropium bromide (ATROVENT) may result in paradoxical bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Ipratropium bromide (ATROVENT) should be discontinued immediately and substituted with an alternative therapy.
Ocular complications: Ipratropium bromide (ATROVENT) should be used with caution in patients predisposed to narrow-angle glaucoma. There have been isolated reports of ocular complications (i.e. mydriasis, increased intraocular 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.
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 should be sought immediately.
Patients must be instructed in the correct administration of Ipratropium bromide (ATROVENT) nebulizer solution.
Care must be taken not to allow the solution or mist into the eyes. It is recommended that the nebulised solution is administered via a mouth piece. 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.
Gastro-intestinal motility disturbances: Patients with cystic fibrosis may be more prone to gastrointestinal motility disturbances.
Effects on ability to drive and use machines: 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 Ipratropium bromide (ATROVENT). Therefore, caution should be recommended when driving a car or operating machinery. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
Renal and urinary effects: Ipratropium bromide (ATROVENT) should be used with caution in patients with pre-existing urinary outflow tract obstruction (e.g. prostatic hyperplasia or bladder-neck obstruction).
Use In Pregnancy & Lactation
Pregnancy: The safety of Ipratropium bromide (ATROVENT) during human pregnancy has not been established. The benefits of using Ipratropium bromide (ATROVENT) during a confirmed or suspected pregnancy must be weighed against possible hazards to the unborn child. Preclinical studies have shown no embryotoxic or teratogenic effects following inhalation or intranasal application at doses considerably higher than those recommended in man.
Lactation: It is not known whether Ipratropium bromide is excreted into breast milk. But it is unlikely that ipratropium bromide would reach the infant to an important extent, especially when administered by inhalation. However, caution should be exercised when Ipratropium bromide (ATROVENT) is administered to nursing mothers.
Fertility: Clinical data on fertility are not available for ipratropium bromide. Nonclinical studies performed with ipratropium bromide showed no adverse effect on fertility (see Pharmacology: Toxicology under Actions).
Lactation: It is not known whether Ipratropium bromide is excreted into breast milk. But it is unlikely that ipratropium bromide would reach the infant to an important extent, especially when administered by inhalation. However, caution should be exercised when Ipratropium bromide (ATROVENT) is administered to nursing mothers.
Fertility: Clinical data on fertility are not available for ipratropium bromide. Nonclinical studies performed with ipratropium bromide showed no adverse effect on fertility (see Pharmacology: Toxicology under Actions).
Adverse Reactions
Many of the listed undesirable effects can be assigned to the anticholinergic properties of Ipratropium bromide (ATROVENT). As with all inhalation therapy Ipratropium bromide (ATROVENT) may show symptoms of local irritation.
Summary of the safety profile:The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastrointestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.
Tabulated summary of adverse reactions: The following adverse reactions have been reported during use of ipratropium bromide (ATROVENT) in clinical trials and during the post-marketing experience.
Summary of the safety profile:The most frequent side effects reported in clinical trials were headache, throat irritation, cough, dry mouth, gastrointestinal motility disorders (including constipation, diarrhoea and vomiting), nausea, and dizziness.
Tabulated summary of adverse reactions: The following adverse reactions have been reported during use of ipratropium bromide (ATROVENT) in clinical trials and during the post-marketing experience.
Drug Interactions
The chronic co-administration of Ipratropium bromide (ATROVENT) inhalation with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of Ipratropium bromide (ATROVENT) with other anticholinergic drugs is not recommended.
Beta-adrenergics and xanthine preparations may intensify the bronchodilatory effect.
The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see Precautions) may be increased when nebulised ipratropium bromide and beta-mimetics are administered simultaneously.
Beta-adrenergics and xanthine preparations may intensify the bronchodilatory effect.
The risk of acute glaucoma in patients with a history of narrow-angle glaucoma (see Precautions) may be increased when nebulised ipratropium bromide and beta-mimetics are administered simultaneously.
Caution For Usage
Instructions for Use and Handling: Please read the instructions for use carefully, to ensure correct administration.
The unit dose vials are intended only for inhalation with suitable nebulising devices and should not be taken orally or administered parenterally.
The unit dose vials of 1 mL are to be diluted with physiological saline up to a final volume of 2-4 mL or may be combined with Berotec solution for inhalation.
Ipratropium bromide (ATROVENT) solution for inhalation can be administered using a range of commercially available nebulising devices. Where wall oxygen is available the solution is best administered at a flow rate of 6-8 litres per minute.
Ipratropium bromide (ATROVENT) solution for inhalation is suitable for concurrent inhalation with the secretomucolytics Mucosolvan solution for inhalation and Bisolvon solution for inhalation, and Berotec solutions for inhalation.
Ipratropium bromide (ATROVENT) UDVs and disodium cromoglycate inhalation solutions should not be administered simultaneously in the same nebuliser.
1. Prepare the nebuliser for filling, according to the instructions provided by the manufacturer or doctor.
2. Tear one unit dose vial from the strip.
3. Open the unit dose vial by firmly twisting the top.
4. Squeeze the content of the unit dose vial into the nebuliser reservoir.
5. Dilute with saline up to a final volume of 2-4 mL.
6. Assemble the nebuliser and use as directed.
7. After use throw away any solution left in the reservoir and clean the nebuliser, following the manufacturer's instructions.
Since the unit dose vials contain no preservative, it is important that the contents are used soon after opening and that a fresh vial is used for each administration to avoid microbial contamination. Partly used, opened or damaged unit dose vials should be discarded.
Unused vials should be discarded three months after opening of the pouch.
The unit dose vials are intended only for inhalation with suitable nebulising devices and should not be taken orally or administered parenterally.
The unit dose vials of 1 mL are to be diluted with physiological saline up to a final volume of 2-4 mL or may be combined with Berotec solution for inhalation.
Ipratropium bromide (ATROVENT) solution for inhalation can be administered using a range of commercially available nebulising devices. Where wall oxygen is available the solution is best administered at a flow rate of 6-8 litres per minute.
Ipratropium bromide (ATROVENT) solution for inhalation is suitable for concurrent inhalation with the secretomucolytics Mucosolvan solution for inhalation and Bisolvon solution for inhalation, and Berotec solutions for inhalation.
Ipratropium bromide (ATROVENT) UDVs and disodium cromoglycate inhalation solutions should not be administered simultaneously in the same nebuliser.
1. Prepare the nebuliser for filling, according to the instructions provided by the manufacturer or doctor.
2. Tear one unit dose vial from the strip.
3. Open the unit dose vial by firmly twisting the top.
4. Squeeze the content of the unit dose vial into the nebuliser reservoir.
5. Dilute with saline up to a final volume of 2-4 mL.
6. Assemble the nebuliser and use as directed.
7. After use throw away any solution left in the reservoir and clean the nebuliser, following the manufacturer's instructions.
Since the unit dose vials contain no preservative, it is important that the contents are used soon after opening and that a fresh vial is used for each administration to avoid microbial contamination. Partly used, opened or damaged unit dose vials should be discarded.
Unused vials should be discarded three months after opening of the pouch.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacotherapeutic group: Anticholinergics. ATC Code: R03BB01.
Pharmacology: Pharmacodynamics: Ipratropium bromide (ATROVENT) is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In preclinical studies, it appears to inhibit vagally mediated reflexes by antagonizing 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 Ipratropium bromide (ATROVENT) is primarily local and site specific to the lung and not systemic in nature.
Non-clinical and clinical evidence suggest no deleterious effect of Ipratropium bromide (ATROVENT) on airway mucous secretion, mucociliary clearance or gas exchange.
Clinical trials: In controlled 85-90 day studies in patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) significant improvements in pulmonary function occurred within 15 minutes, reached a peak in 1-2 hours, and persisted for up to 4-6 hours.
The bronchodilator effect of Ipratropium bromide (ATROVENT) in the treatment of acute bronchospasm associated with asthma has been shown in studies in adults. In most of these studies Ipratropium bromide (ATROVENT) was administered in combination with an inhaled beta-agonist.
Pharmacokinetics: Absorption: The therapeutic effect of Ipratropium bromide (ATROVENT) 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 and inhalation technique. The major part of the dose is swallowed and passes 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 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 relevantly contribute to systemic exposure.
Distribution: Kinetic parameters describing the disposition of ipratropium were calculated from plasma concentrations after i.v. administration. A rapid biphasic decline in plasma concentrations is observed. The apparent volume of distribution at steady-state (Vdss) is approximately 176 L (≈ 2.4 L/kg). The drug is minimally (less than 20%) bound to plasma proteins. Nonclinical data indicate that quaternary amine ipratropium does not cross the placental or blood-brain barrier.
The known metabolites show very little or no affinity for the muscarinic receptor and have to be regarded as ineffective.
Biotransformation: After intravenous administration approximately 60% of a dose is metabolised, the major proportion probably in the liver by oxidation.
The known metabolites are formed by hydrolysis, dehydration or elimination of the hydroxy-methyl group in the tropic acid moiety.
Elimination: The half-life of the terminal elimination phase is approximately 1.6 hours.
Ipratropium has a 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 9.3% after oral administration and 3.2% after inhalation. Total radioactivity excreted via the faeces was 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 3.6 hours.
Toxicology: Local and systemic tolerability of ipratropium bromide have comprehensively been investigated in several animal species using various administration routes.
Single dose toxicity: The acute inhalation, oral and intravenous toxicity has been assessed in several rodent and non-rodent species. When administered by inhalation, the minimum lethal dose in male Guinea pigs was 199 mg/kg. In rats, no mortality was observed up to the highest technically feasible dosages (i.e. 0.05 mg/kg after 4 h of administration or 160 puffs of ipratropium bromide, 0.02 mg/puff).
The oral LD50 values for the mouse, rat and rabbit were 1585, 1925 and 1920 mg/kg, respectively. The intravenous LD50 for the mouse, rat and dog was, respectively, 13.6, 15.8 and about 18.2 mg/kg. Clinical signs included mydriasis, dry oral mucosa, dyspnoea, tremor, spasms and/or tachycardia.
Repeat-dose toxicity: Repeated-dose toxicity studies have been performed in rats, rabbits, dogs and Rhesus monkeys.
In inhalation studies up to 6 months in rats, dogs and Rhesus monkeys, the No Observed Adverse Effect Level (NOAEL) was 0.38 mg/kg/day, 0.18 mg/kg/day and 0.8 mg/kg/day, respectively. Dry oral mucosa and tachycardia were noted in the dogs. No substance-related histopathological lesions were observed in the bronchopulmonary system or in any other organs. In the rat, the NOAEL after 18 months of oral administration was 0.5 mg/kg/day.
Repeated-dose inhalation toxicity studies in rats for up to 6 months and in dogs for up to 3 months with other formulations (intranasal formulation, alternative propellant HFA 134a and lactose powder formulation) revealed no additional information on the general toxicity profile of ipratropium bromide.
Intranasal administration for up to 6 months revealed a No Effect Level (NOEL) > 0.20 mg/kg/day in dogs and confirmed earlier studies with intranasal administration for up to 13 weeks. Repeat-dose toxicity studies of ipratropium bromide have shown the toxicological profiles of the HFA formulation and the conventional CFC formulation to be similar.
Pharmacology: Pharmacodynamics: Ipratropium bromide (ATROVENT) is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In preclinical studies, it appears to inhibit vagally mediated reflexes by antagonizing 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 Ipratropium bromide (ATROVENT) is primarily local and site specific to the lung and not systemic in nature.
Non-clinical and clinical evidence suggest no deleterious effect of Ipratropium bromide (ATROVENT) on airway mucous secretion, mucociliary clearance or gas exchange.
Clinical trials: In controlled 85-90 day studies in patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) significant improvements in pulmonary function occurred within 15 minutes, reached a peak in 1-2 hours, and persisted for up to 4-6 hours.
The bronchodilator effect of Ipratropium bromide (ATROVENT) in the treatment of acute bronchospasm associated with asthma has been shown in studies in adults. In most of these studies Ipratropium bromide (ATROVENT) was administered in combination with an inhaled beta-agonist.
Pharmacokinetics: Absorption: The therapeutic effect of Ipratropium bromide (ATROVENT) 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 and inhalation technique. The major part of the dose is swallowed and passes 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 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 relevantly contribute to systemic exposure.
Distribution: Kinetic parameters describing the disposition of ipratropium were calculated from plasma concentrations after i.v. administration. A rapid biphasic decline in plasma concentrations is observed. The apparent volume of distribution at steady-state (Vdss) is approximately 176 L (≈ 2.4 L/kg). The drug is minimally (less than 20%) bound to plasma proteins. Nonclinical data indicate that quaternary amine ipratropium does not cross the placental or blood-brain barrier.
The known metabolites show very little or no affinity for the muscarinic receptor and have to be regarded as ineffective.
Biotransformation: After intravenous administration approximately 60% of a dose is metabolised, the major proportion probably in the liver by oxidation.
The known metabolites are formed by hydrolysis, dehydration or elimination of the hydroxy-methyl group in the tropic acid moiety.
Elimination: The half-life of the terminal elimination phase is approximately 1.6 hours.
Ipratropium has a 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 9.3% after oral administration and 3.2% after inhalation. Total radioactivity excreted via the faeces was 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 3.6 hours.
Toxicology: Local and systemic tolerability of ipratropium bromide have comprehensively been investigated in several animal species using various administration routes.
Single dose toxicity: The acute inhalation, oral and intravenous toxicity has been assessed in several rodent and non-rodent species. When administered by inhalation, the minimum lethal dose in male Guinea pigs was 199 mg/kg. In rats, no mortality was observed up to the highest technically feasible dosages (i.e. 0.05 mg/kg after 4 h of administration or 160 puffs of ipratropium bromide, 0.02 mg/puff).
The oral LD50 values for the mouse, rat and rabbit were 1585, 1925 and 1920 mg/kg, respectively. The intravenous LD50 for the mouse, rat and dog was, respectively, 13.6, 15.8 and about 18.2 mg/kg. Clinical signs included mydriasis, dry oral mucosa, dyspnoea, tremor, spasms and/or tachycardia.
Repeat-dose toxicity: Repeated-dose toxicity studies have been performed in rats, rabbits, dogs and Rhesus monkeys.
In inhalation studies up to 6 months in rats, dogs and Rhesus monkeys, the No Observed Adverse Effect Level (NOAEL) was 0.38 mg/kg/day, 0.18 mg/kg/day and 0.8 mg/kg/day, respectively. Dry oral mucosa and tachycardia were noted in the dogs. No substance-related histopathological lesions were observed in the bronchopulmonary system or in any other organs. In the rat, the NOAEL after 18 months of oral administration was 0.5 mg/kg/day.
Repeated-dose inhalation toxicity studies in rats for up to 6 months and in dogs for up to 3 months with other formulations (intranasal formulation, alternative propellant HFA 134a and lactose powder formulation) revealed no additional information on the general toxicity profile of ipratropium bromide.
Intranasal administration for up to 6 months revealed a No Effect Level (NOEL) > 0.20 mg/kg/day in dogs and confirmed earlier studies with intranasal administration for up to 13 weeks. Repeat-dose toxicity studies of ipratropium bromide have shown the toxicological profiles of the HFA formulation and the conventional CFC formulation to be similar.
MedsGo Class
Antiasthmatic & COPD Preparations
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