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| Product NDC Code | 70518-3558 | ||||
|---|---|---|---|---|---|
| Drug Name | Ipratropium bromide |
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| Type | Generic | ||||
| Pharm Class | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |
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| Active Ingredients |
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| Route | RESPIRATORY (INHALATION) | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 836358 | ||||
| Application Number | ANDA075693 | ||||
| Labeler Name | REMEDYREPACK INC. | ||||
| Packages |
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Overdosage of Ipratropium Bromide
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Acute systemic overdosage by inhalation solution is unlikely since ipratropium bromide is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration at up to forty-fold the recommended dose. The oral LD 50 of ipratropium bromide ranged between 1001 and 2010 mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300 mg/kg in dogs.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Adverse reaction information concerning ipratropium bromide inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature. All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below. Additional adverse reactions reported in less than three percent of the patients treated with ipratropium bromide include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma, mydriasis, and acute eye pain have been reported. Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of ipratropium bromide therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of ipratropium bromide equals or exceeds 2,000 mcg. Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods. All Adverse Events, from a Double-blind, Parallel, 12-week Study of patients with COPD All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials. PERCENT OF PATIENTS Ipratropium Metaproterenol Ipratropium/ Metaproterenol Albuterol Ipratropium/ Albuterol (500 mcg t.i.d.) (15 mg t.i.d.) (500 mcg t.i.d./ 15 mg t.i.d.) (2.5 mg t.i.d.) (500 mcg t.i.d./ 2.5 mg t.i.d.) n = 219 n = 212 n = 108 n = 205 n = 100 Body as a Whole-General Disorders Headache 6.4 5.2 6.5 6.3 9.0 Pain 4.1 3.3 0.9 2.9 5.0 Influenza-like symptoms 3.7 4.7 6.5 0.5 1.0 Back Pain 3.2 1.9 1.9 2.4 0.0 Chest Pain 3.2 4.2 5.6 2.0 1.0 Cardiovascular Disorders Hypertension/Hypertension Aggravated 0.9 1.9 0.9 1.5 4.0 Central & Peripheral Nervous System Dizziness 2.3 3.3 1.9 3.9 4.0 Insomnia 0.9 0.5 4.6 1.0 1.0 Tremor 0.9 7.1 8.3 1.0 0.0 Nervousness 0.5 4.7 6.5 1.0 1.0 Gastrointestinal System Disorders Mouth Dryness 3.2 0.0 1.9 2.0 3.0 Nausea 4.1 3.8 1.9 2.9 2.0 Constipation 0.9 0.0 3.7 1.0 1.0 Musculo-skeletal System Disorders Arthritis 0.9 1.4 0.9 0.5 3.0 Respiratory System Disorders (Lower) Coughing 4.6 8.0 6.5 5.4 6.0 Dyspnea 9.6 13.2 16.7 12.7 9.0 Bronchitis 14.6 24.5 15.7 16.6 20.0 Bronchospasm 2.3 2.8 4.6 5.4 5.0 Sputum Increased 1.4 1.4 4.6 3.4 0.0 Respiratory Disorder 0.0 6.1 6.5 2.0 4.0 Respiratory System Disorders (Upper) Upper Respiratory Tract Infection 13.2 11.3 9.3 12.2 16.0 Pharyngitis 3.7 4.2 5.6 2.9 4.0 Rhinitis 2.3 4.2 1.9 2.4 0.0 Sinusitus 2.3 2.8 0.9 5.4 4.0
| PERCENT OF PATIENTS | |||||
|---|---|---|---|---|---|
| (500 mcg t.i.d.) | (15 mg t.i.d.) | (500 mcg t.i.d./ 15 mg t.i.d.) | (2.5 mg t.i.d.) | (500 mcg t.i.d./ 2.5 mg t.i.d.) | |
| n = 219 | n = 212 | n = 108 | n = 205 | n = 100 | |
| Headache | 6.4 | 5.2 | 6.5 | 6.3 | 9.0 |
| Pain | 4.1 | 3.3 | 0.9 | 2.9 | 5.0 |
| Influenza-like symptoms | 3.7 | 4.7 | 6.5 | 0.5 | 1.0 |
| Back Pain | 3.2 | 1.9 | 1.9 | 2.4 | 0.0 |
| Chest Pain | 3.2 | 4.2 | 5.6 | 2.0 | 1.0 |
| Hypertension/Hypertension Aggravated | 0.9 | 1.9 | 0.9 | 1.5 | 4.0 |
| Dizziness | 2.3 | 3.3 | 1.9 | 3.9 | 4.0 |
| Insomnia | 0.9 | 0.5 | 4.6 | 1.0 | 1.0 |
| Tremor | 0.9 | 7.1 | 8.3 | 1.0 | 0.0 |
| Nervousness | 0.5 | 4.7 | 6.5 | 1.0 | 1.0 |
| Mouth Dryness | 3.2 | 0.0 | 1.9 | 2.0 | 3.0 |
| Nausea | 4.1 | 3.8 | 1.9 | 2.9 | 2.0 |
| Constipation | 0.9 | 0.0 | 3.7 | 1.0 | 1.0 |
| Arthritis | 0.9 | 1.4 | 0.9 | 0.5 | 3.0 |
| Coughing | 4.6 | 8.0 | 6.5 | 5.4 | 6.0 |
| Dyspnea | 9.6 | 13.2 | 16.7 | 12.7 | 9.0 |
| Bronchitis | 14.6 | 24.5 | 15.7 | 16.6 | 20.0 |
| Bronchospasm | 2.3 | 2.8 | 4.6 | 5.4 | 5.0 |
| Sputum Increased | 1.4 | 1.4 | 4.6 | 3.4 | 0.0 |
| Respiratory Disorder | 0.0 | 6.1 | 6.5 | 2.0 | 4.0 |
| Upper Respiratory Tract Infection | 13.2 | 11.3 | 9.3 | 12.2 | 16.0 |
| Pharyngitis | 3.7 | 4.2 | 5.6 | 2.9 | 4.0 |
| Rhinitis | 2.3 | 4.2 | 1.9 | 2.4 | 0.0 |
| Sinusitus | 2.3 | 2.8 | 0.9 | 5.4 | 4.0 |
Ipratropium Bromide Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipratropium bromide has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Ipratropium bromide is an anticholinergic (parasympatholytic) agent that, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) that are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. The bronchodilation following inhalation of ipratropium bromide is primarily a local, site-specific effect, not a systemic one. Much of an administered dose is swallowed but not absorbed, as shown by fecal excretion studies. Following nebulization of a 2 mg dose, a mean 7% of the dose was absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract. The half-life of elimination is about 1.6 hours after intravenous administration. Ipratropium bromide is minimally (0 to 9% in vitro ) bound to plasma albumin and a 1 -acid glycoproteins. It is partially metabolized. Autoradiographic studies in rats have shown that ipratropium bromide does not penetrate the blood-brain barrier. Ipratropium bromide has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations. In controlled 12-week studies in patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) significant improvements in pulmonary function (FEV 1 increases of 15% or more) occurred within 15 to 30 minutes, reached a peak in 1 to 2 hours, and persisted for periods of 4 to 5 hours in the majority of patients, with about 25% to 38% of the patients demonstrating increases of 15% or more for at least 7 to 8 hours. Continued effectiveness of ipratropium bromide inhalation solution was demonstrated throughout the 12-week period. In addition, significant increases in forced vital capacity (FVC) have been demonstrated. However, ipratropium bromide did not consistently produce significant improvement in subjective symptom scores nor in quality of life scores over the 12-week duration of study. Additional controlled 12-week studies were conducted to evaluate the safety and effectiveness of ipratropium bromide inhalation solution administered concomitantly with the beta adrenergic bronchodilator solutions metaproterenol and albuterol compared with the administration of each of the beta agonists alone. Combined therapy produced significant additional improvement in FEV 1 and FVC. On combined therapy, the median duration of 15% improvement in FEV 1 was 5 to 7 hours, compared with 3 to 4 hours in patients receiving a beta agonist alone.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C 20 H 30 BrNO 3 •H 2 O Mol.Wt. 430.4 Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid. Chemical Structure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION The usual dosage of ipratropium bromide inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Ipratropium bromide inhalation solution unit-dose vials contain 500 mcg ipratropium bromide, USP anhydrous in 2.5 mL normal saline. Ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Spl product data elements
Usually a list of ingredients in a drug product.Ipratropium Bromide Ipratropium Bromide SODIUM CHLORIDE HYDROCHLORIC ACID WATER IPRATROPIUM BROMIDE IPRATROPIUM IPRATROPIUM BROMIDE ANHYDROUS
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of ipratropium bromide. 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/day was unaffected by ipratropium bromide administration. At doses above 90 mg/kg increased resorption and decreased conception rates were observed.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.DRUG: Ipratropium Bromide GENERIC: Ipratropium Bromide DOSAGE: SOLUTION ADMINSTRATION: RESPIRATORY (INHALATION) NDC: 70518-3558-0 PACKAGING: 2.5 mL in 1 AMPULE OUTER PACKAGING: 30 in 1 POUCH OUTER PACKAGING: 2 in 1 CARTON ACTIVE INGREDIENT(S): IPRATROPIUM BROMIDE 0.5mg in 2.5mL INACTIVE INGREDIENT(S): WATER SODIUM CHLORIDE HYDROCHLORIC ACID Remedy_Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Prescribing Information Rx Only
Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Ipratropium Bromide: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Patients should be advised that ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that ipratropium bromide inhalation solution should be used consistently as prescribed throughout the course of therapy. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Patient's Instructions for Use Ipratropium Bromide Inhalation Solution 0.02% Read complete instructions carefully before using. Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir. (Figure 1). Connect the nebulizer reservoir to the mouthpiece or face mask (Figure 2). Connect the nebulizer to the compressor. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask and turn on the compressor. If a face mask is used, care should be taken to avoid leakage around the mask as temporary blurring of vision, pupil enlargement, precipitation or worsening of narrow angle glaucoma, or eye pain may occur if the solution comes into direct contact with the eyes. Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished. Clean the nebulizer (see manufacturer's instructions). Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended. Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour but not with other drugs. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in the nebulizer have not been established. Store between 59°F (15°C) and 86°F (30°). Protect from light. Store unused vials in the foil pouch. ADDITIONAL INSTRUCTIONS: ____________________________________ ____________________________________ ____________________________________ ____________________________________ ____________________________________ ____________________________________ ____________________________________ Figure 1 Figure 2 Figure 3
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers It is not known whether ipratropium bromide is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to a significant extent, especially when taken by inhalation since ipratropium bromide is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when ipratropium bromide is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Ipratropium Bromide Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL. 60 vials per carton / 30 vials per foil pouch NDC: 70518-3558-00 PACKAGING: 2 in 1 CARTON, 30 in 1 POUCH, 2.5 mL in 1 AMPULE TYPE 0 Each vial is made from a low density polyethylene (LDPE) resin. Vials are supplied in a foil pouch. Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Ipratropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Ipratropium bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Information for Patients Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Patients should be advised that ipratropium bromide inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Ipratropium Bromide Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that ipratropium bromide inhalation solution should be used consistently as prescribed throughout the course of therapy. Repackaged By / Distributed By: RemedyRepack Inc. 625 Kolter Drive, Indiana, PA 15701 (724) 465-8762 Drug Interactions Ipratropium bromide has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Ipratropium bromide has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions. Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of ipratropium bromide. 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/day was unaffected by ipratropium bromide administration. At doses above 90 mg/kg increased resorption and decreased conception rates were observed. Pregnancy TERATOGENIC EFFECTS Pregnancy Category B Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg (or approximately 38 and 45 times the recommended human daily dose) respectively, have demonstrated no evidence of teratogenic effects as a result of ipratropium bromide. However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, ipratropium bromide should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether ipratropium bromide is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to a significant extent, especially when taken by inhalation since ipratropium bromide is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when ipratropium bromide is administered to a nursing woman. Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 have not been established.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS The use of ipratropium bromide inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of ipratropium bromide and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation. Immediate hypersensitivity reactions may occur after administration of ipratropium bromide, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API