Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL Solution
Past resolved recalls for this product (1)
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the beta2-Adrenergic Agonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
The combination of albuterol and ipratropium is used to prevent wheezing, difficulty breathing, chest tightness, and coughing in people with chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways) such as chronic bronchitis (swelling of the air passages that lead to the lungs) and emphysema (damage to the air sacs in the lungs). Albuterol and ipratropium combination is used by people whose symptoms have not been controlled by a single inhaled medication. Albuterol and ipratropium are in a class of medications called bronchodilators. Albuterol and ipr...
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
-
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
-
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.081 | $7.31 / 90 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.1271 | $11.44 / 90 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.1058 | $9.52 / 90 ml |
| Medicare Part B allowsASP · J7620 | $0.201 / J7620 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00487-0201-01 | 30 POUCH in 1 CARTON (0487-0201-01) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE | $0.0812 / mL | $7.31 | 2007-12-31 | Active |
| 00487-0201-02 | 30 POUCH in 1 CARTON (0487-0201-02) / 1 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE | — | — | 2007-12-31 | Active |
| 00487-0201-03 You're viewing this | 5 POUCH in 1 CARTON (0487-0201-03) / 6 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE | $0.0812 / mL | $7.31 | 2007-12-31 | Active |
| 00487-0201-60 | 10 POUCH in 1 CARTON (0487-0201-60) / 6 VIAL, SINGLE-USE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-USE | $0.0855 / mL | $15.38 | 2007-12-31 | Active |
This pack effectively ties for the lowest per-mL cost of the 3 priced pack sizes ($0.0812 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 59% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00487-0201-03?
What NDC number is used to bill for this package of Ipratropium Bromide and Albuterol Sulfate .5 mg/3mL; 3 mg/3mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution have not been studied.
The use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy. A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver Ipratropium Bromide and Albuterol Sulfate Inhalation Solution to each patient in one U.S. clinical study.
The safety and efficacy of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution delivered by other nebulizers and compressors have not been established. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.
⛔ Contraindications ▾
CONTRAINDICATIONS Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.
⚠️ Warnings ▾
WARNINGS PARADOXICAL BRONCHOSPASM In the clinical study of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with both inhaled ipratropium bromide and albuterol products and can be life-threatening. If this occurs, Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be discontinued immediately and alternative therapy instituted.
DO NOT EXCEED RECOMMENDED DOSE Fatalities have been reported in association with excessive use of inhaled products containing sympathomimetic amines and with the home use of nebulizers. CARDIOVASCULAR EFFECTS Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution at recommended doses, if they occur, the drug may need to be discontinued.
In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
IMMEDIATE HYPERSENSITIVITY REACTIONS Immediate hypersensitivity reactions to albuterol and/or ipratropium bromide may occur after the administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution as demonstrated by rare cases of urticaria, angioedema, rash, pruritis, oropharyngeal edema, bronchospasm, and anaphylaxis.
PARADOXICAL BRONCHOSPASM In the clinical study of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with both inhaled ipratropium bromide and albuterol products and can be life-threatening. If this occurs, Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be discontinued immediately and alternative therapy instituted.
DO NOT EXCEED RECOMMENDED DOSE Fatalities have been reported in association with excessive use of inhaled products containing sympathomimetic amines and with the home use of nebulizers.
CARDIOVASCULAR EFFECTS Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for Ipratropium Bromide and Albuterol Sulfate Inhalation Solution at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression.
The clinical significance of these findings is unknown. Therefore, Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
IMMEDIATE HYPERSENSITIVITY REACTIONS Immediate hypersensitivity reactions to albuterol and/or ipratropium bromide may occur after the administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution as demonstrated by rare cases of urticaria, angioedema, rash, pruritis, oropharyngeal edema, bronchospasm, and anaphylaxis.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Adverse reaction information concerning Ipratropium Bromide and Albuterol Sulfate Inhalation Solution was derived from the 12-week controlled clinical trial. Additional adverse reactions reported in more than 1% of patients treated with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution included constipation and voice alterations. In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritis, and urticaria.
Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, mydriasis, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat and metabolic acidosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. b5387e98-figure-04
🔄 Drug Interactions ▾
Drug Interactions Anticholinergic agents Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is, therefore, advised in the co-administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution with other drugs having anticholinergic properties. β-adrenergic agents Caution is advised in the co-administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects. β-receptor blocking agents These agents and albuterol sulfate inhibit the effect of each other. β-receptor blocking agents should be used with caution in patients with hyperreactive airways, and if used, relatively selective β 1 selective agents are recommended.
Diuretics The electrocardiogram (ECG) changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β-agonists, especially when the recommended dose of the β-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of β-agonist-containing drugs, such as Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, with non-potassium sparing diuretics.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents because the action of albuterol sulfate on the cardiovascular system may be potentiated.
Anticholinergic agents Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is, therefore, advised in the co-administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution with other drugs having anticholinergic properties.
β-adrenergic agents Caution is advised in the co-administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.
β-receptor blocking agents These agents and albuterol sulfate inhibit the effect of each other. β-receptor blocking agents should be used with caution in patients with hyperreactive airways, and if used, relatively selective β 1 selective agents are recommended.
Diuretics The electrocardiogram (ECG) changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β-agonists, especially when the recommended dose of the β-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of β-agonist-containing drugs, such as Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, with non-potassium sparing diuretics.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents because the action of albuterol sulfate on the cardiovascular system may be potentiated.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Albuterol sulfate Pregnancy Category C Albuterol sulfate has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m 2 basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately equal to the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).
Cleft palate formation also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg isoproterenol (positive control). A reproduction study in Stride rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol was administered orally at a dose of 50 mg/kg (approximately 55 times the maximum recommended daily inhalation dose for adults on mg/m 2 basis). A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established.
Ipratropium bromide Pregnancy Category B Reproduction studies in CD-1 mice, Sprague-Dawley rats and New Zealand rabbits demonstrated no evidence of teratogenicity at oral doses up to 10, 100, and 125 mg/kg, respectively (approximately 15, 270, and 680 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). Reproduction studies in rats and rabbits demonstrated no evidence of teratogenicity at inhalation doses up to 1.5 and 1.8 mg/kg, respectively (approximately 4 and 10 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).
There are no adequate and well-controlled studies of the use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, albuterol sulfate, or ipratropium bromide in pregnant women. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Albuterol sulfate Pregnancy Category C Albuterol sulfate has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m 2 basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately equal to the maximum recommended daily inhalation dose for adults on a mg/m 2 basis). The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m 2 basis).
Cleft palate formation also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg isoproterenol (positive control). A reproduction study in Stride rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol was administered orally at a dose of 50 mg/kg (approximately 55 times the maximum recommended daily inhalation dose for adults on mg/m 2 basis). A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patient…
🧒 Pediatric Use ▾
Pediatric Use The safety and effectiveness of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution in patients below 18 years of age have not been established.
🧓 Geriatric Use ▾
Geriatric Use Of the total number of subjects in clinical studies of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, 62 percent were 65 and over, while 19 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
OVERDOSAGE The effects of overdosage with Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not well absorbed systemically after oral or aerosol administration. The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmia, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of pharmacological effects listed in ADVERSE REACTIONS .
Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. Treatment consists of discontinuation of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution together with appropriate symptomatic therapy.
The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution. The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 540 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/m 2 basis).
The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 and 2000 mg/kg, respectively (approximately 240 and 1100 times the maximum recommended daily inhalation dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution on a mg/m 2 basis, respectively). The inhalation median lethal dose has not been determined in animals. The oral median lethal dose of ipratropium bromide in mice, rats and dogs is greater than 1000 mg/kg, approximately 1700 mg/kg and approximately 400 mg/kg, respectively (approximately 1400, 4600, and 3600 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis, respectively).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a combination of the β 2 -adrenergic bronchodilator, albuterol sulfate, and the anticholinergic bronchodilator, ipratropium bromide. Mechanism of Action Albuterol sulfate The prime action of β-adrenergic drugs is to stimulate adenyl cyclase, the enzyme that catalyzes the formation of cyclic-3’,5’-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). The cAMP thus formed mediates the cellular responses.
In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on β 2 -adrenergic receptors compared with isoproterenol. While it is recognized that β 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicated that 10% to 50% of the β-receptors in the human heart may be β 2 -receptors. The precise function of these receptors, however, is not yet established.
Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other β-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients. Ipratropium bromide Ipratropium bromide is an anticholinergic (parasympatholytic) agent, which blocks the muscarinic receptors of acetylcholine, and, 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 (cGMP), resulting from the interaction of acetylcholine with the muscarinic receptors of bronchial smooth muscle. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is expected to maximize the response to treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms: sympathomimetic (albuterol sulfate) and anticholinergic / parasympatholytic (ipratropium bromide).
Simultaneous administration of both an anticholinergic and a β 2 -sympathomimetic is designed to produce greater bronchodilation effects than when either drug is utilized alone at its recommended dosage. Pharmacokinetics Albuterol sulfate Albuterol sulfate is longer acting than isoproterenol in most patients by any route of administration, because it is not a substrate for the cellular uptake processes for catecholamines nor for the metabolism of catechol-O-methyl transferase. Instead the drug is conjugatively metabolized to albuterol 4’-O - sulfate.
Ipratropium bromide The bronchodilation following inhalation of ipratropium is primarily a local, site-specific effect, not a systemic one. Much of an inhaled dose is swallowed as shown by fecal excretion studies. Following nebulization of a 1 mg dose to healthy volunteers, a mean of 4% of the dose was excreted unchanged in the urine.
Ipratropium bromide is minimally (0% to 9% in vitro ) bound to plasma albumin and α 1 –acid glycoproteins. It is partially metabolized to inactive ester hydrolysis products. Following intravenous administration, approximately one-half is excreted unchanged in the urine.
The half-life of elimination is about 1.6 hours after intravenous administration. Ipratropium bromide that reaches the systemic circulation is reportedly removed by the kidneys rapidly at a rate that exceeds the glomerular filtration rate. The pharmacokinetics of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution or ipratropium bromide have not been studied in the elderly and in patients with hepatic or renal insufficiency (see PRECAUTIONS ).
Ipratropium Bromide and Albuterol Sulf…
🧬 Mechanism of Action ▾
Mechanism of Action Albuterol sulfate The prime action of β-adrenergic drugs is to stimulate adenyl cyclase, the enzyme that catalyzes the formation of cyclic-3’,5’-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). The cAMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on β 2 -adrenergic receptors compared with isoproterenol.
While it is recognized that β 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicated that 10% to 50% of the β-receptors in the human heart may be β 2 -receptors. The precise function of these receptors, however, is not yet established. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.
Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other β-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients. Ipratropium bromide Ipratropium bromide is an anticholinergic (parasympatholytic) agent, which blocks the muscarinic receptors of acetylcholine, and, 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 (cGMP), resulting from the interaction of acetylcholine with the muscarinic receptors of bronchial smooth muscle.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is expected to maximize the response to treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms: sympathomimetic (albuterol sulfate) and anticholinergic / parasympatholytic (ipratropium bromide). Simultaneous administration of both an anticholinergic and a β 2 -sympathomimetic is designed to produce greater bronchodilation effects than when either drug is utilized alone at its recommended dosage.
Albuterol sulfate The prime action of β-adrenergic drugs is to stimulate adenyl cyclase, the enzyme that catalyzes the formation of cyclic-3’,5’-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). The cAMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on β 2 -adrenergic receptors compared with isoproterenol.
While it is recognized that β 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicated that 10% to 50% of the β-receptors in the human heart may be β 2 -receptors. The precise function of these receptors, however, is not yet established. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.
Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other β-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients.
Ipratropium bromide Ipratropium bromide is an anticholinergic (parasympatholytic) agent, which blocks the muscarinic receptors of acetylcholine, and, 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 (cGMP), resulting from the interaction of acetylcholine with the muscarinic receptors of bronch…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store vials in pouch until time of use. Supplied in cartons as listed below.
NDC 0487-0201-01: 30 vials per carton / 1 vial per foil pouch NDC 0487-0201-03: 30 vials per carton / 5 vials per foil pouch NDC 0487-0201-60: 60 vials per carton / 5 vials per foil pouch Storage and Handling PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use. Store at 20°C to 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Manufactured by: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313
📦 Storage and Handling ▾
Storage and Handling PROTECT FROM LIGHT. The unit-dose vial should remain stored in the protective foil pouch until time of use. Store at 20°C to 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Manufactured by: Nephron Pharmaceuticals Corporation West Columbia, SC 29172 For Customer Service, Call 1-800-443-4313
STORING YOUR MEDICINE Store Ipratropium Bromide and Albuterol Sulfate Inhalation Solution at 20°C to 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Vials should be protected from light before use, therefore, keep unused vials in the foil pouch or carton. Do not use after the expiration (EXP) date printed on the carton.
📋 Description ▾
DESCRIPTION The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP are albuterol sulfate, USP and ipratropium bromide, USP. Albuterol sulfate is a salt of racemic albuterol and a relatively selective β 2 -adrenergic bronchodilator chemically described as α 1 -[( tert -Butylamino) methyl]-4-hydroxy- m -xylene- α,α′-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 • H 2 SO 4 .
It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol base is salbutamol. Ipratropium bromide 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.
It has a molecular weight of 430.4 and the empirical formula is C 20 H 30 BrNO 3 • H 2 O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Each 3 mL vial of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP contains 3 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride and hydrochloric acid to adjust to pH 4.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance.
Using the Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of
3.6L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, USP should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION ). chem structure
💬 Information for Patients ▾
Information for Patients The action of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should last up to 5 hours. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should not be used more frequently than recommended. Patients should be instructed not to increase the dose or frequency of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution without consulting their healthcare provider.
If symptoms worsen, patients should be instructed to seek medical consultation. Patients must avoid exposing their eyes to this product as temporary pupillary dilation, blurred vision, eye pain, or precipitation or worsening of narrow-angle glaucoma may occur, and therefore proper nebulizer technique should be assured, particularly if a mask is used. If a patient becomes pregnant or begins nursing while on Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, they should contact their healthcare provider about use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution.
See the illustrated Patient’s Instruction for Use in the product package insert.
PATIENT INFORMATION Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg* Inhalation Solution, USP *Equivalent to 2.5 mg albuterol base Prescription Only. Read the patient information that comes with Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg before you start using it and each time you get a refill. There may be new information.
This leaflet does not take the place of talking with your doctor about your medical condition or your treatment. What is Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg? Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is a combination of two medicines called bronchodilators.
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg contains albuterol sulfate, which is a beta-adrenergic agonist, and ipratropium bromide, which is an anticholinergic. These two medicines work together to help open the airways in your lungs. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is used to help treat airway narrowing (bronchospasm) that happens with chronic obstructive pulmonary disease (COPD) in adult patients who need to use more than one bronchodilator medicine.
Who should not use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3mg? Do not use Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg if you: Are allergic to any of the ingredients in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg or to atropine. The active ingredients are albuterol sulfate and ipratropium bromide.
See the end of this leaflet for a complete list of ingredients in Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg. Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg has not been studied in patients younger than 18 years of age. What should I tell my doctor before I start using Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg?
Tell your doctor about all of your conditions, including if you: Have heart problems. This includes coronary artery disease and heart rhythm problems. Have high blood pressure Have diabetes Have or had seizures Have a thyroid problem called hyperthyroidism Have an eye problem called narrow-angle glaucoma Have liver or kidney problems Have problems urinating due to bladder-neck blockage or an enlarged prostate (men) Are pregnant or planning to become pregnant.
It is not known if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg can harm your unborn baby. You and your doctor will have to decide if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg is right for you during a pregnancy. Are breastfeeding.
It is not known if Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg passes into your milk or if it can harm your baby. You and your doctor should decide whether you should take Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg or breastfeed, but not both. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal su…