Ipratropium Bromide and Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL Solution
🆔 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
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1058 | $9.52 / 90 ml |
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?
🔬 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 | Marketing start | Status |
|---|---|---|---|
| 65862-0906-03 | 30 POUCH in 1 CARTON (65862-906-03) / 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-01) / 3 mL in 1 VIAL, SINGLE-DOSE | 2020-07-09 | Active |
| 65862-0906-30 You're viewing this | 6 POUCH in 1 CARTON (65862-906-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH (65862-906-05) / 3 mL in 1 VIAL, SINGLE-DOSE | 2020-07-09 | Active |
| 65862-0906-60 | 12 POUCH in 1 CARTON (65862-906-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | 2020-07-09 | Active |
Pack size FAQ
What quantity is in NDC 65862-0906-30?
What NDC number is used to bill for this package of Ipratropium Bromide and Albuterol Sulfate 2.5 mg/3mL; .5 mg/3mL Solution?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 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 TM nebulizer (with face mask or mouthpiece) connected to a PRONEB TM 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 Effect 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, pruritus, 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. ADVERSE EVENTS OCCURRING IN ≥ 1% OF ≥ 1 TREATMENT GROUP(S) AND WHERE THE COMBINATION TREATMENT SHOWED THE HIGHEST PERCENTAGE Body System Albuterol Ipratropium Ipratropium Bromide and Albuterol Sulfate Inhalation Solution COSTART Term NUMBER OF PATIENTS N (%) Patients with AE BODY AS A WHOLE Pain Pain chest DIGESTIVE Diarrhea Dyspepsia Nausea MUSCULO-SKELETAL Cramps leg RESPIRATORY Bronchitis Lung Disease Pharyngitis Pneumonia UROGENITAL Infection urinary tract n (%) 761 327 (43) 8 (1.1) 11 (1.4) 5 (0.7) 7 (0.9) 7 (0.9) 8 (1.1) 11 (1.4) 36 (4.7) 27 (3.5) 7 (0.9) 3 (0.4) n (%) 754 329 (43.6) 4 (0.5) 14 (1.9) 9 (1.2) 8 (1.1) 6 (0.8) 6 (0.8) 13 (1.7) 34 (4.5) 27 (3.6) 8 (1.1) 9 (1.2) n (%) 765 367 (48) 10 (1.3) 20 (2.6) 14 (1.8) 10 (1.3) 11 (1.4) 11 (1.4) 13 (1.7) 49 (6.4) 34 (4.4) 10 (1.3) 12 (1.6) 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, pruritus, 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.
🔄 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. ß-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. ß-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 co-administration 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 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 a 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 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.
🧒 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. Albuterol Sulfate Mechanism of Action 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. Pharmacokinetics 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 catecholamine nor for the metabolism of catechol-O-methyl transferase.
Instead the drug is conjugatively metabolized to albuterol 4’-O-sulfate. Animal Pharmacology/Toxicology Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of plasma concentrations. In structures outside of the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those found in whole brain.
Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrythmias and sudden death (with histological evidence of myocardial necrosis) when beta-agonists and methyl-xanthines are administered concurrently. The clinical significance of these findings is unknown. Ipratropium Bromide Mechanism of Action 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. Pharmacokinetics 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 patient…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg/3 mg per 3 mL is a clear, colorless solution. Practically free from visible particles and foreign matters packed in natural BFS LDPE vial and is supplied as a 3 mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Supplied in cartons as listed below.
NDC 65862-906-30 30 x 3 mL unit dose vials per carton (6 pouches, each containing 5 vials per foil pouch) NDC 65862-906-60 60 x 3 mL unit dose vials per carton (12 pouches, each containing 5 vials per foil pouch) NDC 65862-906-03 30 x 3 mL unit dose vials per carton (30 pouches, each containing 1 vial per foil pouch) PROTECT FROM LIGHT. Unit dose vials should remain stored in the protective foil pouch at all times. Once removed from the foil pouch, the individual vials should be used within one week.
Discard if the solution is not colorless. Store between 2º to 25ºC (36º to 77ºF). All brands listed are the trademarks of their respective owners and are not trademarks of Luoxin Aurovitas Pharma (Chengdu) Co., Ltd.
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg/3 mg per 3 mL Patient’s Instructions for Use Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication as you may want to read them again. Ipratropium bromide and albuterol sulfate inhalation solution should only be used under the direction of a physician.
Your physician and pharmacist have more information about ipratropium bromide and albuterol sulfate inhalation solution and the condition for which it has been prescribed. Contact them if you have additional questions. Storing your Medicine Store Ipratropium Bromide and Albuterol Sulfate Inhalation Solution between 2º and 25ºC (36º and 77ºF).
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. Dose Ipratropium bromide and albuterol sulfate inhalation solution is supplied as a single-dose, ready-to-use vial containing 3 mL of solution.
No mixing or dilution is needed. Use one new vial for each nebulizer treatment. FOLLOW THESE DIRECTIONS FOR USE OF YOUR NEBULIZER/COMPRESSOR OR THE DIRECTIONS GIVEN BY YOUR HEALTHCARE PROVIDER.
A TYPICAL EXAMPLE IS SHOWN BELOW. Instructions for Use 1. Remove one vial from the foil pouch.
Place remaining vials back into pouch for storage. 2. Twist the cap completely off the vial and squeeze the contents into the nebulizer reservoir (Figure 1).
3. Connect the nebulizer to the mouthpiece or face mask (Figure 2). 4.
Connect the nebulizer to the compressor. 5. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 3) or put on the face mask (Figure 4); and turn on the compressor.
6. Breathe as calmly, deeply and evenly as possible through your mouth until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes). At this point, the treatment is finished.
7. Clean the nebulizer (see manufacturer’s instructions). Figure 1 Figure 2 Figure 3 and 4
📋 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 molecular formula is (C 13 H 21 NO 3 ) 2 •H 2 SO 4 .
It is a white to practically white crystalline powder, freely soluble in water and slightly soluble in alcohol, chloroform and ether. The World Health Organization 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)-8methyl-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 molecular formula is C 20 H 30 BrNO 3 •H 2 O. It is a white to off white crystalline powder, soluble in water, freely soluble in methanol and slightly soluble in ethanol, insoluble in isopropyl alcohol, chloroform, methylene chloride and benzene. Each 3 mL vial of ipratropium bromide and albuterol sulfate inhalation solution, USP contains 3 mg (0.1%) of albuterol sulfate USP (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide USP in an isotonic, sterile, aqueous solution containing edetate disodium (a chelating agent), sodium chloride and hydrochloric acid to adjust to pH 4.
Ipratropium bromide and albuterol sulfate inhalation solution, USP is a clear, colorless solution. Practically free from visible particles and foreign matters packed in natural BFS LDPE vial. 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 ). Figure 1: Chemical structure of albuterol sulfate. Figure 2: Chemical structure of ipratropium bromide.
💬 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.