Albuterol Sulfate 1.25 mg/3mL Solution
Other active recalls for Albuterol Sulfate (different manufacturers) — 1 · tap to view
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
Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 ye...
Read the full MedlinePlus article ↗- Albuterol quickly relaxes the muscles around your airways, opening them up so you can breathe more easily. Think of it as a fast-acting rescue medicine — you use it when you feel y...
- What exactly does albuterol do, and when should I use it?
- That depends on which inhaler you have. If you have a standard HFA inhaler (like Ventolin HFA or Albuterol Sulfate HFA), shake it well before every puff and prime it with a few tes...
- The most common side effects are pretty mild — a scratchy throat, cough, or upper respiratory irritation, and sometimes a slightly faster heartbeat, shakiness, or headache. Those u...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Albuterol Sulfate — tap one for details:
Albuterol Sulfate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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.
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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.
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UNII O40UQP6WCF
A strong acid used in small amounts to adjust and maintain the pH balance of a medicine, helping ensure stability and proper dissolution of the active ingredients.
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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?
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💲 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 | $0.198 | $14.84 / 75 ml |
| 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J7613 | $0.063 / J7613 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Albuterol 1.25 mg/3mL 00378-7058-52 | Mylan | 5 pouches | $0.198 | AN | Availability likely | — |
| Albuterol Sulfate 1.25 mg/3mLthis 00487-9904-25 | Nephron | 25 pouches | $0.198 | AN | Discontinued | — |
| Albuterol Sulfate 1.25 mg/3mL 50742-0393-25 | Ingenus | 5 pouches | $0.198 | AN | Availability likely | — |
| Albuterol Sulfate 1.25 mg/3mL 62135-0827-84 | Chartwell | 30 pouches | $0.220 | AN | Availability likely | +11% |
| Albuterol Sulfate Inhalation Solution 1.25 mg/3mL 76204-0011-01 | Ritedose | 30 pouches | $0.220 | AN | Availability likely | +11% |
| Albuterol Sulfate 1.25 mg/3mL 59651-0184-25 | Aurobindo | 25 pouches | — | AN | FDA listed | — |
| Albuterol Sulfate 1.25 mg/3mL 64980-0644-02 | Rising | 25 pouches | — | AN | FDA listed | — |
| Albuterol Sulfate 1.25 mg/3mL 81894-0106-25 | Luoxin | 5 pouches | — | AN | FDA listed | — |
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 by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
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 |
|---|---|---|---|---|---|
| 00487-9904-01 | 30 POUCH in 1 CARTON (0487-9904-01) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | $0.2201 / mL | $19.81 | 2004-06-28 | Active |
| 00487-9904-02 | 30 BAG in 1 BOX (0487-9904-02) / 1 POUCH in 1 BAG / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | — | — | 2004-06-28 | Discontinued by firm |
| 00487-9904-25 You're viewing this | 25 POUCH in 1 CARTON (0487-9904-25) / 1 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE | $0.1979 / mL | $14.84 | 2004-06-28 | Discontinued by firm |
This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.1979 NADAC).
This pack accounts for about 23% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 00487-9904-25?
What NDC number is used to bill for this package of Albuterol Sulfate 1.25 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.
🧭 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) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| 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
What does the discontinued status mean for this NDC?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Does this product have a billing J-code?
Where does this data come from?
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The usual starting dosage for patients 2 to 12 years of age is 1.25 mg (0.042%) or 0.63 mg (0.021%) of albuterol inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended. To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 0.042% [1.25 mg] or 3 mL of 0.021% [0.63 mg] inhalation solution) by nebulization.
Adjust nebulizer flow rate to deliver albuterol inhalation solution over 5 to 15 minutes. The use of albuterol inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.
Patients 6 to 12 years of age with more severe asthma (baseline FEV 1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose. Albuterol inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.
If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy. The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol inhalation solution, when mixed with other drugs in a nebulizer have not been established. The safety and efficacy of albuterol inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor.
The safety and efficacy of albuterol inhalation solution when administered with other nebulizer systems have not been established. Albuterol inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.
⛔ Contraindications ▾
CONTRAINDICATIONS Albuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS PARADOXICAL BRONCHOSPASM As with other inhaled beta-adrenergic agonists, albuterol inhalation solution can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, albuterol inhalation solution should be discontinued immediately and alternative therapy instituted. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.
USE OF ANTI-INFLAMMATORY AGENTS The use of beta-adrenergic bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids). DETERIORATION OF ASTHMA Asthma may deteriorate acutely over a period of hours or chronically over several days or longer.
If the patient needs more doses of albuterol inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids). Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is, therefore, essential that the physician instruct the patient in the need for further evaluation, if his/her asthma becomes worse.
CARDIOVASCULAR EFFECTS Albuterol 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 albuterol 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, albuterol inhalation solution, like all 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 may occur after administration of albuterol as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema.
PARADOXICAL BRONCHOSPASM As with other inhaled beta-adrenergic agonists, albuterol inhalation solution can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, albuterol inhalation solution should be discontinued immediately and alternative therapy instituted. It should be noted that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial.
USE OF ANTI-INFLAMMATORY AGENTS The use of beta-adrenergic bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids).
DETERIORATION OF ASTHMA Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol inhalation solution than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration of the possible need for anti-inflammatory treatment (e.g., corticosteroids). Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers.
It is, therefore, essential that the physician instruct the patient in the need for further evaluation, if his/her asthma becomes worse.
CARDIOVASCULAR EFFECTS Albuterol inhalation solution, like other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some pati…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Clinical Trial Experience: Adverse events reported in >1% of patients receiving albuterol sulfate and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table. Table 1: Adverse Events with an Incidence of >1% of Patients Receiving Albuterol Inhalation Solution and Greater than Placebo (expressed as % of treatment group) 1.25 mg (0.042%) Albuterol Inhalation Solution (n = 115) 0.63 mg (0.021%) Albuterol Inhalation Solution (n = 117) Placebo (n = 117) Asthma Exacerbation 13 11.1
8.5Otitis Media 4.3 0.9 0 Allergic Reaction 0.9 3.4
1.7Gastroenteritis 0.9 3.4
0.9Cold Symptoms 0 3.4
1.7Flu Syndrome 2.6 2.6
1.7Lymphadenopathy 2.6 0.9
1.7Skin/Appendage Infection 1.7 0 0 Urticaria 1.7 0.9 0 Migraine 0.9 1.7 0 Chest Pain 0.9 1.7 0 Bronchitis 0.9 1.7
0.9Nausea 1.7 0.9
0.9There was one case of ST segment depression in the 1.25 mg (0.042%) albuterol inhalation solution treatment group. No clinically relevant laboratory abnormalities related to albuterol inhalation solution administration were seen in this study. Postmarketing Experience: Metabolic acidosis has been reported after the use of albuterol inhalation solution.
Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure.
🔄 Drug Interactions ▾
Drug Interactions Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol inhalation solution. Albuterol 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, since the action of albuterol on the vascular system may be potentiated. Beta-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol inhalation solution, but may produce severe bronchospasm in asthmatic patients.
Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.
The 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 beta-agonists, especially when the dose of the beta-agonist is exceeded. Although the clinical significance of these effects is unknown, caution is advised in the co-administration of beta-agonists with non-potassium sparing diuretics. Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days.
The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Pregnancy Category C Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol 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 of albuterol sulfate on a mg/m 2 basis) and cleft palate formation in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately equal to the maximum recommended daily inhalation dose of albuterol sulfate 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 of albuterol sulfate on a mg/m 2 basis).
Cleft palate formation also occurred in 23 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 sulfate was administered orally at 50 mg/kg (approximately 60 times the maximum recommended daily inhalation dose of albuterol sulfate on a mg/m 2 basis). A study in which pregnant rats were dosed with radiolabelled albuterol sulfate demonstrated that drug-related material was transferred from the maternal circulation to the fetus.
There are no adequate and well-controlled studies of the use of albuterol sulfate in pregnant women. Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk 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.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness of albuterol inhalation solution 1.25 mg (0.042%) and 0.63 mg (0.021%) have been established in pediatric patients between the ages of 2 and 12 years. The use of albuterol inhalation solution in these age groups is supported by evidence from adequate and well-controlled studies of albuterol inhalation solution in children age 6 to 12 years and published reports of albuterol sulfate trials in pediatric patients 3 years of age and older. The safety and effectiveness of albuterol inhalation solution in children below 2 years of age have not been established.
🆘 Overdosage ▾
OVERDOSAGE 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, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of the 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 albuterol inhalation solution.
Treatment consists of discontinuation of albuterol 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 albuterol inhalation solution.
The oral median lethal dose of albuterol in mice is greater than 2000 mg/kg (approximately 580 times the maximum recommended daily inhalation dose of albuterol on a mg/m 2 basis). The subcutaneous median lethal dose of albuterol in mature rats and small young rats is approximately 450 mg/kg and 2000 mg/kg, respectively (approximately 260 and 1200 times the maximum recommended daily inhalation dose of albuterol on a mg/m 2 basis). The inhalation median lethal dose has not been determined in animals.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY The prime action of beta-adrenergic drugs is to stimulate adenyl cyclase, the enzyme which catalyzes the formation of cyclic-3',-5'-adenosine monophosphate (cyclic AMP) from adenosine triphosphate (ATP). The cyclic AMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol.
While it is recognized that beta 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicate that 10% to 50% of the beta-receptors in the human heart may be beta 2 -receptors. The precise function of these receptors, however, is not yet established. Controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.
Albuterol 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 catechol- O -methyl transferase. Pharmacokinetics Studies in asthmatic patients have shown that less than 20% of a single albuterol dose was absorbed following either intermittent positive-pressure breathing (IPPB) or nebulizer administration; the remaining amount was recovered from the nebulizer and apparatus, and expired air. Most of the absorbed dose was recovered in urine collected during the 24 hours after drug administration.
Following oral administration of 4 mg albuterol, the elimination half-life was five to six hours. Following a 3 mg dose of nebulized albuterol in adults, the mean maximum albuterol plasma level at 0.5 hours was 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). The pharmacokinetics of albuterol following administration of 0.63 mg (0.021%) or 1.25 mg (0.042%) albuterol inhalation solution by nebulization have not been determined in children 2 to 12 years old.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Albuterol inhalation solution, USP is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg (0.021%) of albuterol (equivalent to 0.75 mg of albuterol sulfate in 3 mL) and 1.25 mg (0.042%) of albuterol (equivalent to 1.5 mg of albuterol sulfate in 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 1 unit-dose LDPE vial. Each strength of albuterol inhalation solution, USP is available in a shelf carton containing multiple foil pouches.
Albuterol Inhalation Solution, USP 0.021% (0.63 mg / 3 mL) (potency expressed as albuterol equivalent to 0.75 mg albuterol sulfate per 3 mL) in unit-dose vials and is available in the following packaging configurations: NDC 0487-0301-01 30 foil pouches, each containing 1 vial, total 30 vials per carton Albuterol Inhalation Solution, USP 0.042% (1.25 mg / 3 mL) (potency expressed as albuterol equivalent to 1.5 mg albuterol sulfate per 3 mL) in unit-dose vials and is available in the following packaging configurations: NDC 0487-9904-01 30 foil pouches, each containing 1 vial, total 30 vials per carton Storage and Handling Store between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial within one week.
Discard the vial if the solution is not colorless. Keep out of the reach of children. Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172
📦 Storage and Handling ▾
Storage and Handling Store between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Store unit-dose vials in protective foil pouch at all times.
Once removed from the foil pouch, use vial within one week. Discard the vial if the solution is not colorless. Keep out of the reach of children.
Rx Only Manufactured By: Nephron Pharmaceuticals Corporation West Columbia, SC 29172
STORING YOUR MEDICINE Store albuterol inhalation solution between 20°C to 25°C (68°F to 77°F) [ See USP Controlled Room Temperature]. Vials should be protected from light before use, therefore keep unused vials in the foil pouch. Once removed use within one week. Discard the vial if the solution is not colorless. Keep out of reach of children. Do not use after the expiration date printed on the vial.
📋 Description ▾
DESCRIPTION Albuterol inhalation solution, USP is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate USP. Albuterol sulfate USP is a relatively selective beta 2 -adrenergic bronchodilator (see CLINICAL PHARMACOLOGY ). The chemical name for albuterol sulfate is α 1 -[( tert -Butylamino)methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows: The molecular weight of albuterol sulfate USP is 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 • H 2 SO 4 .
Albuterol sulfate USP is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization’s recommended name for albuterol is salbutamol. Albuterol inhalation solution, USP is supplied in two strengths in unit-dose vials.
Each unit-dose vial contains either 0.75 mg of albuterol sulfate USP (equivalent to 0.021% or 0.63 mg of albuterol) or 1.5 mg of albuterol sulfate USP (equivalent to 0.042% or 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3 mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to between 3 and 5 (see HOW SUPPLIED ). Albuterol inhalation solution, USP does not require dilution prior to administration by nebulization.
For albuterol 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 Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (0.042% or 1.25 mg strength) and 39% of albuterol (0.021% or 0.63 mg strength) at a mean flow rate of
3.6L/min. The mean nebulization time was 15 minutes or less. Albuterol inhalation solution, USP should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION ). F:\daisy assignment\6月份\06.20\albuterol-sulfate-inhalation-solution-6-20-2008\figure-01.jpg
💬 Information for Patients ▾
Information for Patients The action of albuterol inhalation solution may last up to six hours, and therefore it should not be used more frequently than recommended. Do not increase the dose or frequency of medication without consulting your physician. If you find that treatment with albuterol inhalation solution becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
All asthma medication should only be used under the supervision and direction of a physician. Common effects with medications such as albuterol inhalation solution include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about the use of albuterol inhalation solution.
Effective and safe use of albuterol inhalation solution includes an understanding of the way it should be administered. If the solution in the vial changes color or becomes cloudy, you should not use it. The drug compatibility (physical and chemical), clinical efficacy, and safety of albuterol inhalation solution, when mixed with other drugs in a nebulizer, have not been established.
See illustrated Patient’s Instructions for Use .
PATIENT INFORMATION Albuterol Inhalation Solution, USP 0.021%* (0.63 mg* / 3 mL) and 0.042%* (1.25 mg* / 3mL) *Potency expressed as albuterol Prescription Only. Read the patient information that comes with albuterol inhalation solution before using it and each time you get a refill for your child. There may be new information.
This leaflet does not take the place of talking to your child’s doctor about your child’s medical condition or treatment. What is albuterol inhalation solution? Albuterol inhalation solution is a medicine that is used for the relief of bronchospasms caused by asthma in children ages 2 to 12 years.
Bronchospasm is the tightening and swelling of the muscles around the airways. Albuterol inhalation solution can help relax these airway muscles for up to 6 hours so that your child may breathe more easily. Who should not use albuterol inhalation solution?
Do not give your child albuterol inhalation solution if he or she is allergic to any of its ingredients. The active ingredient is albuterol sulfate. See the end of this leaflet for a complete list of ingredients.
What should I tell my child’s doctor before giving albuterol inhalation solution? Tell your child’s doctor about all of your child’s medical conditions including if your child has: Heart problems High blood pressure Seizures A thyroid problem called hyperthyroidism Diabetes Tell your child’s doctor about all the medicines your child takes, including prescription and non-prescription medicines, vitamins and herbal supplements. Albuterol inhalation solution and some other medicines can affect each other and may cause serious side effects.
Especially tell your child’s doctor if your child is taking or using: Any short-acting bronchodilator medicines (sometimes called rescue inhalers) Epinephrine Medicines called monoamine oxidase inhibitors (MAOIs) or tricyclic antidepressants or has stopped taking them in the past 2 weeks. These medicines are usually used for mental problems. Medicines called beta-blockers (used for heart problems and high blood pressure) Certain diuretic medicines (water pills) Digoxin Know the medicines your child takes.
Keep a list of them and show it to your child’s doctor and pharmacist each time your child gets a new medicine. How should albuterol inhalation solution be given? Read the Patient’s Instructions for Use that comes with albuterol inhalation solution.
Ask your pharmacist for these instructions if they are not with your medicine. Keep the instructions with albuterol inhalation solution because you may want to read them again. Give albuterol inhalation solution exactly as prescribed for your child.
Do not change your child’s dose or how often it is used without talki…