Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Albuterol Sulfate Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg/3 mL and 1.25 mg/3 mL, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 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 5 unit-dose LDPE vials. Each strength of Albuterol Sulfate Inhalation Solution is available in a shelf carton containing multiple foil pouches. Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0378-7057-52 5 foil pouches, each containing 5 vials, total 25 vials per carton Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL (potency expressed as albuterol) contains 1.5 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0378-7058-52 5 foil pouches, each containing 5 vials, total 25 vials per carton Rx only STORAGE Store between 2°C to 25°C (36°F to 77°F). 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(s) within two weeks. Discard the vial if the solution is not colorless. Keep out of the reach of children. The brands listed are trademarks of their respective owners. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC:ASISLD:R2 RPIN0178 Revised: 8/2022; PRINCIPAL DISPLAY PANEL – 0.63 mg/3 mL NDC 0378-7057-52 Albuterol Sulfate Inhalation Solution 0.63 mg*/3 mL *Each unit dose vial contains 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate. For Inhalation Only Sterile Unit-Dose Vials ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from package insert and dispense with solution. Rx only Carton contains: 5 pouches of 5 x 3 mL vials each INGREDIENTS: Active: Albuterol sulfate (0.75 mg/3 mL). Inactive: Sodium chloride, edetate disodium, sulfuric acid (to adjust to pH 3.5) and water for injection. STORAGE CONDITIONS: Protect from light. Store between 2°C to 25°C (36°F to 77°F). Store the unit-dose vials in the protective foil pouch at all times. Once removed from the foil pouch, use the vial(s) within two weeks. Discard the vial if the solution is not colorless. Keep out of reach of children. USUAL DOSAGE: FOR USE IN CHILDREN AGES 2 TO 12. See accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC: 7057:25C:R1 RPSC0453 Mylan.com Albuterol Sulfate Inhalation Solution 0.63 mg/3 mL Carton Label; PRINCIPAL DISPLAY PANEL – 1.25 mg/3 mL NDC 0378-7058-52 Albuterol Sulfate Inhalation Solution 1.25 mg*/3 mL *Each unit dose vial contains 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate. For Inhalation Only Sterile Unit-Dose Vials ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from package insert and dispense with solution. Rx only Carton contains: 5 pouches of 5 x 3 mL vials each INGREDIENTS: Active: Albuterol sulfate (1.5 mg/3 mL). Inactive: Sodium chloride, edetate disodium, sulfuric acid (to adjust to pH 3.5) and water for injection. STORAGE CONDITIONS: Protect from light. Store between 2°C to 25°C (36°F to 77°F). Store the unit-dose vials in the protective foil pouch at all times. Once removed from the foil pouch, use the vial(s) within two weeks. Discard the vial if the solution is not colorless. Keep out of reach of children. USUAL DOSAGE: FOR USE IN CHILDREN AGES 2 TO 12. See accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC: 7058:25C:R1 RPSC0454 Mylan.com Albuterol Sulfate Inhalation Solution 1.25 mg/3 mL Carton Label
- HOW SUPPLIED Albuterol Sulfate Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg/3 mL and 1.25 mg/3 mL, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 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 5 unit-dose LDPE vials. Each strength of Albuterol Sulfate Inhalation Solution is available in a shelf carton containing multiple foil pouches. Albuterol Sulfate Inhalation Solution, 0.63 mg/3 mL (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0378-7057-52 5 foil pouches, each containing 5 vials, total 25 vials per carton Albuterol Sulfate Inhalation Solution, 1.25 mg/3 mL (potency expressed as albuterol) contains 1.5 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration. NDC 0378-7058-52 5 foil pouches, each containing 5 vials, total 25 vials per carton Rx only STORAGE Store between 2°C to 25°C (36°F to 77°F). 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(s) within two weeks. Discard the vial if the solution is not colorless. Keep out of the reach of children. The brands listed are trademarks of their respective owners. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC:ASISLD:R2 RPIN0178 Revised: 8/2022
- PRINCIPAL DISPLAY PANEL – 0.63 mg/3 mL NDC 0378-7057-52 Albuterol Sulfate Inhalation Solution 0.63 mg*/3 mL *Each unit dose vial contains 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate. For Inhalation Only Sterile Unit-Dose Vials ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from package insert and dispense with solution. Rx only Carton contains: 5 pouches of 5 x 3 mL vials each INGREDIENTS: Active: Albuterol sulfate (0.75 mg/3 mL). Inactive: Sodium chloride, edetate disodium, sulfuric acid (to adjust to pH 3.5) and water for injection. STORAGE CONDITIONS: Protect from light. Store between 2°C to 25°C (36°F to 77°F). Store the unit-dose vials in the protective foil pouch at all times. Once removed from the foil pouch, use the vial(s) within two weeks. Discard the vial if the solution is not colorless. Keep out of reach of children. USUAL DOSAGE: FOR USE IN CHILDREN AGES 2 TO 12. See accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC: 7057:25C:R1 RPSC0453 Mylan.com Albuterol Sulfate Inhalation Solution 0.63 mg/3 mL Carton Label
- PRINCIPAL DISPLAY PANEL – 1.25 mg/3 mL NDC 0378-7058-52 Albuterol Sulfate Inhalation Solution 1.25 mg*/3 mL *Each unit dose vial contains 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate. For Inhalation Only Sterile Unit-Dose Vials ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from package insert and dispense with solution. Rx only Carton contains: 5 pouches of 5 x 3 mL vials each INGREDIENTS: Active: Albuterol sulfate (1.5 mg/3 mL). Inactive: Sodium chloride, edetate disodium, sulfuric acid (to adjust to pH 3.5) and water for injection. STORAGE CONDITIONS: Protect from light. Store between 2°C to 25°C (36°F to 77°F). Store the unit-dose vials in the protective foil pouch at all times. Once removed from the foil pouch, use the vial(s) within two weeks. Discard the vial if the solution is not colorless. Keep out of reach of children. USUAL DOSAGE: FOR USE IN CHILDREN AGES 2 TO 12. See accompanying prescribing information. USE ONLY AS DIRECTED BY YOUR PHYSICIAN. DO NOT EXCEED RECOMMENDED DOSAGE. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: The Ritedose Corporation Columbia, SC 29203 U.S.A. TRC: 7058:25C:R1 RPSC0454 Mylan.com Albuterol Sulfate Inhalation Solution 1.25 mg/3 mL Carton Label
Overview
Albuterol sulfate inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate. Albuterol sulfate 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 is 576.7 and the empirical formula is (C 13 H 21 NO 3 ) 2 • H 2 SO 4 . Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol. Albuterol Sulfate Inhalation Solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.63 mg of albuterol equivalent to 0.75 mg of albuterol sulfate or 1.25 mg of albuterol equivalent to 1.5 mg of albuterol sulfate with sodium chloride, edetate disodium (EDTA), and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution, EDTA is added as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid is added to adjust pH of the solution to 3.5 (see HOW SUPPLIED ). Albuterol Sulfate Inhalation Solution does not require dilution prior to administration by nebulization. For Albuterol Sulfate Inhalation Solution, 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 (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol Sulfate Inhalation Solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION ). Albuterol Sulfate Structural Formula
Indications & Usage
Albuterol Sulfate Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).
Dosage & Administration
The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of Albuterol Sulfate 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 1.25 mg or 0.63 mg inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver Albuterol Sulfate Inhalation Solution over 5 to 15 minutes. The use of Albuterol Sulfate 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 Sulfate 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 Sulfate Inhalation Solution, when mixed with other drugs in a nebulizer have not been established. The safety and efficacy of Albuterol Sulfate 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 Sulfate Inhalation Solution when administered with other nebulizer systems have not been established. Albuterol Sulfate 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.
Warnings & Precautions
WARNINGS Paradoxical Bronchospasm As with other inhaled beta-adrenergic agonists, Albuterol Sulfate Inhalation Solution can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Albuterol Sulfate 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 Sulfate Inhalation Solution than usual, this may be a marker of destabilization of asthma and requires re-evaluation 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 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 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, Albuterol Sulfate 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.
Contraindications
Albuterol Sulfate Inhalation Solution is contraindicated in patients with a history of hypersensitivity to any of its components.
Adverse Reactions
Clinical Trial Experience Adverse events reported in >1% of patients receiving Albuterol Sulfate Inhalation Solution 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 Sulfate Inhalation Solution and Greater than Placebo (expressed as % of treatment group) 1.25 mg Albuterol Sulfate Inhalation Solution (N=115) 0.63 mg Albuterol Sulfate Inhalation Solution (N=117) Placebo (N=117) Asthma Exacerbation 13 11.1 8.5 Otitis Media 4.3 0.9 0 Allergic Reaction 0.9 3.4 1.7 Gastroenteritis 0.9 3.4 0.9 Cold Symptoms 0 3.4 1.7 Flu Syndrome 2.6 2.6 1.7 Lymphadenopathy 2.6 0.9 1.7 Skin/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 0.9 Nausea 1.7 0.9 0.9 There was one case of ST segment depression in the 1.25 mg Albuterol Sulfate Inhalation Solution treatment group. No clinically relevant laboratory abnormalities related to Albuterol Sulfate Inhalation Solution administration were seen in this study. Post-marketing Experience Metabolic acidosis has been reported after the use of albuterol sulfate 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
Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with albuterol sulfate inhalation solution. 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, 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 Sulfate 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.
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