About

Inhaler Inhaler

Cipla’s Albuterol Sulfate HFA Inhalation Aerosol is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp’s Proventil® HFA (Albuterol Sulfate) Inhalation Aerosol.1

  • Seamless device transition
  • Approved, on Formulary Generic Alternative4,5,6
  • A Rescue inhaler that may provide cost savings to patients4,5,6
  • Available at Pharmacies Nationwide
Watch the Instructions For Use Video  white button arrow

Proventil® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved.

Dosing & Administration2

Indications & Usage

Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Dosing
  • Treatment or prevention of bronchospasm in adults and children 4 years of age and older: 2 inhalations every 4 to 6 hours. In some patients, one inhalation every 4 hours may be sufficient.
  • Prevention of exercise-induced bronchospasm in adults and children 4 years of age and older: 2 inhalations 15 to 30 minutes before exercise.
A closer look at a Device

Dose Counting Mechanism2

Dosing

Dose Indicator display window shows remaining number of puffs of medicine

Dosing

Each canister contains 200 puffs and the doses required for priming the inhaler.

1
Dosing

Display window background moves after every 10 puffs.

2
Dosing

Number inside dose indicator window changes after every 20 puffs.

3
Dosing

Only 20 puffs left.
Need a refill or a new prescription.

4

Instructions for Use Video

play icon

Coverage & Reimbursement

Formulary Coverage is Important

Cipla’s Albuterol Sulfate HFA Inhalation Aerosol is an approved Formulary Generic Alternative on majority of national formularies4,5,6

This could also mean:

fewer pharmacy icon

Fewer pharmacy callbacks

hassle icon

Less hassle for
you and your staff

dollar icon

Low-cost generic
alternative
for your patients

Contact

Contact Details:

Cipla USA Commercial Offices:

Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ 07059

Product Returns:

Return Authorization Policy

Customer Service:

844-CIPLA US (844-247-5287)

E-mail : Cipla.cs@cipla.com

E-mail : ciplausa@cipla.com

Product Complaints:
For Adverse Events and Medical Inquiries

866-604-3268

E-mail: drugsafety@cipla.com

Cipla USA - Pharmacovigilance

550 S. Research Place
Central lslip, NY 11722

Cipla, Ltd Quality/Drug Safety

R&D Centre
2nd Floor, Bldg. No 5 LBS Marg
Vikhroli(W) Mumbai, 400 083

For Hazardous Materials
[for Dangerous Goods] Incident

Spill, Leak, Fire, Exposure, or Accident
Call CHEMTREC Day or Night
1-800-424-9300 / +1703-527-3887 CCN835888

Indications & Usage

Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information

Contraindications: Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol sulfate inhalation aerosol components.

Warnings
  1. Paradoxical Bronchospasm: Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol sulfate inhalation aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
  2. 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 aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
  3. Use of Anti-inflammatory Agents: The use of beta-adrenergic-agonist 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, to the therapeutic regimen.
  4. Cardiovascular Effects: Albuterol sulfate inhalation aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Albuterol sulfate inhalation aerosol 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 aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  5. Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
  6. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
Precautions:

General: Albuterol sulfate, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

Common adverse effects include: upper respiratory tract infection, stuffy nose, nausea, tremor, vomiting, rapid heart rate, nervousness, fever, inhalation site sensation, allergic reaction.

Pregnancy, Labor/Delivery, Nursing Mothers:

Albuterol sulfate inhalation aerosol should be used during pregnancy and labor only if the benefits clearly outweigh the risk. Caution should be exercised when albuterol sulfate is administered to a nursing woman.

Drug Interactions include beta-blockers, diuretics, albuterol-digoxin, monoamine oxidase inhibitors or tricyclic antidepressants.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Cipla at 1-866-604-3268.

Please see the full Prescribing Information for additional Important Safety Information.

Indications & Usage

Albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information

Contraindications: Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other Albuterol sulfate inhalation aerosol components.

Warnings
  1. Paradoxical Bronchospasm: Inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol sulfate inhalation aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.
  2. 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 aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
  3. Use of Anti-inflammatory Agents: The use of beta-adrenergic-agonist 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, to the therapeutic regimen.
  4. Cardiovascular Effects: Albuterol sulfate inhalation aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Albuterol sulfate inhalation aerosol 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 aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
  5. Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.
  6. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
Precautions:

General: Albuterol sulfate, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

Common adverse effects include: upper respiratory tract infection, stuffy nose, nausea, tremor, vomiting, rapid heart rate, nervousness, fever, inhalation site sensation, allergic reaction.

Pregnancy, Labor/Delivery, Nursing Mothers:

Albuterol sulfate inhalation aerosol should be used during pregnancy and labor only if the benefits clearly outweigh the risk. Caution should be exercised when albuterol sulfate is administered to a nursing woman.

Drug Interactions include beta-blockers, diuretics, albuterol-digoxin, monoamine oxidase inhibitors or tricyclic antidepressants.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Cipla at 1-866-604-3268.

Please see the full Prescribing Information for additional Important Safety Information.

References:
  1. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm. Accessed 12/15/2020.
  2. Albuterol Sulfate Inhalation Aerosol Prescribing Information. Cipla, 2021.
  3. Data on File. Stability. Cipla. 2020.
  4. https://www.express-scripts.com/art/pdf/NPF_Preferred_Formulary_Exclusions2023.pdf. Accessed 8/15/2023.
  5. https://www.caremark.com/portal/asset/Formulary_Exclusion_Drug_List.pdf. Accessed 8/15/2023.
  6. https://professionals.optumrx.com/content/dam/optum3/professional-optumrx/resources/pdfs/Premium_Standard_Abridged_PDF_13188_v98_09072022.pdf. Accessed 8/15/2023.