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 Alternative2,3,4
  • A Rescue inhaler that may provide cost savings to patients2,3,4
  • 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.

Device Features

Cipla’s Generic Albuterol Sulfate HFA Inhalation Aerosol provides seamless transition from Proventil® HFA.5,6

When you receive Cipla’s Albutrol Sulfate HFA Inhalation Aerosol at the pharmacy, you may notice that the device looks different from your previous inhaler. Cipla’s Albuterol Sulfate HFA inhaler contains the same medication as Proventil® HFA (Albuterol Sulfate 90mcg).

90mcg

Albuterol
Dosage

200

Total
Doses

Dose

Dose Counting Mechanism

24month

Shelf-life

A closer look at a Device

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

Dose Counting Mechanism6

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

How to Use

For step-by-step instructions on how to use Cipla’s Albuterol Sulfate HFA Inhalation Aerosol watch how to use video

video play

FAQs6

Albuterol sulfate inhalation aerosol is a prescription inhaled medicine used in patients aged 4 years and older to:

  • Treat or prevent bronchospasm in people who have reversible obstructive airway disease
  • Prevent exercise-induced bronchospasm

It is not known if Albuterol sulfate inhalation aerosol is safe and effective in children younger than 4 years of age.

For the treatment or prevention of sudden asthma symptoms, the usual dosage for adults and children aged 4 years and older is 2 sprays repeated every 4 to 6 hours. In some patients, a dosage of 1 spray every 4 hours may be enough.

For exercise-induced bronchospasm, or EIB, the usual dose for adults and children aged 4 years and older is 2 sprays taken 15 to 30 minutes before exercise.

Cipla’s Albuterol sulfate inhalation aerosol is:

  • Gluten Free
  • Soy Free
  • Preservative Free

Cipla’s Albuterol sulfate inhalation aerosol does not contain:

  • Milk, Dairy, Lactose, Milk Proteins
  • Barley, Wheat, Rye, Corn, Oats
  • Eggs or other Animal Derivatives
  • Peanuts, Treenuts, other Nuts
  • Ibuprofen or other medications
  • Sulphur

Before you use this inhaler for the first time, you need to get it ready. This is called “priming”. This will ensure there is enough medicine in each spray. You do not need to do this every time, but if you did not use your Albuterol sulfate Inhalation Aerosol for more than 2 weeks, you should re-prime it before use.

  • Remove the cap from the mouthpiece. Check inside the mouthpiece for objects before use.
  • Make sure the canister is fully inserted into the actuator.
  • Hold the inhaler in an upright position away from your face and shake the inhaler well.
  • Press down fully on the center of the dose indicator to release a spray of medicine. You may hear a soft click from the dose indicator as it counts down during use.
  • Repeat the priming step 3 more times to release a total of 4 sprays of medicine. Shake the inhaler well before each priming spray.
  • After the 4 priming sprays, the dose indicator should be pointing to 200. There are now 200 puffs of medicine left in the canister.
  • Your inhaler is now ready to use.

Please refer to the Instructions for Use Video or the full Prescribing Information for a guide on how to prime your inhaler.

Contact us at 1-866-604-3268 and we would be happy to help you walk through detailed priming instructions over the phone.

The soft click may be confusing as the dose is not yet released. You must continue with the actuation process and continue to press further to ensure the release of the dose.

Albuterol sulfate inhalation aerosol has a built-in dose counter that counts down each time a spray is released. At any given time, the dose counter shows how many sprays of albuterol are left in your inhaler. When the dose counter turns red and reads ‘20’, you should refill your prescription or ask your doctor if you need another prescription. When it turns ‘0’ replace your inhaler.

At any given time, the dose counter shows the number of sprays left in the canister. The dose indicator display window will continue to move after every 10 puffs. The number changes after every 20 puffs. At 20, the color will change to red. The dose counter stops counting when it reaches ‘0’. The dose counter cannot be reset, and it is permanently attached to the metal canister. Do not try to change the numbers or take the counter off the metal canister.

You could have medicine build-up blocking the spray. Cleaning your inhaler with warm water can help fix this.

Please refer to the Instructions for Use Video or the full Prescribing Information for a guide on how to properly clean your inhaler.

Contact us at 1-866-604-3268 and we would be happy to help you walk through detailed cleaning or priming instructions over the phone.

The two openings at bottom are only for assembly purposes and has no impact on the flow of medication or the functionality of the device.

Cipla’s Albuterol sulfate inhalation aerosol can be used with any anti-static spacer as long as a proper fit is achieved with the inhaler and spacer. Consult with your prescriber to ensure device compatibility and proper usage.

Albuterol sulfate inhalation aerosol may cause serious side effects, including:

  • worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using Albuterol sulfate inhalation aerosol and call your healthcare provider or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.
  • heart problems, including faster heart rate and higher blood pressure
  • possible death in people with asthma who use too much Albuterol sulfate inhalation aerosol
  • serious allergic reactions

Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

  • rash
  • hives
  • swelling of your face, mouth, and tongue
  • breathing problems

Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness.

Call your doctor for medical advice about side effects. 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.

  • When the counter turns red and reads ‘20’, you should refill your prescription or ask your healthcare provider if you need another prescription for Albuterol sulfate inhalation aerosol.
  • Throw the inhaler away when the counter reads ‘0’. You should not keep using the inhaler when the counter reads ‘0’ because you will not receive the right amount of medicine.
  • Do not use the inhaler after the expiration date, which is on the packaging.

Store at 20°C to 25°C (68°F to 77°F). Store the inhaler with the mouthpiece down. Avoid exposing your inhaler to extreme heat and cold. For best results, canister should be at room temperature before use.

Used or expired inhalers should be treated as biomedical waste and must be disposed as per your local guidelines. Consult with your physician or pharmacist for safe disposal instructions.

Please consult with your physician as this is highly dependent on patient’s underlying, co-existing conditions.

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.nhlbi.nih.gov/sites/default/files/media/docs/EPR-3_Asthma_Full_Report_2007.pdf. Accessed 12/15/2020.
  2. https://www.express-scripts.com/art/pdf/NPF_Preferred_Formulary_Exclusions2023.pdf. Accessed 8/15/2023.
  3. https://www.caremark.com/portal/asset/Formulary_Exclusion_Drug_List.pdf. Accessed 8/15/2023.
  4. https://professionals.optumrx.com/content/dam/optum3/professional-optumrx/resources/pdfs/Premium_Standard_Abridged_PDF_13188_v98_09072022.pdf. Accessed 8/15/2023.
  5. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-commonly-used-albuterol-inhaler-treat-and-prevent-bronchospasm. Accessed 12/15/2020.
  6. Albuterol Sulfate Inhalation Aerosol Prescribing Information. Cipla, 2021.
  7. Data on File. Stability. Cipla. 2020.