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Xopenex HFA 45mcg Inhaler
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Indications & Clinical Uses
- Xopenex HFA 45 mcg per actuation is a levalbuterol tartrate inhalation aerosol, a short-acting beta-agonist bronchodilator that you breathe in through the mouth from a pressurised canister.
- It is used to treat or prevent bronchospasm (tightening of the airways) in adults, adolescents and children aged 4 years and older who have reversible obstructive airway disease.
- It is a reliever inhaler that you use yourself, and one canister provides 200 metered inhalations.
- This information comes from the current US label, now held by Lupin Pharmaceuticals; earlier versions of the label were issued by Sepracor.
- Do not confuse this metered-dose inhaler with Xopenex levalbuterol hydrochloride nebulizer solution, which is a different formulation with different strengths (0.31 mg, 0.63 mg and 1.25 mg vials) and is not interchangeable with the inhaler.
Side Effects
- In studies, the most common reactions in adults and adolescents were asthma symptoms (9%), sore throat or pharyngitis (8%), runny nose or rhinitis (7%) and dizziness (3%).
- In children aged 4 to 11 years, vomiting (11%), accidental injury (9%) and pharyngitis (7%) were most frequent.
- Other effects reported with levalbuterol include a fast heartbeat, nervousness, headache, muscle tightness and throat dryness.
- Serious effects need urgent action: life-threatening paradoxical bronchospasm (breathing suddenly gets worse straight after a puff), chest pain or tightness, an irregular or dangerously fast heartbeat, low blood potassium, and allergic reactions such as hives, rash or facial swelling.
- Excessive use can be fatal.
- The label carries no boxed warning.
- Stop the inhaler and seek emergency help if breathing worsens after a dose.
Precautions & Warnings
- Xopenex HFA must not be used by anyone allergic to levalbuterol, racemic albuterol (salbutamol) or any ingredient in the inhaler.
- If your breathing suddenly gets worse after a puff, stop using it and get emergency help.
- Use it with caution if you have heart disease, high blood pressure, thyroid problems or diabetes, because beta-agonists can affect the heart and blood sugar and can lower blood potassium.
- It relieves symptoms but does not replace inhaled or oral corticosteroids.
- Needing more puffs than usual, or finding it works less well, can be a sign of worsening asthma and needs prompt medical review.
- Human pregnancy data are inadequate and there are no data on levalbuterol in breast milk, so discuss use with your healthcare provider.
- Prime the canister with 4 test sprays before first use and after a period of non-use, wash the actuator weekly with warm water, and discard the canister after 200 actuations.
- Store at 20°C to 25°C and protect it from freezing and direct sunlight.
Avoid Interactions
- Medicines and conditions that increase the risk of side effects: other beta-agonist bronchodilators (avoid combining them); monoamine oxidase inhibitors and tricyclic antidepressants, which can potentiate the effect of levalbuterol on the heart and blood vessels; and diuretics, which can lower potassium and cause ECG changes, so potassium may need monitoring.
- Digoxin levels may fall when used with levalbuterol, so your prescriber may check them.
- Medicines that reduce or block the effect: beta-blockers such as atenolol and metoprolol should generally be avoided because they can antagonise levalbuterol.
- Tell your healthcare provider about all prescription medicines, over-the-counter products and supplements you use, and do not use more puffs than prescribed.
References
Frequently Asked Questions
Xopenex HFA (levalbuterol tartrate) is a reliever inhaler that treats or prevents bronchospasm, the tightening of the airways, in people aged 4 years and older with reversible obstructive airway disease. Each puff delivers 45 mcg of levalbuterol. It is not the same product as Xopenex nebulizer solution.
Xopenex HFA is breathed in through the mouth. The usual dose for adults and children aged 4 and over is two puffs every 4 to 6 hours, although one puff every 4 hours may be enough for some people. Prime it with 4 test sprays before first use and after a period of non-use, and wait one minute between puffs.
Common Xopenex HFA (levalbuterol) side effects include sore throat, runny nose, dizziness, fast heartbeat, nervousness and headache; children may also vomit. Stop using it and get urgent help if breathing gets worse right after a puff (paradoxical bronchospasm), or if you have chest pain, an irregular heartbeat or signs of allergy such as hives or facial swelling.
Avoid beta-blockers such as atenolol or metoprolol with Xopenex HFA (levalbuterol), as they can block its effect, and do not combine it with other bronchodilators. Tell your healthcare provider if you take digoxin, diuretics, MAO inhibitors or tricyclic antidepressants. Do not use more puffs than prescribed, because excessive use can be fatal.
Store Xopenex HFA (levalbuterol) at 20°C to 25°C, away from direct sunlight, and never freeze it. Wash the actuator with warm running water at least once a week. The canister holds 200 puffs, so throw it away after 200 actuations even if it still seems to spray.
Xopenex HFA (levalbuterol tartrate) is approved for children aged 4 years and older, at the usual dose of two puffs every 4 to 6 hours. It is not approved for children under 4. In studies of children aged 4 to 11, the most common reactions were vomiting, accidental injury and sore throat.
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