TM Owner Akorn, Inc. (for Oak Pharmaceuticals)
Xopenex 1.25mg/3mL Nebulizer Solution
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Indications & Clinical Uses
- Xopenex Inhalation Solution 1.25 mg/3 mL (levalbuterol hydrochloride) is a bronchodilator given as a breathed-in mist through a nebuliser.
- It is used to treat or prevent bronchospasm (airway tightening) in adults, adolescents and children aged 6 years and older with reversible obstructive airway disease.
- The 1.25 mg/3 mL unit-dose vial is for adults and adolescents 12 and older with more severe asthma, three times daily; the 0.31 mg and 0.63 mg vials are used for smaller doses, and the 0.31 mg vial for children aged 6 to 11.
- It needs no dilution.
- Do not confuse it with Xopenex Inhalation Solution Concentrate (1.25 mg/0.5 mL), which must be diluted with sterile normal saline first.
- The current US label lists Akorn as distributor and Oak Pharmaceuticals as the company it is manufactured for, not Sunovion.
Side Effects
- In adults and adolescents aged 12 and older using 1.25 mg, common side effects were viral infection (12.3%), nervousness (9.6%), tremor (6.8%) and fast heartbeat (2.7%).
- Serious effects include paradoxical bronchospasm, where breathing suddenly worsens after a dose and which can be life-threatening (stop using it and get emergency help), clinically significant cardiovascular effects, low blood potassium (hypokalaemia), and changes in blood sugar.
- Excessive use can be fatal.
- The US label has no boxed warning.
- Contact your healthcare provider if your symptoms are not relieved or you need the medicine more often than usual.
Precautions & Warnings
- Do not use Xopenex if you have had a hypersensitivity reaction to levalbuterol or racemic albuterol.
- It is not a substitute for a corticosteroid, and you should not exceed the prescribed dose.
- Use it with caution if you have heart disease.
- Use in pregnancy only if the benefit justifies the potential risk to the baby (Category C).
- Keep unopened vials in the protective foil pouch at 20 to 25 degrees C, protected from light.
- Once the pouch is opened, use the vials within 2 weeks; a vial taken out of the pouch should be used within 1 week.
- Check the strength printed on the vial, and never use the concentrate without diluting it.
Avoid Interactions
- Increased effect or toxicity: other sympathomimetic (adrenaline-like) medicines can add to its effects; diuretics may worsen ECG changes and low potassium; and monoamine oxidase inhibitors and tricyclic antidepressants may increase the effect on the blood vessels and heart.
- Levalbuterol can lower serum digoxin levels by about 16% to 22%.
- Reduced effect: beta-blockers can block the bronchodilator effect and may cause severe bronchospasm in people with asthma.
- Because several of these combinations can affect your heart rate and potassium level, tell your healthcare provider about all prescription medicines, over-the-counter products, herbal remedies and supplements before using Xopenex.
References
- XOPENEX (levalbuterol hydrochloride) Inhalation Solution 0.31/0.63/1.25 mg per 3 mL - US Prescribing Information, DailyMed
- XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate 1.25 mg/0.5 mL - US Prescribing Information, DailyMed
- XOPENEX (levalbuterol HCl) Inhalation Solution - US Prescribing Information, DailyMed
- Xopenex: Package Insert / Prescribing Information, Drugs.com
Frequently Asked Questions
Xopenex (levalbuterol) inhalation solution treats or prevents bronchospasm, the tightening of the airways, in people aged 6 and over with reversible obstructive airway disease such as asthma. It is breathed in through a nebuliser. The 1.25 mg strength is for adults and adolescents 12 and over.
Use Xopenex (levalbuterol) 1.25 mg/3 mL as a mist through a nebuliser, up to three times daily for adults and adolescents 12 and over, as prescribed. Do not dilute the 3 mL vial. Do not exceed the prescribed dose, and check the strength on the vial before each use.
Common Xopenex side effects include nervousness, tremor, viral infection and fast heartbeat. It can cause paradoxical bronchospasm, where breathing suddenly gets worse after a dose. Stop using it and get emergency help if that happens. Low potassium and heart effects can also occur.
Avoid beta-blockers with Xopenex (levalbuterol), as they can block its effect and cause severe bronchospasm. Diuretics can worsen low potassium, and MAOIs or tricyclic antidepressants can strengthen its heart effects. Do not use it if you are allergic to levalbuterol or albuterol.
Keep unopened Xopenex (levalbuterol) vials in the foil pouch at 20 to 25 degrees C, away from light. Once the pouch is opened, use the vials within 2 weeks; a vial taken out of the pouch should be used within 1 week.
No. Xopenex (levalbuterol) Concentrate is 1.25 mg in 0.5 mL and must be diluted with sterile normal saline before nebulising. The 1.25 mg/3 mL vial is ready to use. Check the label on the vial before every dose to avoid a dosing mistake.
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