Levosalbutamol Suppliers & Bulk Manufacturers

Available Forms: Inhalation Solution

Available Strengths: 0.31 mg/3 mL, 0.63 mg/3 mL, and 1.25 mg/3 mL.

Reference Brands: Xopenex®(US)

Category: Respiratory Disorder

Levosalbutamol (levalbuterol) nebuliser solution in 0.31 mg, 0.63 mg and 1.25 mg per 3 mL unit-dose vials, a short-acting bronchodilator. For hospital pharmacies, importers, distributors and respiratory tender buyers.

Product Description:

Levosalbutamol, called levalbuterol in the US, is the R-enantiomer of salbutamol: the half of the racemic molecule that stimulates beta-2 receptors and relaxes airway muscle. It is a short-acting bronchodilator. This page covers nebuliser solution in unit-dose vials of 0.31 mg, 0.63 mg and 1.25 mg in 3 mL. It suits young children, frail adults and hospital wards where an inhaler and spacer are impractical. Vials are premixed, with no dilution step.

It is licensed for treating and preventing bronchospasm in reversible obstructive airway disease, chiefly asthma, and is used in COPD where the label allows. US labelling gives 0.31 mg three times daily for children aged 6 to 11 and 0.63 mg three times daily from age 12, rising to 1.25 mg in severe cases. Doses go through a jet nebuliser with mouthpiece or mask. Tremor, fast heart rate and low potassium can occur, and paradoxical bronchospasm is rare. Non-selective beta-blockers oppose its effect.

Sourcing notes. Nebuliser solutions are sterile, so ask for evidence of aseptic or blow-fill-seal manufacture, sterility and endotoxin testing, and whether the formula is preservative-free. Vials are usually low-density polyethylene inside foil pouches, because the drug degrades in light; the label should say how long vials last once a pouch is opened. They are kept at room temperature, without a cold chain. A CTD or ACTD dossier should hold zone IVb stability and evidence of equivalence to the reference product. Request a batch CoA, a GMP certificate covering sterile production and a CoPP.