Levalbuterol

XOPENEX

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Pronunciation: lev-al-BYOO-ter-ol

Levalbuterol ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Levalbuterol ballicule

What it isR-enantiomer and beta-2 agonist; rescue treatment of acute bronchospasm.

Why this oneRemoving albuterol's S-enantiomer has not produced a consistent clinical advantage over racemic albuterol.

What limits itTremor, tachycardia, and hypokalemia remain possible; higher cost usually makes albuterol the practical default.

Levalbuterol molecular structure (skeletal formula) — Molecular structure: Levalbuterol

FDA-approved for

bronchospasm (1999)

FDA label

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FDA dosing	Population	Start	Target	Max
Bronchospasm (asthma)	Adults & adolescents ≥12 yr	0.63 mg TID (q6–8h)	0.63 mg TID	1.25 mg TID
Bronchospasm (asthma)	Children 6–11 yr	0.31 mg TID	0.31 mg TID	0.63 mg TID

Renal Use with caution; risk of toxicity may be greater in renal impairment — monitor renal function.

Hepatic Undefined

Instructions

For oral inhalation only via standard jet nebulizer with mouthpiece/face mask.
Do not exceed recommended dose.
Do not mix with other drugs in the nebulizer (compatibility not established).

Available strengths

sol 0.0103, 0.021, 0.042, 0.25 %
inhaler 45 mcg/inh

Contraindications

Hypersensitivity to levalbuterol or racemic albuterol (urticaria, angioedema, anaphylaxis, bronchospasm reported)

Cautions

Paradoxical bronchospasm — discontinue immediately
Deterioration of asthma / needing more doses signals destabilization
Not a substitute for corticosteroids
Cardiovascular effects (↑HR, BP, QTc); caution in CV disease
Do not exceed dose — fatalities with excessive use
Hypokalemia; changes in blood glucose

Adverse reactions

Palpitations, chest pain, tachycardia
Headache, dizziness, tremor, nervousness

Pregnancy No adequate controlled studies; no teratogenicity for levalbuterol in rabbits (racemic albuterol teratogenic in animals at high doses).

Lactation No data on presence in human milk.

Cost

Levalbuterol (XOPENEX)

Strength		#/mo	CostPlus
0.0103 %	sol	per unit	not offered
0.021 %	sol	per unit	not offered
0.042 %	sol	per unit	not offered
0.25 %	sol	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Levalbuterol is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2008

NO BOXED WARNINGS

Principal riskNo proven advantage over albuterol at higher cost

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryC

Defining liabilityTremor, tachycardia or anticholinergic effects; excessive beta-agonist exposure can cause hypokalemia and arrhythmia.

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