XOPENEX Inhalation solution (2022)

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1. Indications and Usage

XOPENEX (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway ...

2. Dosage and Administration

XOPENEX Inhalation Solution is for oral inhalation only. Administer by nebulization using with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended ...

3. Dosage Forms and Strengths

Inhalation Solution 3 mL unit-dose, vials in three dosage strengths of levalbuterol; 0.31 mg, 0.63 mg, 1.25 mg. Each strength of XOPENEX Inhalation Solution is available in a shelf carton containing one ...

4. Contraindications

XOPENEX Inhalation Solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, ...

5. Warnings and Precautions

5.1 Paradoxical Bronchospasm XOPENEX Inhalation Solution can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, XOPENEX Inhalation Solution should be discontinued ...

6. Adverse Reactions

The following serious adverse reactions are described below and elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions (5.1)] Cardiovascular effects [see Warnings ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared with rates in the clinical trials of ...

6.2. Postmarketing Experience

In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in postapproval use of XOPENEX Inhalation Solution. Because these reactions are reported ...

7. Drug Interactions

7.1 Short-Acting Bronchodilators Avoid concomitant use of other short-acting sympathomimetic bronchodilators or epinephrine in patients being treated with XOPENEX Inhalation Solution. If additional adrenergic ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including XOPENEX, during pregnancy. To enroll in MotherToBaby ...

8.2. Lactation

h3.Risk Summary There are no available data on the presence of levalbuterol in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of ...

8.4. Pediatric Use

Pediatric Patients 6 Years of Age and Older The safety and efficacy of XOPENEX Inhalation Solution have been established in pediatric patients 6 years of age and older in an adequate and well-controlled ...

8.5. Geriatric Use

Clinical studies of XOPENEX Inhalation Solution did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Only 5 patients ...

8.6. Renal Impairment

Albuterol is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have ...

10. Overdosage

The expected symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation and/or occurrence or exaggeration of any of the symptoms listed under Adverse Reactions (6), e.g., ...

11. Description

XOPENEX Inhalation Solution is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol ...

12.1. Mechanism of Action

Activation of beta2-adrenergic receptors on airway smooth muscle leads to the activation of adenylate cyclase and to an increase in the intracellular concentration of cyclic-3', 5'-adenosine ...

12.2. Pharmacodynamics

Adults and Adolescents ≥12 Years Old In a randomized, double-blind, placebo-controlled, cross-over study, 20 adults with mild-to-moderate asthma received single doses of XOPENEX Inhalation Solution (0.31 ...

12.3. Pharmacokinetics

Adults and Adolescents ≥12 Years Old The inhalation pharmacokinetics of XOPENEX Inhalation Solution were investigated in a randomized cross-over study in 30 healthy adults following administration of a ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Although there have been no carcinogenesis studies with levalbuterol HCl, racemic albuterol sulfate has been evaluated for its carcinogenic potential. In a 2-year study in Sprague-Dawley rats, dietary ...

14. Clinical Studies

Adults and Adolescents ≥12 Years Old The safety and efficacy of XOPENEX Inhalation Solution were evaluated in a 4-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in ...

16.1. How Supplied

XOPENEX Inhalation Solution is supplied in 3 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol ...

16.2. Storage and Handling

Store XOPENEX Inhalation Solution in the protective foil pouch at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil ...

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information and Instructions for Using XOPENEX Inhalation Solution). Patients should be given the following information: Concomitant Drug Use Inform patients ...