levalbuterol hydrochloride

levalbuterol hydrochloride

Xopenex HFA

Pharmacologic class: Adrenergic beta2 agonist

Therapeutic class: Bronchodilator

Pregnancy risk category C

Action

Binds to beta2-adrenergic receptors on bronchial cell membrane, stimulating the intracellular enzyme adenylate cyclase to convert adenosine triphosphate to cyclic-3′,5′-adenosine monophosphate. This action relaxes smooth muscles, dilates bronchioles, and increases diuresis.

Availability

Solution for inhalation: 0.31 mg/3 ml, 0.63 mg/3 ml, 1.25 mg/3 ml

Indications and dosages

Prevention and treatment of bronchospasm

Adults and children ages 12 and older: 0.63 to 1.25 mg by oral inhalation via nebulizer q 6 to 8 hours

Children ages 6 to 11: 0.31 to 0.63 mg by oral inhalation via nebulizer t.i.d.

Contraindications

• Hypersensitivity to drug or racemic albuterol

Precautions

Use cautiously in:
• renal, hepatic, or cardiac impairment; hyperthyroidism; diabetes mellitus; hypertension; prostatic hypertrophy; angle-closure glaucoma; seizures
• pregnant patients.

Administration

• Use only with nebulizer system designed for this drug.
• Keep unopened vials in foil pouch. Once pouch is opened, use within 2 weeks.
• If vial is removed from pouch, protect from light and use within 1 week.

Adverse reactions

CNS: anxiety, dizziness, hypertonia, insomnia, migraine, headache, nervousness, paresthesia, syncope, tremor

CV: chest pain, hypertension, hypotension, tachycardia

EENT: rhinitis, sinusitis, dry throat

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia, dry mouth

Metabolic: hypokalemia

Musculoskeletal: muscle cramps, myalgia

Respiratory: cough, dyspnea, asthma exacerbation, paradoxical bronchospasm

Other: sour taste, flulike symptoms, lymphadenopathy, chills

Interactions

Drug-drug.Aerosol bronchodilators: increased action of both drugs

Antidepressants: increased risk of adverse cardiovascular effects

Beta-adrenergic blockers: inhibition of levalbuterol effect

Digoxin: decreased digoxin blood level

Loop and thiazide diuretics: increased risk of hypokalemia

Drug-food.Caffeine-containing foods and beverages: increased stimulation

Drug-herbs.Cola nut, ephedra (ma huang), guarana, yerba maté: increased stimulation

Patient monitoring

• Monitor vital signs and ECG closely.
• Assess cardiovascular and neurologic status. Institute safety measures as needed to prevent injury.

Monitor for paradoxical bronchospasm. If it occurs, stop drug therapy and notify prescriber immediately.
• Check electrolyte levels for hypokalemia.
• Assess patient's response to drug. Contact prescriber if patient needs more frequent doses for same effect.

Patient teaching

• Teach patient how to prepare drug, administer it with nebulizer, and maintain and clean nebulizer.
• Advise patient to continue treatment for about 5 to 15 minutes or until mist no longer forms in nebulizer reservoir.

Tell patient to immediately report increased difficulty breathing or tightness in chest.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, foods, and herbs mentioned above.

References in periodicals archive ?
that will resolve the parties' patent litigation in connection with Mylan Specialty's Abbreviated New Drug Application (ANDA) for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.
for a generic version of levalbuterol hydrochloride inhalation solution.
in relation to Dey's Abbreviated New Drug Application (ANDA) for Levalbuterol Hydrochloride (HCl) Inhalation Solution, 0.
In September 2005, Sepracor announced that the FDA received an abbreviated new drug application (ANDA) from Breath Limited for a generic version of levalbuterol hydrochloride inhalation solution.