levalbuterol hydrochloride

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Overview

What is levalbuterol hydrochloride?

Levalbuterol HCl Inhalation Solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta -adrenergic receptor agonist (see ). The chemical name for levalbuterol HCl is (R)-α -[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:

The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C H NO •HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water.

Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States.

Levalbuterol HCl Inhalation Solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and sulfuric acid to adjust the pH to between 3.3 and 4.5.

What does levalbuterol hydrochloride look like?

What are the available doses of levalbuterol hydrochloride?

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What should I talk to my health care provider before I take levalbuterol hydrochloride?

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How should I use levalbuterol hydrochloride?

Levalbuterol HCl Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

Children 6–11 years old:

What interacts with levalbuterol hydrochloride?

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What are the warnings of levalbuterol hydrochloride?

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What are the precautions of levalbuterol hydrochloride?

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What are the side effects of levalbuterol hydrochloride?

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What should I look out for while using levalbuterol hydrochloride?

Levalbuterol HCl Inhalation Solution is contraindicated in patients with a history of hypersensitivity to levalbuterol HCl or racemic albuterol.

What might happen if I take too much levalbuterol hydrochloride?

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 , e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with the abuse of Levalbuterol HCl Inhalation Solution. Treatment consists of discontinuation of Levalbuterol HCl Inhalation Solution together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Levalbuterol HCl Inhalation Solution.

The intravenous median lethal dose of levalbuterol HCl in mice is approximately 66 mg/kg (approximately 70 times the maximum recommended daily inhalation dose of levalbuterol HCl for adults and children on a mg/m basis). The inhalation median lethal dose has not been determined in animals.

How should I store and handle levalbuterol hydrochloride?

Shake well before using. Store at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in a well-closed container as defined in the USP.Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394 Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394 Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394 Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394 Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394 Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394 Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394 Levalbuterol HCl Inhalation Solution, USP 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 (0.31 mg, 0.63 mg, 1.25 mg). Each strength of Levalbuterol HCl Inhalation Solution, USP is available in a shelf-carton containing one or more foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol HCl Inhalation Solution, USP 0.31 mg (foil pouch label color green(foil pouch label color yellow(foil pouch label color red)Store Levalbuterol HCl Inhalation Solution in the protective foil pouch at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and excessive heat. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless. Actavis Pharma Inc.,To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or 221394

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Results from an study of binding to human beta-adrenergic receptors demonstrated that levalbuterol has approximately 2-fold greater binding affinity than racemic albuterol and approximately 100-fold greater binding affinity than (S)-albuterol. In guinea pig airways, levalbuterol HCl and racemic albuterol decreased the response to spasmogens (e.g., acetylcholine and histamine), whereas (S)-albuterol was ineffective. These results suggest that the bronchodilatory effects of racemic albuterol are attributable to the (R)-enantiomer.

Intravenous studies in rats with racemic albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5.0% of the plasma concentrations. In structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain.

Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown.

Non-Clinical Toxicology

Levalbuterol HCl Inhalation Solution is contraindicated in patients with a history of hypersensitivity to levalbuterol HCl or racemic albuterol.

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should be used with caution with levalbuterol. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

Levalbuterol HCl, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after the use of any beta-adrenergic bronchodilator.

Large doses of intravenous racemic albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-adrenergic agonist medications, levalbuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

Adverse events reported in ≥ 2% of patients in any treatment group and more frequently than in patients receiving placebo in a 3-week, controlled clinical trial are listed in .

Changes in heart rate, plasma glucose, and serum potassium are shown in . The clinical significance of these small differences is unknown.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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