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Levalbuterol Hydrochloride (Levalbuterol)

Trade Name : Levalbuterol

Amneal Pharmaceuticals of New York LLC

SOLUTION

Strength 0.31 mg/3mL

LEVALBUTEROL HYDROCHLORIDE Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levalbuterol Hydrochloride (Levalbuterol) which is also known as Levalbuterol and Manufactured by Amneal Pharmaceuticals of New York LLC. It is available in strength of 0.31 mg/3mL per ml. Read more

Levalbuterol Hydrochloride (Levalbuterol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Levalbuterol 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.
  • Levalbuterol Inhalation Solution, USP is a beta-adrenergic agonist indicated for:n n nn
  • Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. ()n n n n
  • Levalbuterol Inhalation Solution, USP is for oral inhalation only. Administer by nebulization using a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose.
  • FOR ORAL INHALATION ONLY ()n n n n
  • Children 6-11 years old:
  • Adults and Adolescents n- 12 years old:
  • For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. ()n n n n
  • Inhalation Solution 3 mL unit-dose, vials in three dosage strengths of levalbuterol; 0.31 mg, 0.63 mg, 1.25 mg.
  • Inhalation Solution (unit-dose vial for nebulization): 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL. ()n
  • Levalbuterol Inhalation Solution, USP is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see n n n n ].n n nn
  • Hypersensitivity to levalbuterol or racemic albuterol. ()n n n n
  • No data
  • Life-threatening paradoxical bronchospasm may occur. Discontinue Levalbuterol Inhalation Solution, USP immediately and treat with alternative therapy. ()n n n n
  • Need for more doses of Levalbuterol Inhalation Solution, USP than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ()n n n n
  • Levalbuterol Inhalation Solution, USP is not a substitute for corticosteroids. ()n n n n
  • Cardiovascular effects may occur. Consider discontinuation of Levalbuterol Inhalation Solution, USP if these effects occur. Use with caution in patients with underlying cardiovascular disorders. ()n n n n
  • Excessive use may be fatal. Do not exceed recommended dose. ()n n n n
  • Immediate hypersensitivity reactions may occur. Discontinue Levalbuterol Inhalation Solution, USP immediately. ()n n n n
  • Hypokalemia and changes in blood glucose may occur. (, n n n n )n n n n
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • Most common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness. ()n n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact u00a0Amneal Pharmaceuticals at 1-877-835-5472 u00a0or FDA at 1-800-FDA-1088 or n
  • No data
  • Other short-acting sympathomimetic aerosol bronchodilators and adrenergic drugs: May potentiate effect. ()n
  • Beta-blockers: May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. Patients with asthma should not normally be treated with beta-blockers. ()n
  • Diuretic: May worsen electrocardiographic changes or hypokalemia associated with diuretic may worsen. Consider monitoring potassium levels. ()n
  • Digoxin: May decrease serum digoxin levels. Consider monitoring digoxin levels. ()n
  • Monoamine oxidase inhibitors (MAOs) or tricyclic antidepressants: May potentiate effect of albuterol on the cardiovascular system. ()n
  • No data
  • 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 n n n n , 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 Inhalation Solution, USP. Treatment consists of discontinuation of Levalbuterol Inhalation Solution, USP 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 Inhalation Solution, USP.n n nn
  • Levalbuterol 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 n ]. The chemical name for levalbuterol HCl is (R)-u03b1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:n
  • The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is CHNOu2219HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187u00b0C and solubility of approximately 180 mg/mL in water.n
  • Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States.
  • Levalbuterol 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/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).
  • No data
  • 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 administration of racemic albuterol sulfate resulted in a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at doses of 2 mg/kg/day and greater (approximately 4 times the MRDI dose of levalbuterol HCl for adults and approximately 5 times the MRDI dose of levalbuterol HCl for children on a mg/m basis). In an 18-month study in CD-1 mice and a 22-month study in the golden hamster, dietary administration of racemic albuterol sulfate showed no evidence of tumorigenicity. Dietary doses in CD-1 mice were up to 500 mg/kg/day (approximately 540 times the MRDI dose of levalbuterol HCl for adults and approximately 630 times the MRDI dose of levalbuterol HCl for children on a mg/m basis) and doses in the golden hamster study were up to 50 mg/kg/day (approximately 90 times the MRDI dose of levalbuterol HCl for adults on a mg/m basis and approximately 105 times the MRDI dose of levalbuterol HCl for children on a mg/m basis).n n nn
  • Levalbuterol HCl was not mutagenic in the Ames test or the CHO/HPRT Mammalian Forward Gene Mutation Assay. Levalbuterol HCl was not clastogenic in the n n n n micronucleus test in mouse bone marrow. Racemic albuterol sulfate was not clastogenic in an n n n n chromosomal aberration assay in CHO cell cultures.n n nn
  • No fertility studies have been conducted with levalbuterol hydrochloride. Reproduction studies in rats using racemic albuterol sulfate demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg/day (approximately 108 times the maximum recommended daily inhalation dose of levalbuterol HCl for adults on a mg/m basis).n n nn
  • No data
  • Levalbuterol 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).
  • Levalbuterol Inhalation Solution, USP, 0.31 mg/3 mLn- foil pouch label color green
  • Levalbuterol Inhalation Solution, USP, 0.63 mg/3 mLn- foil pouch label color yellow
  • Levalbuterol Inhalation Solution, USP, 1.25 mg/3 mLn- foil pouch label color red
  • Store Levalbuterol Inhalation Solution, USP in the protective foil pouch at 20u00b0- 25u00b0C (68u00b0- 77u00b0F) [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.
  • Rx only
  • See FDA-approved patient labeling n n n n and n n n n ).n n nn
  • Patients should be given the following information:
  • Manufactured By:u00a0u00a0 n n Columbia, SC 29203 USA
  • Distributed by:n n Bridgewater, NJ 08807
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 orn n
  • Rev. 12-2018-00
  • Levalbuterol Inhalation Solution, USP
  • 0.31 mg, 0.63 mg, 1.25 mgn- 3 mL Unit-Dose Vials
  • Read this Patient Information Leaflet before you start to use Levalbuterol Inhalation Solution, USP and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
  • What is Levalbuterol Inhalation Solution, USP?
  • Levalbuterol Inhalation Solution, USP is an inhaled prescription medicine used for the treatment or prevention of bronchospasm in people 6 years of age and older.
  • Levalbuterol Inhalation Solution, USP has not been shown to be safe and effective in children younger than 6 years of age.
  • Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose vials in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg). The vials do not require dilution before use.
  • Who should not use Levalbuterol Inhalation Solution, USP?
  • Do not use Levalbuterol Inhalation Solution, USP if you
  • What should I tell my doctor before using Levalbuterol Inhalation Solution, USP?
  • Before you use Levalbuterol Inhalation Solution, USP, tell your doctor if you have:
  • Tell your doctor about all the medicines you take
  • Especially tell your doctor if you take:
  • Ask your doctor if you are not sure if any of your medicines are the kinds listed above.
  • Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
  • How should I use Levalbuterol Inhalation Solution, USP?
  • What are the possible side effects of Levalbuterol Inhalation Solution, USP?
  • Levalbuterol Inhalation Solution, USP can cause serious side effects including:
  • Call your doctor or go to the nearest hospital emergency room right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.
  • The most common side effects of Levalbuterol Inhalation Solution, USP include:
  • Tell your doctor if you have any side effects that bother you or that do not go away.
  • These are not all the possible side effects of Levalbuterol Inhalation Solution, USP. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Levalbuterol Inhalation Solution, USP?
  • Keep Levalbuterol Inhalation Solution, USP and all medicines out of the reach of children.
  • General information about the safe and effective use of Levalbuterol Inhalation Solution, USP.
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Levalbuterol Inhalation Solution, USP for a condition for which it was not prescribed. Do not give Levalbuterol Inhalation Solution, USP to other people, even if they have the same symptoms that you have. It may harm them.
  • This Patient Information Leaflet summarizes the most important information about Levalbuterol Inhalation Solution, USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Levalbuterol Inhalation Solution, USP that is written for health professionals.
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or n
  • What are the ingredients in Levalbuterol Inhalation Solution, USP?
  • Active ingredient: levalbuterol hydrochloride
  • Inactive ingredients: sodium chloride, edetate disodium, sulfuric acid, and water
  • Levalbuterol Inhalation Solution, USP vial (see n Figure A): n
  • Figure An
  • Using your Levalbuterol Inhalation Solution, USP:
  • Read the following Steps before
  • Step 1.n- see n Figure B
  • Figure B
  • Step 2.n- see n Figure C
  • Figure Cn
  • Step 3.n- see n Figure C
  • Step 4.n- see n Figure D
  • Figure Dn
  • Step 5.n- see n Figure E.1n- see n Figure E.2
  • Step 6.n- see n Figure F
  • Figure Fn
  • Step 7.n- see n Figure G.1n- see n Figure G.2
  • Step 8.
  • Step 9.
  • This Patient Information Leaflet and Instructions for Use have been approved by the U.S. Food and Drug Administration.
  • Manufactured by:u00a0u00a0 n n Columbia, SC 29203 USA
  • Distributed by:n Bridgewater, NJ 08807u00a0u00a0u00a0u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Rev. 12-2018-00
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • NDC 0115-9930-78
  • Levalbuterol Inhalation Solution, USP
  • 0.31 mg (0.0103%)
  • 0.31 mg/3 mL
  • Rx only
  • NDC 0115-9931-78
  • Levalbuterol Inhalation Solution, USP
  • 0.63 mg (0.021%)
  • 0.63 mg/3 mL
  • Rx only
  • NDC 0115-9932-78
  • Levalbuterol Inhalation Solution, USP
  • 1.25 mg (0.042%)
  • 1.25 mg/3 mL
  • Rx only

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