Albuterol Sulfate


Chartwell Rx, Llc
Human Prescription Drug
NDC 62135-189
Albuterol Sulfate is a human prescription drug labeled by 'Chartwell Rx, Llc'. National Drug Code (NDC) number for Albuterol Sulfate is 62135-189. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Albuterol Sulfate drug includes Albuterol Sulfate - 2 mg/5mL . The currest status of Albuterol Sulfate drug is Active.

Drug Information:

Drug NDC: 62135-189
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Albuterol Sulfate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Albuterol Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Chartwell Rx, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Syrup
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ALBUTEROL SULFATE - 2 mg/5mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 26 Jun, 2007
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 14 Jun, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA077788
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Chartwell RX, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:755497
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0362135189419
0362135189471
UPC stands for Universal Product Code.
UNII:021SEF3731
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Adrenergic beta2-Agonists [MoA]
beta2-Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
62135-189-41120 mL in 1 CONTAINER (62135-189-41)08 Jun, 2022N/ANo
62135-189-47473 mL in 1 CONTAINER (62135-189-47)08 Jun, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Albuterol sulfate albuterol sulfate hypromellose, unspecified anhydrous citric acid trisodium citrate dihydrate sodium benzoate sorbitol solution fd&c yellow no. 6 albuterol sulfate albuterol orange-yellow

Indications and Usage:

Indications and usage albuterol sulfate syrup is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.

Warnings:

Warnings cardiovascular effects albuterol sulfate syrup, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. although such effects are uncommon after administration of albuterol sulfate syrup at recommended doses, if they occur, the drug may need to be discontinued. in addition, beta-agonists have been reported to produce electrocardiogram (ecg) changes, such as flattening of the t wave, prolongation of the qtc interval, and st segment depression. the clinical significance of these findings is unknown. therefore, albuterol sulfate syrup, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. deterioration of asthma asthma may deteriorate acutely over a period of hours or chronically over several days or longer. if the patient needs more doses
of albuterol sulfate syrup than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. paradoxical bronchospasm albuterol sulfate syrup can produce paradoxical bronchospasm, which may be life threatening. if paradoxical bronchospasm occurs, albuterol sulfate syrup should be discontinued immediately and alternative therapy instituted. use of anti-inflammatory agents the use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. immediate hypersensitivity reactions immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. albuterol, like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. rarely, erythema multiforme and stevens-johnson syndrome have been associated with the administration of albuterol sulfate in children.

Dosage and Administration:

Dosage and administration the following dosages of albuterol sulfate syrup are expressed in terms of albuterol base. usual dosage adults and children over 14 years of age: the usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day. children over 6 years to 14 years of age: the usual starting dosage for children over 6 years to 14 years of age is 2 mg (1 teaspoonful) three or four times a day. children 2 to 5 years of age: dosing in children 2 to 5 years of age should be initiated at 0.1 mg/kg of body weight three times a day. this starting dosage should not exceed 2 mg (1 teaspoonful) three times a day. dosage adjustment adults and children over 14 years of age: for adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only when the patient fails to respond. if a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased s
tepwise up to a maximum of 8 mg four times a day as tolerated. children over 6 years to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day: for children over 6 years to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses). children 2 to 5 years of age who do not respond satisfactorily to the initial dosage: for children from 2 to 5 years of age who do not respond satisfactorily to the initial starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day. elderly patients and those sensitive to beta-adrenergic stimulators: the initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

Contraindications:

Contraindications albuterol sulfate syrup is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.


Adverse Reactions:

Adverse reactions in clinical trials, the most frequent adverse reactions to albuterol sulfate syrup in adults and older children were: percent incidence of adverse reactions in adults and children (6-14 years of age) reaction percent incidence central nervous system tremor 10% nervousness 9% shakiness 9% headache 4% dizziness 3% hyperactivity 2% excitement 2% sleeplessness 1% disturbed sleep <1% irritable behavior <1% dilated pupils <1% weakness <1% cardiovascular tachycardia 1% palpitations <1% sweating <1% chest pain <1% ear, nose, and throat epistaxis 1% gastrointestinal increased appetite 3% epigastric pain <1% stomachache <1% musculoskeletal muscle spasm <1% respiratory cough <1% in clinical trials, the following adverse reactions to albuterol sulfate syrup were noted more frequently in young children 2 to 6 years of age than in older children and adults: percent incidence of adverse reactions noted more frequently in children 2 to 6 years of age than in older children and adults
reaction percent incidence central nervous system excitement 20% nervousness 15% hyperkinesia 4% sleeplessness 2% emotional lability 1% fatigue 1% cardiovascular tachycardia 2% pallor 1% gastrointestinal gastrointestinal symptoms 2% loss of appetite 1% ophthalmologic conjunctivitis 1% cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate syrup. in addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx. the reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol sulfate syrup. in selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.

Adverse Reactions Table:

Percent Incidence of Adverse Reactions in Adults and Children (6-14 Years of Age)
ReactionPercent Incidence
Central nervous system
Tremor10%
Nervousness9%
Shakiness9%
Headache4%
Dizziness3%
Hyperactivity2%
Excitement2%
Sleeplessness1%
Disturbed sleep<1%
Irritable behavior<1%
Dilated pupils<1%
Weakness<1%
Cardiovascular
Tachycardia1%
Palpitations<1%
Sweating<1%
Chest pain<1%
Ear, nose, and throat
Epistaxis1%
Gastrointestinal
Increased appetite3%
Epigastric pain<1%
Stomachache<1%
Musculoskeletal
Muscle spasm<1%
Respiratory
Cough<1%

Percent Incidence of Adverse Reactions Noted More Frequently in Children 2 to 6 Years of Age Than in Older Children and Adults
ReactionPercent Incidence
Central nervous system
Excitement20%
Nervousness15%
Hyperkinesia4%
Sleeplessness2%
Emotional lability1%
Fatigue1%
Cardiovascular
Tachycardia2%
Pallor1%
Gastrointestinal
Gastrointestinal symptoms2%
Loss of Appetite1%
Ophthalmologic
Conjunctivitis1%

Overdosage:

Overdosage the expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under adverse reactions, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. hypokalemia may also occur. as with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate syrup. treatment consists of discontinuation of albuterol sulfate syrup 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 albuterol sulfate syrup. the oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 240 times the maximum recommended daily oral dose for adults and children on a mg/m 2 basis). in mature rats the subcutaneous (sc) median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults and children on a mg/m 2 basis). in small young rats the oral median lethal dose is approximately 2000 mg/kg (approximately 480 times the maximum recommended daily oral dose for adults and children on a mg/m 2 basis).

Description:

Description albuterol sulfate syrup contains albuterol sulfate, usp, the racemic form of albuterol and a relatively selective beta 2 -adrenergic bronchodilator. albuterol sulfate has the chemical name α 1 -[( tert -butylamino)methyl]-4-hydroxy- m -xylene-α,α'-diolsulfate (2:1) (salt) and the following chemical structure: (c 13 h 21 no 3 ) 2 •h 2 so 4 m.w. 576.7 albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per usp definition. the world health organization recommended name for albuterol base is salbutamol. albuterol sulfate syrup for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 ml). albuterol sulfate syrup also contains the inactive ingredients purified water, hypromellose, citric acid anhydrous, sodium citrate dihydrate, sodium benzoate, sorbitol solution, strawberry flavor, and fd&c yellow # 6. the ph of the syrup is 3.2 to 4.2. albuterol sulphate chemical structure

Clinical Pharmacology:

Clinical pharmacology in vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. while it is recognized that beta 2 -adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta 2 -receptors in the human heart existing in a concentration between 10% and 50%. the precise function of these receptors has not been established (see warnings ). the pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (atp) to cyclic-3', 5'-adenosine monophosphate (cyclic amp). increased cyclic amp levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity
from cells, especially from mast cells. albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol- o -methyl transferase. preclinical intravenous studies in rats with 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 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. pharmacokinetics albuterol is rapidly absorbed after oral administration of 10 ml of albuterol sulfate syrup (4 mg of albuterol) in normal volunteers. maximum plasma concentrations of about 18 ng/ml of albuterol are achieved within 2 hours, and the drug is eliminated with a half-life of about 5 hours. in other studies, the analysis of urine samples of patients given 8 mg of tritiated albuterol orally showed that 76% of the dose was excreted over three days, with the majority of the dose being excreted within the first 24 hours. sixty percent of this radioactivity was shown to be the metabolite. feces collected over this period contained 4% of the administered dose. clinical trials in controlled clinical trials in patients with asthma, the onset of improvement in pulmonary function, as measured by maximum midexpiratory flow rate (mmef) and forced expiratory volume in 1 second (fev 1 ), was within 30 minutes after a dose of albuterol sulfate syrup, with peak improvement occurring between 2 and 3 hours. in a controlled clinical trial involving 55 children, clinically significant improvement (defined as maintaining a 15% or more increase in fev 1 and a 20% or more increase in mmef over baseline values) continued to be recorded up to 6 hours. no decrease in the effectiveness was reported in one uncontrolled study of 32 children who took albuterol sulfate syrup for a 3-month period.

How Supplied:

How supplied albuterol sulfate syrup, a clear, orange-yellow liquid with a strawberry flavor, contains 2 mg of albuterol (present as the sulfate) per 5 ml and is supplied in the following containers: 4 fl oz (120 ml) ndc 62135-189-41 16 fl oz (473 ml) ndc 62135-189-47 dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the usp/nf. store at 20º to 25ºc (68º to 77ºf) [see usp controlled room temperature]. manufactured by: chartwell pharmaceuticals, llc. congers, ny 10920 manufactured for: chartwell rx, llc congers, ny 10920 rev 05/2022 l70767

Package Label Principal Display Panel:

Package label.principal display panel albuterol sulfate syrup - ndc 62135-189-41 - 120 ml container label albuterol sulfate syrup - ndc 62135-189-47 - 473 ml container label image description image description


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