Carbinoxamine Maleate

Breckenridge Pharmaceutical, Inc.
Human Prescription Drug
NDC 51991-333

Carbinoxamine Maleate is a human prescription drug labeled by 'Breckenridge Pharmaceutical, Inc.'. National Drug Code (NDC) number for Carbinoxamine Maleate is 51991-333. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Carbinoxamine Maleate drug includes Carbinoxamine Maleate - 4 mg/1 . The currest status of Carbinoxamine Maleate drug is Active.

Drug Information:

Drug NDC:	51991-333
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:	Carbinoxamine Maleate
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:	Carbinoxamine Maleate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Breckenridge Pharmaceutical, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
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:	CARBINOXAMINE MALEATE - 4 mg/1
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:	10 Dec, 2012
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	09 Jun, 2025
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:	ANDA040442
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:	22 Dec, 2025
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:	Breckenridge Pharmaceutical, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1010696 1012904
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:	0351991333012 0351991334040
UPC stands for Universal Product Code.
UNII:	02O55696WH
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:	Histamine H1 Receptor Antagonists [MoA] Histamine-1 Receptor Antagonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
51991-333-01	100 TABLET in 1 BOTTLE, PLASTIC (51991-333-01)	10 Dec, 2012	09 Jun, 2025	No
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.

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Karbinal Er

Product Elements:

Carbinoxamine maleate carbinoxamine maleate anhydrous lactose cellulose, microcrystalline magnesium stearate sodium starch glycolate type a potato carbinoxamine maleate carbinoxamine 109;c carbinoxamine maleate carbinoxamine maleate anhydrous citric acid glycerin methylparaben propylene glycol propylparaben sodium citrate sorbitol water carbinoxamine maleate carbinoxamine

Drug Interactions:

Drug interactions monoamine oxidase inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. carbinoxamine maleate has additive effects with alcohol and other cns depressants (hypnotics sedatives, tranquilizers, etc.).

Indications and Usage:

Indications and usage carbinoxamine maleate is effective for the symptomatic treatment of: seasonal and perennial allergic rhinitis. vasomotor rhinitis. allergic conjunctivitis due to inhalant allergens and foods. mild, uncomplicated allergic skin manifestations of urticaria and angioedema. dermatographism. as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. amelioration of the severity of allergic reactions to blood or plasma.

Warnings:

Warnings deaths have been reported in children less than 2 years of age who were taking antihistamines, including carbinoxamine-containing drug products, therefore, carbinoxamine maleate is contraindicated in children younger than 2 years of age (see contraindications ). antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction.

General Precautions:

General as many other antihistamines, carbinoxamine maleate has an atropine-like action and, therefore, should be used with caution in patients with: increased intraocular pressure, hyperthyroidism, cardiovascular disease, hypertension. antihistamines such as carbinoxamine maleate should not be used to treat lower respiratory tract symptoms, including asthma.

Dosage and Administration:

Dosage and administration carbinoxamine maleate is contraindicated in children younger than 2 years of age (see contraindications ). carbinoxamine maleate should be taken on an empty stomach with water. dosage should be individualized according to the needs and the response of the patient. carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. the drug is well tolerated in adults in doses as high as 24 mg daily, in divided doses, over prolonged periods. on the other hand, some patients respond to as little as 4 mg daily. clinical experience suggests the following dosage schedules: tablets usual adult dosage: 1 or 2 tablets (4 to 8 mg) 3 to 4 times daily usual childâs dosage: six to eleven years â 1/2 to 1 tablet (2 to 4 mg) 3 to 4 times daily. oral solution usual adult dosage: 1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily usual child's dosage (approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 doses): six to el Read more...

even years - Â½ to 1 teaspoonful (2 to 4 mg) 3 to 4 times daily. dosing for children 2 to 5 years of age should be based on weight whenever possible. the usual dosage for children 2 to 5 years of age is approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 daily doses. in general, this corresponds to a dose of 1/4 to 1/2 teaspoonful (1 to 2 mg) 3 to 4 times daily.

Contraindications:

Contraindications carbinoxamine maleate is contraindicated in children younger than 2 years of age. carbinoxamine maleate is contraindicated in nursing mothers. carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy. (see drug interactions section).

Adverse Reactions:

Adverse reactions the most frequent adverse reactions are underlined: body as a whole: urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. cardiovascular: hypotension, headache, palpitations, tachycardia, extrasystoles. hematologic: hemolytic anemia, thrombocytopenia, agranulocytosis. central nervous system: sedation , sleepiness , dizziness , disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. gastrointestinal: epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. urogenital: urinary frequency, difficult urination, urinary retention, early menses. respiratory: thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Drug Interactions:

Use in Pregnancy:

Pregnancy pregnancy category c : animal reproductive studies have not been conducted with carbinoxamine maleate. it is also not known whether carbinoxamine maleate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. carbinoxamine maleate should be given to a pregnant woman only if clearly needed

Pediatric Use:

Pediatric use carbinoxamine maleate is contraindicated in children younger than 2 years of age (see contraindications ). neonates have an increased susceptibility to anticholinergic side effects, such as cns excitation, which may lead to convulsions. carbinoxamine maleate may diminish mental alertness in children. in the young child, particularly, they may produce excitation.

Geriatric Use:

Geriatric use carbixonaxime maleate is more likely to cause dizziness, sedation, and hypotension in elderly patients (approximately 60 years or older). sedating drugs may also cause confusion and over sedation in the elderly. therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic renal, or cardiac function, and of concomitant disease or other drug therapy.

Overdosage:

Overdosage manifestations: antihistamine overdosage reactions may vary from central nervous system depression to stimulation. stimulation is particularly likely in children. atropine-like signs and symptoms - dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur. especially in infants and children, antihistamine overdosage may cause hallucinations, convulsions, or death. the oral ld 50 of carbinoxamine maleate in guinea pigs is 411 mg/kg. treatement: the treatment of overdosage with carbinoxamine maleate is essentially symptomatic and supportive. vital signs (including respiration, pulse, blood pressure, and temperature) and ekg should be monitored. induction of vomiting is not recommended. activated charcoal should be given and gastric lavage should be considered after ingestion of a potentially life-threatening amount of drug. in the presence of severe anticholinergic effects, physostigmine may be useful. vasopressors may be used to treat hypotension.

Description:

Description carbinoxamine maleate is a histamine-h 1 receptor blocking agent. each tablet contains 4 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. each 5 ml (teaspoonful) of oral solution contains 4 mg carbinoxamine maleate and the following inactive ingredients: artificial bubble gum flavor, citric acid (anhydrous), glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate (hydrous) and sorbitol solution. carbinoxamine maleate is freely soluble in water. its structure is: 2-[(4-chlorophenyl)-2-pyridinylmethoxy]- n , n -dimethylethanamine (z)-2-butenedioate (1:1) c 16 h 19 cin 2 oâc 4 h 4 o 4 mw = 406.86 carbinoxamine maleate chemical structure

Clinical Pharmacology:

Clinical pharmacology mechanism of action carbinoxamine maleate, an ethanolamine derivative, is an antihistamine with anticholinergic (drying) and sedative properties. carbinoxamine appears to compete with histamine (type h1) for receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract. pharmacokinetics and metabolism carbinoxamine is well absorbed from the gi tract and appears to be extensively metabolized by the liver, and excreted in the urine as inactive metabolites within 24 hours. virtually no intact drug is extended in the urine. in a study comparing a controlled-release suspension and a solution of carbinoxamine, healthy volunteers were administered a single dose of 8 mg carbinoxamine. a time to maximum concentration (tmax) was between 1.5 hours to 5 hours, a peak plasma concentration (cmax) of about 24 ng/ml was observed and extent of exposure (auc) was about 286 ng hr/ml. the serum half-life is reported to be 10 to 20 hours. drug/foo Read more...

d interactions carbinoxamine should not be used in patients with hypersensitivity to carbinoxamine. carbinoxamine may increase the effects of other drugs such as barbiturates, tcas, mao inhibitors such as phenelzine (nardil), tranylcypromine (parnate), or selegiline (eldepryl), alcohol, other antihistamines, and cns depressants. carbinoxamine can be taken with or without food. cardiovascular effects cardiac effects, including prolongation of qt interval have not been adequately studied. unlike other newer antihistamines, severe adverse cardiovascular effects are uncommon, and usually limited to over dosage situations. special populations pediatric patients carbinoxamine should not be used in newborn or premature infants. neonates have an increased susceptibility to anticholinergic side effects, such as cns excitation, which may lead to convulsions. pregnancy and lactation safe use of carbinoxamine during pregnancy has not been established. therefore, carbinoxamine should not be used in women who are, or may become pregnant. carbinoxamine is in the fda pregnancy category c. women who are breast-feeding should avoid use of carbinoxamine, since small amounts appear to be distributed into breast milk. geriatric patients carbinoxamine is more likely to cause dizziness, sedation, and hypotension in elderly patients. the incidence of adverse reactions is higher in the elderly; therefore, a dosing adjustment may be necessary in this sub-population.

Mechanism of Action:

Mechanism of action carbinoxamine maleate, an ethanolamine derivative, is an antihistamine with anticholinergic (drying) and sedative properties. carbinoxamine appears to compete with histamine (type h1) for receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract.

Pharmacokinetics:

Pharmacokinetics and metabolism carbinoxamine is well absorbed from the gi tract and appears to be extensively metabolized by the liver, and excreted in the urine as inactive metabolites within 24 hours. virtually no intact drug is extended in the urine. in a study comparing a controlled-release suspension and a solution of carbinoxamine, healthy volunteers were administered a single dose of 8 mg carbinoxamine. a time to maximum concentration (tmax) was between 1.5 hours to 5 hours, a peak plasma concentration (cmax) of about 24 ng/ml was observed and extent of exposure (auc) was about 286 ng hr/ml. the serum half-life is reported to be 10 to 20 hours.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility no long-term studies in animals have been performed to determine the possible effects of carbinoxamine maleate on carcinogenesis, mutagenesis, and fertility.

How Supplied:

How supplied carbinoxamine maleate tablets, usp 4 mg are supplied as white, round, scored tablets, debossed â109â on one side and score over âcâ on the other side, and is supplied in bottles of 100 tablets, ndc 51991-333-01. carbinoxamine maleate oral solution, 4 mg/5 ml is supplied as clear, colorless liquid with a bubble gum aroma, and is supplied in 4 fl. oz. bottles, ndc 51991-334-04.

Information for Patients:

Information for patients carbinoxamine maleate may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. avoid alcoholic beverages while taking this product. do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. use caution when driving a motor vehicle or operating machinery.

Package Label Principal Display Panel:

Package label - principal display panel - 100 count bottle carbinoxamine maleate tablets

Package label - principal display panel - 4 fl oz bottle carbinoxamine maleate oral solution

Comments/ Reviews:

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