Dibenzyline
Phenoxybenzamine Hydrochloride
Concordia Pharmaceuticals Inc.
Human Prescription Drug
NDC 59212-001Dibenzyline also known as Phenoxybenzamine Hydrochloride is a human prescription drug labeled by 'Concordia Pharmaceuticals Inc.'. National Drug Code (NDC) number for Dibenzyline is 59212-001. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Dibenzyline drug includes Phenoxybenzamine Hydrochloride - 10 mg/1 . The currest status of Dibenzyline drug is Active.
Drug Information:
| Drug NDC: | 59212-001 |
| 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: | Dibenzyline |
| 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: | Phenoxybenzamine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Concordia Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| 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: | PHENOXYBENZAMINE HYDROCHLORIDE - 10 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: | NDA |
| 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 Jan, 1953 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jan, 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: | NDA008708 |
| 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: | Concordia Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 861402
861404
|
| 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: | 0359212001016
|
| UPC stands for Universal Product Code. |
| UNII: | X1IEG24OHL
|
| 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 alpha-Antagonists [MoA]
alpha-Adrenergic Blocker [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 |
|---|
| 59212-001-01 | 100 CAPSULE in 1 BOTTLE (59212-001-01) | 26 Jan, 1953 | N/A | No |
| 59212-001-02 | 100 CAPSULE in 1 BOTTLE (59212-001-02) | 01 Sep, 2020 | N/A | 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. |
Product Elements:
Dibenzyline phenoxybenzamine hydrochloride phenoxybenzamine hydrochloride phenoxybenzamine d&c red no. 33 fd&c red no. 3 fd&c yellow no. 6 gelatin lactose red wpc;001;10;mg
Drug Interactions:
Drug interactions 2 dibenzyline (phenoxybenzamine hydrochloride) may interact with compounds that stimulate both alpha- and beta- adrenergic receptors (i.e., epinephrine) to produce an exaggerated hypotensive response and tachycardia. (see warning ) dibenzyline blocks hyperthermia production by levarterenol, and blocks hypothermia production by reserpine.
Indications and Usage:
Indication and usage dibenzyline is indicated in the treatment of pheochromocytoma, to control episodes of hypertension and sweating. if tachycardia is excessive, it may be necessary to use a beta -blocking agent concomitantly.
Warnings:
Warning dibenzyline-induced alpha -adrenergic blockade leaves beta -adrenergic receptors unopposed. compounds that stimulate both types of receptors may, therefore, produce an exaggerated hypotensive response and tachycardia.
Dosage and Administration:
Dosage and administration the dosage should be adjusted to fit the needs of each patient. small initial doses should be slowly increased until the desired effect is obtained or the side effects from blockade become troublesome. after each increase, the patient should be observed on that level before instituting another increase. the dosage should be carried to a point where symptomatic relief and/or objective improvement are obtained, but not so high that the side effects from blockade become troublesome. initially, 10 mg of dibenzyline (phenoxybenzamine hydrochloride) twice a day. dosage should be increased every other day, usually to 20 to 40 mg 2 or 3 times a day, until an optimal dosage is obtained, as judged by blood pressure control. long-term use of phenoxybenzamine is not recommended (see precautions carcinogenesis and mutagenesis ).
Contraindications:
Contraindications conditions where a fall in blood pressure may be undesirable; hypersensitivity to the drug or any of its components.
Adverse Reactions:
Adverse reactions the following adverse reactions have been observed, but there are insufficient data to support an estimate of their frequency. autonomic nervous system * : postural hypotension, tachycardia, inhibition of ejaculation, nasal congestion, miosis. * these so-called "side effects" are actually evidence of adrenergic blockade and vary according to the degree of blockade. miscellaneous: gastrointestinal irritation, drowsiness, fatigue. to report suspected adverse reactions, contact concordia pharmaceuticals at 1-877-370-1142 or fda at 1-800-fda-1088 or www.fda.gov/medwatch
Adverse Reactions Table:
| To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch |
Drug Interactions:
Drug interactions 2 dibenzyline (phenoxybenzamine hydrochloride) may interact with compounds that stimulate both alpha- and beta- adrenergic receptors (i.e., epinephrine) to produce an exaggerated hypotensive response and tachycardia. (see warning ) dibenzyline blocks hyperthermia production by levarterenol, and blocks hypothermia production by reserpine.
Use in Pregnancy:
Pregnancy teratogenic effects adequate reproductive studies in animals have not been performed with dibenzyline (phenoxybenzamine hydrochloride). it is also not known whether dibenzyline can cause fetal harm when administered to a pregnant woman. dibenzyline should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients have not been established.
Overdosage:
Overdosage symptoms â these are largely the result of blocking of the sympathetic nervous system and of the circulating epinephrine. they may include postural hypotension, resulting in dizziness or fainting; tachycardia, particularly postural; vomiting; lethargy; shock.
Description:
Description each dibenzyline capsule, with red cap and body, is imprinted wpc 001 and 10 mg, and contains 10 mg of phenoxybenzamine hydrochloride usp. inactive ingredients consist of d&c red no. 33, and fd&c red no. 3, fd&c yellow no. 6, gelatin nf, and lactose nf. dibenzyline is n -(2-chloroethyl)- n -(1-methyl-2-phenoxyethyl)benzylamine hydrochloride: phenoxybenzamine hydrochloride is a colorless, crystalline powder with a molecular weight of 340.3, which melts between 136° and 141°c. it is soluble in water, alcohol and chloroform; insoluble in ether. structure
Clinical Pharmacology:
Clinical pharmacology dibenzyline (phenoxybenzamine hydrochloride) is a long-acting, adrenergic, alpha -receptor-blocking agent, which can produce and maintain "chemical sympathectomy" by oral administration. it increases blood flow to the skin, mucosa and abdominal viscera, and lowers both supine and erect blood pressures. it has no effect on the parasympathetic system. twenty to 30 percent of orally administered phenoxybenzamine appears to be absorbed in the active form. 1 the half-life of orally administered phenoxybenzamine hydrochloride is not known; however, the half-life of intravenously administered drug is approximately 24 hours. demonstrable effects with intravenous administration persist for at least 3 to 4 days, and the effects of daily administration are cumulative for nearly a week. 1
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis and mutagenesis case reports of carcinoma in humans after long-term treatment with phenoxybenzamine have been reported. hence long-term use of phenoxybenzamine is not recommended. 3,4 carefully weigh the benefits and risks before prescribing this drug. phenoxybenzamine hydrochloride showed in vitro mutagenic activity in the ames test and mouse lymphoma assay; it did not show mutagenic activity in vivo in the micronucleus test in mice. in rats and mice, repeated intraperitoneal administration of phenoxybenzamine hydrochloride (three times per week for up to 52 weeks) resulted in peritoneal sarcomas. chronic oral dosing in rats (for up to 2 years) produced malignant tumors of the small intestine and non-glandular stomach, as well as ulcerative and/or erosive gastritis of the glandular stomach. whereas squamous cell carcinomas of the non-glandular stomach were observed at all tested doses of phenoxybenzamine hydrochloride, there was a no-observed-effect-level of 10 mg/kg fo
Read more...r tumors (carcinomas and sarcomas) of the small intestine. this dose is, on a body surface area basis, about twice the maximum recommended human dosage of 20 mg b.i.d.
How Supplied:
How supplied dibenzyline (phenoxybenzamine hydrochloride) capsules, 10 mg, in bottles of 100 (ndc 59212-001-01) and (ndc 59212-001-02)
Package Label Principal Display Panel:
Package label ndc 59212-001-01 dibenzyline ® (phenoxybenzamine hydrochloride capsules, usp) 10 mg 100 capsules r x only concordia pharmaceuticals bottle-label-100