Phentolamine Mesylate

Precision Dose Inc.
Human Prescription Drug
NDC 68094-101

Phentolamine Mesylate is a human prescription drug labeled by 'Precision Dose Inc.'. National Drug Code (NDC) number for Phentolamine Mesylate is 68094-101. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Phentolamine Mesylate drug includes Phentolamine Mesylate - 5 mg/1 . The currest status of Phentolamine Mesylate drug is Active.

Drug Information:

Drug NDC:	68094-101
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:	Phentolamine Mesylate
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:	Phentolamine Mesylate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Precision Dose Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Injection
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:	PHENTOLAMINE MESYLATE - 5 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAMUSCULAR INTRAVENOUS
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:	15 Jul, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	28 Dec, 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:	ANDA207686
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:	Precision Dose Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1361023
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.
UNII:	Y7543E5K9T
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
68094-101-10	10 CARTON in 1 TRAY (68094-101-10) / 1 VIAL in 1 CARTON (68094-101-20) / 1 INJECTION in 1 VIAL	15 Jul, 2017	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.

Other medicines with the same generic name

Oraverse

Phentolamine Mesylate

Injection, Solution
Septodont, Inc.
NDC: 0362-0101

Product Elements:

Phentolamine mesylate phentolamine mesylate phentolamine mesylate phentolamine mannitol mannitol natural latex rubber

Drug Interactions:

Drug interactions see dosage and administration , diagnosis of pheochromocytoma , preparation .

Indications and Usage:

Indications and usage phentolamine mesylate for injection, usp is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision. phentolamine mesylate for injection, usp is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. phentolamine mesylate for injection, usp is also indicated for the diagnosis of pheochromocytoma by the phentolamine mesylate for injection, usp blocking test.

Warnings:

Warnings myocardial infarction, cerebrovascular spasm, and cerebrovascular occlusion have been reported to occur following the administration of phentolamine mesylate for injection, usp, usually in association with marked hypotensive episodes. for screening tests in patients with hypertension, the generally available urinary assay of catecholamines or other biochemical assays have largely replaced the phentolamine mesylate for injection, usp and other pharmacological tests for reasons of accuracy and safety. none of the chemical or pharmacological tests is infallible in the diagnosis of pheochromocytoma. the phentolamine mesylate for injection, usp blocking test is not the procedure of choice and should be reserved for cases in which additional confirmatory evidence is necessary and the relative risks involved in conducting the test have been considered.

General Precautions:

General tachycardia and cardiac arrhythmias may occur with the use of phentolamine mesylate for injection, usp or other alpha-adrenergic blocking agents. when possible, administration of cardiac glycosides should be deferred until cardiac rhythm returns to normal.

Dosage and Administration:

Dosage and administration the reconstituted solution should be used upon preparation and should not be stored. note: parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 1. prevention or control of hypertensive episodes in the patient with pheochromocytoma. for preoperative reduction of elevated blood pressure, 5 mg of phentolamine mesylate for injection, usp (1mg for children) is injected intravenously or intramuscularly 1 or 2 hours before surgery, and repeated if necessary. during surgery, phentolamine mesylate for injection, usp (5 mg for adults, 1 mg for children) is administered intravenously as indicated, to help prevent or control paroxysms of hypertension, tachycardia, respiratory depression, convulsions, or other effects of epinephrine intoxication. (postoperatively, norepinephrine may be given to control the hypotension that commonly follows complete removal of a pheoch Read more...

romocytoma.) 2. prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. for prevention: 10 mg of phentolamine mesylate for injection, usp is added to each liter of solution containing norepinephrine. the pressor effect of norepinephrine is not affected. for treatment: 5-10 mg of phentolamine mesylate for injection, usp in 10 ml of saline is injected into the area of extravasation within 12 hours. 3. diagnosis of pheochromocytoma â phentolamine mesylate for injection, usp blocking test. the test is most reliable in detecting pheochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. false-positive tests may occur in patients with hypertension without pheochromocytoma. a. intravenous preparation the contraindications , warnings , and precautions sections should be reviewed. sedatives, analgesics, and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 -72 hours, prior to the test. antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. this test is not performed on a patient who is normotensive. procedure the patient is kept at rest in the supine position throughout the test, preferably in a quiet, darkened room. injection of phentolamine mesylate for injection, usp is delayed until blood pressure is stabilized, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes. five milligrams of phentolamine mesylate for injection, usp is dissolved in 1ml of sterile water for injection. the dose for adults is 5 mg; for children, 1 mg. the syringe needle is inserted into the vein, and injection is delayed until pressor response to venipuncture has subsided. phentolamine mesylate for injection, usp is injected rapidly. blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes. interpretation a positive response, suggestive of pheochromocytoma, is indicated when the blood pressure is reduced more than 35 mmhg systolic and 25 mmhg diastolic. a typical positive response is a reduction in pressure of 60 mmhg systolic and 25 mmhg diastolic. usually, maximal effect is evident within 2 minutes after injection. a return to preinjection pressure commonly occurs within 15-30 minutes but may occur more rapidly. if blood pressure decreases to a dangerous level, the patient should be treated as outlined under overdosage . a positive response should always be confirmed by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites. a negative response is indicated when the blood pressure is elevated, unchanged, or reduced less than 35 mmhg, systolic and 25 mmhg diastolic after injection of phentolamine mesylate for injection, usp. a negative response to this test does not exclude the diagnosis of pheochromocytoma, especially in patients with paroxysmal hypertension in whom the incidence of false-negative responses is high. b. intramuscular if the intramuscular test for pheochromocytoma is preferred, preparation is the same as for the intravenous test. five milligrams of phentolamine mesylate for injection, usp is then dissolved in 1ml of sterile water for injection. the dose for adults is 5 mg intramuscularly; for children, 3 mg. blood pressure is recorded every 5 minutes for 30-45 minutes following injection. a positive response is indicated when the blood pressure is reduced 35 mmhg systolic and 25 mmhg diastolic, or more, within 20 minutes following injection.

1. prevention or control of hypertensive episodes in the patient with pheochromocytoma. for preoperative reduction of elevated blood pressure, 5 mg of phentolamine mesylate for injection, usp (1mg for children) is injected intravenously or intramuscularly 1 or 2 hours before surgery, and repeated if necessary. during surgery, phentolamine mesylate for injection, usp (5 mg for adults, 1 mg for children) is administered intravenously as indicated, to help prevent or control paroxysms of hypertension, tachycardia, respiratory depression, convulsions, or other effects of epinephrine intoxication. (postoperatively, norepinephrine may be given to control the hypotension that commonly follows complete removal of a pheochromocytoma.)

2. prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine. for prevention: 10 mg of phentolamine mesylate for injection, usp is added to each liter of solution containing norepinephrine. the pressor effect of norepinephrine is not affected. for treatment: 5-10 mg of phentolamine mesylate for injection, usp in 10 ml of saline is injected into the area of extravasation within 12 hours.

3. diagnosis of pheochromocytoma â phentolamine mesylate for injection, usp blocking test. the test is most reliable in detecting pheochromocytoma in patients with sustained hypertension and least reliable in those with paroxysmal hypertension. false-positive tests may occur in patients with hypertension without pheochromocytoma.

A. intravenous preparation the contraindications , warnings , and precautions sections should be reviewed. sedatives, analgesics, and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 -72 hours, prior to the test. antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. this test is not performed on a patient who is normotensive. procedure the patient is kept at rest in the supine position throughout the test, preferably in a quiet, darkened room. injection of phentolamine mesylate for injection, usp is delayed until blood pressure is stabilized, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes. five milligrams of phentolamine mesylate for injection, usp is dissolved in 1ml of sterile water for injection. the dose for adults is 5 mg; for children, 1 mg. the syringe needle is inserted into the vein, and Read more...

injection is delayed until pressor response to venipuncture has subsided. phentolamine mesylate for injection, usp is injected rapidly. blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes. interpretation a positive response, suggestive of pheochromocytoma, is indicated when the blood pressure is reduced more than 35 mmhg systolic and 25 mmhg diastolic. a typical positive response is a reduction in pressure of 60 mmhg systolic and 25 mmhg diastolic. usually, maximal effect is evident within 2 minutes after injection. a return to preinjection pressure commonly occurs within 15-30 minutes but may occur more rapidly. if blood pressure decreases to a dangerous level, the patient should be treated as outlined under overdosage . a positive response should always be confirmed by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites. a negative response is indicated when the blood pressure is elevated, unchanged, or reduced less than 35 mmhg, systolic and 25 mmhg diastolic after injection of phentolamine mesylate for injection, usp. a negative response to this test does not exclude the diagnosis of pheochromocytoma, especially in patients with paroxysmal hypertension in whom the incidence of false-negative responses is high.

Preparation the contraindications , warnings , and precautions sections should be reviewed. sedatives, analgesics, and all other medications except those that might be deemed essential (such as digitalis and insulin) are withheld for at least 24 hours, and preferably 48 -72 hours, prior to the test. antihypertensive drugs are withheld until blood pressure returns to the untreated, hypertensive level. this test is not performed on a patient who is normotensive.

Procedure the patient is kept at rest in the supine position throughout the test, preferably in a quiet, darkened room. injection of phentolamine mesylate for injection, usp is delayed until blood pressure is stabilized, as evidenced by blood pressure readings taken every 10 minutes for at least 30 minutes. five milligrams of phentolamine mesylate for injection, usp is dissolved in 1ml of sterile water for injection. the dose for adults is 5 mg; for children, 1 mg. the syringe needle is inserted into the vein, and injection is delayed until pressor response to venipuncture has subsided. phentolamine mesylate for injection, usp is injected rapidly. blood pressure is recorded immediately after injection, at 30-second intervals for the first 3 minutes, and at 60-second intervals for the next 7 minutes.

Interpretation a positive response, suggestive of pheochromocytoma, is indicated when the blood pressure is reduced more than 35 mmhg systolic and 25 mmhg diastolic. a typical positive response is a reduction in pressure of 60 mmhg systolic and 25 mmhg diastolic. usually, maximal effect is evident within 2 minutes after injection. a return to preinjection pressure commonly occurs within 15-30 minutes but may occur more rapidly. if blood pressure decreases to a dangerous level, the patient should be treated as outlined under overdosage . a positive response should always be confirmed by other diagnostic procedures, preferably by measurement of urinary catecholamines or their metabolites. a negative response is indicated when the blood pressure is elevated, unchanged, or reduced less than 35 mmhg, systolic and 25 mmhg diastolic after injection of phentolamine mesylate for injection, usp. a negative response to this test does not exclude the diagnosis of pheochromocytoma, especially in pa Read more...

tients with paroxysmal hypertension in whom the incidence of false-negative responses is high.

B. intramuscular if the intramuscular test for pheochromocytoma is preferred, preparation is the same as for the intravenous test. five milligrams of phentolamine mesylate for injection, usp is then dissolved in 1ml of sterile water for injection. the dose for adults is 5 mg intramuscularly; for children, 3 mg. blood pressure is recorded every 5 minutes for 30-45 minutes following injection. a positive response is indicated when the blood pressure is reduced 35 mmhg systolic and 25 mmhg diastolic, or more, within 20 minutes following injection.

Contraindications:

Contraindications myocardial infarction, history of myocardial infarction, coronary insufficiency, angina or other evidence suggestive of coronary artery disease; hypersensitivity to phentolamine or related compounds.

Adverse Reactions:

Adverse reactions acute and prolonged hypotensive episodes, tachycardia, and cardiac arrhythmias have been reported. in addition, weakness, dizziness, flushing, orthostatic hypotension, nasal stuffiness, nausea, vomiting, and diarrhea may occur. to report suspected adverse reactions, contact precision dose inc. at 1-844-668-3942 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

Drug Interactions:

Drug interactions see dosage and administration , diagnosis of pheochromocytoma , preparation .

Use in Pregnancy:

Pregnancy category c administration of phentolamine mesylate for injection, usp to pregnant rats and mice at oral doses 24-30 times the usual daily human dose (based on a 60-kg human) resulted in slightly decreased growth and slight skeletal immaturity of the fetuses. immaturity was manifested by increased incidence of incomplete or unossified calcanei and phalangeal nuclei of the hind limb and of incompletely ossified sternebrae. at oral doses 60 times the usual daily human dose (based on a 60-kg human), a slightly lower rate of implantation was found in the rat. phentolamine mesylate for injection, usp did not affect embryonic or fetal development in the rabbit at oral doses 20 times the usual daily human dose (based on a 60-kg human). no teratogenic or embryo toxic effects were observed in the rat, mouse, or rabbit studies. there are no adequate and well-controlled studies in pregnant women. phentolamine mesylate for injection, usp should be used during pregnancy only if the potenti Read more...

al benefit justifies the potential risk to the fetus.

Overdosage:

Overdosage acute toxicity no deaths due to acute poisoning with phentolamine mesylate for injection, usp have been reported. oral ld 50 's (mg/kg): mice, 1000; rats, 1250. signs and symptoms overdosage with phentolamine mesylate for injection, usp is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock. in addition, the following might occur: excitation, headache, sweating, pupillary contraction, visual disturbances; nausea, vomiting, diarrhea; hypoglycemia. treatment there is no specific antidote. a decrease in blood pressure to dangerous levels or other evidence of shock like conditions should be treated vigorously and promptly. the patient's legs should be kept raised and a plasma expander should be administered. if necessary, intravenous infusion of norepinephrine, titrated to maintain blood pressure at the normotensive level, and all available supportive measures should be included. epinephrine should not be used, since it may cause a paradoxical reduction in blood pressure.

Acute toxicity no deaths due to acute poisoning with phentolamine mesylate for injection, usp have been reported. oral ld 50 's (mg/kg): mice, 1000; rats, 1250.

Signs and symptoms overdosage with phentolamine mesylate for injection, usp is characterized chiefly by cardiovascular disturbances, such as arrhythmias, tachycardia, hypotension, and possibly shock. in addition, the following might occur: excitation, headache, sweating, pupillary contraction, visual disturbances; nausea, vomiting, diarrhea; hypoglycemia.

Treatment there is no specific antidote. a decrease in blood pressure to dangerous levels or other evidence of shock like conditions should be treated vigorously and promptly. the patient's legs should be kept raised and a plasma expander should be administered. if necessary, intravenous infusion of norepinephrine, titrated to maintain blood pressure at the normotensive level, and all available supportive measures should be included. epinephrine should not be used, since it may cause a paradoxical reduction in blood pressure.

Description:

Description phentolamine mesylate for injection, usp is an antihypertensive, available in vials for intravenous and intramuscular administration. each vial contains phentolamine mesylate, usp, 5 mg, and mannitol usp, 25 mg, in sterile, lyophilized form. phentolamine mesylate, usp is 4,5-dihydro-2-[n-( m -hydroxyphenyl)-n-( p -methylphenyl) amino methyl]-1 h - imidazole 1:1 methanesulfonate, and its structural formula is phentolamine mesylate, usp is a white or off-white, odorless crystalline powder with a molecular weight of 377.46. its solutions are acid to litmus. it is freely soluble in water and in alcohol, and slightly soluble in chloroform. it melts at about 178Â°c. chemical structure

Clinical Pharmacology:

Clinical pharmacology phentolamine mesylate for injection, usp produces an alpha-adrenergic block of relatively short duration. it also has direct, but less marked, positive inotropic and chronotropic effects on cardiac muscle and vasodilator effects on vascular smooth muscle. phentolamine mesylate for injection, usp has a half-life in the blood of 19 minutes following intravenous administration. approximately 13% of a single intravenous dose appears in the urine as unchanged drug.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility long-term carcinogenicity studies, mutagenicity studies, and fertility studies have not been conducted with phentolamine mesylate for injection, usp .

How Supplied:

How supplied vialsâ each containing 5 mg of phentolamine mesylate, usp, and 25 mg of mannitol, usp, in sterile, lyophilized form. trays of 10 with ndc 68094-101-10 cartons of 1 with ndc 68094-101-20 the reconstituted solution should be used upon preparation and should not be stored. store at 20Â° to 25Â°c (68Â° - 77Â°f) with excursions between 15Â° to 30Â°c (59Â° to 86Â°f) [usp controlled room temperature] you can also call precision dose inc. at 1-800-397-9228 or visit www.precisiondose.com. distributed by: precision dose, inc. south beloit, il 61080 revised: 10/2017

Package Label Principal Display Panel:

Principal display panel - 5 mg vial carton ndc 68094- 101 -20 1 vial phentolamine mesylate for injection, usp 5 mg/vial for im or iv use lyophilized rx only precisiondose principal display panel - 5 mg vial carton

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