Hydralazine Hydrochloride

Medical Purchasing Solutions, Llc
Human Prescription Drug
NDC 71872-7145

Hydralazine Hydrochloride is a human prescription drug labeled by 'Medical Purchasing Solutions, Llc'. National Drug Code (NDC) number for Hydralazine Hydrochloride is 71872-7145. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Hydralazine Hydrochloride drug includes Hydralazine Hydrochloride - 20 mg/mL . The currest status of Hydralazine Hydrochloride drug is Active.

Drug Information:

Drug NDC:	71872-7145
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:	Hydralazine Hydrochloride
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:	Hydralazine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Medical Purchasing Solutions, Llc
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:	HYDRALAZINE HYDROCHLORIDE - 20 mg/mL
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:	05 Sep, 2001
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	30 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:	ANDA040388
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:	Medical Purchasing Solutions, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	966571
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.
UNII:	FD171B778Y
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:	Arteriolar Vasodilation [PE] Arteriolar Vasodilator [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
71872-7145-1	1 VIAL, SINGLE-DOSE in 1 BAG (71872-7145-1) / 1 mL in 1 VIAL, SINGLE-DOSE	04 Oct, 2018	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.

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Hydralazine

Hydralazine Hydrochloride

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Hydralazine Hydrochloride

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Hydralazine Hydrochloride

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Product Elements:

Hydralazine hydrochloride hydralazine hydrochloride propylene glycol methylparaben propylparaben hydrochloric acid sodium hydroxide hydralazine hydrochloride hydralazine

Indications and Usage:

Indications and usage: severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.

Warnings:

Warnings: in a few patients, hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. in such patients, hydralazine should be discontinued unless the benefit-to-risk determination requires continued antihypertensive therapy with this drug. symptoms and signs usually regress when the drug is discontinued but residua have been detected many years later. long-term treatment with steroids may be necessary (see precautions , laboratory tests ).

Dosage and Administration:

Dosage and administration: when there is urgent need, therapy in the hospitalized patient may be initiated intramuscularly or as a rapid intravenous bolus injection directly into the vein. hydralazine hydrochloride injection should be used only when the drug cannot be given orally. the usual dose is 20-40 mg, repeated as necessary. certain patients (especially those with marked renal damage) may require a lower dose. blood pressure should be checked frequently. it may begin to fall within a few minutes after injection, with the average maximal decrease occurring in 10-80 minutes. in cases where there has been increased intracranial pressure, lowering the blood pressure may increase cerebral ischemia. most patients can be transferred to oral hydralazine hydrochloride within 24-48 hours. the product should be used immediately after the vial is opened. the product should not be added to infusion solutions. hydralazine hydrochloride injection may discolor upon contact with metal; discolore Read more...

d solutions should be discarded. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Contraindications:

Contraindications: hypersensitivity to hydralazine, coronary artery disease, mitral valvular rheumatic heart disease.

Adverse Reactions:

Adverse reactions: adverse reactions with hydralazine hydrochloride are usually reversible when dosage is reduced. however, in some cases it may be necessary to discontinue the drug. the following adverse reactions have been observed, but there has not been enough systematic collection of data to support an estimate of their frequency. common: headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris. less frequent: digestive -constipation, paralytic ileus. cardiovascular - hypotension, paradoxical pressor response, edema. respiratory - dyspnea. neurologic - peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps, psychotic reactions characterized by depression, disorientation, or anxiety. genitourinary - difficulty in urination. hematologic - blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. hypersensitive reac Read more...

tions - rash, urticaria, pruritis, fever, chills, arthralgia, eosinophilia, and, rarely, hepatitis. other - nasal congestion, flushing, lacrimation, conjunctivitis.

Overdosage:

Overdosage: acute toxicity no deaths due to acute poisoning have been reported. highest known dose survived: adults, 10 g orally. oral ld 50 in rats: 173 and 187 mg/kg. signs and symptoms signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock. treatment there is no specific antidote. support of the cardiovascular system is of primary importance. shock should be treated with plasma expanders. if possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia. tachycardia responds to beta blockers. digitalization may be necessary, and renal function should be monitored and supported as required. no experience has been reported with extracorporeal or peritoneal dialysis.

Acute toxicity no deaths due to acute poisoning have been reported. highest known dose survived: adults, 10 g orally. oral ld 50 in rats: 173 and 187 mg/kg.

Signs and symptoms signs and symptoms of overdosage include hypotension, tachycardia, headache, and generalized skin flushing. complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock.

Treatment there is no specific antidote. support of the cardiovascular system is of primary importance. shock should be treated with plasma expanders. if possible, vasopressors should not be given, but if a vasopressor is required, care should be taken not to precipitate or aggravate cardiac arrhythmia. tachycardia responds to beta blockers. digitalization may be necessary, and renal function should be monitored and supported as required. no experience has been reported with extracorporeal or peritoneal dialysis.

Description:

Description: rx only hydralazine hydrochloride injection, usp is an antihypertensive available in a 2 ml vial for intravenous and intramuscular administration. each ml of the sterile, nonpyrogenic colorless solution contains hydralazine hydrochloride usp, 20 mg; methylparaben nf, 0.65 mg; propylparaben nf, 0.35 mg; propylene glycol usp, 103.6 mg, and water for injection usp q.s. the ph of the solution is 3.4 to 4.4. ph may be adjusted with hydrochloric acid and/or sodium hydroxide. hydralazine hydrochloride is 1-hydrazinophthalazine monohydrochloride, and its structural formula is: hydralazine hydrochloride usp is a white to off-white, odorless crystalline powder. it is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. it melts at about 275Â°c, with decomposition. structure

Clinical Pharmacology:

Clinical pharmacology: although the precise mechanism of action of hydralazine is not fully understood, the major effects are on the cardiovascular system. hydralazine apparently lowers blood pressure by exerting a peripheral vasodilating effect through a direct relaxation of vascular smooth muscle. hydralazine, by altering cellular calcium metabolism, interferes with the calcium movements within the vascular smooth muscle that are responsible for initiating or maintaining the contractile state. the peripheral vasodilating effect of hydralazine results in decreased arterial blood pressure (diastolic more than systolic); decreased peripheral vascular resistance; and an increased heart rate, stroke volume and cardiac output. the preferential dilatation of arterioles, as compared to veins, minimizes postural hypotension and promotes the increase in cardiac output. hydralazine usually increases renin activity in plasma presumably as a result of increased secretion of renin by the renal jux Read more...

taglomerular cells in response to reflex sympathetic discharge. this increase in renin activity leads to the production of angiotensin ii, which then causes stimulation of aldosterone and consequent sodium reabsorption. hydralazine also maintains or increases renal and cerebral blood flow. the average maximal decrease in blood pressure usually occurs 10-80 minutes after administration of hydralazine hydrochloride injection. no other pharmacokinetic data on hydralazine hydrochloride injection are available.

How Supplied:

How supplied: product no. ndc no. 601401 63323-614-01 hydralazine hydrochloride injection, usp, 20 mg per ml, 1 ml fill, in a 2 ml single dose vial, 25 vials per tray. the container closure is not made with natural rubber latex. store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature].

Package Label Principal Display Panel:

Principal display panel - vial label hydralazine 1 ml single dose vial label hydralazine hydrochloride injection, usp 2 0 mg per ml for im or iv use. warning: discard unused portion 1 ml single dose vial rx only vial

Principal display panel - outer package ndc 71872-7145-1 rx only hydralazine hydrochloride injection, usp 20 mg/ml 1 - 1 ml single dose vial for intramuscular or intravenous use sterile pdp

Comments/ Reviews:

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