NDC 54868-6266 Hydralazine Hydrochloride

NDC Product Code 54868-6266

NDC 54868-6266-0

Package Description: 10 VIAL, SINGLE-DOSE in 1 BOX > 1 mL in 1 VIAL, SINGLE-DOSE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Hydralazine Hydrochloride with NDC 54868-6266 is a product labeled by Physicians Total Care, Inc.. The generic name of Hydralazine Hydrochloride is . The product's dosage form is and is administered via form.

Labeler Name: Physicians Total Care, Inc.

Dosage Form: -

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Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Physicians Total Care, Inc.
Labeler Code: 54868
Start Marketing Date: 05-17-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Hydralazine

Hydralazine is pronounced as (hye dral' a zeen)

Why is hydralazine medication prescribed?
Hydralazine is used to treat high blood pressure. Hydralazine is in a class of medications called vasodilators. It works by relaxing the blood vessels so that blood can f...
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Hydralazine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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Description

Hydralazine Hydrochloride Injection, USP is an antihypertensive
available in a 1 mL vial for intravenous and intramuscular administration.
Hydralazine Hydrochloride Injection USP is a sterile, nonpyrogenic colorless
solution.Each mL contains:Active:
Hydralazine Hydrochloride USP, 20 mgPreservatives:
Methylparaben NF, 0.65 mg; Propylparaben NF, 0.35 mgInactives: Propylene Glycol USP, 103.6 mg; Sodium Hydroxide
and/or Hydrochloric Acid USP to adjust pH (3.4 to 4.4) and Water for Injection.
Hydralazine Hydrochloride USP is 1-hydrazinophthalazine monohydrochloride, and
its structural formula is:Molecular Formula C8H8N4•HClHydralazine 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 275°C, with decomposition, and has a
molecular weight of 196.64.

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 juxtaglomerular 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.

Indications And Usage

Severe essential hypertension when the drug cannot be given
orally or when there is an urgent need to lower blood pressure.

Contraindications

Hypersensitivity to hydralazine; coronary artery disease; mitral
valvular rheumatic heart disease.

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.)

Precautions

GeneralMyocardial stimulation produced by hydralazine can cause anginal
attacks and ECG changes of myocardial ischemia. The drug has been implicated in
the production of myocardial infarction. It must, therefore, be used with
caution in patients with suspected coronary artery disease.The "hyperdynamic" circulation caused by hydralazine may accentuate specific
cardiovascular inadequacies. For example, hydralazine may increase pulmonary
artery pressure in patients with mitral valvular disease. The drug may reduce
the pressor responses to epinephrine. Postural hypotension may result from
hydralazine hydrochloride but is less common than with ganglionic blocking
agents. It should be used with caution in patients with cerebral vascular
accidents.In hypertensive patients with normal kidneys who are treated with
hydralazine, there is evidence of increased renal blood flow and a maintenance
of glomerular filtration rate. In some instances where control values were below
normal, improved renal function has been noted after administration of
hydralazine. However, as with any antihypertensive agent, hydralazine should be
used with caution in patients with advanced renal damage.Peripheral neuritis, evidenced by paresthesia, numbness, and tingling, has
been observed. Published evidence suggests an antipyridoxine effect, and that
pyridoxine should be added to the regimen if symptoms develop.Laboratory TestsComplete blood counts and antinuclear antibody titer
determinations are indicated before and periodically during prolonged therapy
with hydralazine even though the patient is asymptomatic. These studies are also
indicated if the patient develops arthralgia, fever, chest pain, continued
malaise, or other unexplained signs or symptoms.A positive antinuclear antibody titer requires that the physician carefully
weigh the implications of the test results against the benefits to be derived
from antihypertensive therapy with hydralazine hydrochloride.Blood dyscrasias, consisting of reduction in hemoglobin and red cell count,
leukopenia, agranulocytosis, and purpura, have been reported. If such
abnormalities develop, therapy should be discontinued.Drug InteractionsMAO inhibitors should be used with caution in patients receiving
hydralazine.When other potent parenteral antihypertensive drugs, such as diazoxide, are
used in combination with hydralazine, patients should be continuously observed
for several hours for any excessive fall in blood pressure. Profound hypotensive
episodes may occur when diazoxide injection and hydralazine injection are used
concomitantly.Carcinogenesis, Mutagenesis, Impairment of
FertilityIn a lifetime study in Swiss albino mice, there was a
statistically significant increase in the incidence of lung tumors (adenomas and
adenocarcinomas) of both male and female mice given hydralazine continuously in
their drinking water at a dosage of about 250 mg/kg per day (about 80 times the
maximum recommended human dose). In a 2-year carcinogenicity study of rats given
hydralazine by gavage at dose levels of 15, 30, and 60 mg/kg/day (approximately
5 to 20 times the recommended human daily dosage), microscopic examination of
the liver revealed a small, but statistically significant, increase in benign
neoplastic nodules in male and female rats from the high-dose group and in
female rats from the intermediate-dose group. Benign interstitial cell tumors of
the testes were also significantly increased in male rats from the high-dose
group. The tumors observed are common in aged rats and a significantly increased
incidence was not observed until 18 months of treatment. Hydralazine was shown
to be mutagenic in bacterial systems (Gene Mutation and DNA Repair) and in one
of two rats and one rabbit hepatocyte in vitro DNA
repair studies.Additional in vivo and in
vitro studies using lymphoma cells, germinal cells, and fibroblasts from
mice, bone marrow cells from Chinese hamsters and fibroblasts from human cell
lines did not demonstrate any mutagenic potential for hydralazine.The extent to which these findings indicate a risk to man is uncertain. While
long-term clinical observation has not suggested that human cancer is associated
with hydralazine use, epidemiologic studies have so far been insufficient to
arrive at any conclusions.PregnancyTeratogenic effectsPregnancy Category CAnimal studies indicate that hydralazine is teratogenic in mice
at 20-30 times the maximum daily dose of 200-300 mg and possibly in rabbits at
10-15 times the maximum daily human dose, but that it is nonteratogenic in rats.
Teratogenic effects observed were cleft palate and malformations of facial and
cranial bones.There are no adequate and well-controlled studies in pregnant women. Although
clinical experience does not include any positive evidence of adverse effects on
the human fetus, hydralazine should be used during pregnancy only if the
expected benefit justifies the potential risk to the fetus.Nursing MothersIt is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when
hydralazine injection is administered to a nursing woman.Pediatric UseSafety and effectiveness in pediatric patients have not been
established in controlled clinical trials, although there is experience with the
use of hydralazine hydrochloride in children. The usual recommended parenteral
dosage, administered intramuscularly or intravenously, is 1.7-3.5 mg/kg of body
weight daily, divided into four to six doses.

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 Reactions: rash, urticaria, pruritus, fever,
chills, arthralgia, eosinophilia, and, rarely, hepatitis.Other: nasal congestion, flushing, lacrimation,
conjunctivitis.

Overdosage

Acute Toxicity:No deaths due to acute poisoning have been reported.Highest
known dose survived: adults, 10 g orally.Oral LD50 in
rats: 173 and 187 mg/kg.Signs and SymptomsSigns 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.TreatmentThere 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.

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. It should
not be added to infusion solutions. Hydralazine hydrochloride injection may
discolor upon contact with metal; discolored solutions should be discarded.Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container
permit.

How Supplied

Hydralazine Hydrochloride Injection USP, 20 mg/mL1 mL Single Dose VialPackaged in boxes of 10NDC 54868-6266-0StorageStore at 20° to 25°C (68° to 77°F) [see USP Controlled Room
Temperature].Manufactured by: Akorn Inc.Lake Forest, IL 60045HY00NRev. 04/09Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK      74146

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