Hydralazine Hydrochloride (Page 2 of 2)

Nursing Mothers

Hydralazine has been shown to be excreted in breast milk.

Pediatric Use

Safety 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 to 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 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.

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 to 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 to 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 to 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/mL)

NDC 0517-0901-25 1 mL Single Dose Vial Packaged in boxes of 25

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN0901
Rev. 10/18
MG # 11928

PRINICIPAL DISPLAY PANEL — Container

NDC 0517-0901-01

Hydralazine Hydrochloride
Injection, USP
20 mg/mL

1 mL SINGLE DOSE VIAL
FOR IM OR IV USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

Container Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Carton

HydrALAZINE Hydrochloride
Injection,USP

20 mg/mL

NDC 0517-0901-25
25 X 1 mL
SINGLE DOSE VIALS

FOR INTRAMUSCULAR OR INTRAVENOUS USE

Rx Only

Each mL contains: Hydralazine Hydrochloride 20 mg, Propylene Glycol 103.6 mg, Methylparaben 0.65 mg, Propylparaben 0.35 mg, and Water for Injection q.s. pH of the solution is 3.4 — 4.4. pH may be adjusted with Hydrochloric Acid and/or Sodium Hydroxide.
Sterile, nonpyrogenic. For emergency use only in patients unable to take oral medication.WARNING: DISCARD UNUSED PORTION.
Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 10/18

Carton Labeling
(click image for full-size original)

Serialization Label

Serialization Label
(click image for full-size original)
HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-0901
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE) HYDRALAZINE HYDROCHLORIDE 20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL 103.6 mg in 1 mL
METHYLPARABEN 0.65 mg in 1 mL
PROPYLPARABEN 0.35 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-0901-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE
1 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-0901-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040136 06/30/1997
Labeler — American Regent, Inc. (002033710)
Establishment
Name Address ID/FEI Operations
American Regent, Inc. 002033710 ANALYSIS (0517-0901), MANUFACTURE (0517-0901), STERILIZE (0517-0901)

Revised: 05/2019 American Regent, Inc.

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