Hydralazine has been shown to be excreted in breast milk.
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 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.
Headache, anorexia, nausea, vomiting, diarrhea, palpitations, tachycardia, angina pectoris.
Digestive: constipation, paralytic ileus.
Cardiovascular: hypotension, paradoxical pressor response, edema.
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.
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 of overdosage include hypotension, tachycardia, headache, and generalized skin flushing.
Complications can include myocardial ischemia and subsequent myocardial infarction, cardiac arrhythmia, and profound shock.
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.
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.
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).
SHIRLEY, NY 11967
MG # 11928
1 mL SINGLE DOSE VIAL
FOR IM OR IV USE
AMERICAN REGENT, INC.
SHIRLEY, NY 11967
25 X 1 mL
SINGLE DOSE VIALS
FOR INTRAMUSCULAR OR INTRAVENOUS USE
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.
SHIRLEY, NY 11967
|HYDRALAZINE HYDROCHLORIDE hydralazine hydrochloride injection, solution|
|Labeler — American Regent, Inc. (002033710)|
|American Regent, Inc.||002033710||ANALYSIS (0517-0901), MANUFACTURE (0517-0901), STERILIZE (0517-0901)|
Revised: 05/2019 American Regent, Inc.
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