Drug Facts
Composition & Profile
Identifiers & Packaging
How Supplied HYDRALAZINE HYDROCHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1388-1 HYDRALAZINE HYDROCHLORIDE INJECTION, USP 20mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Hydralazine Hydrochloride Injection USP, 20 mg/mL Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 HY00N Rev. 06/16 How Supplied; Principal Display Panel, Vial Vial Labeling; Principal Display Panel, Serialized Labeling Serialized Labeling
- How Supplied HYDRALAZINE HYDROCHLORIDE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1388-1 HYDRALAZINE HYDROCHLORIDE INJECTION, USP 20mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Hydralazine Hydrochloride Injection USP, 20 mg/mL Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 HY00N Rev. 06/16 How Supplied
- Principal Display Panel, Vial Vial Labeling
- Principal Display Panel, Serialized Labeling Serialized Labeling
Overview
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 mg Preservatives: Methylparaben NF, 0.65 mg; Propylparaben NF, 0.35 mg Inactives: 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•HCl 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 275°C, with decomposition, and has a molecular weight of 196.64. Structure
Indications & Usage
Indications & Usage Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
Dosage & Administration
Dosage & 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.
Warnings & Precautions
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).
Contraindications
Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
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. Adverse Reactions
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