Label: HYDRALAZINE HYDROCHLORIDE injection, solution

  • NDC Code(s): 0641-6231-01, 0641-6231-25
  • Packager: Hikma Pharmaceuticals USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 10, 2024

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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 ...
  • 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 ...
  • 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 ...
  • PRECAUTIONS
    General - Myocardial 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 ...
  • 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 ...
  • 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 ...
  • 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 ...
  • HOW SUPPLIED
    Hydralazine Hydrochloride Injection USP, 20 mg/mL - NDC 0641-6231-25 - 1 mL Single-dose Vial - Packaged in boxes of 25 - Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room ...
  • Principal Display Panel - Vial Label
    NDC 0641-6231-01     Rx only - hydrALAZINE - Hydrochloride - Injection, USP - 20 mg/mL - For IM or IV Use - Preservative-Free - Warning: Discard - Unused Portion - 1 mL Single Dose Vial
  • Principal Display Panel - Carton Label
    NDC 0641-6231-25        Rx only - hydrALAZINE - Hydrochloride Injection, USP - 20 mg/mL - For Intramuscular or - Intravenous Use - Preservative-Free - Warning: Discard Unused Portion - 25 X 1 mL Single ...
  • INGREDIENTS AND APPEARANCE
    Product Information