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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DESCRIPTIONHydralazine Hydrochloride Injection, USP is an antihypertensive available in a 1 mL vial for intravenous and intramuscular administration. Hydralazine Hydrochloride Injection, USP is a sterile ...
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CLINICAL PHARMACOLOGYAlthough 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 ...
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INDICATIONS AND USAGESevere essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
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CONTRAINDICATIONSHypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.
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WARNINGSIn a few patients hydralazine may produce a clinical picture simulating systemic lupus erythematosus including glomerulonephritis. In such patients hydralazine should be discontinued unless the ...
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PRECAUTIONSGeneral - 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 ...
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ADVERSE REACTIONSAdverse 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 ...
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OVERDOSAGEAcute 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 ...
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DOSAGE AND ADMINISTRATIONWhen 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 ...
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HOW SUPPLIEDHydralazine 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 ...
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Principal Display Panel - Vial LabelNDC 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
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Principal Display Panel - Carton LabelNDC 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 ...
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