Hydralazine Hydrochloride (28 brand names, 3 dosage forms, 2 routes)
Available dosage forms: TABLET, INJECTABLE, CAPSULE.
Routes of administration: ORAL, INJECTION.
Brand Names
- APRESAZIDE
- APRESOLINE
- APRESOLINE-ESIDRIX
- BIDIL
- CAM-AP-ES
- DRALSERP
- DRALZINE
- HYDRA-ZIDE
- HYDRALAZINE AND HYDROCHLOROTHIAZIDE
- HYDRALAZINE HYDROCHLORIDE
- HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50
- HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25
- HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
- HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE
- HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE
- HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE
- HYDRAP-ES
- HYDROCHLOROTHIAZIDE W/ HYDRALAZINE
- HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE …and 8 more
Indications and Usage
Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
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. The product 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.
Contraindications
Hypersensitivity to hydralazine, coronary artery disease, mitral valvular rheumatic heart disease.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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, pruritis, fever, chills, arthralgia, eosinophilia, and, rarely, hepatitis. Other-nasal congestion, flushing, lacrimation, conjunctivitis.
Overdosage
No deaths due to acute poisoning have been reported. Highest known dose survived: adults, 10 g orally. Oral LD 50 in rats: 173 and 187 mg/kg.