Hydralazine Hydrochloride
Generic: HYDRALAZINE HYDROCHLORIDE
Basic Information
Manufacturer
Cardinal Health 107, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
43ce0ecb-6d62-44bf-8539-823ae03eb9f4
Indications & Usage
INDICATIONS AND USAGE: Severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure.
Warnings
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 ).
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 ).
Adverse Reactions
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.
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.