Hydralazine Hydrochloride
Generic: HYDRALAZINE HYDROCHLORIDE
Basic Information
Manufacturer
Ascend Laboratories, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e7bfec3d-5222-4a26-8f99-6c2a28e14aa6
Indications & Usage
INDICATIONS & USAGE Essential hypertension, alone or as an adjunct.
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 Adverse reactions with HydrALAZINE 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, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis.
Other: nasal congestion, flushing, lacrimation, conjunctivitis.
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, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis.
Other: nasal congestion, flushing, lacrimation, conjunctivitis.