HYDRALAZINE TABS 10 MG 100CT
Generic: Hydralazine Hydrochloride
HYDRALAZINE TABS 10 MG 100CT
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Identification
Hydralazine Hydrochloride
Hydralazine Hydrochloride
Camber Pharmaceuticals, Inc.
HUMAN PRESCRIPTION DRUG
Administration
TABLET
ORAL
ANDA040901
Active Ingredients
| Ingredient | Strength |
|---|---|
| HYDRALAZINE HYDROCHLORIDE | 10 mg/1 |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Clinical Drug Information
Indications & Usage
INDICATIONS AND 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.)
Dosage & Administration
DOSAGE AND ADMINISTRATION Initiate therapy in gradually increasing dosages; adjust according to individual response. Start with 10 mg four times daily for the first 2 to 4 days, increase to 25 mg four times daily for the balance of the first week. For the second and subsequent weeks, increase dosage to 50 mg four times daily. For maintenance, adjust dosage to the lowest effective levels. The incidence of toxic reactions, particularly the L.E. cell syndrome, is high in the group of patients receiving large doses of hydrALAZINE. In a few resistant patients, up to 300 mg of hydrALAZINE daily may be required for a significant antihypertensive effect. In such cases, a lower dosage of hydrALAZINE combined with a thiazide and/or reserpine or a beta blocker may be considered. However, when combining therapy, individual titration is essential to ensure the lowest possible therapeutic dose of each drug.
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. o Cardiovascular: hypotension, paradoxical pressor response, edema. o Respiratory: dyspnea o Neurologic: peripheral neuritis, evidenced by paresthesia, numbness, and tingling; dizziness; tremors; muscle cramps; psychotic reactions characterized by depression, disorientation, or anxiety. o Genitourinary: difficulty in urination o Hematologic: blood dyscrasias, consisting of reduction in hemoglobin and red cell count, leukopenia, agranulocytosis, purpura; lymphadenopathy; splenomegaly. o Hypersensitivity Reactions: rash, urticaria, pruritus, fever, chills, arthralgia, eosinophilia, and rarely, hepatitis. o Other: nasal congestion, flushing, lacrimation, conjunctivitis.
Information for Patients
Information for Patients Patients should be informed of possible side effects and advised to take the medication regularly and continuously as directed.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.