FDA Section 5 \u2022 cited verbatim

Hydralazine - Warnings and Precautions

The following warnings and precautions are taken directly from the US FDA-approved drug label for Hydralazine. This is the same information dispensing pharmacists read.

5 WARNINGS AND PRECAUTIONS May cause symptomatic hypotension Symptomatic Lupus Erythematosus Syndromes: Consider discontinuation if clinically appropriate Myocardial ischemia and angina Peripheral Neuritis: May be treated with Pyridoxine 5.1 Hypotension Symptomatic hypotension, particularly with upright posture, may occur with even small doses of isosorbide dinitrate and hydralazine hydrochloride tablets.

Hypotension is most likely to occur in patients who have been volume or salt depleted; correct prior to initiation of isosorbide dinitrate and hydralazine hydrochloride tablets [see Adverse Reactions ] .

5.2 Systemic Lupus Erythematosus Hydralazine hydrochloride has been reported to cause a drug-induced systemic lupus erythematosus (SLE) syndrome.

Symptoms and signs usually regress when hydralazine hydrochloride is discontinued.

5.3 Worsening Ischemic Heart Disease Hydralazine hydrochloride can cause tachycardia and hypotension potentially leading to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy.

5.4 Peripheral Neuritis Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness, and tingling, which may be related to an antipyridoxine effect.

Pyridoxine should be added to isosorbide dinitrate and hydralazine hydrochloride tablets therapy if such symptoms develop.

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