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PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) TABLETS: SPECIAL WARNINGS

Cardiac Effects, including Cardiomyopathy and QT prolongation

Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported with use of Hydroxychloroquine Sulfate (Plaquenil) tablets as well as with use of chloroquine. Patients may present with atrioventricular block, pulmonary hypertension, sick sinus syndrome or with cardiac complications. ECG findings may include atrioventricular, right or left bundle branch block. Signs or symptoms of cardiac compromise have appeared during acute and chronic treatment. Clinical monitoring for signs and symptoms of cardiomyopathy is advised, including use of appropriate diagnostic tools such as ECG to monitor patients for cardiomyopathy during Plaquenil therapy. Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy are diagnosed. If cardiotoxicity is suspected, prompt discontinuation of Plaquenil (Hydroxychloroquine) may prevent life-threatening complications.

Plaquenil prolongs the QT interval. Ventricular arrhythmias and torsades de pointes have been reported in patients taking this medicine. Therefore, Plaquenil (Hydroxychloroquine) tablets should not be administered with other drugs that have the potential to prolong the QT interval.

Worsening of psoriasis and porphyria

Use of Plaquenil in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria the condition may be exacerbated. The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard.

Proximal Myopathy and Neuropathy

Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported. Muscle and nerve biopsies have been associated with curvilinear bodies and muscle fiber atrophy with vacuolar changes. Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with Plaquenil (Hydroxychloroquine Sulfate).

Neuropsychiatric events, including suicidality

Suicidal behavior has been rarely reported in patients treated with Plaquenil.

Hypoglycemia

Plaquenil (Hydroxychloroquine Sulfate) tablets has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with or without antidiabetic medications. Patients treated with Plaquenil should be warned about the risk of hypoglycemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycemia during treatment with Hydroxychloroquine (Plaquenil) should have their blood glucose checked and treatment reviewed as necessary.

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