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Fluvoxamine Maleate

HOME >> API >> API List1 >> Fluvoxamine Maleate >> Precautions

PRECAUTIONS
Fluvoxamine Maleate CAS number 61718-82-9

Activation of Mania/Hypomania: During premarketing studies involving primarily depressed patients, hypomania or mania occurred in approximately 1% of patients treated with fluvoxamine. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, fluvoxamine maleate should be used cautiously in patients with a history of mania.

Seizures: During premarketing studies, seizures were reported in 0.2% of fluvoxamine-treated patients. Fluvoxamine maleate should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.

Suicide: The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary disorder such as OCD. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for fluvoxamine maleate should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.

Use in Patients with Concomitant Illness: Closely monitored clinical experience with fluvoxamine maleate in patients with concomitant systemic illness is limited. Caution is advised in administering fluvoxamine maleate to patients who diseases or conditions that could affect hemodynamic responses or metabolism.

Interference with Cognitive or Motor Performance: Since any psychoactive drug may impair judgement, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain that fluvoxamine maleate therapy does not adversely affect their ability to engage in such activities.

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