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Risperdal - Warnings & Precautions

[Risperidone]



Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.


PRECAUTIONS

General

Orthostatic Hypotension

RISPERDAL ® ( risperidone) may induce orthostatic hypotension associated with dizziness, tachycardia, and in some patients, syncope, especially during the initial dose-titration period, probably reflecting its alpha-adrenergic antagonistic properties.

Syncope was reported in 0.2% ( 6/ 2607) of RISPERDAL ® -treated patients in Phase 2 and 3 studies. The risk of orthostatic hypotension and syncope may be minimized by limiting the initial dose to 2 mg total ( either QD or 1 mg BID) in normal adults and 0.5 mg BID in the elderly and patients with renal or hepatic impairment ( see DOSAGE AND ADMINISTRATION) . Monitoring of orthostatic vital signs should be considered in patients for whom this s of concern. A dose reduction should be considered if hypotension occurs. RISPERDAL ® should be used with particular caution in patients with known cardiovascular disease ( history of myocardial nfarction or schemia, heart failure, or conduction abnormalities) , cerebrovascular disease, and conditions which would predispose patients to hypotension, e. g. , dehydration and hypovolemia. Clinically significant hypotension has been observed with concomitant use of RISPERDAL ® and antihypertensive medication.

Seizures

During premarketing testing, seizures occurred in 0.3% ( 9/ 2607) of RISPERDAL ® -treated patients, two in association with hyponatremia. RISPERDAL ® should be used cautiously in patients with a history of seizures.
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