|
PRECAUTIONS
General Orthostatic Hypotension Text Continues Below
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. Dysphagia Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality n patients with advanced Alzheimer' s dementia. RISPERDAL ® and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Hyperprolactinemia As with other drugs that antagonize dopamine D 2 receptors, risperidone elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro , a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. As is common with compounds which ncrease prolactin release, an increase in pituitary gland, mammary gland, and pancreatic slet cell hyperplasia and/ or neoplasia was observed in the risperidone carcinogenicity studies conducted in mice and rats ( see PRECAUTIONS Carcinogenesis, Mutagenesis, Impairment of Fertility) . However, neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
