Fluphenazine decanoate package insert

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Neuroleptic drugs elevate prolactin levels; 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 a previously detected breast cancer . Although disturbances such as galactorrhea , amenorrhea , gynecomastia , and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

Oral:
-Initial dose: to 10 mg orally in divided doses every 6 to 8 hours
-Maintenance dose: 1 to 5 mg/day
-Maximum dose: Up to 40 mg/day

Oral Comments:
-Maintenance doses may be given as single daily doses.
-Many patients achieve therapeutic effect with doses of less than 20 mg. Patients who are severely disturbed or inadequately controlled may require a dose of up to 40 mg/day.

Parenteral:
Fluphenazine Decanoate for Injection:
-Initial dose: to 25 mg deep IM injection into the gluteal region
-Maintenance dose: to 100 mg IM, usually every 3 to 4 weeks
-Maximum dose: 100 mg/injection

Fluphenazine HCl for Injection:
-Initial dose: to 10 mg IM, given as divided doses every 6 to 8 hours
-Maximum dose: Up to 10 mg/day

Parenteral Comments:
-Patients may switch from Fluphenazine HCl for Injection to oral formulations when symptoms are controlled. The dose of an oral formulation is approximately 2 to 3 times the dose of fluphenazine HCl for injection.

-Fluphenazine decanoate for injection may be given subcutaneously.

Uses:
-Management of manifestations of schizophrenia
-Management of patients requiring prolonged parenteral neuroleptic therapy (., patients with chronic schizophrenia)

Fluphenazine decanoate package insert

fluphenazine decanoate package insert

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