RVP

Drug Catalog - Product Detail

FLUPHENAZINE HCL TB 5MG 100

NDC Mfr Size Str Form
00527-1790-01 LANNETT 100 5MG TABLET
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Description
DESCRIPTION Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. The chemical designation is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl] propyl]-1-piperazineethanol dihydrochloride. The structural formula is represented below: Fluphenazine Hydrochloride Tablets, USP, for oral administration, contain 1 mg, 2.5 mg, 5 mg, or 10 mg fluphenazine hydrochloride, USP per tablet. Each tablet also contains corn starch, D&C Red No. 27 (2.5 mg and 5 mg tablet), D&C Red No. 30 (5 mg tablet), D&C Yellow No. 10 (5 mg tablet), dibasic calcium phosphate dihydrate, FD&C Blue No. 1 (5 mg tablet), FD&C Blue No. 2 (2.5 mg tablet), FD&C Red No. 40 (10 mg tablet), FD&C Yellow No. 6 (10 mg tablet), hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, purified water, and titanium dioxide. fluphenazine-molec-structure
How Supplied
HOW SUPPLIED Fluphenazine Hydrochloride Tablets, USP are available as follows: 1 mg tablets are white, round, film-coated tablets debossed "LCI" on one side and "1788" on the other side. They are supplied in bottles of 100 (NDC 0527-1788-01) and 500 (NDC 0527-1788-05). 2.5 mg tablets are blue, round, film-coated tablets debossed "LCI" on one side and "1789" on the other side. They are supplied in bottles of 100 (NDC 0527-1789-01) and 500 (NDC 0527-1789-05). 5 mg tablets are dark pink, round, film-coated tablets debossed "LCI" on one side and "1790" on the other side. They are supplied in bottles of 100 (NDC 0527-1790-01) and 500 (NDC 0527-1790-05). 10 mg tablets are orange, round, film-coated tablets debossed "LCI" on one side and "1791" on the other side. They are supplied in bottles of 100 (NDC 0527-1791-01) and 500 (NDC 0527-1791-05). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 CIB70359C Rev. 08/17
Indications & Usage
INDICATIONS AND USAGE Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
Dosage and Administration
DOSAGE AND ADMINISTRATION Depending on severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 mg to 10 mg and should be divided and given at 6 to 8 hour intervals. The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the oral dose has been found to be approximately 2 to 3 times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses. When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 mg to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient’s requirements. For psychotic patients who have been stabilized on a fixed daily dosage of orally administered fluphenazine hydrochloride dosage forms, conversion to the long-acting fluphenazine decanoate may be indicated (see package insert for fluphenazine decanoate for conversion information). For geriatric patients, the suggested starting dose is 1 mg to 2.5 mg daily, adjusted according to the response of the patient.