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Drug Catalog - Product Detail

FLUPHENAZINE HCL TB 2.5MG 100

NDC Mfr Size Str Form
00378-6009-01 MYLAN 100 2.5MG TABLET
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Description
DESCRIPTION Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Chemically it is 4-[3-[2-(Trifluoromethyl) phenothiazin-10-yl]propyl]-1-piperazineethanol dihydrochloride which may be represented by the following structural formula: Each tablet, for oral administration, contains 1 mg, 2.5 mg, 5 mg, or 10 mg of fluphenazine hydrochloride, USP per tablet. Inactive ingredients are: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate and titanium dioxide. The following additional product specific inactive ingredients are employed: 1 mg – calcium sulfate, hydroxypropyl cellulose and talc 2.5 mg – lecithin, polydextrose, sodium alginate and triacetin 5 mg – hydroxypropyl cellulose 10 mg – lecithin, polydextrose, sodium alginate and triacetin The following coloring agents are employed: 2.5 mg – D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake 5 mg – FD&C Blue No.1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake 10 mg – FD&C Yellow No. 6 Aluminum Lake. Fluphenazine Hydrochloride Structural Formula
How Supplied
HOW SUPPLIED Fluphenazine Hydrochloride Tablets, USP are available containing either 1 mg, 2.5 mg, 5 mg or 10 mg of fluphenazine hydrochloride, USP. The 1 mg tablets are white film-coated, triangular shaped tablets debossed with M on one side of the tablet and 4 on the other side. They are available as follows: NDC 0378-6004-01 bottles of 100 tablets NDC 0378-6004-05 bottles of 500 tablets The 2.5 mg tablets are yellow film-coated, triangular shaped tablets debossed with M on one side of the tablet and 9 on the other side. They are available as follows: NDC 0378-6009-01 bottles of 100 tablets NDC 0378-6009-05 bottles of 500 tablets The 5 mg tablets are green film-coated, triangular shaped tablets debossed with M on one side of the tablet and 74 on the other side. They are available as follows: NDC 0378-6074-01 bottles of 100 tablets NDC 0378-6074-05 bottles of 500 tablets The 10 mg tablets are orange film-coated, triangular shaped tablets debossed with M on one side of the tablet and 97 on the other side. They are available as follows: NDC 0378-6097-01 bottles of 100 tablets NDC 0378-6097-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 11/2016 FPHZ:R12 Repackaged by: Clinical Solutions Wholesale Franklin, TN 37067
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 the 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 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.