Drug Catalog - Product Detail
TRIFLUOPERAZINE HCL 5MG TB 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-2405-01 | MYLAN | 100 | 5MG | TABLET |
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Description
DESCRIPTION Each film-coated tablet, for oral administration, contains trifluoperazine hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine. The structural formula is: 10-[3-(4-Methyl-1-piperazinyl)propyl]-2-(trifluoromethyl) phenothiazine dihydrochloride In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, titanium dioxide, and triacetin. The 5 mg and 10 mg tablets contain the following coloring agents: D&C Red No. 30 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, and FD&C Yellow No. 6 Aluminum Lake. Structural Formula
How Supplied
HOW SUPPLIED Trifluoperazine Hydrochloride Tablets, USP are available containing trifluoperazine hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg or 10 mg of trifluoperazine. The 1 mg tablets are white film-coated, round, unscored tablets debossed with T3 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-2401-01 bottles of 100 tablets The 2 mg tablets are white film-coated, round, unscored tablets debossed with T4 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-2402-01 bottles of 100 tablets For psychiatric patients who are hospitalized under close supervision. The 5 mg tablets are lavender film-coated, round, unscored tablets debossed with T5 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-2405-01 bottles of 100 tablets The 10 mg tablets are lavender film-coated, round, unscored tablets debossed with T6 on one side of the tablet and M on the other side. They are available as follows: NDC 0378-2410-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 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 MARCH 2015 TFPZ:R10
Indications & Usage
INDICATIONS AND USAGE For the management of schizophrenia. Trifluoperazine hydrochloride tablets, USP are effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine hydrochloride tablets are not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). When used in the treatment of non-psychotic anxiety, trifluoperazine hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of trifluoperazine hydrochloride tablets as a treatment for non-psychotic anxiety was established in a 4-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine hydrochloride tablets will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (i.e., physical illness, organic mental conditions, agitated depression, character pathologies, etc.). Trifluoperazine hydrochloride tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.
Dosage and Administration
DOSAGE AND ADMINISTRATION-ADULTS Dosage should be adjusted to the needs of the individual. The lowest effective dosage should always be used. Dosage should be increased more gradually in debilitated or emaciated patients. When maximum response is achieved, dosage may be reduced gradually to a maintenance level. Because of the inherent long action of the drug, patients may be controlled on convenient b.i.d. administration; some patients may be maintained on once a day administration. When trifluoperazine hydrochloride is administered by intramuscular injection, equivalent oral dosage may be substituted once symptoms have been controlled. Note: Although there is little likelihood of contact dermatitis due to the drug, persons with known sensitivity to phenothiazine drugs should avoid direct contact. Elderly Patients In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients. Non-Psychotic Anxiety Usual dosage is 1 mg or 2 mg twice daily. Do not administer at doses of more than 6 mg per day or for longer than 12 weeks. Schizophrenia Oral Usual starting dosage is 2 mg to 5 mg b.i.d. (Small or emaciated patients should always be started on the lower dosage.) Most patients will show optimum response on 15 mg or 20 mg daily, although a few may require 40 mg a day or more. Optimum therapeutic dosage levels should be reached within 2 or 3 weeks.