Trifluoperazine Tablets

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.

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