trifluoperazine hydrochloride

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 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 HCl 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 or 2 mg twice daily. Do not administer at doses of more than 6 mg per day or for longer than 12 weeks. Psychotic Disorders 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 two or three weeks. Psychotic Children Dosage should be adjusted to the weight of the child and the severity of the symptoms. These dosages are for children ages 6 to 12, who are hospitalized or under close supervision. ORAL: The starting dosage is 1 mg administered once a day or b.i.d. Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome. While it is usually not necessary to exceed dosages of 15 mg daily, some older children with severe symptoms may require higher dosages.

CONTRAINDICATIONS A known hypersensitivity to phenothiazines, comatose or greatly depressed states due to central nervous system depressants and, in cases of existing blood dyscrasias, bone marrow depression and pre-existing liver damage.

ADVERSE REACTIONS Drowsiness, dizziness, skin reactions, rash, dry mouth, insomnia, amenorrhea, fatigue, muscular weakness, anorexia, lactation, blurred vision and neuromuscular (extrapyramidal) reactions. Extrapyramidal Symptoms These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases, barbiturates by suitable route of administration will suffice. (Or, injectable diphenhydramine hydrochloride may be useful.) In more severe cases, the administration of an anti-parkinsonism agent, except levodopa, usually produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed. Dystonia Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. Motor Restlessness Symptoms may include agitation or jitteriness and sometimes insomnia. These symptoms often disappear spontaneously. At times these symptoms may be similar to the original neurotic or psychotic symptoms. Dosage should not be increased until these side effects have subsided. If this phase becomes too troublesome, the symptoms can usually be controlled by a reduction of dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful. Pseudo-parkinsonism Symptoms may include: mask-like facies; drooling, tremors; pill-rolling motion; cogwheel rigidity; and shuffling gait. Reassurance and sedation are important. In most cases, these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism agents should be used only when required. Generally, therapy of a few weeks to two to three months will suffice. After this time patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of trifluoperazine HCl or to discontinue the drug. Tardive Dyskinesia As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it is impossible to rely upon prevalence estimates to predict at the inception of neuroleptic treatment which patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described. There is no known effect …

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: C 21 H 24 F 3 N 3 S•2HCl M.W. 480.43 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 (corn), sodium lauryl sulfate, titanium dioxide, and triacetin. The 5 mg and 10 mg tablets also contain D&C Red No. 30 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Structural Formula

OVERDOSAGE (See also under ADVERSE REACTIONS .) Symptoms Primarily involvement of the extrapyramidal mechanism producing some of the dystonic reactions described above. Symptoms of central nervous system depression to the point of somnolence or coma. Agitation and restlessness may also occur. Other possible manifestations include convulsions, EKG changes and cardiac arrhythmias, fever and autonomic reactions such as hypotension, dry mouth and ileus. Treatment It is important to determine other medications taken by the patient since multiple dose therapy is common in overdosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage. Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus. Extrapyramidal symptoms may be treated with antiparkinsonism drugs, barbiturates, or diphenhydramine hydrochloride. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression. If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended. Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided. If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable to administer a vasoconstrictor, norepinephrine bitartrate and phenylephrine hydrochloride are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating action of these agents and cause a further lowering of blood pressure. Limited experience indicates that phenothiazines are not dialyzable.

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 48433-140-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 48433-141-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 48433-142-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). 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 48433-143-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Safecor Health LLC Rockford, IL 61103 U.S.A. 75108197 Revised: 1/2025 MXA:TFPZ:R3