Drugplain

Trifluoperazine Hydrochloride 5 mg/1

trifluoperazine hydrochloride · TABLET, FILM COATED · Mylan Pharmaceuticals Inc.

No Recall History
Plain English

Trifluoperazine Hydrochloride is a tablet, film coated containing trifluoperazine hydrochloride at 5 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..

Key Facts

Brand Name
Trifluoperazine Hydrochloride
Generic Name
trifluoperazine hydrochloride
NDC Code (Product)
0378-2405
Manufacturer
Mylan Pharmaceuticals Inc.
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA040209
Marketing Start
08/29/1997

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective46 reports
euphoric mood45 reports
suicide attempt45 reports
toxicity to various agents45 reports
weight increased43 reports
akathisia41 reports
leukopenia41 reports
antipsychotic drug level below therapeutic40 reports
disinhibition40 reports
increased appetite40 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is 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 HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of trifluoperazine HCl as a treatment for non-psychotic anxiety was established in a four-week clinical multicenter study of outpatients with generalized anxiety disorder (DSM-III). This evidence does not predict that trifluoperazine HCl 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.)…

Dosage & 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 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-p…

Warnings

WARNINGS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Trifluoperazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with neuroleptic (antipsychotic) drugs. Although the prevalence of the syndrome appears to be highest among the elderly, 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. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of neuroleptic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relat…

Contraindications

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

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 firs…

Frequently Asked Questions

What is Trifluoperazine Hydrochloride used for?

Trifluoperazine Hydrochloride contains trifluoperazine hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Trifluoperazine Hydrochloride a controlled substance?

Trifluoperazine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Trifluoperazine Hydrochloride?

The generic name for Trifluoperazine Hydrochloride is trifluoperazine hydrochloride. There are no other listed brand versions of trifluoperazine hydrochloride.

What is the NDC code for Trifluoperazine Hydrochloride 5 mg/1?

The NDC (National Drug Code) for Trifluoperazine Hydrochloride 5 mg/1 is 0378-2405, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-2405

Package NDC

0378-2405-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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