Trifluoperazine Hydrochloride

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Side Effects & Adverse Reactions

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 relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if neuroleptic treatment is withdrawn. Neuroleptic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, neuroleptics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic neuroleptic treatment should generally be reserved for patients who suffer from a chronic illness that 1) is known to respond to neuroleptic drugs, and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.

For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on PRECAUTIONS and ADVERSE REACTIONS.

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN and FBS) has occurred in a few patients treated with lithium plus a neuroleptic. In some instances, the syndrome was followed by irreversible brain damage. Because of a possible causal relationship between these events and the concomitant administration of lithium and neuroleptics, patients receiving such combined therapy should be monitored closely for early evidence of neurologic toxicity and treatment discontinued promptly if such signs appear. This encephalopathic syndrome may be similar to or the same as neuroleptic malignant syndrome (NMS).

Patients who have demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not be re-exposed to any phenothiazine, including trifluoperazine HCl, unless in the judgment of the physician, the potential benefits of treatment outweigh the possible hazard.

Trifluoperazine HCl may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, caution patients about activities requiring alertness (e.g., operating vehicles or machinery).

If agents such as sedatives, narcotics, anesthetics, tranquilizers, or alcohol are used either simultaneously or successively with the drug, the possibility of an undesirable additive depressant effect should be considered.

Usage In Pregnancy

Safety for the use of trifluoperazine HCl during pregnancy has not been established. Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgment of the physician, it is essential. The potential benefits should clearly outweigh possible hazards. There are reported instances of prolonged jaundice, extrapyramidal signs, hyperreflexia or hyporeflexia in newborn infants whose mothers received phenothiazines.

Reproductive studies in rats given over 600 times the human dose showed an increased incidence of malformations above controls and reduced litter size and weight linked to maternal toxicity. These effects were not observed at half this dosage. No adverse effect on fetal development was observed in rabbits given 700 times the human dose nor in monkeys given 25 times the human dose.

Non-teratogenic Effects

Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Trifluoperazine Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

There is evidence that phenothiazines are excreted in the breast milk of nursing mothers. Because of the potential for serious adverse reactions in nursing infants from trifluoperazine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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.).

Trifluoperazine HCl has not been shown effective in the management of behavioral complications in patients with mental retardation.

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History

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Other Information

Each tablet for oral administration contains trifluoperazine hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine. The structural formula is:

10-H -Phenothiazine, 10-[3-(4-methyl-1-piperazinyl)propyl]-2-(trifluoromethyl)-, dihydrochloride.

Inactive ingredients: D & C Red #30 Aluminum Lake, FD & C Blue #2 Aluminum Lake, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, polyethylene glycol, povidone, starch (corn), and titanium dioxide.

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Trifluoperazine Hydrochloride Manufacturers

Sandoz Inc

Trifluoperazine Hydrochloride | Sandoz Inc

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.

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Remedyrepack Inc.

Trifluoperazine Hydrochloride | Remedyrepack Inc.

Adults

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.

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Mylan Institutional Inc.

Trifluoperazine Hydrochloride | Walgreen Co.

do not use more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

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Remedyrepack Inc.

Trifluoperazine Hydrochloride | Remedyrepack Inc.

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.

DOSAGE AND ADMINISTRATION-SCHIZOPHRENIA IN CHILDREN
Dosage should be adjusted to the weight of the child and 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.

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Lake Erie Medical Dba Quality Care Products Llc

Trifluoperazine Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

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.

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Remedyrepack Inc.

Trifluoperazine Hydrochloride | Remedyrepack Inc.

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.

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.

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.

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.

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.

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State Of Florida Doh Central Pharmacy

Trifluoperazine Hydrochloride | State Of Florida Doh Central Pharmacy

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.

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Mylan Pharmaceuticals Inc.

Trifluoperazine Hydrochloride | Actavis Pharma, Inc.

Patients controlled on diltiazem alone or in combination with other medications may be switched to diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) at the nearest equivalent total daily dose. Higher doses of diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) may be needed in some patients. Patients should be closely monitored. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. The incidence of side effects increases as the dose increases with first-degree AV block, dizziness, and sinus bradycardia bearing the strongest relationship to dose.

Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 240 to 360 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily.

Angina. Dosages for the treatment of angina should be adjusted to each patient’s needs, starting with a dose of 120 or 180 mg once daily. Individual patients may respond to higher doses of up to 480 mg once daily. When necessary, titration may be carried out over a 7- to 14-day period.
Diltiazem Hydrochloride Extended-release
Capsules USP (Once-a-day dosage) Strength Qty. NDC# Description 120 mg 7's 62037-597-07 White/orange opaque capsule 30's 62037-597-30 imprinted with "Andrx 597" 90's 62037-597-90 on one end and "120 mg" on 500's 60237-597-05 the other. 1000's 62037-597-10 180 mg 7's 62037-598-07 Yellow/orange opaque capsule 30's 62037-598-30 imprinted with "Andrx 598" 90's 62037-598-90 on one end and "180 mg" on 500's 62037-598-05 the other. 1000's 62037-598-10 240 mg 7's 62037-599-07 Light brown/orange opaque 30's 62037-599-30 capsule imprinted with 90's 62037-599-90 "Andrx 599" on one end and 500's 62037-599-05 "240 mg" on the other. 1000's 62037-599-10 300 mg 7's 62037-600-07 Orange/orange opaque capsule 30's 62037-600-30 imprinted with "Andrx 600" 90's 62037-600-90 on one end and "300 mg" on 500's 62037-600-05 the other. 1000's 62037-600-10
Concomitant Use With Other Cardiovascular Agents
1. Sublingual NTG. May be taken as required to abort acute anginal attacks during diltiazem hydrochloride extended-release capsules, (Once A Day Dosage) therapy.

2. Prophylactic Nitrate Therapy. Diltiazem hydrochloride extended-release capsules, (Once A Day Dosage) may be safely coadministered with short- and long-acting nitrates.

3. Beta-blockers (see WARNINGS and PRECAUTIONS).

4. Antihypertensives. Diltiazem hydrochloride extended-release capsules (Once A Day Dosage) have an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride extended-release capsules USP (once-a-day dosage) or the concomitant antihypertensives may need to be adjusted when adding one to the other.

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