"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.
Antipsychotic drugs are used to "...
For the management of schizophrenia.
Stelazine (trifluoperazine HCl) is effective for the short-term treatment of generalized non-psychotic anxiety. However, Stelazine (trifluoperazine) 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, Stelazine (trifluoperazine) should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of Stelazine (trifluoperazine) at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).
The effectiveness of Stelazine (trifluoperazine) 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 Stelazine (trifluoperazine) 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.).
Stelazine (trifluoperazine HC1) has not been shown effective in the management of behavioral complications in patients with mental retardation.
DOSAGE AND ADMINISTRATION
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 Stelazine (trifluoperazine HCl) is administered by intramuscular injection, equivalent oral dosage may be substituted once symptoms have been controlled.
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.
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 2 or 3 weeks.
When the Concentrate dosage form is to be used, it should be added to 60 mL (2 fl oz) or more of diluent just prior to administration to insure palatability and stability. Vehicles suggested for dilution are: tomato or fruit juice, milk, simple syrup, orange syrup, carbonated beverages, coffee, tea or water. Semisolid foods (soup, puddings, etc.) may also be used.
Intramuscular (for prompt control of severe symptoms): Usual dosage is 1 mg to 2 mg (V2 to 1 mL) by deep intramuscular injection q4 to 6h, p.r.n. More than 6 mg within 24 hours is rarely necessary.
Only in very exceptional cases should intramuscular dosage exceed 10 mg within 24 hours. Injections should not be given at intervals of less than 4 hours because of a possible cumulative effect.
Note: Stelazine (trifluoperazine HCl) Injection has been usually well tolerated and there is little, if any, pain and irritation at the site of injection.
This solution should be protected from light. This is a clear, colorless to pale yellow solution; a slight yellowish discoloration will not alter potency. If markedly discolored, solution should be discarded.
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.
Intramuscular: There has been little experience with the use of Stelazine (trifluoperazine HCl) Injection in children. However, if it is necessary to achieve rapid control of severe symptoms, 1 mg (V2 mL) of the drug may be administered intramuscularly once or twice a day.
Tablets, 1 mg, 2 mg, 5 mg and 10 mg in bottles of 100.
1 mg 100's: NDC 0108-4903-20
2 mg 100's: NDC 0108-4904-20
5 mg 100's: NDC 0108-4906-20
10 mg 100's: NDC 0108-4907-20
Multi-Dose Vials, 10 mL (2 mg/mL), in 1's: NDC 0108-4902-01
Concentrate (for institutional use), 10 mg/mL, in 2 fl oz bottles and in cartons of 12 bottles.
The Concentrate form is light-sensitive. For this reason, it should be protected from light and dispensed in amber bottles. Refrigeration is not required.
10 mg/mL 2 fl oz (carton of 12): NDC 0108-4901-42
Store all Stelazine (trifluoperazine HCl) formulations between 15° and 30°C (59° and 86°F).
Date Of Issuance Mar.. 2002. GlaxoSmithKline., Research Triangle Park, NC 27709
Last reviewed on RxList: 4/10/2009
This monograph has been modified to include the generic and brand name in many instances.
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