Product Description.:
M, T5
tablet , film-coated , lavender , round round
Tablets: Each round, blue, film-coated tablet contains trifluoperazine hydrochloride equivalent to trifluoperazine as follows: 1 mg imprinted SKF and S03 2 mg imprinted SKF and S04 5 mg imprinted SKF and S06 10 mg imprinted SKF and S07. Inactive ingredients consist of cellulose, croscarmellose sodium, FD&C Blue No. 2, FD&C Yellow No. 6, FD&C Red No. 40, gelatin, iron oxide, lactose, magnesium stearate, talc, titanium dioxide and trace amounts of other inactive ingredients.
Multi-Dose Vials, 10 mL (2 mg/mL)?Each mL contains, in aqueous solution, trifluoperazine, 2 mg, as the hydrochloride sodium tartrate, 4.75 mg sodium biphosphate, 11.6 mg sodium saccharin, 0.3 mg benzyl alcohol, 0.75%, as preservative.
Concentrate?Each mL of clear, yellow, banana-vanilla-flavored liquid contains 10 mg of trifluoperazine as the hydrochloride. Inactive ingredients consist of D&C Yellow No. 10, FD&C Yellow No. 6, flavor, sodium benzoate, sodium bisulfite, sucrose and water.
N.B.: The Concentrate is for use in schizophrenia when oral medication is preferred and other oral forms are considered impractical.
INDICATIONS
For the management of schizophrenia.
Stelazine (trifluoperazine HCl) is effective for the short-term treatment of generalized non-psychotic anxiety. However, Stelazine 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 should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of Stelazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).
The effectiveness of Stelazine 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 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.
SIDE EFFECTS
Drowsiness, dizziness, skin reactions, rash, dry mouth, insomnia, amenorrhea, fatigue, muscular weakness, anorexia, lactation, blurred vision and neuromuscular (extrapyramidal) reactions.
Neuromuscular (Extrapyramidal) Reactions
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 Benadryl? may be useful.) In more severe cases, the administration of an anti-parkinsonism agent, except levodopa (see PDR), usually produces rapid reversal of symptoms. Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed.
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.
Dystonias: Symptoms may include: spasm of the neck muscles, sometimes progressing to torticollis extensor rigidity of back muscles, sometimes progressing to opisthotonos carpopedal spasm, trismus, swallowing difficulty, oculogyric crisis and protrusion of the tongue.
These usually subside within a few hours, and almost always within 24 to 48 hours, after the drug has been discontinued.
In mild cases, reassurance or a barbiturate is often sufficient. In moderate cases, barbiturates will usually bring rapid relief. In more severe adult cases, the administration of an anti-parkinsonism agent, except levodopa (see PDR), usually produces rapid reversal of symptoms. Also, intravenous caffeine with sodium benzoate seems to be effective. In children, reassurance and barbiturates will usually control symptoms. (Or, injectable Benadryl may be useful.) Note: See Benadryl prescribing information for appr
