"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 "...
- Patient Information:
Details with Side Effects
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.
What are the possible side effects of trifluoperazine (Stelazine)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using trifluoperazine and call your doctor at once if you have a serious side effect such as:
- twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
- tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;
- feeling restless, jittery, or agitated;
- very stiff (rigid) muscles, high fever, sweating, confusion,...
Last reviewed on RxList: 4/10/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Stelazine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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