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TORECAN (thiethylperazine) Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Since TORECAN (thiethylperazine) may impair mental and/or physical ability required in the performance of potentially hazardous tasks such as driving a car or operating machinery, it is recommended that patients be warned accordingly.
With the use of this drug to control postoperative nausea and vomiting occurring in patients undergoing elective surgical procedures, restlessness and postoperative CNS depression during anesthesia recovery may occur. Possible postoperative complications of a severe degree of any of the known reactions of this class of drug must be considered. Postural hypotension may occur after an initial injection, rarely with the tablet.
Should a vasoconstrictive agent be required, the most suitable are norepinephrifle bitartrate and phenylephrine.
Abnormal movements such as extrapyramidal symptoms (E.P.S.) (e.g., dystonia, torticollis, dysphasia, oculogyric crises, akathisia) have occurred. Convulsions have also been reported. The varied symptom complex is more likely to occur in young adults and children. Extrapyramidal effects must be treated by reduction of dosage or cessation of medication.
TORECAN (thiethylperazine) tablets contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Use in patients with bone marrow depression only when potential benefits outweigh risks.
Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex, has been reported in association with phenothiazine drugs. Clinical manifestations include: hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability.
The extrapyramidal symptoms which can occur secondary to TORECAN (thiethylperazine) may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reye†s Syndrome or other encephalopathy. The use of TORECAN (thiethylperazine) and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye†s Syndrome.
Phenothiazine drugs may cause elevated prolactin levels that persist during chronic administration. Since approximately one-third of human breast cancers are prolactin-dependent in vitro, this elevation is of potential importance if phenothiazine drug administration is contemplated in a patient with a previously-detected breast cancer. Neither clinical nor epidemiologic studies to date, however, have shown an association between the chronic administration of phenothiazine drugs and mammary tumorigenesis.
Postoperative Nausea and Vomiting
When used in the treatment of nausea and/or vomiting associated with anesthesia and surgery, it is recommended that TORECAN (thiethylperazine) should be administered by deep intramuscular injection at or shortly before the termination of anesthesia.
Information for Patients
Patients receiving TORECAN (thiethylperazine) should be cautioned about possible combined effects with alcohol and other CNS depressants. Patients should be cautioned not to operate machinery or drive a motor vehicle after ingesting the drug.
Phenothiazines are capable of potentiating CNS depressants (e.g., barbiturates, anesthetics, opiates, alcohol, etc.) as well as atropine and phosphorous insecticides.
Laboratory Test Interactions
Information is not available concerning the excretion of TORECAN (thiethylperazine) in the milk of nursing mothers. As a general rule, nursing should not be undertaken while the patient is on a drug, since many drugs are excreted in human milk.
Safety and effectiveness in pediatric patients have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
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