Torecan

TORECAN (thiethylperazine) is indicated for the relief of nausea and vomiting.

• Nausea and Vomiting (Causes, Natural Remedies, Diet, Medication)

© Torecan Patient Information is supplied by Cerner Multum, Inc. and Torecan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Thiethylperazine is a phenothiazine medicine. It is used to treat nausea and vomiting.

This medicine is available only with your doctor's prescription.

Thiethylperazine is used only to relieve or prevent nausea and vomiting. Use it only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

For patients taking this medicine by mouth:

• This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients using the suppository form of this medicine :

• To insert suppository: First, remove foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
• Wash your hands with soap and water.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nausea and vomiting:
  • For oral dosage form (tablets):
    • Adults—10 milligrams (mg) one to three times a day.
    • Children—Use and dose must be determined by your doctor.
  • For injection dosage form:
    • Adults—10 mg one to three times a day, injected into a muscle.
    • Children—Use and dose must be determined by your doctor.
  • For rectal dosage form (suppositories):
    • Adults—10 mg one to three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

If you are going to be taking this medicine for a long time, your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow your dosage to be changed if necessary to meet your needs.

Thiethylperazine will add to the effects of alcohol and other CNS depressants (medicines that cause you to feel drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

When using thiethylperazine on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin or other salicylates at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by this medicine.

Thiethylperazine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Severe central nervous system (CNS) depression and comatose states.

Use of Torecan® (thiethylperazine) is contraindicated in patients who have demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) to phenothiazines.

Because severe hypotension has been reported after the intravenous administration of phenothiazines, this route of administration is contraindicated.

Usage in Pregnancy

Torecan® (thiethylperazine) is contraindicated in pregnancy.

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.

Phenothiazines are capable of potentiating CNS depressants (e.g., barbiturates, anesthetics, opiates, alcohol, etc.) as well as atropine and phosphorous insecticides.

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.

Postoperative Nausea and Vomiting

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.

The administration of epinephrine should be avoided in the treatment of drug-induced hypotension in view of the fact that phenothiazines may induce a reversed epinephrine effect on occasion.

Should a vasoconstrictive agent be required, the most suitable are norepinephrine bitartrate and phenylephrine.

The use of this drug has not been studied following intracardiac and intracranial surgery.

Central Nervous System

Serious: Convulsions have been reported. Extrapyramidal symptoms (E.P.S.) may occur, such as dystonia, torticollis, oculogyric crises, akathisia and gait disturbances. Others: Occasional cases of dizziness, headache, fever and restlessness have been reported.

Drowsiness may occur on occasion, following an initial injection. Generally this effect tends to subside with continued therapy or is usually alleviated by a reduction in dosage.

Autonomic Nervous System

Dryness of the mouth and nose, blurred vision, tinnitus. An occasional case of sialorrhea together with altered gustatory sensation has been observed.

Endocrine System

Peripheral edema of the arms, hands and face.

Hepatotoxicity

An occasional case of cholestatic jaundice has been observed.

Other

An occasional case of cerebral vascular spasm and trigeminal neuralgia has been reported.

Phenothiazine Derivatives

The physician should be aware that the following have occurred with one or more phenothiazines and should be considered whenever one of these drugs is used:

Blood Dyscrasias Serious–Agranulocytosis, leukopenia, thrombocytopenia, aplastic anemia, pancytopenia. Other: Eosinophilia, leukocytosis.

Autonomic Reactions–Miosis, obstipation, anorexia, paralytic ileus.

Cutaneous Reactions Serious–Erythema, exfoliative dermatitis, contact dermatitis.

Hepatotoxicity Serious–Jaundice, biliary stasis.

Cardiovascular Effects Serious–Hypotension, rarely leading to cardiac arrest; electrocardiographic (ECG) changes.

Extrapyramidal Symptoms Serious–Akathisia, agitation, motor restlessness, dystonic reactions, trismus, torticollis, opisthotonos, oculogyric crises, tremor, muscular rigidity, akinesia–some of which have persisted for several months or years especially in patients of advanced age with brain damage.

Endocrine Disturbances–Menstrual irregularities, altered libido, gynecomastia, weight gain. False positive pregnancy tests have been reported.

Urinary Disturbances–Retention, incontinence.

Allergic Reactions Serious–Fever, laryngeal edema, angioneurotic edema, asthma.

Others: Hyperpyrexia. Behavioral effects suggestive of a paradoxical reaction have been reported. These include excitement, bizarre dreams, aggravation of psychoses and toxic confusional states. While there is no evidence at present that ECG changes observed in patients receiving phenothiazines are in any way precursors of any significant disturbance of cardiac rhythm, it should be noted that sudden and unexpected deaths apparently due to cardiac arrest have been reported in a few instances in hospitalized psychotic patients previously showing characteristic ECG changes. A peculiar skin-eye syndrome has also been recognized as a side effect following long-term treatment with certain phenothiazines. This reaction is marked by progressive pigmentation of areas of the skin or conjunctiva and/or accompanied by discoloration of the exposed sclera and cornea. Opacities of the anterior lens and cornea described as irregular or stellate in shape have also been reported.

Torecan® (thiethylperazine maleate) Tablets, USP

10 mg

Each tablet contains 10 mg thiethylperazine maleate, USP.

Bottles of 100 tablets (NDC 0054-4748-25).

Below 86°F (30°C). Dispense in tight, light-resistant container as defined in the USP/NF.

Torecan® (thiethylperazine malate) Injection, USP

2 mL Ampul

Each 2 mL ampul contains aqueous solution 10 mg thiethylperazine malate, USP.

Boxes of 20 ampuls (NDC 0054-1701-07).

Boxes of 100 ampuls (NDC 0054-1701-25).

Below 86°F (30°C); protect from light. Administer only if clear and colorless.

Manufactured by

Novartis Pharmaceuticals Corporation

East Hanover, NJ 07936

Distributed by

Roxane Laboratories, Inc.

Columbus, Ohio 43216

REV: APRIL 1999                                          T1999-31

                                                        89007701

Applies to thiethylperazine: intramuscular solution, oral tablet

Nervous system

Nervous system side effects have included sedation, dizziness, or headache. Extrapyramidal reactions have been reported in less than 1% of patients and included dystonia, torticollis, oculogyric crises, akathisia, and gait disturbances. Pseudo-parkinsonian reactions including mask-like facies, drooling, cogwheel rigidity, and shuffling gait have been reported. Convulsions have also been reported rarely. Neuroleptic malignant syndrome has been reported with other phenothiazines, and the potential to occur with thiethylperazine (the active ingredient contained in Torecan) should be considered.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dryness of the mouth and nose, sialorrhea, and altered taste sensation.[Ref]

Hepatic

Hepatic side effects have rarely included the development of cholestatic jaundice.[Ref]

Hematologic

Hematologic side effects associated with phenothiazine derivatives have rarely included leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, pancytopenia, eosinophilia, and leukocytosis.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension during intravenous administration.[Ref]

Dermatologic

Dermatologic side effects have rarely included erythema, exfoliative dermatitis, and contact dermatitis.[Ref]

Ocular

Ocular side effects have included blurred vision.[Ref]

Hypersensitivity

Hypersensitivity side effects including at least one case of anaphylactic reaction have been reported.[Ref]

A 15-year-old female was admitted for angioedema and respiratory distress coincident with thiethylperazine therapy. She had been prescribed thiethylperazine (total of three doses) for abdominal pain and heavy nausea lasting for 2 days. Three hours after the last dose, she began to complain of face and tongue edema, speech difficulties, and dysphagia. On physical examination, she was in good general condition and showed an angioedema and erythema of the face, the upper thorax, and the tongue. An anaphylactic reaction was suspected and treatment was initiated. Her symptoms improved after treatment with intravenous biperiden, two aerosols of albuterol and budesonide, and intravenous methylprednisolone.[Ref]

Some side effects of Torecan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.