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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.
Central Nervous System
Serious: Convulsions have been reported. Extrapyramidal symptoms (E.P.S.) may occur, such as dystonia, torticoilis, 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.
Peripheral edema of the arms, hands and face.
An occasional case of cholestatic jaundice has been observed.
An occasional case of cerebral vascular spasm and trigeminal neuralgia has been reported.
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 - Erytherna, 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.
DRUG ABUSE AND DEPENDENCE
TORECAN (thiethylperazine) is not a controlled substance.
Read the entire FDA prescribing information for Torecan (Thiethylperazine)Read More »
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.
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antiemetic
Pharmacologic Class: Phenothiazine
Chemical Class: Piperazine (class)
Before Using Torecan
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Children are usually more sensitive than adults to the effects of phenothiazine medicines such as thiethylperazine. Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration.
Elderly patients are usually more sensitive to the effects of phenothiazine medicines such as thiethylperazine. Confusion; difficult or painful urination; dizziness; drowsiness; feeling faint; or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, uncontrolled movements may be more likely to occur in elderly patients taking thiethylperazine.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Morphine Sulfate Liposome
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aminolevulinic Acid
- Belladonna Alkaloids
- Betel Nut
- Evening Primrose
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse—This medicine, if taken together with alcohol, may lower the blood pressure and cause CNS depressant effects, such as severe drowsiness
- Asthma attack or
- Other lung diseases—Thiethylperazine may cause secretions to become thick so that it might be difficult to cough them up, for example, during an asthma attack
- Blood disease or
- Heart or blood vessel disease—This medicine may cause more serious conditions to develop
- Difficult urination or
- Enlarged prostate—This medicine may cause urinary problems to get worse
- Glaucoma—This medicine may cause an increase in inner eye pressure
- Liver disease—Thiethylperazine may accumulate in the body, increasing the chance of side effects, such as muscle spasms
- Parkinson's disease or
- Seizure disorders—The chance of thiethylperazine causing seizures or uncontrolled movements is greater when these conditions are present
Torecan® (thiethylperazine) is a phenothiazine. Thiethylperazine is characterized by a substituted thioethyl group at position 2 in the phenothiazine nucleus, and a piperazine moiety in the side chain. The chemical designation is: 2-ethyl-mercapto-10-[3’- (1”-methyl-piperazinyl-4”)-propyl-1’] phenothiazine. Thiethylperazine has the following structural formula:
Tablet, 10 mg, for oral administration
Active Ingredient: thiethylperazine maleate USP, 10 mg.
Inactive Ingredients: acacia, carnauba wax, FD&C Yellow No. 5 aluminum lake (tartrazine), FD&C Yellow No. 6 aluminum lake, gelatin, lactose, magnesium stearate, povidone, sodium benzoate, sorbitol, starch, stearic acid, sucrose, talc, titanium dioxide.
Ampul, 2 mL, for intramuscular administration
Active Ingredient: thiethylperazine malate USP, 10 mg per 2 mL.
Inactive Ingredients: sodium metabisulfite NF, 0.5 mg; ascorbic acid USP, 2.0 mg; sorbitol NF, 40 mg; carbon dioxide gas q.s.; water for injection USP, q.s. to 2 mL.
The pharmacodynamic action of Torecan® (thiethylperazine) in humans is unknown. However, a direct action of Torecan® (thiethylperazine) on both the CTZ and the vomiting center may be concluded from induced vomiting experiments in animals.
Drug abuse and dependence
Torecan® (thiethylperazine) is not a controlled substance.
Torecan Dosage and Administration
Usual daily dose range is 10 mg to 30 mg.
Oral: One tablet, one to three times daily.
Intramuscular: 2 mL IM, one to three times daily. (See PRECAUTIONS.)
Appropriate dosage of Torecan® (thiethylperazine) has not been determined in pediatric patients.
For the Consumer
Applies to thiethylperazine: solution, suppository, tablet
Along with its needed effects, thiethylperazine (the active ingredient contained in Torecan) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur while taking thiethylperazine:Less common or rare
- Abdominal or stomach pains
- aching muscles and joints
- blurred vision, change in color vision, or difficulty in seeing at night
- confusion (especially in the elderly)
- convulsions (seizures)
- difficulty in speaking or swallowing
- fast heartbeat
- fever and chills
- inability to move eyes
- lip smacking or puckering
- loss of balance control
- mask-like face
- muscle spasms (especially of face, neck, and back)
- nausea, vomiting, or diarrhea
- nightmares (continuing)
- puffing of cheeks
- rapid or fine, worm-like movements of tongue
- shuffling walk
- skin itching (severe)
- sore throat and fever
- stiffness of arms or legs
- swelling of arms, hands, and face
- tic-like or twitching movements
- trembling and shaking of hands and fingers
- twisting movements of body
- uncontrolled chewing movements
- uncontrolled movements of arms or legs
- unusual bleeding or bruising
- unusual excitement, nervousness, restlessness, or irritability
- unusual tiredness or weakness
- weakness of arms and legs
- yellow eyes or skin
- Confusion (severe)
- convulsions (seizures)
- dizziness (severe)
- drowsiness (severe)
- dry mouth (severe)
- hyperextension of neck and trunk
- inability to move eyes
- loss of consciousness
- spasms of face and neck
- stuffy nose
- troubled breathing
Some side effects of thiethylperazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- dizziness or lightheadedness, especially when getting up from a lying or sitting position
- dryness of mouth, nose and throat
- ringing or buzzing in ears
- skin rash