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Thorazine

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Antipsychotic drugs are used to "...

Thorazine

Thorazine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Thorazine (chlorpromazine) is used to treat psychotic disorders such as schizophrenia or manic-depression, and severe behavioral problems in children. It is also used to treat nausea and vomiting, anxiety before surgery, chronic hiccups, acute intermittent porphyria, and symptoms of tetanus. It is a phenothiazine anti-psychotic medication. The brand name Thorazine is discontinued in the U.S. Generic forms may be available. Common side effects include dizziness, drowsiness, anxiety, sleep problems (insomnia), breast swelling or discharge, changes in menstrual periods, weight gain, swelling in hands or feet, dry mouth or stuffy nose, blurred vision, constipation, impotence, or trouble having an orgasm.

Dosing of chlorpromazine depends on severity of the condition, and the patient's response to the drug. Chlorpromazine may interact with atropine, lithium, phenytoin, antibiotics, birth control pills or hormone replacement estrogens, blood pressure medications, blood thinners, asthma medications or bronchodilators, incontinence medications, insulin or oral diabetes medications, medication for nausea, vomiting, or motion sickness, medications to treat or prevent malaria, medications used for general anesthesia, medicines used to prevent organ transplant rejection, numbing medicine, stimulants, ADHD medication, ulcer or irritable bowel medication, medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor. Many other medicines can interact with chlorpromazine. Tell your doctor all medications you use. During pregnancy, chlorpromazine should be used only if prescribed. It may cause side effects in a newborn if the mother takes the medication during pregnancy. Chlorpromazine can pass into breast milk and may harm a nursing baby. Consult your doctor before breast-feeding. Withdrawal symptoms may occur if you are on a high dosage of this medication and abruptly stop taking it.

Our Thorazine (chlorpromazine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Thorazine in Detail - Patient Information: Side Effects

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 taking chlorpromazine 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;
  • feeling like you might pass out;
  • seizure (black-out or convulsions);
  • nausea upper stomach pain, itching, and jaundice (yellowing of the skin or eyes);
  • pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;
  • high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;
  • unusual thoughts or behavior;
  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;
  • urinating less than usual or not at all;
  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, and patchy skin color; or
  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

Less serious side effects may include:

  • dizziness, drowsiness, anxiety, sleep problems (insomnia);
  • breast swelling or discharge;
  • changes in menstrual periods;
  • weight gain, swelling in your hands or feet;
  • dry mouth or stuffy nose, blurred vision;
  • constipation; or
  • impotence, trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Thorazine (Chlorpromazine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Thorazine FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Note: Some adverse effects of Thorazine (chlorpromazine) may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses.

Drowsiness, usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered.

B Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; however, chronic jaundice has been reported.

There is no conclusive evidence that preexisting liver disease makes patients more susceptible to jaundice. Alcoholics with cirrhosis have been successfully treated with Thorazine (chlorpromazine) without complications. Nevertheless, the medication should be used cautiously in patients with liver disease. Patients who have experienced jaundice with a phenothiazine should not, if possible, be reexposed to Thorazine (chlorpromazine) or other phenothiazines.

If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment.

Liver function tests in jaundice induced by the drug may mimic extrahepatic obstruction; withhold exploratory laparotomy until extrahepatic obstruction is confirmed.

Hematological Disorders, including agranulocytosis, eosinophilia, leukopenia, hemolytic anemia, aplastic anemia, thrombocytopenic purpura and pancytopenia have been reported.

Agranulocytosis — Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy.

Most cases have occurred between the fourth and tenth weeks of therapy; patients should be watched closely during that period.

Moderate suppression of white blood cells is not an indication for stopping treatment unless accompanied by the symptoms described above.

Cardiovascular

Hypotensive EffectsPostural hypotension, simple tachycardia, momentary fainting and dizziness may occur after the first injection; occasionally after subsequent injections; rarely, after the first oral dose. Usually recovery is spontaneous and symptoms disappear within 1 / 2 to 2 hours. Occasionally, these effects may be more severe and prolonged, producing a shock-like condition.

To minimize hypotension after injection, keep patient lying down and observe for at least 1 / 2 hour. To control hypotension, place patient in head-low position with legs raised. If a vasoconstrictor is required, Levophed® *** and Neo-Synephrine® § are the most suitable. Other pressor agents, including epinephrine, should not be used as they may cause a paradoxical further lowering of blood pressure.

EKG Changes — particularly nonspecific, usually reversible Q and T wave distortions— have been observed in some patients receiving phenothiazine tranquilizers, including Thorazine (chlorpromazine).

Note: Sudden death, apparently due to cardiac arrest, has been reported.

CNS Reactions

Neuromuscular (Extrapyramidal) Reactions — Neuromuscular reactions include dystonias, motor restlessness, pseudo-parkinsonism and tardive dyskinesia, and appear to be dose-related. They are discussed in the following paragraphs:

Dystonias: Symptoms may include spasm of the neck muscles, sometimes progressing to acute, reversible 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, usually produces rapid reversal of symptoms. In children (1 to 12 years of age), reassurance and barbiturates will usually control symptoms. (Or, parenteral Benadryl® ll may be useful. See Benadryl prescribing information for appropriate children's dosage.) If appropriate treatment with anti-parkinsonism agents or Benadryl fails to reverse the signs and symptoms, the diagnosis should be reevaluated.

Suitable supportive measures such as maintaining a clear airway and adequate hydration should be employed when needed. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should not be reinstituted.

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 these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug. Treatment with anti-parkinsonian agents, benzodiazepines or propranolol may be helpful.

Pseudo-parkinsonism: Symptoms may include: mask-like facies, drooling, tremors, pillrolling motion, cogwheel rigidity and shuffling gait. In most cases these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly. Anti-parkinsonism agents should be used only when required. Generally, therapy of a few weeks to 2 or 3 months will suffice. After this time patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in antipsychotic-induced pseudo-parkinsonism.) Occasionally it is necessary to lower the dosage of Thorazine (chlorpromazine) or to discontinue the drug.

Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The syndrome can also develop, although much less frequently, after relatively brief treatment periods at low doses. This syndrome appears in all age groups. Although its prevalence appears to be highest among elderly patients, especially elderly women, it is impossible to rely upon prevalence estimates to predict at the inception of antipsychotic treatment which patients are likely to develop the syndrome. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. In rare instances, these involuntary movements of the extremities are the only manifestations of tardive dyskinesia. A variant of tardive dyskinesia, tardive dystonia, has also been described.

There is no known effective treatment for tardive dyskinesia; anti-parkinsonism agents do not alleviate the symptoms of this syndrome. If clinically feasible, it is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked.

It has been reported that fine vermicular movements of the tongue may be an early sign of the syndrome and if the medication is stopped at that time the syndrome may not develop.

Adverse Behavioral Effects — Psychotic symptoms and catatonic-like states have been reported rarely.

Other CNS EffectsNeuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. (See WARNINGS.) Cerebral edema has been reported.

Convulsive seizures (petit mal and grand mal) have been reported, particularly in patients with EEG abnormalities or history of such disorders.

Abnormality of the cerebrospinal fluid proteins has also been reported.

Allergic Reactions of a mild urticarial type or photosensitivity are seen. Avoid undue exposure to sun. More severe reactions, including exfoliative dermatitis, have been reported occasionally.

Contact dermatitis has been reported in nursing personnel; accordingly, the use of rubber gloves when administering Thorazine (chlorpromazine) liquid or injectable is recommended.

In addition, asthma, laryngeal edema, angioneurotic edema and anaphylactoid reactions have been reported.

Endocrine Disorders: Lactation and moderate breast engorgement may occur in females on large doses. If persistent, lower dosage or withdraw drug. False-positive pregnancy tests have been reported, but are less likely to occur when a serum test is used. Amenorrhea and gynecomastia have also been reported. Hyperglycemia, hypoglycemia and glycosuria have been reported.

Autonomic Reactions: Occasional dry mouth; nasal congestion; nausea; obstipation; constipation; adynamic ileus; urinary retention; priapism; miosis and mydriasis, atonic colon, ejaculatory disorders/impotence.

Special Considerations in Long-Term Therapy: Skin pigmentation and ocular changes have occurred in some patients taking substantial doses of Thorazine (chlorpromazine) for prolonged periods.

Skin Pigmentation — Rare instances of skin pigmentation have been observed in hospitalized mental patients, primarily females who have received the drug usually for 3 years or more in dosages ranging from 500 mg to 1500 mg daily. The pigmentary changes, restricted to exposed areas of the body, range from an almost imperceptible darkening of the skin to a slate gray color, sometimes with a violet hue. Histological examination reveals a pigment, chiefly in the dermis, which is probably a melanin-like complex. The pigmentation may fade following discontinuance of the drug.

Ocular Changes — Ocular changes have occurred more frequently than skin pigmentation and have been observed both in pigmented and nonpigmented patients receiving Thorazine (chlorpromazine) usually for 2 years or more in dosages of 300 mg daily and higher. Eye changes are characterized by deposition of fine particulate matter in the lens and cornea. In more advanced cases, star-shaped opacities have also been observed in the anterior portion of the lens. The nature of the eye deposits has not yet been determined. A small number of patients with more severe ocular changes have had some visual impairment. In addition to these corneal and lenticular changes, epithelial keratopathy and pigmentary retinopathy have been reported. Reports suggest that the eye lesions may regress after withdrawal of the drug.

Since the occurrence of eye changes seems to be related to dosage levels and/or duration of therapy, it is suggested that long-term patients on moderate to high dosage levels have periodic ocular examinations.

Etiology — The etiology of both of these reactions is not clear, but exposure to light, along with dosage/duration of therapy, appears to be the most significant factor. If either of these reactions is observed, the physician should weigh the benefits of continued therapy against the possible risks and, on the merits of the individual case, determine whether or not to continue present therapy, lower the dosage, or withdraw the drug.

Other Adverse Reactions: Mild fever may occur after large I.M. doses. Hyperpyrexia has been reported. Increases in appetite and weight sometimes occur. Peripheral edema and a systemic lupus erythematosus-like syndrome have been reported.

Note: There have been occasional reports of sudden death in patients receiving phenothiazines. In some cases, the cause appeared to be cardiac arrest or asphyxia due to failure of the cough reflex.

Read the entire FDA prescribing information for Thorazine (Chlorpromazine) »

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