Thorazine

Name: Thorazine

Adverse Effects

Frequency Not Defined

Extrapyramidal symptoms

  • Akathisia
  • Dystonia
  • Muscle stiffness
  • Neuroleptic malignant syndrome (NMS; infrequent but serious)
  • Parkinsonism
  • Tardive dyskinesia

Common

  • Anticholinergic effects
  • Sedation
  • Weight gain
  • Erectile dysfunction
  • Oligomenorrhea or amenorrhea

Less common

  • Cerebral edema, orthostatic hypotension (after IM injection), tachycardia
  • Agitation, anxiety, depression, dizziness, euphoria, headache, insomnia, poikilothermia, restlessness, weakness
  • Anorexia, constipation, dyspepsia, ileus
  • Lens opacities (prolonged use)

Uncommon

  • ECG changes
  • Photosensitivity
  • Pruritus
  • Galactorrhea
  • Ejaculatory disorder
  • Diarrhea
  • Blood dyscrasia

Rare

  • Seizure
  • Priapism
  • Cholestatic jaundice

Warnings

Black Box Warnings

Patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk for death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

This drug is not approved for treatment of patients with dementia-related psychosis

Contraindications

Hypersensitivity to phenothiazines

Coma, severe hypotension, severe central nervous system (CNS) depression, concurrent administration of large amounts of CNS depressants, subcortical brain damage, poorly controlled seizure disorder

Severe cardiovascular disease

Lactation

Cautions

Avoid using in children with suspected Reye syndrome

Use caution in glaucoma, prostatic hypertrophy, stenosing peptic ulcer disease (PUD), history of NMS, Parkinson disease, hypocalcemia, renal or hepatic impairment, history of severe reaction to insulin or electroconvulsive therapy (ECT), history of seizures, asthma, respiratory tract infection, cardiovascular disease, myelosuppression

Risk of extrapyramidal symptoms (EPS), NMS, hypotension

Significant hypotension may occur, especially with parenteral administraiton; hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency; in case of severe hypotension, use norepinephrine or phenylepinephrine, and do not use epinephrine or dopamine

May alter cardiac conduction; life threatening arrhythmias reported with therapeutic doses of phenothiazines; may cause QT prolongation and subsequent torsade de pointes; avoid use in patients diagnosed or suspected congenital long QT syndrome

May cause anticholinergic effects; use caution in patients with paralytic ileus, gastrointestinal motility, urinary retention, xerostomia, or visual problems

Agranulocytosis, leukopenia, and neutropenia reported with antipsychotic use; periodic blood count assessment recommended in patients with history of risk factors, including history of drug-induced leuko/neutropenia or preexisting low WBC

Esophageal dysmotility and aspiration reported with antipsychotic use; use caution in patients at risk of pneumonia

May cause extrapyramidal symptoms, including akathisia, acute dystonic reactions, and pseudoparkinsonism, and tardive dyskinesia; risk of dystonia greater with increased doses

Therapy is associated with increased prolactin levels; significance unknown

May cause pigmentary retinopathy, and lenticular and corneal deposits with prolonged therapy

May cause orthostatic hypotension; use caution in patients with risk factors, including patients who do not tolerate transient hypotensive episodes such as hypovolemia, cerebrovascular disease, cardiovascular disease, or medicatioin predisposing to hypotension/bradycardia

May impair physical or mental abilities due to sedating properties; use caution when operating heavy machinery

Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia

Antiemetic effect may obscure toxicity of chemotherapeutic drugs

Anticholinergic antiparkinsonian agent may be needed to counter EPS

Strong anticholinergic agent and alpha blocker

Potential for priapism

US Food and Drug Administration (FDA) warning regarding off-label use for dementia in elderly

What should i avoid while taking chlorpromazine (thorazine)?

Chlorpromazine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase some of the side effects of chlorpromazine.

Avoid exposure to sunlight or tanning beds. Chlorpromazine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Where can i get more information?

Your pharmacist can provide more information about chlorpromazine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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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 Effects — Postural 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 Effects— Neuroleptic 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)

Read More »

Thorazine Drug Class

Thorazine is part of the drug class:

  • Phenothiazines with aliphatic side chain

Thorazine Dosage and Administration

General

  • Adjust dosage carefully according to individual requirements and response; use the lowest possible effective dosage.105 106 c

  • Periodically evaluate patients receiving long-term therapy to determine whether maintenance dosage can be decreased or drug therapy discontinued.105 106 c (See Tardive Dyskinesia under Cautions.)

Psychotic Disorders

  • For symptomatic relief of psychotic disorders, initial therapeutic response to antipsychotic therapy usually occurs within 1–4 weeks and optimum therapeutic response occurs within 6 months or longer.105 106 d g

  • For prompt control of severe psychotic symptoms, administer IM; after symptoms are controlled, oral therapy should replace parenteral therapy.105 106 c d

  • Once optimum dosage is achieved, continue this dosage for 2 weeks, then gradually reduce to lowest possible effective dosage.105 106 c

Administration

Administer orally, by deep IM or direct IV injection, or by IV infusion.105 106 c

Sub-Q administration not recommended because of local irritation.106 c

Avoid skin and clothing contact with chlorpromazine hydrochloride injection, since contact dermatitis has occurred rarely.106 c

Reserve parenteral therapy for recumbent patients;106 c however, if cautions are taken to avoid orthostatic hypotension (i.e., patient remains recumbent for ≥30 minutes after injection), acutely agitated ambulatory patients may receive the drug IM.106 c

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Direct IV injection for use only during surgery to control nausea and vomiting and in the adjunctive treatment of tetanus.106 c

IV infusion is intended only for use in adjunctive treatment of intractable hiccups in adults.106 c

Avoid IV administration of undiluted drug.106 c

Dilution

For direct IV injection, dilute with 0.9% sodium chloride injection to a concentration not exceeding 1 mg/mL.106 c

For IV infusion, add injection to 500–1000 mL of 0.9% sodium chloride.106 c

Rate of Administration

Children: For direct IV injection, administer diluted solution at a rate of 0.5 mg/minute.106 c

Adults: For direct IV injection, administer diluted solution at a rate of 1 mg/minute.106 c For IV infusion, administer diluted solution slowly.106 c

IM Administration

Inject slowly, deep into a large muscle mass such as the upper outer quadrant of the gluteus maximus.106 c

Dilution

If irritation at IM injection site occurs, may dilute with 0.9% sodium chloride injection or 2% procaine hydrochloride.106 c

Dosage

Available as chlorpromazine hydrochloride; dosage expressed in terms of the hydrochloride salt.105 106 c

Manufacturers state that the 100- and 200-mg tablets are intended for use in patients with severe neuropsychiatric conditions.105 c

Chlorpromazine should generally not be used in children <6 months of age unless the condition to be treated is potentially life-threatening; dosage in this age group has not been established.105 106 c

Pediatric Patients

Adolescents 13–17 years of age: No specific dosage recommendations; dosage is based on patient weight and clinician judgment.k l

Nausea and Vomiting Oral

Children 6 months to 12 years of age: Usually, 0.55 mg/kg every 4–6 hours as necessary.105 c Adjust dosage based on symptom severity and patient response.105 c

IM

Children 6 months to 12 years of age: Initially, 0.55 mg/kg every 6–8 hours as necessary; carefully adjust subsequent dosage based on symptom severity and patient response.106 c

Surgery Preoperative Sedation Oral

Children 6 months to 12 years of age: 0.55 mg/kg administered 2–3 hours before surgery.105 c

IM

Children 6 months to 12 years of age: 0.55 mg/kg administered 1–2 hours before surgery.106 c

Nausea and Vomiting During Surgery IV

Children 6 months to 12 years of age: Fractional 1-mg doses may be given at 2-minute intervals up to a total dosage of 0.275 mg/kg;106 c may repeat fractional dosage regimen after 30 minutes if necessary and if hypotension does not occur.106 c

IM

Children 6 months to 12 years of age: 0.275 mg/kg;106 c may repeat dosage in 30 minutes if necessary and if hypotension does not occur.106 c

Tetanus IM or IV

Children 6 months to 12 years of age: 0.55 mg/kg every 6–8 hours by IM or direct IV injection.106 c

In children weighing <22.7 kg, maximum parenteral dosage is 40 mg daily.106 c In children weighing 22.7–45.5 kg, maximum parenteral dosage is ≤75 mg daily, except in severe cases.106 c

Disruptive Behavior Disorder and ADHD Outpatients Oral or IM

Children 1–12 years of age: Initially, 0.55 mg/kg orally every 4–6 hours or IM every 6–8 hours as necessary;105 106 c increase dosage gradually as required.105 106 c

Hospitalized Patients Oral or IM

Initiate with low dosage as with outpatients and increase dosage gradually.105 106 c For severe behavior disorders, higher dosages (50–100 mg daily, and in older children: ≥200 mg daily) may be necessary.105 106 c There is little evidence that behavior improvement in severely disturbed, mentally retarded patients is further enhanced at dosages >500 mg daily.105 106 c

IM

Maximum 40 mg daily for children <5 years (or 22.7 kg).106 c

Maximum ≤75 mg daily for children 5–12 years of age (or 22.7–45.5 kg);106 c dosage may be further increased in unmanageable patients.106 c

Adults

Psychotic Disorders

Usual oral dosage during maintenance therapy is 200 mg daily; however, oral dosages up to 800 mg daily may be required in some patients.105 106 c

Outpatients with Relatively Mild Symptomatology Oral

30–75 mg daily, given in 2–4 divided doses.105 c

Outpatients with More Severe Symptomatology Oral

Initially, 25 mg 3 times daily.105 c After 1 or 2 days, may gradually increase dosage twice weekly by 20–50 mg until symptoms are controlled.105 c

If used to replace parenteral therapy after prompt control of symptoms achieved, initiate oral therapy at 25–50 mg 3 times daily.105 106 c

IM

For prompt control of severe symptoms, 25 mg IM initially; may repeat in 1 hour if necessary.106 c After symptoms are controlled, replace parenteral therapy with oral therapy at dosage of 25–50 mg 3 times daily.105 106 c

Hospitalized Patients Oral

Dosages of 500 mg daily are generally sufficient in most patients.105 c Dosages >2 g daily may be required in some patients; however, little therapeutic gain is achieved with dosages >1 g daily administered for extended periods.105 c

Less acutely agitated patients: Initially, 25 mg 3 times daily;105 c gradually increase subsequent dosage.105 Usually do not exceed 400 mg daily.105 c

IM

In acute schizophrenic or manic patients: Initially, 25 mg.106 c May administer an additional IM dose of 25–50 mg in 1 hour if necessary.106 c Increase subsequent dosage gradually over several days to a maximum of 400 mg every 4–6 hours in exceptionally severe cases until symptoms are controlled.106 c

Usually, patients become quiet and cooperative within 24–48 hours after therapy initiation;105 106 oral therapy can then replace parenteral therapy.106

Nausea and Vomiting Oral

10–25 mg every 4–6 hours;105 c may increase dosage if necessary.105 c

IM

Initially, usual dose is 25 mg.106 c If hypotension does not occur, may administer additional IM doses of 25–50 mg every 3–4 hours until symptoms subside; oral therapy should then replace parenteral therapy if necessary.106 c

Surgery Preoperative Sedation Oral

25–50 mg, 2–3 hours before surgery.105 c

IM

12.5–25 mg, 1–2 hours before surgery.106 c

Nausea and Vomiting During Surgery IV

Fractional 2-mg doses may be given IV at 2-minute intervals up to a maximum total dosage of 25 mg.106 c

IM

12.5 mg; may repeat dose in 30 minutes if hypotension does not occur.106 c

Acute Intermittent Porphyria Oral

25–50 mg 3 or 4 times daily.105 c Can discontinue therapy after several weeks; however, some patients may require maintenance therapy.105 c

IM

25 mg 3 or 4 times daily until patient can take oral therapy.106 c

Tetanus IV

25–50 mg by direct IV injection.106 c

IM

25–50 mg 3 or 4 times daily, usually in conjunction with barbiturates.106 c Determine total dosage and administration frequency by patient response, starting with low dosage and increasing gradually.106

Intractable Hiccups Oral or IM

Initially, 25–50 mg orally 3 or 4 times daily.105 c If symptoms persist for 2–3 days, may give 25–50 mg IM.105 106 c

IV

If hiccups persist after oral and IM therapy, may administer 25–50 mg by slow IV infusion with patient in a supine position.106 c Closely monitor BP.106 c

Prescribing Limits

Pediatric Patients

Nausea and Vomiting IM

Maximum 40 mg daily for children 6 months to <5 years of age (or <22.7 kg).106 c

Maximum 75 mg daily for children 5–12 years of age (or 22.7–45.5 kg), except in severe cases.106 c

Tetanus IM or IV

Maximum 40 mg daily for children <22.7 kg.106 c

Maximum ≤75 mg daily for children 22.7–45.5 kg, except in severe cases.106 c

Disruptive Behavior Disorder and ADHD Hospitalized Patients Oral or IM

Maximum effective dosage not established, but there is little evidence that behavior improvement in severely disturbed mentally retarded patients is further enhanced at dosages >500 mg daily.105 106 c

IM

Maximum 40 mg daily for children <5 years (or <22.7 kg).106 c

Maximum ≤75 mg daily for children 5–12 years of age (or from 22.7–45.5 kg); dosage may be further increased in unmanageable patients.106 c

Adults

Psychotic Disorders Hospitalized Patients Oral

Little therapeutic gain achieved by dosages >1 g daily administered for extended periods.105 c

Less acutely agitated patients: Usually do not exceed 400 mg daily.105 c

IM

Maximum IM dosage of 400 mg every 4–6 hours.106 c

Surgery Nausea and Vomiting During Surgery IV

Maximum total dosage of 25 mg.106 c

Special Populations

Geriatric Patients

No specific dosage recommendations for geriatric patients, but generally select dosage at the lower end of recommended range; increase dosage more gradually and monitor closely.105 106 c d (See Geriatric Use under Cautions.)

Debilitated or Emaciated Patients

Increase dosage more gradually.105 106 c d

Advice to Patients

  • Importance of advising patients and caregivers that elderly patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.101 105 106 n Patients and caregivers also should be informed that chlorpromazine is not approved for treating elderly patients with dementia-related psychosis.105 106 n

  • Importance of informing patients with a sulfite allergy that chlorpromazine hydrochloride injection contains sulfites and may precipitate allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes).106

  • Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.105 106

  • Importance of avoiding alcohol during chlorpromazine therapy.105 106

  • Importance of informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.105 106 d

  • Importance of clinicians informing patients of risk of extrapyramidal reactions and providing reassurance that these reactions usually can be controlled by administration of antiparkinsonian drugs (e.g., benztropine) and by subsequent dosage reduction.105 106 d

  • Importance of avoiding exposure to temperature extremes.105 106 d

  • Risk of leukopenia/neutropenia.105 106 Importance of advising patients with a preexisting low WBC count or history of drug-induced leukopenia/neutropenia that their CBC count should be monitored during chlorpromazine therapy.105 106

  • Importance of informing clinician if sore throat or other signs of infection occur.105 106 d

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular disease).105 106 d

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.105 106 q Importance of clinicians informing patients about the benefits and risks of taking antipsychotics during pregnancy (see Fetal/Neonatal Morbidity under Cautions).105 q Importance of advising patients not to stop taking chlorpromazine if they become pregnant without consulting their clinician; abruptly stopping antipsychotic agents may cause complications.q Importance of advising patients not to breast-feed during chlorpromazine therapy.105 106

  • Importance of informing patients of other important precautionary information.105 106 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

chlorproMAZINE Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg*

chlorproMAZINE Hydrochloride Tablets

25 mg*

chlorproMAZINE Hydrochloride Tablets

50 mg*

chlorproMAZINE Hydrochloride Tablets

100 mg*

chlorproMAZINE Hydrochloride Tablets

200 mg*

chlorproMAZINE Hydrochloride Tablets

Parenteral

Injection

25 mg/mL*

chlorproMAZINE Hydrochloride Injection

Baxter

For the Consumer

Applies to chlorpromazine: oral tablets, parenteral injection

Side effects include:

Extrapyramidal reactions (e.g., Parkinson-like symptoms, dystonia, akathisia, tardive dyskinesia), drowsiness, dizziness, skin reactions or rash, dry mouth, orthostatic hypotension, amenorrhea, galactorrhea, weight gain.

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