Chlorpromazine

What is Chlorpromazine?

• Chlorpromazine (Promapar; Thorazine) is a dimethylamine derivative of phenothiazine use as an antipsychotic medication.

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Chlorpromazine

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What are the uses of this medicine?

Chlorpromazine (Promapar;Thorazine) is used:

• For the management of manifestations of psychotic disorders.
• For the treatment of schizophrenia.
• To control nausea and vomiting.
• For relief of restlessness and apprehension before surgery.
• For acute intermittent porphyria.
• As an adjunct in the treatment of tetanus.
• To control the manifestations of the manic type of manic-depressive illness.
• For relief of intractable hiccups.
• For the treatment of severe behavioral problems in children (1 to 12 years of age).

How does this medicine work?

• The hydrochloride salt form of chlorpromazine, a phenothiazine and traditional antipsychotic agent with anti-emetic activity.
• Chlorpromazine hydrochloride exerts its antipsychotic effect by blocking postsynaptic dopamine receptors in cortical and limbic areas of the brain, thereby preventing the excess of dopamine in the brain.
• This leads to a reduction in psychotic symptoms, such as hallucinations and delusions.
• Chlorpromazine hydrochloride appears to exert its anti-emetic activity by blocking the dopamine receptors in the chemical trigger zone (CTZ) in the brain, thereby relieving nausea and vomiting.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to phenothiazines.
• comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc).

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• anticoagulants (blood thinners) such as warfarin (Coumadin)
• antidepressants
• antihistamines
• atropine (in Motofen, in Lomotil, in Lonox)
• barbiturates such as pentobarbital (Nembutal), phenobarbital (Luminal), and secobarbital (Seconal)
• cancer chemotherapy
• diuretics (water pills)
• epinephrine (Epipen)
• guanethidine (not available in the US)
• ipratropium (Atrovent)
• lithium (Eskalith, Lithobid)
• medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems
• medications for seizures such as phenytoin (Dilantin)
• narcotic medications for pain
• propranolol (Inderal)
• sedatives
• sleeping pills
• tranquilizers

Is this medicine FDA approved?

• Chlorpromazine was approved for use in the United States in 1957 and was formerly the most commonly prescribed antipsychotic medication, being the prototypic, standard neuroleptic agent against which other antipsychotic agents were tested.
• In recent years, chlorpromazine has been replaced in large part by the atypical antipsychotics, which have fewer extrapyramidal and hepatic side effects.

How should this medicine be used?

Recommended dosage:

• The 100 mg and 200 mg tablets are for use in severe neuropsychiatric conditions.

Psychotic Disorders:

• Increase dosage gradually until symptoms are controlled.
• Maximum improvement may not be seen for weeks or even months.
• Continue optimum dosage for 2 weeks; then gradually reduce dosage to the lowest effective maintenance level.
• Daily dosage of 200 mg is not unusual.
• Some patients require higher dosages (e.g., 800 mg daily is not uncommon in discharged mental patients).

Acute Schizophrenic or Manic States:

• It is recommended that initial treatment be with chlorpromazine hydrochloride injection until patient is controlled.
• Usually patient becomes quiet and co-operative within 24 to 48 hours and oral doses may be substituted and increased until the patient is calm.
• 500 mg a day is generally sufficient.
• While gradual increases to 2,000 mg a day or more may be necessary, there is usually little therapeutic gain to be achieved by exceeding 1,000 mg a day for extended periods.

Less Acutely Disturbed:

• 25 mg t.i.d. Increase gradually until effective dose is reached – usually 400 mg daily.

More Severe Cases:

• 25 mg t.i.d. After 1 or 2 days, daily dosage may be increased by 20 to 50 mg at semi-weekly intervals until patient becomes calm and cooperative.

Prompt Control of Severe Symptoms:

• Initial treatment should be with intramuscular chlorpromazine.
• Subsequent doses should be oral, 25 mg to 50 mg t.i.d.

Nausea and Vomiting:

• 10 mg to 25 mg q4 to 6h, p.r.n., increased, if necessary.

Presurgical Apprehension:

• 25 mg to 50 mg, 2 to 3 hours before the operation.

Intractable Hiccups:

• 25 mg to 50 mg t.i.d. or q.i.d.
• If symptoms persist for 2 to 3 days, parenteral therapy is indicated.

Acute Intermittent Porphyria:

• 25 mg to 50 mg t.i.d. or q.i.d.
• Can usually be discontinued after several weeks, but maintenance therapy may be necessary for some patients.

Administration:

• Chlorpromazine comes as a tablet to take by mouth.
• Chlorpromazine is usually taken two to four times a day.
• When chlorpromazine is used to control nausea and vomiting, it is usually taken every 4-6 hours as needed.
• When chlorpromazine is used to relieve nervousness before surgery, it is usually taken 2-3 hours before surgery.
• When chlorpromazine is used to relieve hiccups, it is usually taken 3-4 times a day for up to 3 days or until the hiccups stop.
• If the hiccups do not stop after 3 days of treatment, a different medication should be used. If you are taking chlorpromazine on a regular schedule, take it at around the same times every day.
• Your doctor may start you on a low dose of chlorpromazine and gradually increase your dose.
• Your doctor may decrease your dose once your condition is controlled. Be sure to tell your doctor how you are feeling during your treatment with chlorpromazine.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablets of 10, 25, 50, 100 and 200 mg, as extended release capsules of 200 and 300 mg, and as syrup in various concentrations.

This medicine is available in fallowing brand namesː

• Promapar; Thorazine

What side effects can this medication cause?

The most common side effects of this medicine include:

• drowsiness, dizziness, headache, blurred vision, dry mouth, constipation, tremor, restlessness, muscle spasms and weight gain

Less common but serious side effects may include:

• Jaundice
• Hematological Disorders
• Agranulocytosis
• Hypotensive Effects
• EKG Changes
• Extrapyramidal Symptoms
• Dystonia
• Motor Restlessness
• Pseudoparkinsonism
• Tardive Dyskinesia
• Neuroleptic Malignant Syndrome
• Allergic Reactions
• Endocrine Disorders
• Autonomic Reactions
• Skin Pigmentation
• Ocular Changes

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Chlorpromazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis
• The use of chlorpromazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome.
• Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.
• Chlorpromazine may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, caution patients about activities requiring alertness (e.g., operating vehicles or machinery).
• The use of alcohol with this drug should be avoided due to possible additive effects and hypotension.
• Chlorpromazine may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.
• In clinical trial and post marketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents. Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.
• Chlorpromazine should be administered cautiously to persons with cardiovascular, liver or renal disease. There is evidence that patients with a history of hepatic encephalopathy due to cirrhosis have increased sensitivity to the CNS effects of chlorpromazine (i.e., impaired cerebration and abnormal slowing of the EEG).
• Use with caution in persons who will be exposed to extreme heat, organophosphorus insecticides, and in persons receiving atropine or related drugs.
• Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration.
• As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, chlorpromazine should be used with caution in patients with glaucoma.
• If you are having a myelogram (x-ray examination of the spine), tell your doctor and the radiographer that you are taking chlorpromazine. Your doctor will probably tell you not to take chlorpromazine for 2 days before the myelogram and for one day after the myelogram.
• Plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Chlorpromazine may make your skin sensitive to sunlight.
• Chlorpromazine can cause mild and transient serum enzyme elevations and is also a well known cause of clinically apparent acute and chronic cholestatic liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• somnolence or coma
• Hypotension and extrapyramidal symptoms

• Other possible manifestations include agitation and restlessness, convulsions, fever, autonomic reactions such as dry mouth and ileus. EKG changes and cardiac arrhythmias.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment is essentially symptomatic and supportive.
• Early gastric lavage is helpful.
• Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe over dosage.
• Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus.
• Extrapyramidal symptoms may be treated with anti-parkinsonism drugs, barbiturates, or diphenhydramine hydrochloride.
• Care should be taken to avoid increasing respiratory depression.
• If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended.
• Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.
• If hypotension occurs, the standard measures for managing circulatory shock should be initiated.
• If it is desirable to administer a vasoconstrictor, norepinephrine and phenylephrine are most suitable.
• Other pressor agents, including epinephrine, are not recommended.
• Limited experience indicates that phenothiazines are not dialyzable.

Can this medicine be used in pregnancy?

• Safety for the use of chlorpromazine during pregnancy has not been established.
• Therefore, it is not recommended that the drug be given to pregnant patients except when, in the judgment of the physician, it is essential.

Can this medicine be used in children?

• Chlorpromazine is used for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Chlorpromazine hydrochloride

Inactive ingredients:

• hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide.
• Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac.

Who manufactures and distributes this medicine?

Manufactured by:

• Amneal Pharmaceuticals Pvt. Ltd.
• Oral Solid Dosage Unit
• Ahmedabad, INDIA

Distributed by:

• Amneal Pharmaceuticals LLC
• Bridgewater, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).
• Protect from light and moisture.
• This package is not for household dispensing.
• If dispensed for outpatient use, a well closed, light-resistant, child-resistant container should be utilized.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Chlorpromazine
• FDA Chlorpromazine

Chlorpromazine Resources
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