Prochlorperazine

What is Prochlorperazine?

• Prochlorperazine (Compazine; Compro; Procomp) is a phenothiazine derivative, used as an anti-emetic and antipsychotic agent.

Prochlorperazine

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What are the uses of this medicine?

Prochlorperazine (Compazine; Compro; Procomp) tablets are used:

• for the control of severe nausea and vomiting.
• for the treatment of schizophrenia.
• for the short-term treatment of generalized non-psychotic anxiety.

• When used in the treatment of non-psychotic anxiety, prochlorperazine maleate tablets should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine maleate tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible.

• Prochlorperazine suppositories are only used to control severe nausea and vomiting.

How does this medicine work?

• Prochlorperazine (proe" klor per' a zeen) is a tricyclic aliphatic phenothiazine which acts by postsynaptic inhibition of dopamine receptors. Prochlorperazine has other peripheral and central nervous system effects, producing both alpha adrenergic stimulation and blocking histamine- and serotonin-mediated effects.
• Prochlorperazine is indicated primarily for the therapy of nausea and vomiting.

Who Should Not Use this medicine ?

This medicine cannot be used:

• in patients with known hypersensitivity to phenothiazines.
• in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).
• in pediatric surgery.
• in pediatric patients under 2 years of age or under 20 lbs.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• 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)
• diuretics ('water pills')
• epinephrine (Epipen)
• guanethidine (not available in the US)
• ipratropium (Atrovent)
• lithium (Eskalith, Lithobid), medications for anxiety, irritable bowel disease, mental illness, Parkinson's disease, motion sickness, ulcers, or urinary problems
• medications for seizures such as phenytoin (Dilantin)
• narcotic medications for pain
• propranolol (Inderal)
• sedatives
• sleeping pill
• tranquilizers

Is this medicine FDA approved?

• Prochlorperazine was FDA approved for use in the United States in 1956 and is still widely used in therapy of nausea and vomiting.

How should this medicine be used?

Recommended dosage: To Control Severe Nausea and Vomiting:

• Adjust dosage to the response of the individual.
• Begin with the lowest recommended dosage.
• Usually one 5 mg or 10 mg tablet 3 or 4 times daily.
• Daily dosages above 40 mg should be used only in resistant cases.

In Adult Psychiatric Disorders:

• Adjust dosage to the response of the individual and according to the severity of the condition.
• Begin with the lowest recommended dose.
• Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen.

Non-Psychotic Anxiety:

• Usual dosage is 5 mg 3 or 4 times daily.
• Do not administer in doses of more than 20 mg per day or for longer than 12 weeks.

Psychotic Disorders including Schizophrenia:

• In relatively mild conditions, as seen in private psychiatric practice or in outpatient clinics, dosage is 5 mg or 10 mg 3 or 4 times daily.
• In moderate to severe conditions, for hospitalized or adequately supervised patients, usual starting dosage is 10 mg 3 or 4 times daily.
• Some patients respond satisfactorily on 50 mg to 75 mg daily.
• In more severe disturbances, optimum dosage is usually 100 mg to 150 mg daily.

Rectal Dosage:

• 25 mg twice daily.

Elderly Patients:

• In general, dosages in the lower range are sufficient for most elderly patients.
• Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely.
• Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly.
• Dosage should be increased more gradually in elderly patients.

Administration:

• Prochlorperazine comes as a tablet to take by mouth and as a suppository to place in the rectum.
• Prochlorperazine tablets are usually taken three to four times a day by adults and are usually given to children one to three times a day.
• Prochlorperazine suppositories are usually inserted twice a day.
• Use prochlorperazine at around the same times every day.
• Your doctor may start you on a low dose of prochlorperazine and gradually increase your dose, not more often than once every 2-3 days.
• If you are using prochlorperazine to treat schizophrenia, prochlorperazine may help control your symptoms but will not cure your condition.
• Continue to use prochlorperazine even if you feel well.
• Do not stop using prochlorperazine without talking to your doctor.

* If you suddenly stop using prochlorperazine, you may experience withdrawal symptoms such as nausea, vomiting, dizziness, and shakiness.

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

This medicine is available in fallowing doasage form:

• As a tablet to take by mouth and as a suppository to place in the rectum

This medicine is available in fallowing brand namesː

• Compazine; Compro; Procomp

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.

Additional side effects may include:

• amenorrhea
• skin reactions
• hypotension may occur
• Neuroleptic Malignant Syndrome (NMS)
• Cholestatic jaundice
• Leukopenia and agranulocytosis
• Extrapyramidal Symptoms
• Dystonia
• Motor Restlessness
• Pseudoparkinsonism
• Tardive Dyskinesia

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis.
• The use of prochlorperazine 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.
• The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. T
• Patients with bone marrow depression or who have previously demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not receive any phenothiazine, including prochlorperazine, unless in the judgment of the physician the potential benefits of treatment outweigh the possible hazards.
• Prochlorperazine 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).
• Phenothiazines may intensify or prolong the action of central nervous system depressants (e.g., alcohol, anesthetics, narcotics).
• Prochlorperazine maleate tablets may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries
• There is evidence that phenothiazines are excreted in the breast milk of nursing mothers. Caution should be exercised when prochlorperazine is administered to a nursing woman.
• The antiemetic action of prochlorperazine may mask the signs and symptoms of overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such as intestinal obstruction, brain tumor and Reye’s syndrome.
• Aspiration of vomitus has occurred in a few postsurgical patients who have received prochlorperazine as an antiemetic.
• Deep sleep, from which patients can be aroused, and coma have been reported, usually with overdosage.
• Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration.
• As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, prochlorperazine should be used with caution in patients with glaucoma.
• you should know that prochlorperazine may make it harder for your body to cool down when it gets very hot. Use with caution in persons who will be exposed to extreme heat.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using prochlorperazine.
• If you will be having a myelogram (x-ray examination of the spine), tell your doctor and the radiographer that you are taking prochlorperazine. Your doctor will probably tell you not to take prochlorperazine for 2 days before the myelogram and for one day after the myelogram.
• In rare instances, prochlorperazine can cause clinically apparent acute and chronic cholestatic liver injury.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• dystonic reactions
• somnolence or coma
• Agitation and restlessness
• convulsions
• EKG changes and cardiac arrhythmias
• fever
• autonomic reactions such as hypotension, dry mouth and ileus.

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 overdosage.
• 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 antiparkinsonism drugs, barbiturates or diphenhydramine HCl.
• 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 bitartrate and phenylephrine HCl 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?

• Prochlorperazine maleate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Can this medicine be used in children?

• Safety and efficacy in children have not been established.

What are the active and inactive ingredients in this medicine?

Prochlorperazine maleate tablets:

• Active Ingredient:
• prochlorperazine maleate
• Inactive Ingredients:
• colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, sodium lauryl sulfate, titanium dioxide, and triacetin.

Prochlorperazine Suppositories:

• Active Ingredient:
• prochlorperazine
• Inactive Ingredients:
• glycerin, glyceryl monostearate, hydrogenated coconut oil fatty acids, hydrogenated palm kernel oil fatty acids.

Who manufactures and distributes this medicine?

Prochlorperazine maleate tablets:

• Mylan Pharmaceuticals Inc.
• Morgantown, WV U.S.A.

Prochlorperazine Suppositories: Distributed by:

• Cosette Pharmaceuticals, Inc.
• South Plainfield, NJ

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

Prochlorperazine maleate tablets:

• Store at 20° to 25°C (68° to 77°F).

Prochlorperazine Suppositories:

• Store at 20-25°C (68-77°F).
• Do not remove from foil until ready to use.

• Dailymed label info on Prochlorperazine
• FDA Prochlorperazine

Prochlorperazine Resources
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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