Prochlorperazine (oral)

Prochlorperazine (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Prochlorperazine (oral) is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of severe nausea and vomiting, schizophrenia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

For control of severe nausea and vomiting.

For the treatment of schizophrenia.

Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines).

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

The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).

Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.

Nausea and vomiting, Severe

• Dosing Information

• Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.

Oral Dosage – Tablets:

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.

Schizophrenia

• Dosing Information

• 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 two, longer treatment is usually required before maximal improvement is seen.

Oral Dosage: Psychotic Disorders including Schizophrenia – In relatively mild conditions, as seen in private psychiatric practice or in outpatient clinics, dosage is 5 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. Increase dosage gradually until symptoms are controlled or side effects become bothersome. When dosage is increased by small increments every 2 or 3 days, side effects either do not occur or are easily controlled. Some patients respond satisfactorily on 50 to 75 mg daily.

In more severe disturbances, optimum dosage is usually 100 to 150 mg daily.

Anxiety, Nonpsychotic

• Dosing Information

• 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.

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Radiation-induced nausea and vomiting; Treatment and Prophylaxis

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Prochlorperazine (oral) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Prochlorperazine (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Nausea and vomiting (Severe)( 2 years or older; 20 pounds or greater)

• Dosing Information

• Prochlorperazine should not be used in pediatric patients under 20 pounds in weight or 2 years of age. It should not be used in conditions for which children’s dosages have not been established. Dosage and frequency of administration should be adjusted according to the severity of the symptoms and the response of the patient. The duration of activity following intramuscular administration may last up to 12 hours. Subsequent doses may be given by the same route if necessary.

Oral Dosage:

More than 1 day’s therapy is seldom necessary.

Schizophrenia( 2 years or older; 20 pounds or greater)

• Dosing Information

• Oral Dosage:

For children 2 to 12 years, starting dosage is 2-1/2 mg 2 or 3 times daily. Do not give more than 10 mg the first day. Then increase dosage according to patient’s response.

FOR AGES 2 to 5, total daily dosage usually does not exceed 20 mg.

FOR AGES 6 to 12, total daily dosage usually does not exceed 25 mg.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Prochlorperazine (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Prochlorperazine (oral) in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Prochlorperazine (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Prochlorperazine (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Prochlorperazine (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Prochlorperazine (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Prochlorperazine (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Prochlorperazine (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Prochlorperazine (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Prochlorperazine (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Prochlorperazine (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Prochlorperazine (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Prochlorperazine (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Prochlorperazine (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Prochlorperazine (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Prochlorperazine (oral) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Prochlorperazine (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Prochlorperazine (oral) in the drug label.

Pharmacology

There is limited information regarding Prochlorperazine (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Prochlorperazine (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Prochlorperazine (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Prochlorperazine (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Prochlorperazine (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Prochlorperazine (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Prochlorperazine (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Prochlorperazine (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Prochlorperazine (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Compazine, Compro.

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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