Promethazine (oral)

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Promethazine (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: Vignesh Ponnusamy, M.B.B.S. [2]

Disclaimer

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Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
  • PROMETHAZINE HCl SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
  • POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCl IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
  • CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

Overview

Promethazine (oral) is a phenothiazine derivative that is FDA approved for the {{{indicationType}}} of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis, mild, uncomplicated allergic skin manifestations of urticaria and angiodema, amelioration of allergic reactions to blood or plasma, dermographism, preoperative, postoperative, or obstetric sedation, prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery, adjunctive to meperidine or other analgesics for control of postoperative pain, motion sickness, antiemetic therapy in postoperative patients. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1
  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage

Off-Label Use and Dosage (Adult)

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 Promethazine (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 Promethazine (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Promethazine (oral) in pediatric patients.

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 Promethazine (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 Promethazine (oral) in pediatric patients.

Contraindications

  • Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age.
  • Promethazine hydrochloride tablets are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
  • PROMETHAZINE HCl SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
  • POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCl IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
  • CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
  • CNS Depression
  • Promethazine HCl tablets may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS: Information for Patients and Drug Interactions).
  • Respiratory Depression
  • Promethazine HCl tablets may lead to potentially fatal respiratory depression.
  • Use of promethazine HCl tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided.
  • Lower Seizure Threshold
  • Promethazine HCl tablets may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.
  • Bone-Marrow Depression
  • Promethazine HCl tablets should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.
  • Neuroleptic Malignant Syndrome
  • A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).
  • The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
  • The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, 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. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
  • Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.
  • Use in Pediatric Patients
  • Promethazine Hcl tablets are contraindicated for the use in pediatric patients less than two years of age.
  • Caution should be exercised when administering promethazine hcl tablets to pediatric patients 2 years of age and older because of the potential for fatal respiratory depression. Respiratory depression and apnea,sometimes associated with death, are strongly associated with promethazine products and are not directly related to individualized weight-based dosing, which might otherwise permit safe administration, concomitant administration of promethazine products with other respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients.
  • Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. The extrapyramidal symptoms which can occur secondary to promethazine hcl tablets administration may be confused with the CNS signs of undiagnosed primary disease, e.g., encephalopathy or reye's syndrome. The use of promethazine hcl tablets should be avoided in pediatric patients whose signs and symptoms may suggest Reye's syndrome or other hepatic diseases.
  • Excessively large dosages of antihistamines, including promethazine HCl tablets in pediatric patients may cause sudden death. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine HCl in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of promethazine HCl.
  • Other Considerations
  • Administration of promethazine HCl has been associated with reported cholestatic jaundice.

Precautions

  • Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction.
  • Promethazine HCl tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Promethazine (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 Promethazine (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

  • CNS Depressants
  • Promethazine HCl tablets may increase, prolong, or intensify the sedative action of other central-nervous system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with promethazine HCl tablets, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain.
  • Epinephrine
  • Because of the potential for promethazine HCl to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine HCl tablets overdose.
  • Anticholinergics
  • Concomitant use of other agents with anticholinergic properties should be undertaken with caution.
  • Monoamine Oxidase Inhibitors (MAOI)
  • Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with promethazine HCl tablets.

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 Promethazine (oral) in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Promethazine (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

  • Long-term animal studies have not been performed to assess the carcinogenic potential of promethazine, nor are there other animal or human data concerning carcinogenicity, mutagenicity, or impairment of fertility with this drug. Promethazine was nonmutagenic in the Salmonella test system of Ames.

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Promethazine (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

  • Promethazine HCl tablets may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment. Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities.
  • Patients should be advised to report any involuntary muscle movements.
  • Avoid prolonged exposure to the sun.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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