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Promethazine

    DEA Class; Rx

    Common Brand Names; Phenergan, Phenadoz

    • Antiemetic Agents; 
    • Antihistamines, 1st Generation

    Phenothiazine derivative with primarily antihistaminic effects and also has antiemetic, anticholinergic, sedative actions
    Not an effective neuroleptic; used in cough and cold products for antihistaminic actions; also commonly used for post-operative nausea/vomiting
    Contraindicated in pediatric patients less than 2 years of age due to risk of fatal respiratory depression
    Intravenous administration not recommended as it carries a risk of severe tissue damage

    Indicated for the prevention of motion sickness.

    For the treatment of active nausea/vomiting, including post-operative nausea/vomiting (PONV) and for post-operative nausea/vomiting (PONV) prophylaxis.
    For the treatment of allergic reactions to blood or plasma, for anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, or other uncomplicated allergic conditions, such as pruritus.
    For sedation induction.

    Hypersensitivity

    Newborn/premature infants <2 years old (risk of potentially fatal respiratory depression)

    SC or intra-arterial administration

    Coma

    Treatment of lower respiratory tract symptoms, including asthma

    • Sedation
    • Confusion
    • Disorientation
    • Blurred vision
    • Hallucinations
    • Dystonias
    • Catatonic states
    • Euphoria
    • Excitation
    • Extrapyramidal symptoms
    • Tachycardia
    • Bradycardia
    • Leukopenia (rare)
    • Agranulocytosis (rare)
    • Obstructive jaundice
    • Photosensitivity
    • Dry mouth
    • Angioneurotic edema
    • Tardive dyskinesia
    • Urticaria
    • Xerostomia
    • Impotence
    • Urinary retention

    Use caution in asthma, hepatic impairment, peptic ulcer disease, respiratory impairment, bone marrow suppression, anaphylaxis in susceptible individuals

    May impair ability to drive or perform hazardous tasks

    May impair core body temperature regulation; caution when taking medications with anticholinergic effects, heat exposure, or strenuous exercise

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

    May alter cardiac conduction (life-threatening arrhythmias reported)

    Antiemetic effect may obscure toxicity of chemotherapeutic drugs

    Monitor closely in patients with cardiovascular disease, hepatic impairment, Reye syndrome, or history of sleep apnea

    Has anticholinergic effects; use with caution in patients with decreased gastrointestinal motility or obstructions (partial or complete), urinary retention, urinary obstructions, xerostomia, BPH, or visual problems

    May cause extrapyramidal symptoms including pseudoparkinsonism, acute dystonic reactions, tardive dyskinesia, and akathisia

    Neuroleptic malignant syndrome reported with use; monitor for fever, muscle rigidity and/or autonomic instability, or mental status changes

    May cause orthostatic hypotension; use caution in patients at risk of experiencing hypotensive episodes (cardiovascular disease, cerebrovascular disease, hypovolemia or taking medications that may predispose to bradycardia or hypotension)

    May cause photosensitivity

    Pyloroduodenal obstruction, stenosing peptic ulcer disease, bladder neck obstruction

    Anticholinergic effects of promethazine may exacerbate condition in patients with narrow-angle glaucoma or myasthenia gravis

    Pregnancy category: C

    Lactation: Not known whether drug crosses into breast milk; discontinue drug, or do not nurse

    Adults

    50 mg/dose; generally 100 mg/day. Dosage should not exceed maximum recommendations per indication.

    Geriatric

    50 mg/dose; generally 100 mg/day. Dosage should not exceed maximum recommendations per indication.

    Adolescents

    1.1 mg/kg/dose PO/PR/IM/IV (Max: 25 mg/dose). Dosage should not exceed maximum recommendations per indication.

    Children

    >= 2 years: 1.1 mg/kg/dose PO/PR/IM/IV (Max: 25 mg/dose). Dosage should not exceed maximum recommendations per indication.
    < 2 years: Use is contraindicated due to the risk for fatal respiratory depression.

    Infants

    Use is contraindicated due to the risk for fatal respiratory depression.

    Neonates

    Use is contraindicated due to the risk for fatal respiratory depression.

    Promethazine hydrochloride

    tablet

    • 12.5mg
    • 25mg
    • 50mg

    suppository

    • 12.5mg
    • 25mg
    • 50mg

    injectable solution

    • 25mg/mL
    • 50 mg/mL

    syrup

    • 6.25mg/5mL