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Promethazine/Dextromethorphan

    Brands

    DEA Class; Rx

    Common Brand Names; Promethazine DM

    • Antitussives, Non-narcotic Combos

    Oral non-opioid antitussive and phenothiazine class sedating antihistamine combination
    Used to relieve cough and upper respiratory symptoms of allergy or common cold
    Boxed warning against use of promethazine in pediatric patients less than 2 years of age due to respiratory depression, including fatalities

    Temporary relief of cough and upper respiratory tract symptoms associated with allergy or the common cold

    Promethazine

    • Hypersensitivity

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

    • Subcutaneous or intra-arterial administration

    • BPH

    • Narrow angle glaucoma

    • Pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction

    • Severe CNS depression

    • Coma, Severe respiratory depression

    Dextromethorphan

    • Concurrent nonselective MAO inhibitors: serotonin syndrome

    • 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

    Promethazine

    • CVD, asthma, hepatic impairment, peptic ulcer, respiratory impairment

    • Anaphylaxis in susceptible individuals

    • May impair ability to drive or perform hazardous tasks

    • Monitor closely in patients with

    • -Cardiovascular disease

    • – Hepatic impairment

    • – Reye syndrome

    • – History of sleep apnea

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

    • Antiemetic effect may obscure toxicity of chemotherapeutic drugs

    Dextromethorphan

    • Phenylketonuria: Contains aspartame

    Pregnancy category: C

    Lactation: Not recommended

    Adults

    Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).

    Geriatric

    Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).

    Adolescents

    Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).

    Children

    12 years: Do not exceed 30 mL/day PO (i.e., not to exceed promethazine 37.5 mg in combination with dextromethorphan 90 mg per 24 hours).
    6 to 11 years: Do not exceed 20 mL/day PO (i.e., not to exceed promethazine 25 mg in combination with dextromethorphan 60 mg per 24 hours).
    2 to 5 years: Do not exceed 10 mL/day PO (i.e., not to exceed promethazine 12.5 mg in combination with dextromethorphan 30 mg per 24 hours).
    Less than 2 years: Contraindicated. Safety and efficacy have not been established.

    Infants

     Contraindicated.

    Promethazine/dextromethorphan

    oral syrup

    • (6.25mg/15mg)/5mL

    dextromethorphan hydrobromide/promethazine hydrochloride