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Doxylamine/Pyridoxine

    Brands

    DEA Class; Rx

    Common Brand Names; Diclegis, Bonjesta

    • Antiemetic Agents

    Combination product containing doxylamine (sedating antihistamine of ethanolamine class) and pyridoxine (Vitamin B6).
    Used for the treatment of pregnancy-induced nausea/vomiting in women who do not respond to conservative management (i.e., diet and lifestyle modifications)
    Doxylamine may cause drowsiness or sleepiness, which may be pronounced

    Indicated for the treatment of pregnancy-induced nausea/vomiting unresponsive to conservative management.

    Hypersensitivity to drug or excipients

    Concomitant use with MAO inhibitors

    • Somnolence (14.3%)
    • Cardiac disorders: Dyspnea, palpitation, tachycardia
    • Ear and labyrinth disorders: Vertigo
    • Eye disorders: Vision blurred, visual disturbances
    • Gastrointestinal disorders: Abdominal distension, abdominal pain, constipation, diarrhea
    • General disorders and administration site conditions: Chest discomfort, fatigue, irritability, malaise
    • Immune system disorders: Hypersensitivity
    • Nervous system disorders: Dizziness, headache, migraines, paresthesia, psychomotor hyperactivity
    • Psychiatric disorders: Anxiety, disorientation, insomnia, nightmares
    • Renal and urinary disorders: Dysuria, urinary retention
    • Skin and subcutaneous tissue disorders: Hyperhidrosis, pruritus, rash, rash maculopapular

    Not evaluated for use in hyperemesis gravidarum

    Coadministration with alcohol and other CNS depressants may cause additive sedation and is not recommended; combination may cause severe drowsiness leading to falls or accidents

    Somnolence due to anticholinergic effects is common; avoid activities requiring mental alertness

    Anticholinergic effects may exacerbate conditions such as asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder-neck obstruction

    Pregnancy

    Intended for treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management; maternal risks are discussed throughout the labeling; no increased risk for congenital malformations reported in epidemiologic studies in pregnant women

    Lactation

    Women should not breastfeed while on therapy; molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected; excitement, irritability and sedation reported in nursing infants presumably exposed to doxylamine succinate through breast milk; infants with apnea or other respiratory syndromes may be particularly vulnerable to sedative effects of drug resulting in worsening of their apnea or respiratory conditions

    Pyridoxine hydrochloride is excreted into breast milk; adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk reported

    Adults

    4 tablets/day PO for delayed-release tablets (e.g., Diclegis); 2 tablets/day PO for extended-release tablets (e.g., Bonjesta).

    Geriatric

    Safety and efficacy have not been established.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Not indicated.

    Neonates

    Not indicated.

    Doxylamine/pyridoxine

    tablet, delayed-release

    • 10mg/10mg (Diclegis)

    tablet, extended-release

    • 20mg/20mg (Bonjesta)
    • Consist of enteric-coated core of 10 mg doxylamine and 10 mg pyridoxine for extended-release, and immediate-release coating of 10 mg doxylamine and 10 mg pyridoxine