Classes
DEA Class; Rx
Common Brand Names; Diclegis, Bonjesta
- Antiemetic Agents
Description
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
Indications
Contraindications
Hypersensitivity to drug or excipients
Concomitant use with MAO inhibitors
Adverse Effects
- 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
Warnings
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 and Lactation
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
Maximum Dosage
4 tablets/day PO for delayed-release tablets (e.g., Diclegis); 2 tablets/day PO for extended-release tablets (e.g., Bonjesta).
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
Not indicated.
How supplied
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
