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
Lactation: Do not breast feed; doxylamine molecular weight is low enough to distribute into human breast milk
Excitement, irritability, and sedation reported in nursing infants presumably exposed to doxylamine through breast milk; infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects resulting in worsening of apnea or respiratory conditions
Pyridoxine is excreted in breast milk; there have been no reports of adverse effects in infants
Indication
Nausea & Vomiting of Pregnancy
Contra Indication
Hypersensitivity
MAO inhibitors intensify and prolong doxylamine?s adverse effects (ie, anticholinergic, CNS)
Dose
N/A
Side Effect
>10%
Somnolence (14.3%)
Pregnancy Category
Name :
Not Classified
Description
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Doxylamine: Ethanolamine derivative antihistamine
Pyridoxine: Vitamin B6 analog
Doxylamine is an antihistamine that blocks Histamine (H1) receptor. It affects the vestibular system and decreases the stimulation of the vomiting center. Its mascarinic receptor inhibition may also play a role in antihistamine antiemetic activity.
Pyridoxine (Vitamin B6) is a vitamin used to prevent nausea and vomiting due to its antiemetic properties.
Interaction
N/A
Pregnancy Category Note
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
Adult Dose
Oral
Nausea & Vomiting of Pregnancy
Indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
Delayed-release Tablet
2 delayed-release tablets PO on a daily basis at bedtime
If symptoms not adequately controlled, increase dose to 4 tablets each day (1 tab in AM, 1 tab mid-afternoon, and 2 tabs at bedtime)
Conventional Tablet
Initially, take one tablet orally at bedtime (Day 1).
If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only.
If symptoms persist, increase the daily dose to one tablet in the morning and one tablet at bedtime.
The maximum recommended dose is two tablets per day, one in the morning and one at bedtime.
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
N/A
Administration
Take on empty stomach with water; food further delays onset of action and lowers peak levels
Swallow tablet whole, do not chew, crush, or split
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The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.