DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (doxylamine succinate)

The pharmacokinetics of doxylamine succinate and pyridoxine hydrochloride has been characterized in healthy non-pregnant adult women. Pharmacokinetic results for doxylamine and pyridoxine, including its vitamin B 6 metabolites, pyridoxal, pyridoxal 5’-phosphate, pyridoxamine and pyridoxamine 5’-phosphate, are summarized in Tables 2 to 5. Absorption A single-dose (two tablets) and multiple-dose (four tablets daily), open-label study was conducted to assess the safety and pharmacokinetic profile o...

A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of doxylamine succinate and pyridoxine hydrochloride in the treatment of nausea and vomiting of pregnancy. Adult women 18 years of age or older and 7 weeks to 14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to 14 days of doxylamine succinate and pyridoxine hydrochloride or placebo. Two tablets of doxylamine succinate and pyridoxine hydrochloride were administered at bedtime on Day 1. If symptoms of nausea and vomiting persist...

The following adverse reactions are discussed elsewhere in the labeling: Somnolence [see Warnings and Precautions (5.1) ] Falls or other accidents resulting from the effect of the combined use of doxylamine succinate and pyridoxine hydrochloride with CNS depressants including alcohol [see Warnings and Precautions (5.1) ] The most common adverse reaction with doxylamine succinate and pyridoxine hydrochloride (≥ 5 percent and exceeding the rate in placebo) is somnolence. ( 6 ) To report SUSPECTED ...

Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets are contraindicated in women with any of the following conditions: Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation. Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system e...

Activities requiring mental alertness: Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using doxylamine succinate and pyridoxine hydrochloride until cleared to do so by a healthcare provider. ( 5.1 ) Central nervous system (CNS) depressants: Concurrent use with alcohol or other CNS depressants is not recommended. ( 5.1 ) Anticholinergic actions: Use with caution in patients with increased intraocular pressure, narrow angle gla...

7 DRUG INTERACTIONS Severe drowsiness can occur when used in combination with alcohol or other sedating medications. ( 7 ) 7.1 Drug Interactions Use of doxylamine succinate and pyridoxine hydrochloride is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines. Concurrent use of alcohol and oth...