BONJESTA

The pharmacokinetics of BONJESTA has been characterized in healthy non-pregnant adult women.

AbsorptionIn a single-dose, crossover clinical trial conducted in 48 healthy, premenopausal women under fasting conditions, one BONJESTA (20 mg doxylamine succinate and 20 mg pyridoxine) tablet was bioequivalent to two combination tablets of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride based on the exposure (AUC) and peak concentration (C max ) of doxylamine and baseline corrected pyrid...

There have been no efficacy and safety trials conducted with BONJESTA. A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets (a different formulation and dosage strength than BONJESTA) in the treatment of nausea and vomiting of pregnancy. Adult women 18 years of age or older and 7 to 14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to 14 days of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride t...

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 BONJESTA with CNS depressants including alcohol [see Warnings and Precautions (5.1) ] The most common adverse reaction (≥5 percent and exceeding the rate in placebo) with combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets is somnolence. ( 6 ) To report SUSPECTED ADVE...

BONJESTA is 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 effects of BONJESTA [see Drug Interactions (7.1) ] . Known hypersen...

Somnolence: BONJESTA may cause somnolence. Avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using BONJESTA 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 glaucoma, stenosing peptic ulcer, pylorodu...

7 DRUG INTERACTIONS Severe drowsiness can occur when used in combination with alcohol or other sedating medications. ( 7 ) 7.1 Drug Interactions Use of BONJESTA is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the adverse central nervous system effects (the anticholinergic effects) of antihistamines. Concurrent use of alcohol and other CN...