HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BONJESTA safely and effectively. See full prescribing information for BONJESTA. 

 

BONJESTA (doxylamine succinate and pyridoxine hydrochloride), extended-release tablets, for oral use. 

Initial U.S. Approval: 1976 

 

INDICATIONS AND USAGE 

 

BONJESTA is a fixed dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a Vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. (1) 

 

DOSAGE AND ADMINISTRATION 

 

On Day 1, take one tablet at bedtime. On Day 2, if symptoms are not adequately controlled, the dose can be increased to one tablet in the morning and one tablet at bedtime. The maximum recommended dose is two tablets daily, one in the morning and one at bedtime, as described in the full prescribing information. (2) 

 

DOSAGE FORMS AND STRENGTHS 

 

Extended-release tablets containing 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride. (3) 

 

CONTRAINDICATIONS 

 

Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation (4)

Monoamine oxidase (MAO) inhibitors (4, 7)

 

WARNINGS AND PRECAUTIONS 

 

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 asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction (5.2)

ADVERSE REACTIONS 

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 ADVERSE REACTIONS, contact Duchesnay Inc. at 1-855-722-7734 or medicalinfo@duchesnayusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

 

DRUG INTERACTIONS 

 

Severe drowsiness can occur when used in combination with alcohol or other sedating medications. (7)

 

USE IN SPECIFIC POPULATIONS 

 

BONJESTA is intended for use in pregnant women. (8.1) 

 

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

 

Revised: 11/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

 

 

 

1 INDICATIONS AND USAGE 

 

2 DOSAGE AND ADMINISTRATION 

 

2.1 Dosage Information 

 

3 DOSAGE FORMS AND STRENGTHS 

 

4 CONTRAINDICATIONS 

 

5 WARNINGS AND PRECAUTIONS