5.2 Concomitant Medical Conditions 

 

6 ADVERSE REACTIONS 

 

6.1 Clinical Trial Experience 

 

6.2 Postmarketing Experience 

 

7 DRUG INTERACTIONS 

 

7.1 Drug Interactions 

 

7.2 Drug-Food Interactions 

 

8 USE IN SPECIFIC POPULATIONS 

 

8.1 Pregnancy 

 

8.2 Lactation 

 

8.4 Pediatric Use 

 

10 OVERDOSAGE 

 

10.1 Signs and Symptoms of Overdose 

 

10.2 Management of Overdose 

 

11 DESCRIPTION 

 

12 CLINICAL PHARMACOLOGY 

 

12.1 Mechanism of Action 

 

12.3 Pharmacokinetics 

 

13 NONCLINICAL TOXICOLOGY 

 

13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility 

 

14 CLINICAL STUDIES 

 

16 HOW SUPPLIED/STORAGE AND HANDLING 

 

16.1 How supplied 

 

16.2 Storage and Handling 

 

17 PATIENT COUNSELING INFORMATION 

 

Somnolence 

* Sections or subsections omitted from the full prescribing information are not listed. Close 

1 INDICATIONS AND USAGE

 

BONJESTA is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

 

Limitations of Use 

 

BONJESTA has not been studied in women with hyperemesis gravidarum.

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2 DOSAGE AND ADMINISTRATION

 

2.1 Dosage Information

 

Initially, take one BONJESTA extended-release tablet orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking one tablet daily at bedtime only. However, if symptoms persist on Day 2, 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.

 

Take on an empty stomach with a glass of water [see Clinical Pharmacology (12.3)]. Swallow tablets whole. Do not crush, chew, or split BONJESTA tablets.

 

Take daily and not on an as needed basis. Reassess the woman for continued need for BONJESTA as her pregnancy progresses.

 

3 DOSAGE FORMS AND STRENGTHS

 

BONJESTA extended-release tablets are pink, round, film coated tablets containing 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride, imprinted on one side with the pink image of a pregnant woman and a "D" on the other side.

 

4 CONTRAINDICATIONS

 

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)].

 

5 WARNINGS AND PRECAUTIONS

 

5.1 Somnolence