BONJESTA 20 mg/1

doxylamine succinate and pyridoxine hydrochloride · TABLET, EXTENDED RELEASE · Duchesnay USA, Inc.

No Recall History

Plain English

BONJESTA is a tablet, extended release containing doxylamine succinate and pyridoxine hydrochloride at 20 mg/1, taken oral. Manufactured by Duchesnay USA, Inc..

Key Facts

Brand Name: BONJESTA
Generic Name: doxylamine succinate and pyridoxine hydrochloride
NDC Code (Product): 55494-120
Manufacturer: Duchesnay USA, Inc.
Strength: 20 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA209661
Marketing Start: 02/19/2018

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

maternal exposure during pregnancy22 reports

nausea17 reports

exposure during pregnancy16 reports

drug ineffective15 reports

off label use13 reports

abortion spontaneous12 reports

product use in unapproved indication10 reports

serotonin syndrome10 reports

somnolence10 reports

vomiting10 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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. BONJESTA is a fixed dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a Vitamin B 6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. ( 1 )

Dosage & Administration

2 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 ) 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.

Contraindications

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) ] . 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 )

Drug Interactions

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 CNS depressants (such as hypnotic sedatives and tranquilizers) with BONJESTA is not recommended. 7.2 Drug-Food Interactions A food-effect trial demonstrated that the delay in the onset of action of BONJESTA may be further delayed, and a reduction in absorption may occur when tablets are taken with food [see Dosage and Administration (2) , Clinical Pharmacology (12.3) ] . Therefore, BONJESTA should be taken on an empty stomach with a glass of water [ see Dosage and Administration (2 )]. 7.3 False Positive Urine Tests for Methadone, Opiates and PCP False positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use. Confirmatory tests, such as Gas Chromatography Mass Spectrometry (GC-MS), should be used to confirm the identity of the sub…

Adverse Reactions

6 ADVERSE REACTIONS 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 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. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets compared to placebo was studied in a double-blind, randomized, multi-center trial in 261 women with nausea and vomiting of pregnan…

Frequently Asked Questions

What is BONJESTA used for?

BONJESTA contains doxylamine succinate and pyridoxine hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is BONJESTA a controlled substance?

BONJESTA is not classified as a controlled substance by the DEA.

What is the generic name for BONJESTA?

The generic name for BONJESTA is doxylamine succinate and pyridoxine hydrochloride. There are 8 other brand versions of doxylamine succinate and pyridoxine hydrochloride.

What is the NDC code for BONJESTA 20 mg/1?

The NDC (National Drug Code) for BONJESTA 20 mg/1 is 55494-120, listed by Duchesnay USA, Inc..

Product NDC

55494-120

Package NDC

55494-120-10

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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