Bonjesta
(pyridoxine hydrochloride)Dosage & 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.
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Bonjesta Prescribing Information
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.
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.
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.
Pregnancy
Risk Summary
BONJESTA is intended for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Maternal risks are discussed throughout the labeling. No increased risk for congenital malformations has been reported in epidemiologic studies in pregnant women.
In the U.S. general population, the estimated background risks for major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.
Data
Human Data
The combination of doxylamine succinate and pyridoxine hydrochloride has been the subject of many epidemiological studies (cohort, case control and meta-analyses) designed to detect possible teratogenicity. A meta-analysis of 16 cohort and 11 case-control studies published between 1963 and 1991 reported no increased risk for malformations from first trimester exposures to doxylamine succinate and pyridoxine hydrochloride, with or without dicyclomine hydrochloride. A second meta-analysis of 12 cohort and 5 case-control studies published between 1963 and 1985 reported no statistically significant relationships between fetal abnormalities and the first trimester use of the combination of doxylamine succinate and pyridoxine hydrochloride with or without dicyclomine hydrochloride.
Lactation
Risk Summary
Women should not breastfeed while using BONJESTA.
The molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected. Excitement, irritability and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of BONJESTA resulting in worsening of their apnea or respiratory conditions.
Pyridoxine hydrochloride is excreted into breast milk. There have been no reports of adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk.
Pediatric Use
The safety and effectiveness of BONJESTA in children under 18 years of age have not been established.
Fatalities have been reported from doxylamine overdose in children. The overdose cases have been characterized by coma, grand mal seizures and cardiorespiratory arrest. Children appear to be at a high risk for cardiorespiratory arrest. A toxic dose for children of more than 1.8 mg/kg has been reported. A 3 year old child died 18 hours after ingesting 1,000 mg doxylamine succinate. However, there is no correlation between the amount of doxylamine ingested, the doxylamine plasma level and clinical symptomatology.
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)].
Somnolence and Severe Drowsiness
BONJESTA may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using BONJESTA until cleared to do so by their healthcare provider.
BONJESTA use is not recommended if a woman is concurrently using central nervous system (CNS) depressants including alcohol. The combination may result in severe drowsiness leading to falls or accidents [ see Drug Interactions (7.1)].
Concomitant Medical Conditions
BONJESTA has anticholinergic properties and, therefore, should be used with caution in women with: increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.
Interference with Urine Screen for Methadone, Opiates and Phencyclidine Phosphate (PCP)
There have been reports of false positive urine screening tests for methadone, opiates, and PCP with doxylamine succinate/pyridoxine hydrochloride use [see Drug Interactions (7.3)].