Immune system disorders: hypersensitivity

 

Nervous system disorders: dizziness, headache, migraines, paresthesia, psychomotor hyperactivity

 

Psychiatric disorders: anxiety, disorientation, insomnia, nightmares

 

Renal and urinary disorders: dysuria, urinary retention

 

Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash, rash maculopapular

 

7 DRUG INTERACTIONS

 

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)]. 

 

8 USE IN SPECIFIC POPULATIONS

 

8.1 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.

 

8.2 Lactation

 

​Risk Summary 

 

Women should not breastfeed while using BONJESTA.