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)].

 

5.2 Concomitant Medical Conditions

 

BONJESTA has anticholinergic properties and, therefore, should be used with caution in women with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction or urinary bladder-neck obstruction.

 

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)] 

 

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 pregnancy. The mean gestational age at enrollment was 9.3 weeks, range 7 to 14 weeks gestation [see Clinical Studies (14)]. Adverse reactions that occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1.

 

Table 1: Number (Percent) of Women with ≥ 5 Percent Adverse Reactions in a 15-Day Placebo-Controlled Trial of Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride Tablets (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence than Placebo are Shown) 

 

Adverse Reaction 

 

Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride Tablets 

 

(N = 133)

 

Placebo 

 

(n = 128)

 

 

Somnolence

 

19 (14.3%)

 

15 (11.7%)

 

6.2 Postmarketing Experience

 

The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 

 

Cardiac disorders: dyspnea, palpitation, tachycardia

 

Ear and labyrinth disorders: vertigo

 

Eye disorders: vision blurred, visual disturbances

 

Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea