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.

 

8.4 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.

 

10 OVERDOSAGE

 

10.1 Signs and Symptoms of Overdose

 

BONJESTA is an extended-release formulation, therefore, signs and symptoms of intoxication may not be apparent immediately.

 

Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia.

 

At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.

 

10.2 Management of Overdose

 

If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. For additional information about overdose treatment, call a poison control center (1-800-222-1222).

 

11 DESCRIPTION

 

BONJESTA extended-release tablets consist of an enteric-coated core containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride, and an immediate release coating of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride.

 

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

 

Inactive ingredients are as follows: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27 aluminum lake, denatured alcohol, ferrosoferric oxide, FD&C Blue #2 aluminum lake, hypromellose, iron oxide red, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 3350, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

 

BONJESTA is certified Kosher Kosher Symbol and Halal Halal Symbol.

 

Doxylamine Succinate  

 

Doxylamine succinate is classified as an antihistamine. The chemical name for doxylamine succinate is ethanamine, N,N-dimethyl-2-[1-phenyl-1-(2-pyridinyl)ethoxy]-, butanedioate (1:1). The empirical formula is C17H22N2O • C4H6O4 and the molecular mass is 388.46. The structural formula is:

 

structure-1