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Indication and Important Safety Information for Bonjesta® and Diclegis® (doxylamine succinate and pyridoxine hydrochloride)

INDICATION

Bonjesta® is a fixed-dose combination drug product of 20 mg doxylamine succinate, an antihistamine, and 20 mg pyridoxine hydrochloride, a vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Diclegis® is a fixed-dose combination drug product of 10 mg doxylamine succinate, an antihistamine, and 10 mg pyridoxine hydrochloride, a vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

LIMITATIONS OF USE

Neither Bonjesta® nor Diclegis® has been studied in women with hyperemesis gravidarum.

IMPORTANT SAFETY INFORMATION

Contraindications:

Bonjesta® and Diclegis® are 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® and Diclegis®.

Warnings and Precautions:

  • Somnolence: Bonjesta® and Diclegis® 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® or Diclegis® until cleared to do so by their healthcare provider.
  • Central nervous system (CNS) depressants: Use of Bonjesta® or Diclegis® is not recommended if a woman is concurrently using CNS depressants, such as alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates, and sleep aids. The combination of Bonjesta® or Diclegis® and CNS depressants could result in severe drowsiness leading to falls or other accidents.
  • Concomitant Medical Conditions: Use Bonjesta® or Diclegis® with caution in women with (1) asthma, (2) increased intraocular pressure, (3) narrow angle glaucoma, (4) a stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) 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. Women should be informed that use of Bonjesta® or Diclegis® may result in false positive urine drug screening for methadone, opiates and PCP.

Adverse Reactions: 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 or 20 mg doxylamine succinate and 20 mg pyridoxine hydrochloride is somnolence.

Drug-Food Interactions: A food-effect trial demonstrated that the delay in the onset of action of Bonjesta® or Diclegis® may be further delayed and a reduction in absorption may occur when tablets are taken with food. Therefore, Bonjesta® or Diclegis® should be taken on an empty stomach with a glass of water.

Use in Specific Populations:

Pregnancy: Bonjesta® and Diclegis® are intended for use in pregnant women.

  • Lactation: Women should not breastfeed while using Bonjesta® or Diclegis® because the antihistamine component (doxylamine succinate) in Bonjesta® and Diclegis® can pass into breast milk. 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® and Diclegis®, resulting in worsening of their apnea or respiratory conditions.
  • Pediatric Use: The safety and effectiveness of Bonjesta® and Diclegis® in children under 18 years of age have not been established. Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest.

Overdose: Because Bonjesta® is an extended-release formulation, and Diclegis® is a delayed-release formulation, 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. If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. If you suspect an overdose or seek additional information about overdose treatment, call a poison control center at 1-800-222-1222.

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.

 

 

 

Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

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