Queezy

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. 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.

How supplied

Dosage Forms And Strengths

Queezy are pink, round, film-coated tablets containing 20 mg Doxylamine succinate (Queezy) and 20 mg Pyridoxine hydrochloride (Queezy), imprinted on one side with the pink image of a pregnant woman and a “D” on the other side.

BONJESTA extended-release tablets are supplied in a high-density polyethylene bottle with a polypropylene child-resistant cap and a silica gel desiccant canister. Each pink, round, film-coated, extended-release tablet contains 20 mg Doxylamine succinate (Queezy) and 20 mg Pyridoxine hydrochloride (Queezy), and is imprinted on one side with the pink image of a pregnant woman and a “D” on the other side. BONJESTA tablets are provided as follows:

NDC 55494-120-10 Bottles of 100.

Storage And Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep bottle tightly closed and protect from moisture. Do not remove desiccant canister from bottle.

Manufactured by: Duchesnay Inc. 950 boul. Michèle-Bohec Blainville, Qu

BONJESTA is contraindicated in women with any of the following conditions:

• Known hypersensitivity to Doxylamine succinate (Queezy), other ethanolamine derivative antihistamines, Pyridoxine hydrochloride (Queezy) or any inactive ingredient in the formulation
• Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of BONJESTA.

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.

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. Therefore, BONJESTA should be taken on an empty stomach with a glass of water.

The following adverse reactions are discussed elsewhere in the labeling:

• Somnolence
• Falls or other accidents resulting from the effect of the combined use of BONJESTA with CNS depressants including alcohol

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 (Queezy) and 10 mg Pyridoxine hydrochloride (Queezy) 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. 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 (Queezy) and 10 mg Pyridoxine hydrochloride (Queezy) Tablets (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence than Placebo are Shown)

Postmarketing Experience

The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg Doxylamine succinate (Queezy) and 10 mg Pyridoxine hydrochloride (Queezy). 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

General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise

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