doxylamine/pyridoxine (Rx)

Brand and Other Names:Diclegis, Bonjesta
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

doxylamine/pyridoxine

tablet, delayed-release

  • 10mg/10mg (Diclegis)

tablet, extended-release

  • 20mg/20mg (Bonjesta)
  • Tablets consist of an enteric-coated core containing 10 mg doxylamine and 10 mg pyridoxine for extended-release, and an immediate-release coating of 10 mg doxylamine and 10 mg pyridoxine
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Nausea & Vomiting of Pregnancy

Indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management

Diclegis

  • 2 delayed-release tablets PO on a daily basis at bedtime
  • If symptoms not adequately controlled, increase dose to 4 tablets each day (1 tab in AM, 1 tab mid-afternoon, and 2 tabs at bedtime)

Bonjesta

  • Day 1: Take 1 extended-release tablet PO at bedtime
  • If this dose adequately controls symptoms the next day, continue taking 1 tablet daily at bedtime only
  • If symptoms persist on Day 2, increase the daily dose to 1 tablet in the morning and 1 tablet at bedtime
  • Not to exceed 2 tablets/day (ie, 1 tab in the morning and 1 tab at bedtime)

Dosing Considerations

Not studied in women with hyperemesis gravidarum

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and doxylamine/pyridoxine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Somnolence (14.3%)

            Postmarketing Reports

            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

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            Warnings

            Contraindications

            Hypersensitivity

            MAO inhibitors intensify and prolong doxylamine’s adverse effects (ie, anticholinergic, CNS)

            Cautions

            Coadministration with alcohol and other CNS depressants may cause additive sedation and is not recommended; combination may cause severe drowsiness leading to falls or accidents

            Somnolence due to anticholinergic effects is common; avoid activities requiring mental alertness

            Anticholinergic effects may exacerbate conditions such as asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder-neck obstruction

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            Pregnancy & Lactation

            Pregnancy Category: A

            Lactation: Do not breast feed; doxylamine molecular weight is low enough to distribute into human breast milk

            Excitement, irritability, and sedation reported in nursing infants presumably exposed to doxylamine through breast milk; infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects resulting in worsening of apnea or respiratory conditions

            Pyridoxine is excreted in breast milk; there have been no reports of adverse effects in infants

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Mechanism of action for efficacy for morning sickness is unknown

            Doxylamine: Ethanolamine derivative antihistamine

            Pyridoxine: Vitamin B6 analog

            Absorption

            Peak plasma time: 7.8 hr (doxylamine); 5.6 hr (pyridoxine)

            Peak plasma concentration: 168.6 ng/mL (doxylamine); 46.1 ng/mL (pyridoxine)

            AUC: 3721 ng•hr/mL (doxylamine); 64.5 ng•hr/mL (pyridoxine)

            Distribution

            Protein bound: Pyridoxine is highly protein bound (primarily to albumin); main active metabolite (PLP) accounts for at least 60% of circulating vitamin B6 concentrations

            Metabolism

            Doxylamine is biotransformed in the liver by N-dealkylation to its principle metabolites N-desmethyldoxylamine and N, N-didesmethyldoxylamine

            Pyridoxine is a prodrug primarily metabolized in the liver to pyridoxal 5’-phosphate (PLP), pyridoxal, pyridoxamine, and pyridoxamine 5’-phosphate

            Elimination

            Half-life: 12.5 hr (doxylamine); 0.5 hr (pyridoxine)

            Excretion: Principle metabolites of doxylamine excreted in urine

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            Administration

            Oral Administration

            Take on empty stomach with water; food further delays onset of action and lowers peak levels

            Swallow tablet whole, do not chew, crush, or split

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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