doxylamine/pyridoxine (Rx)

Brand and Other Names:Diclegis, Bonjesta
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Dosing & Uses

AdultPediatric

Dosing Forms & Strengths

doxylamine/pyridoxine

tablet, delayed-release

  • 10mg/10mg (Diclegis)

tablet, extended-release

  • 20mg/20mg (Bonjesta)
  • Consist of enteric-coated core of 10 mg doxylamine and 10 mg pyridoxine for extended-release, and immediate-release coating of 10 mg doxylamine and 10 mg pyridoxine

Nausea & Vomiting of Pregnancy

Indicated for 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)
  • Take daily and not on an as needed basis; reassess continued need for therapy as pregnancy progresses

Dosing Considerations

Not studied in women with hyperemesis gravidarum

Safety and efficacy not established

Next:

Interactions

Interaction Checker

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              Serious - Use Alternative (16)

              • benzhydrocodone/acetaminophen

                benzhydrocodone/acetaminophen, doxylamine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • calcium/magnesium/potassium/sodium oxybates

                doxylamine, calcium/magnesium/potassium/sodium oxybates. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • fentanyl

                fentanyl, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

              • fentanyl intranasal

                fentanyl intranasal, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

              • fentanyl transdermal

                fentanyl transdermal, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

              • fentanyl transmucosal

                fentanyl transmucosal, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration with other CNS depressants, such as skeletal muscle relaxants, may cause respiratory depression, hypotension, profound sedation, coma, and/or death. Consider dose reduction of either or both agents to avoid serious adverse effects. Monitor for hypotension, respiratory depression, and profound sedation.

              • hydrocodone

                hydrocodone, doxylamine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • isocarboxazid

                isocarboxazid increases effects of doxylamine by Other (see comment). Avoid or Use Alternate Drug. Comment: Isocarboxazid should not be administered in combination with antihistamines because of potential additive CNS depressant effects. MAO inhibitors also prolong and intensify anticholinergic effects of antihistamines. .

              • lemborexant

                lemborexant, doxylamine. Either increases effects of the other by sedation. Avoid or Use Alternate Drug. Use of lemborexant with other drugs to treat insomnia is not recommended.

              • methylene blue

                methylene blue and doxylamine both increase serotonin levels. Avoid or Use Alternate Drug. If drug combination must be administered, monitor for evidence of serotonergic or opioid-related toxicities

              • metoclopramide intranasal

                doxylamine, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              • selinexor

                selinexor, pyridoxine. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

                selinexor, doxylamine. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

              • sodium oxybate

                doxylamine, sodium oxybate. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • sufentanil SL

                sufentanil SL, doxylamine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration may result in hypotension, profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • tranylcypromine

                tranylcypromine increases effects of doxylamine by Other (see comment). Avoid or Use Alternate Drug. Comment: Tranylcypromine should not be administered in combination with antihistamines because of potential additive CNS depressant effects. MAO inhibitors also prolong and intensify anticholinergic effects of antihistamines. .

              • valerian

                valerian and doxylamine both increase sedation. Avoid or Use Alternate Drug.

              Monitor Closely (153)

              • alfentanil

                doxylamine and alfentanil both increase sedation. Use Caution/Monitor.

              • alprazolam

                alprazolam and doxylamine both increase sedation. Use Caution/Monitor.

              • amifampridine

                doxylamine increases toxicity of amifampridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Amifampridine can cause seizures. Coadministration with drugs that lower seizure threshold may increase this risk.

              • amitriptyline

                doxylamine and amitriptyline both increase sedation. Use Caution/Monitor.

              • amobarbital

                amobarbital and doxylamine both increase sedation. Use Caution/Monitor.

              • amoxapine

                doxylamine and amoxapine both increase sedation. Use Caution/Monitor.

              • apomorphine

                doxylamine and apomorphine both increase sedation. Use Caution/Monitor.

              • aripiprazole

                doxylamine and aripiprazole both increase sedation. Use Caution/Monitor.

              • azelastine

                azelastine and doxylamine both increase sedation. Use Caution/Monitor.

              • azithromycin

                azithromycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • baclofen

                doxylamine and baclofen both increase sedation. Use Caution/Monitor.

              • belladonna and opium

                doxylamine and belladonna and opium both increase sedation. Use Caution/Monitor.

              • benperidol

                doxylamine and benperidol both increase sedation. Use Caution/Monitor.

              • benzphetamine

                doxylamine increases and benzphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • brexanolone

                brexanolone, doxylamine. Either increases toxicity of the other by sedation. Use Caution/Monitor.

              • brompheniramine

                brompheniramine and doxylamine both increase sedation. Use Caution/Monitor.

              • buprenorphine

                doxylamine and buprenorphine both increase sedation. Use Caution/Monitor.

              • buprenorphine buccal

                doxylamine and buprenorphine buccal both increase sedation. Use Caution/Monitor.

              • buprenorphine, long-acting injection

                doxylamine increases toxicity of buprenorphine, long-acting injection by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of buprenorphine and benzodiazepines or other CNS depressants increases risk of adverse reactions including overdose, respiratory depression, and death. Cessation of benzodiazepines or other CNS depressants is preferred in most cases. In some cases, monitoring at a higher level of care for tapering CNS depressants may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or other CNS depressant or decreasing to the lowest effective dose may be appropriate.

              • butabarbital

                butabarbital and doxylamine both increase sedation. Use Caution/Monitor.

              • butalbital

                butalbital and doxylamine both increase sedation. Use Caution/Monitor.

              • butorphanol

                doxylamine and butorphanol both increase sedation. Use Caution/Monitor.

              • carbinoxamine

                carbinoxamine and doxylamine both increase sedation. Use Caution/Monitor.

              • carisoprodol

                doxylamine and carisoprodol both increase sedation. Use Caution/Monitor.

              • cenobamate

                cenobamate, doxylamine. Either increases effects of the other by sedation. Use Caution/Monitor.

              • chloral hydrate

                chloral hydrate and doxylamine both increase sedation. Use Caution/Monitor.

              • chlordiazepoxide

                chlordiazepoxide and doxylamine both increase sedation. Use Caution/Monitor.

              • chlorpheniramine

                chlorpheniramine and doxylamine both increase sedation. Use Caution/Monitor.

              • chlorpromazine

                doxylamine and chlorpromazine both increase sedation. Use Caution/Monitor.

              • chlorzoxazone

                doxylamine and chlorzoxazone both increase sedation. Use Caution/Monitor.

              • cinnarizine

                cinnarizine and doxylamine both increase sedation. Use Caution/Monitor.

              • cisplatin

                pyridoxine decreases effects of cisplatin by unknown mechanism. Use Caution/Monitor. Use of pyridoxine, vitamin B6 with cisplatin and altretamine (hexamethylmelamine) may not be advisable.

              • clarithromycin

                clarithromycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • clemastine

                clemastine and doxylamine both increase sedation. Use Caution/Monitor.

              • clobazam

                doxylamine, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).

              • clomipramine

                doxylamine and clomipramine both increase sedation. Use Caution/Monitor.

              • clonazepam

                clonazepam and doxylamine both increase sedation. Use Caution/Monitor.

              • clonidine

                clonidine, doxylamine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration enhances CNS depressant effects.

              • clorazepate

                clorazepate and doxylamine both increase sedation. Use Caution/Monitor.

              • clozapine

                doxylamine and clozapine both increase sedation. Use Caution/Monitor.

              • codeine

                doxylamine and codeine both increase sedation. Use Caution/Monitor.

              • cyclizine

                cyclizine and doxylamine both increase sedation. Use Caution/Monitor.

              • cyclobenzaprine

                doxylamine and cyclobenzaprine both increase sedation. Use Caution/Monitor.

              • cyproheptadine

                cyproheptadine and doxylamine both increase sedation. Use Caution/Monitor.

              • dantrolene

                doxylamine and dantrolene both increase sedation. Use Caution/Monitor.

              • desipramine

                doxylamine and desipramine both increase sedation. Use Caution/Monitor.

              • deutetrabenazine

                doxylamine and deutetrabenazine both increase sedation. Use Caution/Monitor.

              • dexchlorpheniramine

                dexchlorpheniramine and doxylamine both increase sedation. Use Caution/Monitor.

              • dexfenfluramine

                doxylamine increases and dexfenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dexmedetomidine

                dexmedetomidine and doxylamine both increase sedation. Use Caution/Monitor.

              • dextromoramide

                doxylamine and dextromoramide both increase sedation. Use Caution/Monitor.

              • diamorphine

                doxylamine and diamorphine both increase sedation. Use Caution/Monitor.

              • diazepam

                diazepam and doxylamine both increase sedation. Use Caution/Monitor.

              • diazepam intranasal

                diazepam intranasal, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may potentiate the CNS-depressant effects of each drug.

              • dichlorphenamide

                dichlorphenamide, pyridoxine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.

              • difenoxin hcl

                doxylamine and difenoxin hcl both increase sedation. Use Caution/Monitor.

              • dimenhydrinate

                dimenhydrinate and doxylamine both increase sedation. Use Caution/Monitor.

              • diphenhydramine

                diphenhydramine and doxylamine both increase sedation. Use Caution/Monitor.

              • diphenoxylate hcl

                doxylamine and diphenoxylate hcl both increase sedation. Use Caution/Monitor.

              • dipipanone

                doxylamine and dipipanone both increase sedation. Use Caution/Monitor.

              • dopexamine

                doxylamine increases and dopexamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • dosulepin

                doxylamine and dosulepin both increase sedation. Use Caution/Monitor.

              • doxepin

                doxylamine and doxepin both increase sedation. Use Caution/Monitor.

              • droperidol

                doxylamine and droperidol both increase sedation. Use Caution/Monitor.

              • erythromycin base

                erythromycin base will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • erythromycin lactobionate

                erythromycin lactobionate will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • erythromycin stearate

                erythromycin stearate will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • esketamine intranasal

                esketamine intranasal, doxylamine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.

              • estazolam

                estazolam and doxylamine both increase sedation. Use Caution/Monitor.

              • ethanol

                doxylamine and ethanol both increase sedation. Use Caution/Monitor.

              • etomidate

                etomidate and doxylamine both increase sedation. Use Caution/Monitor.

              • fenfluramine

                doxylamine increases and fenfluramine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • flibanserin

                doxylamine and flibanserin both increase sedation. Modify Therapy/Monitor Closely. Risk for sedation increased if flibanserin is coadministration with other CNS depressants.

              • fluphenazine

                doxylamine and fluphenazine both increase sedation. Use Caution/Monitor.

              • flurazepam

                flurazepam and doxylamine both increase sedation. Use Caution/Monitor.

              • gabapentin

                gabapentin, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • gabapentin enacarbil

                gabapentin enacarbil, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • gotu kola

                gotu kola increases effects of doxylamine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

              • haloperidol

                doxylamine and haloperidol both increase sedation. Use Caution/Monitor.

              • hawthorn

                hawthorn increases effects of doxylamine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

              • hops

                hops increases effects of doxylamine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

              • hyaluronidase

                doxylamine decreases effects of hyaluronidase by Other (see comment). Use Caution/Monitor. Comment: Antihistamines, when given in large systemic doses, may render tissues partially resistant to the action of hyaluronidase. Patients may require larger amounts of hyaluronidase for equivalent dispersing effect. .

              • hydromorphone

                doxylamine and hydromorphone both increase sedation. Use Caution/Monitor.

              • hydroxyzine

                hydroxyzine and doxylamine both increase sedation. Use Caution/Monitor.

              • iloperidone

                doxylamine and iloperidone both increase sedation. Use Caution/Monitor.

              • imipramine

                doxylamine and imipramine both increase sedation. Use Caution/Monitor.

              • kava

                kava increases effects of doxylamine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

              • ketamine

                ketamine and doxylamine both increase sedation. Use Caution/Monitor.

              • ketotifen, ophthalmic

                doxylamine and ketotifen, ophthalmic both increase sedation. Use Caution/Monitor.

              • lasmiditan

                lasmiditan, doxylamine. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.

              • levodopa

                pyridoxine decreases levels of levodopa by increasing metabolism. Use Caution/Monitor.

              • levorphanol

                doxylamine and levorphanol both increase sedation. Use Caution/Monitor.

              • lofepramine

                doxylamine and lofepramine both increase sedation. Use Caution/Monitor.

              • lofexidine

                doxylamine and lofexidine both increase sedation. Use Caution/Monitor.

              • loprazolam

                loprazolam and doxylamine both increase sedation. Use Caution/Monitor.

              • lorazepam

                lorazepam and doxylamine both increase sedation. Use Caution/Monitor.

              • lormetazepam

                lormetazepam and doxylamine both increase sedation. Use Caution/Monitor.

              • loxapine

                doxylamine and loxapine both increase sedation. Use Caution/Monitor.

              • loxapine inhaled

                doxylamine and loxapine inhaled both increase sedation. Use Caution/Monitor.

              • lurasidone

                lurasidone, doxylamine. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.

              • maprotiline

                doxylamine and maprotiline both increase sedation. Use Caution/Monitor.

              • marijuana

                doxylamine and marijuana both increase sedation. Use Caution/Monitor.

              • melatonin

                doxylamine and melatonin both increase sedation. Use Caution/Monitor.

              • meperidine

                doxylamine and meperidine both increase sedation. Use Caution/Monitor.

              • meprobamate

                doxylamine and meprobamate both increase sedation. Use Caution/Monitor.

              • metaxalone

                doxylamine and metaxalone both increase sedation. Use Caution/Monitor.

              • methadone

                doxylamine and methadone both increase sedation. Use Caution/Monitor.

              • methocarbamol

                doxylamine and methocarbamol both increase sedation. Use Caution/Monitor.

              • methylenedioxymethamphetamine

                doxylamine increases and methylenedioxymethamphetamine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • midazolam

                midazolam and doxylamine both increase sedation. Use Caution/Monitor.

              • midazolam intranasal

                midazolam intranasal, doxylamine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • mirtazapine

                doxylamine and mirtazapine both increase sedation. Use Caution/Monitor.

              • morphine

                doxylamine and morphine both increase sedation. Use Caution/Monitor.

              • motherwort

                doxylamine and motherwort both increase sedation. Use Caution/Monitor.

              • moxonidine

                doxylamine and moxonidine both increase sedation. Use Caution/Monitor.

              • nabilone

                doxylamine and nabilone both increase sedation. Use Caution/Monitor.

              • nalbuphine

                doxylamine and nalbuphine both increase sedation. Use Caution/Monitor.

              • nortriptyline

                doxylamine and nortriptyline both increase sedation. Use Caution/Monitor.

              • olanzapine

                doxylamine and olanzapine both increase sedation. Use Caution/Monitor.

              • oliceridine

                oliceridine, doxylamine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

              • omadacycline

                pyridoxine will decrease the level or effect of omadacycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Multivalent cation-containing products may impair absorption of tetracyclines, which may decrease its efficacy. Separate dosing of tetracyclines from these products.

              • opium tincture

                doxylamine and opium tincture both increase sedation. Use Caution/Monitor.

              • orphenadrine

                doxylamine and orphenadrine both increase sedation. Use Caution/Monitor.

              • oxazepam

                oxazepam and doxylamine both increase sedation. Use Caution/Monitor.

              • oxycodone

                doxylamine and oxycodone both increase sedation. Use Caution/Monitor.

              • oxymorphone

                doxylamine and oxymorphone both increase sedation. Use Caution/Monitor.

              • paliperidone

                doxylamine and paliperidone both increase sedation. Use Caution/Monitor.

              • papaveretum

                doxylamine and papaveretum both increase sedation. Use Caution/Monitor.

              • papaverine

                doxylamine and papaverine both increase sedation. Use Caution/Monitor.

              • passion flower

                passion flower increases effects of doxylamine by pharmacodynamic synergism. Use Caution/Monitor. May enhance CNS depression.

              • pentazocine

                doxylamine and pentazocine both increase sedation. Use Caution/Monitor.

              • pentobarbital

                pentobarbital and doxylamine both increase sedation. Use Caution/Monitor.

              • perphenazine

                doxylamine and perphenazine both increase sedation. Use Caution/Monitor.

              • phenelzine

                phenelzine increases effects of doxylamine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Coadministration of phenelzine and antihistamines may result in additive CNS depressant effects. MAO inhibitors also prolong and intensify anticholinergic effects of antihistamines. .

              • phenobarbital

                phenobarbital and doxylamine both increase sedation. Use Caution/Monitor.

              • phenylephrine PO

                doxylamine increases and phenylephrine PO decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor. .

              • pholcodine

                doxylamine and pholcodine both increase sedation. Use Caution/Monitor.

              • pimozide

                doxylamine and pimozide both increase sedation. Use Caution/Monitor.

              • pregabalin

                pregabalin, doxylamine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration of CNS depressants can result in serious, life-threatening, and fatal respiratory depression. Use lowest dose possible and monitor for respiratory depression and sedation.

              • primidone

                primidone and doxylamine both increase sedation. Use Caution/Monitor.

              • prochlorperazine

                doxylamine and prochlorperazine both increase sedation. Use Caution/Monitor.

              • promethazine

                promethazine and doxylamine both increase sedation. Use Caution/Monitor.

              • propofol

                propofol and doxylamine both increase sedation. Use Caution/Monitor.

              • propylhexedrine

                doxylamine increases and propylhexedrine decreases sedation. Effect of interaction is not clear, use caution. Use Caution/Monitor.

              • protriptyline

                doxylamine and protriptyline both increase sedation. Use Caution/Monitor.

              • quazepam

                quazepam and doxylamine both increase sedation. Use Caution/Monitor.

              • quetiapine

                doxylamine and quetiapine both increase sedation. Use Caution/Monitor.

              • ramelteon

                doxylamine and ramelteon both increase sedation. Use Caution/Monitor.

              • remimazolam

                remimazolam, doxylamine. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely. Coadministration may result in profound sedation, respiratory depression, coma, and/or death. Continuously monitor vital signs during sedation and recovery period if coadministered. Carefully titrate remimazolam dose if administered with opioid analgesics and/or sedative/hypnotics.

              • risperidone

                doxylamine and risperidone both increase sedation. Use Caution/Monitor.

              • roxithromycin

                roxithromycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.

              • scullcap

                doxylamine and scullcap both increase sedation. Use Caution/Monitor.

              Minor (56)

              • amikacin

                amikacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • amiodarone

                pyridoxine increases toxicity of amiodarone by unspecified interaction mechanism. Minor/Significance Unknown. Increased risk of photosensitivity.

              • ashwagandha

                ashwagandha increases effects of doxylamine by pharmacodynamic synergism. Minor/Significance Unknown. May enhance CNS depression.

              • aztreonam

                aztreonam will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • bazedoxifene/conjugated estrogens

                bazedoxifene/conjugated estrogens decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • brimonidine

                brimonidine increases effects of doxylamine by pharmacodynamic synergism. Minor/Significance Unknown. Increased CNS depression.

              • cefadroxil

                cefadroxil will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cefamandole

                cefamandole will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cefotetan

                cefotetan will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cefpirome

                cefpirome will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ceftibuten

                ceftibuten will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • cephalexin

                cephalexin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • chlorhexidine oral

                chlorhexidine oral will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ciprofloxacin

                ciprofloxacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • clindamycin

                clindamycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • conjugated estrogens

                conjugated estrogens decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • conjugated estrogens, vaginal

                conjugated estrogens, vaginal decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • dapsone

                dapsone will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • demeclocycline

                demeclocycline will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • doxycycline

                doxycycline will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ertapenem

                ertapenem will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • estradiol

                estradiol decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • estrogens conjugated synthetic

                estrogens conjugated synthetic decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • estrogens esterified

                estrogens esterified decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • estropipate

                estropipate decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • ethotoin

                pyridoxine decreases levels of ethotoin by increasing metabolism. Minor/Significance Unknown. High dose of pyridoxine (vitamin B6), >=200 mg/day.

              • eucalyptus

                doxylamine and eucalyptus both increase sedation. Minor/Significance Unknown.

              • fleroxacin

                fleroxacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • fosfomycin

                fosfomycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • fosphenytoin

                pyridoxine decreases levels of fosphenytoin by increasing metabolism. Minor/Significance Unknown. High dose of pyridoxine (vitamin B6), >=200 mg/day.

              • gemifloxacin

                gemifloxacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • gentamicin

                gentamicin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • hydralazine

                hydralazine decreases levels of pyridoxine by unspecified interaction mechanism. Minor/Significance Unknown.

              • isoniazid

                isoniazid decreases levels of pyridoxine by unspecified interaction mechanism. Minor/Significance Unknown. If INH dose >10 mg/kg/day, supplement 50 100mg pyridoxine/day.

              • levofloxacin

                levofloxacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • linezolid

                linezolid will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • meropenem

                meropenem will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • meropenem/vaborbactam

                meropenem/vaborbactam will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • mestranol

                mestranol decreases levels of pyridoxine by altering metabolism. Minor/Significance Unknown.

              • metronidazole

                metronidazole will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • minocycline

                minocycline will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • moxifloxacin

                moxifloxacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • neomycin PO

                neomycin PO will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • nettle

                nettle increases effects of doxylamine by pharmacodynamic synergism. Minor/Significance Unknown. (High dose nettle; theoretical interaction) May enhance CNS depression.

              • nitrofurantoin

                nitrofurantoin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • ofloxacin

                ofloxacin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • oxytetracycline

                oxytetracycline will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • paromomycin

                paromomycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • penicillamine

                penicillamine decreases levels of pyridoxine by unspecified interaction mechanism. Minor/Significance Unknown.

              • phenobarbital

                pyridoxine decreases levels of phenobarbital by increasing metabolism. Minor/Significance Unknown.

              • phenytoin

                pyridoxine decreases levels of phenytoin by increasing metabolism. Minor/Significance Unknown. High dose of pyridoxine (vitamin B6), >=200 mg/day.

              • pivmecillinam

                pivmecillinam will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • quinupristin/dalfopristin

                quinupristin/dalfopristin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

              • sage

                doxylamine and sage both increase sedation. Minor/Significance Unknown.

              • Siberian ginseng

                Siberian ginseng increases effects of doxylamine by pharmacodynamic synergism. Minor/Significance Unknown. May enhance CNS depression.

              • streptomycin

                streptomycin will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.

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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 to drug or excipients

              Concomitant use with MAO inhibitors

              Cautions

              Not evaluated for use in hyperemesis gravidarum

              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

              Drug interaction overview

              • False positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use; confirmatory tests, such as Gas Chromatography Mass Spectrometry (GC-MS), should be used to confirm identity of substance in the event of positive immunoassay result
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              Pregnancy & Lactation

              Pregnancy

              Intended for treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management; maternal risks are discussed throughout the labeling; no increased risk for congenital malformations reported in epidemiologic studies in pregnant women

              Lactation

              Women should not breastfeed while on therapy; molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected; excitement, irritability and sedation reported in nursing infants presumably exposed to doxylamine succinate through breast milk; infants with apnea or other respiratory syndromes may be particularly vulnerable to sedative effects of drug resulting in worsening of their apnea or respiratory conditions

              Pyridoxine hydrochloride is excreted into breast milk; adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk reported

              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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              Images

              No images available for this drug.
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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

              FormularyPatient Discounts

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              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.
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              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.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.