Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
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.
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
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
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.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
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
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