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Doxylamine and pyridoxine: Drug information

Doxylamine and pyridoxine: Drug information
(For additional information see "Doxylamine and pyridoxine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Bonjesta;
  • Diclegis
Brand Names: Canada
  • APO-Doxylamine/B6;
  • Diclectin;
  • PMS-Doxylamine-Pyridoxine
Pharmacologic Category
  • Ethanolamine Derivative;
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, First Generation;
  • Vitamin, Water Soluble
Dosing: Adult
Nausea and vomiting, pregnancy associated

Nausea and vomiting, pregnancy-associated: Note: May be considered when nausea persists despite initial nonpharmacologic measures and pyridoxine monotherapy or as initial therapy for more severe symptoms (eg, nausea with vomiting) (Ref).

Doxylamine 10 mg/pyridoxine 10 mg extended release (Diclegis): Oral: Initial: Two tablets at bedtime on days 1 and 2; if symptoms persist, take 1 tablet in morning and 2 tablets at bedtime on day 3; if symptoms persist, may further increase to 1 tablet in morning, 1 tablet mid-afternoon, and 2 tablets at bedtime on day 4 (maximum: doxylamine 40 mg/pyridoxine 40 mg [4 tablets] per day).

Doxylamine 20 mg/pyridoxine 20 mg extended release (Bonjesta): Oral: Initial: One tablet at bedtime on day 1; if symptoms persist on day 2, increase to 1 tablet in morning and 1 tablet at bedtime (maximum: doxylamine 40 mg/pyridoxine 40 mg [2 tablets] per day).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Avoid use (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adult women. Also see individual agents.

>10%: Nervous system: Drowsiness (14%)

Postmarketing:

Cardiovascular: Chest discomfort, palpitations (Koren 2015), syncope (Koren 2015), tachycardia

Dermatologic: Hyperhidrosis, maculopapular rash, pruritus, skin rash

Gastrointestinal: Abdominal distention, abdominal pain, constipation, diarrhea (Koren 2015), xerostomia (Koren 2015)

Genitourinary: Dysuria, urinary retention

Hypersensitivity: Hypersensitivity reaction (Koren 2010)

Nervous system: Anxiety, disorientation, dizziness (Koren 2015), fatigue (Koren 2015), headache, insomnia, irritability, malaise, migraine, nightmares, paresthesia, psychomotor agitation (including jitteriness) (Koren 2015), vertigo

Neuromuscular & skeletal: Back pain (Persaud 2018)

Ophthalmic: Blurred vision, visual disturbance

Respiratory: Dyspnea

Contraindications

Hypersensitivity to doxylamine, pyridoxine, ethanolamine-derivative antihistamines, or any component of the formulation; concomitant use with MAO inhibitors.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, or at risk for asthmatic attack

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

Disease-related concerns:

• Asthma: Use caution in patients with asthma.

• Bladder neck obstruction: Use with caution in patients with urinary bladder neck obstruction.

• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or angle-closure glaucoma.

• Peptic ulcer: Use caution in patients with stenosing peptic ulcer.

• Pyloroduodenal obstruction: Use with caution in patients with pyloroduodenal obstruction.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Delayed Release, Oral:

Diclegis: Doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Generic: doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg

Tablet Extended Release, Oral:

Bonjesta: doxylamine succinate 20 mg and pyridoxine hydrochloride 20 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic Equivalent Available: US

May be product dependent

Pricing: US

Tablet, controlled release (Bonjesta Oral)

20-20 mg (per each): $13.94

Tablet, EC (Diclegis Oral)

10-10 mg (per each): $6.53

Tablet, EC (Doxylamine-Pyridoxine Oral)

10-10 mg (per each): $7.40 - $7.82

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Delayed Release, Oral:

Diclectin: doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg [contains fd&c blue #2 (indigotine,indigo carmine), polysorbate 80]

Generic: doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg

Administration: Adult

Oral: Administer on an empty stomach with a glass of water. Swallow tablets whole, do not chew, crush, or split. Tablets should be administered as scheduled and not on an as needed basis.

Bariatric surgery: Tablet, delayed release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Cannot crush tablet. However, this medication should not be an issue since its only indication is refractory pregnancy-induced nausea and vomiting and patients are implicitly instructed to avoid pregnancy during the first several months after bariatric surgery. Most programs only have patients crush tablets or open capsules for a few weeks after surgery.

Use: Labeled Indications

Nausea and vomiting, pregnancy-associated: Treatment of pregnancy-associated nausea and vomiting in patients not responsive to conservative management.

Limitations of use: Has not been evaluated in patients with hyperemesis gravidarum.

Medication Safety Issues
Sound-alike/look-alike issues:

Doxylamine may be confused with doxycycline

Older Adult: High-Risk Medication

Beers Criteria: Doxylamine, a first-generation antihistamine, is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potent anticholinergic properties resulting in increased risk of confusion, dry mouth, constipation, and other anticholinergic effects or toxicity; use should also be avoided due to reduced clearance with advanced age and tolerance associated with use as a hypnotic. Exposure to concurrent anticholinergic drugs also increases risk of falls, delirium, and dementia; consider total anticholinergic burden when conducting medication reviews (Beers Criteria [AGS 2023]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Alcohol (Ethyl): May enhance the CNS depressant effect of Doxylamine. Risk X: Avoid combination

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Altretamine: Pyridoxine may diminish the therapeutic effect of Altretamine. Specifically when altretamine is used in combination with Cisplatin the response duration may be diminished. Management: Consider avoiding concomitant use of pyridoxine in a altretamine/cisplatin regimen. Although pyridoxine may have beneficial effects on altretamine-associated neurotoxicity, it may reduce the duration of response to altretamine. Risk D: Consider therapy modification

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Amezinium: Antihistamines may enhance the stimulatory effect of Amezinium. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Betahistine may diminish the therapeutic effect of Antihistamines. Risk C: Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modification

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modification

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Chlorprothixene: Anticholinergic Agents may enhance the anticholinergic effect of Chlorprothixene. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification

CNS Depressants: May enhance the CNS depressant effect of Doxylamine. Risk C: Monitor therapy

Daridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modification

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

DroPERidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modification

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modification

Fosphenytoin-Phenytoin: Pyridoxine may decrease the serum concentration of Fosphenytoin-Phenytoin. Risk C: Monitor therapy

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Risk C: Monitor therapy

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider therapy modification

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Ixabepilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modification

Levodopa-Foslevodopa: Pyridoxine may diminish the therapeutic effect of Levodopa-Foslevodopa. Management: The concomitant use of pyridoxine and levodopa (in the absence of a dopa decarboxylase inhibitor (DDI)) should be avoided. Use of a DDI (eg, carbidopa) with levodopa will essentially eliminate the risk of this interaction. Risk D: Consider therapy modification

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modification

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the anticholinergic effect of Doxylamine. Risk X: Avoid combination

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Oxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider therapy modification

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

PHENobarbital: Pyridoxine may decrease the serum concentration of PHENobarbital. Risk C: Monitor therapy

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pitolisant: Antihistamines may diminish the therapeutic effect of Pitolisant. Risk X: Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

Primidone: Pyridoxine may decrease serum concentrations of the active metabolite(s) of Primidone. Specifically, concentrations of phenobarbital may be reduced. Risk C: Monitor therapy

Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification

Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Zuranolone: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider therapy modification

Food Interactions

Food decreases absorption and delays onset of action. Management: Administer on an empty stomach.

Pregnancy Considerations

This combination of doxylamine and pyridoxine is intended for use in pregnant patients. Adequate well-controlled studies in pregnant patients have not shown an increased risk of fetal abnormalities.

Early treatment of pregnancy-associated nausea and vomiting is recommended to prevent the possible progression to hyperemesis gravidarum. The patient's perception of the severity of symptoms and request for treatment should also be considered. Doxylamine succinate and pyridoxine hydrochloride are recommended individually and in combination as first-line pharmacotherapy to manage nausea and vomiting in pregnancy (ACOG 2018).

Breastfeeding Considerations

Doxylamine succinate is expected to be found in breast milk; pyridoxine is present in breast milk.

Excitement, irritability and sedation have been observed in nursing infants. These effects are presumed to be from doxylamine and infants with apnea or other respiratory conditions may be more vulnerable. Adverse events have not been observed in infants exposed to pyridoxine in breast milk. Breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

Daily episodes of vomiting, heaves, length of nausea; assess need for therapy as pregnancy progresses

Mechanism of Action

Doxylamine competes with histamine for H1-receptor sites on effector cells; blocks chemoreceptor trigger zone, diminishes vestibular stimulation, and depresses labyrinthine function through its central anticholinergic activity.

Pyridoxine is a precursor to pyridoxal, which functions in the metabolism of proteins, carbohydrates, and fats; pyridoxal also aids in the release of liver and muscle-stored glycogen and in the synthesis of GABA (within the central nervous system) and heme.

Pharmacokinetics (Adult Data Unless Noted)

Refer to individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Apo doxylamine/b6 | Diclegis;
  • (AR) Argentina: Melout | Reliveran doxi;
  • (BD) Bangladesh: Dicliz plus | Novea | Npv | Pyridox | Sicmon | Vertina d | Vomix dr;
  • (CI) Côte d'Ivoire: Nosic;
  • (CL) Chile: Doxavit | Pluriamin | Vitomit;
  • (CO) Colombia: Nyvodem | Pluriamin | Prebb;
  • (DO) Dominican Republic: Gesemet | Pluriamin;
  • (EC) Ecuador: Asarel | Pluriamin;
  • (EG) Egypt: Vomibreak;
  • (FI) Finland: Xonvea;
  • (FR) France: Xonvea;
  • (GB) United Kingdom: Xonvea;
  • (IN) India: Amnos | Bookey | Damoxy | Dbsix | Dixip | Domi 6 | Dopy | Doxal | Doxilar | Doxinate | Doxipreg | Doxmine | Doxstem | Doxyfol | Doxyla-b6 | Emefreze | Emestat | Emetrol | Emistat | Emnetic | Emstal plus | Ezipreg | Filbet | Gooday | Goodmorn | Gravidox | Gravinate | Gud m | Indaxin-b6 | Lami 6 | Ms-dos | Nosic | Novoter | Nvtab od | Predox | Pregarest | Pregcare | Pregdox | Pregnadur | Pregnidoxin nu | Pregnimine | Pregvom | Pyrinate | Rest Aid | Vomena | Vominate | Vomipreg | Vomitex | Vomsafe;
  • (KE) Kenya: Domi 6 | Filbet | Nosic | Vomistop;
  • (KR) Korea, Republic of: Amilectin | Diclamine | Diclectin | Dinerzia | Prelectin;
  • (MX) Mexico: Bonjesta;
  • (NL) Netherlands: Xonvea;
  • (NO) Norway: Xonvea;
  • (PE) Peru: Gestagramin;
  • (PK) Pakistan: Envepe | Femiroz | Morniglo dr | Natalia dr | Nausidox | Omit | Pregnova | Pyridoxy | Ubelkeit | Vomipreg | Xyquil DR;
  • (PL) Poland: Xonvea;
  • (PR) Puerto Rico: Bonjesta | Doxylamine succinate and pyridoxine hcl | Doxylamine succinate and pyridoxine hydrochloride;
  • (PY) Paraguay: Oxal compositum | Pluriamin;
  • (SE) Sweden: Xonvea;
  • (SG) Singapore: Diclectin;
  • (TR) Turkey: Prifemyn dr | Prilam dr;
  • (TW) Taiwan: Bendol | Seulin;
  • (UG) Uganda: Nosic;
  • (UY) Uruguay: Benedit | Dopirin;
  • (VE) Venezuela, Bolivarian Republic of: Cariban;
  • (ZM) Zambia: Nosic
  1. 2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081. doi:10.1111/jgs.18372 [PubMed 37139824]
  2. American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 189: nausea and vomiting of pregnancy. Obstet Gynecol. 2018;131(1):e15-e30. doi:10.1097/AOG.0000000000002456 [PubMed 29266076]
  3. Bonjesta (doxylamine and pyridoxine) [prescribing information]. Bryn Mawr, PA: Duchesnay USA; June 2018.
  4. Campbell K, Rowe H, Azzam H, Lane CA. The management of nausea and vomiting of pregnancy. J Obstet Gynaecol Can. 2016;38(12):1127-1137. doi:10.1016/j.jogc.2016.08.009 [PubMed 27986189]
  5. Diclectin (doxylamine succinate and pyridoxine hydrochloride) [product monograph]. Blainville, Quebec, Canada: Duchesnay Inc; January 2021.
  6. Diclegis (doxylamine succinate and pyridoxine hydrochloride) [prescribing information]. Bryn Mawr, PA: Duchesnay USA Inc; March 2022.
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Topic 9392 Version 290.0

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