doxylamine/pyridoxine

Absorption: Well absorbed following oral administration. Food delays/↓ absorption.

Distribution: Doxylamine probably enters breast milk

Metabolism/Excretion: Doxylamine is mostly metabolized by the liver, inactive metabolites are renally excreted. Pyridoxine is a pro-drug, converted to its active metabolite by the liver.

Half-Life: Doxylamine: 12.5 hr; pyridoxine: 0.4–0.5 hr

Time/Action Profile ⬆ ⬇

(anti-emetic effect)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	8–24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to doxylamine or pyridoxine;
Concurrent use of monoamine oxidase (MAO) inhibitors;
Lactation: Doxylamine probably enters breast milk and may cause irritability, excitement, or sedation in infants; breastfeeding should be avoided.

Use Cautiously in:

↑intraocular pressure or narrow angle glaucoma;
Stenosing peptic ulcer or pyloroduodenal obstruction;
Urinary bladder-neck obstruction;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Neuro: drowsiness

Interactions ⬆ ⬇

Drug-drug:

MAO inhibitors↑ intensity/duration of adverse CNS (anticholinergic) reactions; concurrent use contraindicated.
↑risk of CNS depression with other CNS depressants including alcohol, other antihistamines, opioid analgesics, and sedative/hypnotics.

Route/Dosage ⬆ ⬇

Delayed-Release Tablets

PO (Adults ): Day 1: 2 tablets (doxylamine 10 mg/pyridoxine 10 mg) at bedtime; if symptoms are controlled continue this regimen; Day 2, if symptoms persist into afternoon on day 2: 2 tablets at bedtime on day 2 and then 1 tablet in the morning on day 3 and 2 tablets in the evening; if symptoms are controlled, continue this regimen; Day 4, if symptoms persist: 1 tablet in the morning, 1 tablet mid-afternoon and 2 tablets at bedtime (not to exceed 4 tablets daily).

Extended-Release Tablets

PO (Adults ): Day 1: 1 tablet (doxylamine 20 mg/pyridoxine 20 mg) at bedtime; if symptoms are controlled, continue this regimen; Day 2, if symptoms persist on day 2: 1 tablet in AM and 1 tablet at bedtime on day 2; if symptoms are controlled, continue this regimen (not to exceed two tablets daily).

Availability ⬆ ⬇

(Generic available)

Delayed-release tablets (Diclegis): doxylamine 10 mg/pyridoxine 10 mg
Extended-release tablets (Bonjesta): doxylamine 20 mg/pyridoxine 20 mg

Assessment ⬆ ⬇

Assess for frequency and amount of emesis daily during therapy. Reassess need for medication as pregnancy progresses.
Monitor hydration status to prevent dehydration.

Lab Test Considerations:

May cause false positive urine screening tests for methadone, opiates, and PCP.

Implementation ⬆ ⬇

PO: Administer on an empty stomach with a full glass of water; food delays onset of medication. DNC: Swallow tablets whole; do not crush, break, or chew.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take as directed. Do not take more than prescribed amount.
May cause drowsiness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
Advise patient to avoid alcohol and CNS depressants, including sedatives, tranquilizers, antihistamines, opioids, and some cough and cold medications with doxylamine pyridoxine.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise female patient to avoid breastfeeding during therapy.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in frequency of nausea and vomiting during pregnancy.

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆

NDC Code

0591- Actavis Pharma, Inc.
- 0591-2132- Doxylamine succinate and pyridoxine hydrochloride
  - 0591-2132-01- 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01)

55494- Duchesnay USA, Inc.
- 55494-100- DICLEGIS
  - 55494-100-10- 100 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-10)

55494- Duchesnay USA, Inc.
- 55494-100- DICLEGIS
  - 55494-100-99- 12 TABLET, DELAYED RELEASE in 1 BOTTLE (55494-100-99)

55494- Duchesnay USA, Inc.
- 55494-120- BONJESTA
  - 55494-120-10- 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10)

55494- Duchesnay USA, Inc.
- 55494-120- BONJESTA
  - 55494-120-60- 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60)

55494- Duchesnay USA, Inc.
- 55494-120- BONJESTA
  - 55494-120-99- 6 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99)

70505- Analog Pharma
- 70505-100- Doxylamine succinate and pyridoxine hydrochloride
  - 70505-100-10- 100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇