doxylamine/pyridoxine

Contraindicated in:

Hypersensitivity to doxylamine or pyridoxine;
Concurrent use of MAO inhibitors;
Lactation: Lactation.

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.

Availability ⬆ ⬇

(Generic available)

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

Route/Dosage ⬆ ⬇

Delayed-Release Tablets

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

Extended-Release Tablets

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

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Combination of an antihistamine and a vitamin B₆ analog. Mechanism not known.

Therapeutic effects:

Decreased nausea and vomiting associated with pregnancy.

Classifications ⬆ ⬇

Therapeutic Classification: antiemetics

Pharmacologic Classification: antihistamines, vitamin B6 analogues

Pharmacokinetics ⬆ ⬇

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

Distribution: Unknown.

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

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

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

( antiemetic effect)

ROUTE		ONSET		PEAK		DURATION
PO		unknown		unknown		8–24 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. Instruct to take as directed. Do not take more than prescribed amount.
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.
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.
Advise women that a result of a false-positive urine drug screening for methadone, opioids, and PCP may occur.
Rep: Advise women to avoid breastfeeding during therapy.

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Indications ⬇

Contraind./Precautions ⬆ ⬇