doxylamine/pyridoxine

General

Pronunciation:
dox-il-a-meen peer-ih-dox-een


Trade Name(s)

  • Diclegis
  • DiclectinCanadian Tradename

Ther. Class.
antiemetics

Pharm. Class.
antihistamines
vitamin B6 analogues

Indications

Treatment of nausea and vomiting during pregnancy that has not responded to conservative management.

Action

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

Therapeutic Effect(s):

Decreased nausea and vomiting associated with pregnancy.

Pharmacokinetics

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

Distribution: Doxylamine probably enters breast milk

Metabolism and 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)

ROUTEONSETPEAKDURATION
POunkunk8–24 hr

Contraindication/Precautions

Contraindicated in:

  • Hypersensitivity to doxylamine or pyridoxine
  • Concurrent use of MAOIs
  • Lactation: Doxylamine probably enters breast milk and may cause irritability, excitement, or sedation in infants; breast feeding should be avoided.

Use Cautiously in:

  • Asthma
  • ↑ intraocular pressure or narrow angle glaucoma
  • Stenosing peptic ulcer or pyloroduodenal obstruction
  • Urinary bladder-neck obstruction
  • Pedi: Safety and effectiveness not established

Adverse Reactions/Side Effects

CNS: drowsiness

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

  • ↑ risk of CNS depression with other CNS depressants including alcohol, other antihistamines, opioid analgesics, and sedative/hypnotics.
  • Concurrent use of MAOIs ↑ intensity/duration of adverse CNS (anticholinergic) reactions

Route/Dosage

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 four tablets daily).

Availability (generic available)

Delayed-release tablets: doxylamine 10 mg/pyridoxine 10 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.

Potential Diagnoses

Implementation

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

Patient/Family Teaching

  • Instruct patient to take as directed.
  • 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.
  • Advise female patient to avoid breast feeding during therapy.

Evaluation/Desired Outcomes

Decrease in frequency of nausea and vomiting during pregnancy.

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