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an antihistamine with sedative and anticholinergic effects; used as the succinate salt in the treatment of nasal, eye, and skin manifestations of allergic reactions, including allergic rhinitis, conjunctivitis, and itching, as an ingredient in cough and cold preparations, and in the short-term treatment of insomnia, administered orally.


(dox-il-a-meen peer-ih-dox-een ),


(trade name),


(trade name)


Therapeutic: antiemetics
Pharmacologic: antihistamines
Pregnancy Category: A


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


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

Therapeutic effects

Decreased nausea and vomiting associated with pregnancy.


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)

POunkunk8–24 hr


Contraindicated in: Hypersensitivity to doxylamine or pyridoxineConcurrent 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: AsthmaIncreased intraocular pressure or narrow angle glaucomaStenosing peptic ulcer or pyloroduodenal obstructionUrinary bladder-neck obstruction Pediatric: Safe and effective use in children <18 yr has not been established

Adverse Reactions/Side Effects

Central nervous system

  • drowsiness (most frequent)


Drug-Drug interaction

↑ 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


Oral (Adults) Day 1—Two 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—two tablets at bedtime on day 2 and then one tablet in the morning on day 3 and two tablets in the evening, if symptoms are controlled, continue this regimen; Day 4, if symptoms persist—one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime (not to exceed four tablets daily).


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

Nursing implications

Nursing assessment

  • Assess for frequency and amount of emesis daily during therapy. Reassess need for medication as pregnancy progresses.

Potential Nursing Diagnoses

Nausea (Indications)
Risk for injury (Adverse Reactions)


  • Oral: 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.


/dox·yl·amine/ (dok-sil´ah-mēn) an antihistamine with anticholinergic and sedative effects, used as the succinate salt.


an antihistamine used in the treatment of allergic reactions and laminitis in cattle and horses.
References in periodicals archive ?
About Diclegis Diclegis (doxylamine succinate 10 mg, pyridoxine hydrochloride 10 mg) delayed-release tablets are the only FDA-approved prescription treatment for nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.
6] analog pyridoxine hydrochloride was marketed in the United States as Bendectin to treat nausea and vomiting of pregnancy--the same combination that was approved by the Food and Drug Administration in April and is being marketed as Diclegis.
Wisconsin joins a growing list of influential State Medicaid programs, like California, Texas, Connecticut and Tennessee that cover Diclegis without special authorization requirements.
In a dear sign that the issue has been resolved, the FDA has assigned Diclegis a category A pregnancy risk rating, with a statement in the label summarizing the epidemiologic studies indicating that the combination of the two active ingredients has not been associated with increased risks to the fetus.
Connecticut joins a growing list of influential State Medicaid programs, like California, Texas and Tennessee that cover Diclegis with preferred status, indicating special authorization is not required.
July 9, 2015 /PRNewswire/ -- Duchesnay USA today announced that Diclegis (doxylamine succinate and pyridoxine hydrochloride) Delayed-Release Tablets for the treatment of Nausea and Vomiting of Pregnancy (NVP) in women who do not respond to conservative management[1] are now available through Humana's Commercial Prescription Drug Program.
1] With this decision, Diclegis is eligible for tier-three coverage without restriction among most members in the Aetna network, one of the nation's leading healthcare insurance providers serving an estimated 15 million pharmacy members.
Texas joins the growing list of states that cover Diclegis through Medicaid programs.
Diclegis is an FDA-approved medicine and a safe and effective treatment for NVP.
6]] Approved in April 2013, the FDA granted Diclegis Pregnancy Category A status, its highest rating.
Diclegis also received Kosher for Passover certification and confirmed as gluten, lactose and tartrazine free, making the product accessible for women suffering from celiac disease or gluten and lactose intolerance.
July 9, 2013 /PRNewswire/ -- Duchesnay USA today announced that Diclegis (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP), more commonly known as morning sickness, is now available for coverage under the state and federal Medicaid program effective July 1st, 2013.