doxylamine

(redirected from Diclegis)

doxylamine

 [dok″sil-am´ēn]
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.
Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved.

doxylamine/pyridoxine

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

Diclegis

(trade name),

Diclectin

(trade name)

Classification

Therapeutic: antiemetics
Pharmacologic: antihistamines
Pregnancy Category: A

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 effects

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

Contraindications/Precautions

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)

Interactions

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

Route/Dosage

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).

Availability

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)

Implementation

  • 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.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
The recent trial was part of the reason that the Food and Drug Administration (FDA) approved the popular morning sickness drug known as Diclegis.
The study cohort included three groups: women treated with more than four tablets per day of doxylamine/pyridoxine (Diclegis); women treated with up to four tablets per day of the drug; and women who did not receive pharmacotherapy (Obstet Gynecol.
(16) In fact, the message might be originating from a compensated blogger or brand ambassador, as was the case with celebrity Kim Kardashian's paid endorsement of morning sickness drug, Diclegis, disseminated via Instagram post.
But when the expectant mother posted on Instagram about Diclegis, a morning sickness pill, the post yielded a warning letter from the Food and Drug Administration to the maker of the drug, Duchesnay USA.
The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis.
This week the reality TV star was harangued by the US Food and Drug Administration for being paid a fortune to take one of her trademark selfies, posing with the morning sickness medication Diclegis.
The US Food and Drug Administration (FDA) has approved the combination of doxylamine plus pyridoxine (vitamin [B.sub.6]) in a delayed-release formulation for treatment of NVP (Diclegis).
Thirty years after Bendectin's withdrawal from the market, the drug (now renamed Diclegis) has won Food and Drug Administration approval as the only FDA-approved treatment for morning sickness (FDA News Release, "FDA approves Diclegis for pregnant women experiencing nausea and vomiting", online: US Food and Drug Administration <www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ucm347087.htm>, accessed 13 April 2013; Associated Press, "Morning Sickness Drug Returns", The New York Times (8 April 2013), online: The New York Times <www.nytimes.com/2013/04/09/us/moming-sickness-drug-retums.html?
In April 2013, the FDA approved Diclegis, the combination of doxylamine succinate 10 mg plus pyridoxine hydrochloride 10 mg delayed-release tablets, for the treatment of NVP in women who do not respond to conservative management.
M2 EQUITYBITES-May 24, 2013-i" Duchesnay USA introduces Diclegis in US pharmacies(C)2013 M2 COMMUNICATIONS http://www.m2.com
M2 PHARMA-May 24, 2013-i" Duchesnay USA introduces Diclegis in US pharmacies(C)2013 M2 COMMUNICATIONS