doxylamine

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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.

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.

doxylamine

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

doxylamine

an antihistamine used in the treatment of allergic reactions and laminitis in cattle and horses.
References in periodicals archive ?
Diclegis has been available in Canada under the trade name Diclectin for more than 30 years as the only prescription drug specifically indicated and approved for the management of nausea and vomiting of pregnancy (NVP), also known as morning sickness.
0x20 Preemptive Diclectin therapy for the management of nausea and vomiting of pregnancy and hyperemesis gravidarum.
A Canadian company has since disproved the causes of the scare and it is now being reintroduced here under the name Diclectin.
The Canadian company Duchesnay will soon market the drug called Diclectin in the U.
Because it was off-patent, a Canadian company, Duchesnay, began manufacturing the drug and marketed it as Diclectin in Canada, where it remained available and has been widely used, with a solid safety profile and no evidence of an increased risk of congenital malformations/teratogenicity.
market, it was already available as a generic in Canada as Diclectin and was never taken off the market.
The combination has been available for years as Diclectin in Canada but, in the United States, could be obtained only as individual OTC components.
I still believe that when there is an unexpected serious birth defect in a patient born to a woman who has taken this medication, the possibility of lawsuit with or without monetary settlement is a significant risk to both the physician for prescribing or recommending off-label usage of Diclectin and to its manufacturer.
In a double-blind, randomized clinical trial conducted at three centers in the United States, the Canadian sustained-release formulation of Diclectin was compared with placebo for the treatment of nausea and vomiting (Am.
A product combining these two components is not yet available in the United States, but it is available in Canada as Diclectin, added Mr.
But this combination has been shown to be safe in large studies conducted since that time, and has been approved and available continuously as Diclectin in Canada.