Adult Dosing

Nausea and vomiting of pregnancy in women

• Initially, take two tablets orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. If symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime). Tablets should not be taken on an as needed basis. Maximum dose = 4 tablets daily.

Pediatric Dosing

• Safety and effectiveness in children < 18 years of age have not been established

• Treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management

• Hypersensitivity to any of the ingredients of the product
• Known hypersensitivity to other ethanolamine derivative antihistamines
• Monoamine oxidase (MAO) inhibitors

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined; use with caution

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined; use with caution

• Therapy may lead to somnolence due to the anticholinergic properties of doxylamine succinate. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery
• Coadministration with alcohol and other CNS depressants may cause additive sedation and is not recommended; combination may cause severe drowsiness leading to falls or accidents
• Drug has anticholinergic properties, use cautiously in women with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction

Pregnancy Category:A

Breastfeeding: Women should not breastfeed while on therapy. The molecular weight of doxylamine succinate is low enough that it may pass into breast milk. Pyridoxine hydrochloride is excreted into breast milk.

• CNS: Somnolence

• First generation antihistamines; mechanism of action for efficacy for morning sickness is unknown
• Extensively metabolized by liver by N-dealkylation to its principle metabolites N-desmethyldoxylamine and N, N-didesmethyldoxylamine
• Excreted primarily in urine
• Half life: 12.5 hrs
• Vitamin B6 analog; mechanism of action for efficacy for morning sickness is unknown
• Metabolized in the liver to pyridoxal 5’-phosphate (PLP), pyridoxal, pyridoxamine, and pyridoxamine 5’-phosphate
• Half life: 0.5 hrs

US Trade Name(s)

• Diclegis

US Availability

Diclegis (doxylamine/pyridoxine)

• Delayed Release TABS: (10 /10 mg)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Antineoplastics

Alkylating Agents