Doxylamine-Pyridoxine

Doxylamine-Pyridoxine is a combination of prescription medicines used for treating nausea and vomiting experienced during pregnancy.

• Doxylamine-Pyridoxine is available under the following different brand names: Diclegis, Bonjesta

Adult dosage

Tablet, delayed-release

• 10mg/10mg (Diclegis)

Tablet, extended-release

• 20mg/20mg (Bonjesta)
• Consists of an enteric-coated core of 10 mg doxylamine and 10 mg pyridoxine for extended-release, and an immediate-release coating of 10 mg doxylamine and 10 mg pyridoxine

Nausea & Vomiting of Pregnancy

Adult dosage

• Diclegis
  • 2 delayed-release tablets orally on a daily basis at bedtime
  • If symptoms are not adequately controlled, increase the dose to 4 tablets each day (1 tab in the morning, 1 tab mid-afternoon, and 2 tabs at bedtime)
• Bonjesta
  • Day 1: Take 1 extended-release tablet PO at bedtime
  • If this dose adequately controls symptoms the next day, continue taking 1 tablet daily at bedtime only
  • If symptoms persist on Day 2, increase the daily dose to 1 tablet in the morning and 1 tablet at bedtime
  • Not to exceed 2 tablets/day (i.e., 1 tab in the morning and 1 tab at bedtime)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of the Doxylamine-Pyridoxine include:

• sleepiness,
• drowsiness,
• dizziness,
• stomach upset,
• diarrhea,
• constipation,
• headache,
• trouble sleeping (insomnia),
• blurred vision,
• shortness of breath,
• palpitations,
• fast heart rate, vertigo,
• bloating,
• fatigue,
• irritability,
• malaise,
• numbness and tingling,
• anxiety, nightmares,
• difficulty urinating,
• itching, or
• rash

Serious side effects of the Doxylamine-Pyridoxine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• drowsiness

Rare side effects of the Doxylamine-Pyridoxine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Doxylamine-Pyridoxine has severe interactions with no other drugs.
• Doxylamine-Pyridoxine has serious interactions with the following drugs:
  • benzhydrocodone/acetaminophen
  • calcium/magnesium/potassium/sodium oxybates
  • fentanyl
  • fentanyl intranasal
  • fentanyl transdermal
  • fentanyl transmucosal
  • hydrocodone
  • isocarboxazid
  • lemborexant
  • methylene blue
  • metoclopramide intranasal
  • selinexor
  • sodium oxybate
  • sufentanil SL
  • tranylcypromine
  • valerian
• Doxylamine-Pyridoxine has moderate interactions with at least 156 other drugs.
• Doxylamine-Pyridoxine has minor interactions with at least 56 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to drugs or excipients
• Concomitant use with MAO inhibitors

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Doxylamine-Pyridoxine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Doxylamine-Pyridoxine?”

Cautions

• Not evaluated for use in hyperemesis gravidarum
• Coadministration with alcohol and other CNS depressants may cause additive sedation and is not recommended; a combination may cause severe drowsiness leading to falls or accidents
• Somnolence due to anticholinergic effects are common; avoid activities requiring mental alertness
• Anticholinergic effects may exacerbate conditions such as asthma, increased intraocular pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder-neck obstruction
• Drug interaction overview
  • False-positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate-Pyridoxine hydrochloride use; confirmatory tests, such as Gas Chromatography-Mass Spectrometry (GC-MS), should be used to confirm the identity of substance in the event of positive immunoassay result

Pregnancy and Lactation

• Intended for the treatment of nausea and vomiting during pregnancy in women who do not respond to conservative management; maternal risks are discussed throughout the labeling; no increased risk for congenital malformations reported in epidemiologic studies in pregnant women
• Lactation
  • Women should not breastfeed while on therapy; molecular weight of doxylamine succinate is low enough that passage into breast milk can be expected; excitement, irritability, and sedation reported in nursing infants presumably exposed to doxylamine succinate through breast milk; infants with apnea or other respiratory syndromes may be particularly vulnerable to sedative effects of the drug resulting in worsening of their apnea or respiratory conditions
  • Pyridoxine hydrochloride is excreted into breast milk; adverse events in infants presumably exposed to pyridoxine hydrochloride through breast milk reported