Generic Name: doxylamine and pyridoxine
Date of Approval: April 8, 2013
Company: Duchesnay USA, Inc.

Treatment for: Nausea and Vomiting of Pregnancy (NVP)

FDA Approves Diclegis

The Food and Drug Administration (FDA) has granted approval for Diclegis (doxylamine succinate 10mg and pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management. It is the only FDA-approved treatment for NVP, more commonly known as morning sickness, in more than 30 years.

What is Diclegis?

  • Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.
  • It is not known if Diclegis is safe and effective in children under 18 years of age.

Who should not take Diclegis?

Do not take Diclegis if you:

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  • are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. See the end of this page for a complete list of ingredients in Diclegis.
  • take monoamine oxidase inhibitors (MAOIs) (Marplan, Nardil, Emsam, Eldepryl, Zelapar, Parnate)

Before taking Diclegis, tell your healthcare provider about all of your medical conditions, including;

  • if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements.

How should I take Diclegis?

  • Talk to your healthcare provider about how much Diclegis to take and when to take it.
  • Take Diclegis everyday as prescribed by your healthcare provider.

Do not stop taking Diclegis without talking to your healthcare provider first.

  • See the following schedule for the usual way you should start taking Diclegis:
    • Day 1: Take two tablets, by mouth at bedtime.
    • Day 2: Take two tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take two tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise.
    • Day 3: If you still had nausea and vomiting on Day 2, take three tablets on Day 3 (one tablet in the morning and two tablets at bedtime).
    • Day 4: If your nausea and vomiting was better or controlled on Day 3, continue to take three tablets each day (one tablet in the morning and two tablets at bedtime). If you still had nausea and vomiting on Day 3, start taking four tablets each day (one tablet in the morning, one tablet in the afternoon, and two tablets at bedtime).
  • Do not take more than four tablets (one in the morning, one in the mid-afternoon, and two at bedtime) in one day.
  • Take Diclegis on an empty stomach with a glass of water.
  • Take Diclegis tablets whole. Do not crush, chew, or break Diclegis tablets before swallowing. If you cannot swallow Diclegis tablets whole, tell your healthcare provider.
  • If you take too much Diclegis (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking Diclegis, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

Diclegis side effects

Diclegis may cause side effects, including drowsiness.

  • Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so.
  • Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents.

These are not all the possible side effects of Diclegis.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Diclegis?

  • Store Diclegis between 68°F to 77°F (20°C to 25°C).
  • Keep Diclegis tablets dry, in a tightly closed container, and out of the light.
  • Safely throw away medicine that is out of date or no longer needed.

Keep Diclegis and all medicines out of the reach of children.

General information about the safe and effective use of Diclegis

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

You can ask your pharmacist or healthcare provider for information about Diclegis that is written for health professionals. Do not use Diclegis for a condition for which it was not prescribed. Do not give Diclegis to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in Diclegis?

Active ingredient: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).

Inactive ingredients: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue #2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, talc, titanium dioxide.