Doxylamine and pyridoxine

Generic Name: doxylamine and pyridoxine (dox-IL-a-meen PIR-i-DOX-een)
Brand Name: Diclegis

Doxylamine and pyridoxine is used for:

Treating nausea and vomiting caused by pregnancy. It may also be used for other conditions as determined by your doctor.

Doxylamine and pyridoxine is an antihistamine and vitamin B6 combination. The way it works to treat nausea and vomiting is unknown.

Do NOT use doxylamine and pyridoxine if:

  • you are allergic to any ingredient in doxylamine and pyridoxine or other similar medicines
  • you are breast-feeding
  • you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using doxylamine and pyridoxine:

Some medical conditions may interact with doxylamine and pyridoxine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have asthma, increased pressure in the eye, narrow-angle glaucoma, stomach or bowel problems (eg, ulcers, blockage), or bladder blockage

Some MEDICINES MAY INTERACT with doxylamine and pyridoxine. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • MAOIs (eg, phenelzine) because they may increase the risk of doxylamine and pyridoxine's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if doxylamine and pyridoxine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use doxylamine and pyridoxine:

Use doxylamine and pyridoxine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with doxylamine and pyridoxine. Talk to your pharmacist if you have questions about this information.
  • Take doxylamine and pyridoxine by mouth on an empty stomach with a full glass of water (8 oz [240 mL]).
  • Swallow doxylamine and pyridoxine whole. Do not break, crush, or chew before swallowing. If you cannot swallow doxylamine and pyridoxine whole, tell your doctor.
  • Take doxylamine and pyridoxine on a regular schedule unless your doctor tells you otherwise.
  • If you miss a dose of doxylamine and pyridoxine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not make up for a missed dose by taking 2 doses at once. Do not take more than 4 tablets in one day.

Ask your health care provider any questions you may have about how to use doxylamine and pyridoxine.

Important safety information:

  • Doxylamine and pyridoxine may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use doxylamine and pyridoxine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using doxylamine and pyridoxine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or stop taking doxylamine and pyridoxine without checking with your doctor.
  • Tell your doctor or dentist that you take doxylamine and pyridoxine before you receive any medical or dental care, emergency care, or surgery.
  • Doxylamine and pyridoxine has pyridoxine (vitamin B6) in it. Before you begin taking any new medicine, check the label to see if it has pyridoxine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Doxylamine and pyridoxine should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Doxylamine and pyridoxine is intended for use during pregnancy. Doxylamine and pyridoxine is found in breast milk. Do not breast-feed while taking doxylamine and pyridoxine.

Possible side effects of doxylamine and pyridoxine:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast or irregular heartbeat; loss of coordination; severe drowsiness; trouble urinating; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of doxylamine and pyridoxine:

Store doxylamine and pyridoxine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep doxylamine and pyridoxine out of the reach of children and away from pets.

General information:

  • If you have any questions about doxylamine and pyridoxine, please talk with your doctor, pharmacist, or other health care provider.
  • Doxylamine and pyridoxine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine. This information is a summary only. It does not contain all information about doxylamine and pyridoxine.

This information should not be used to decide whether or not to take doxylamine and pyridoxine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about doxylamine and pyridoxine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to doxylamine and pyridoxine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using doxylamine and pyridoxine.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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