Brand Name(s):

    
  • Diclegis®
  • WHY is this medicine prescribed?

    The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women who have not improved after changing their diet or using other non-medicine treatments. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of certain natural substances in the body that may contribute to nausea and vomiting. Pyridoxine (vitamin B6) is a vitamin. It is given because a lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.

    HOW should this medicine be used?

    The combination of doxylamine and pyridoxine comes as a tablet to take by mouth. It is usually taken on an empty stomach (at least 1 hour before or 2 hours after a meal) with a full glass of water. At first, your doctor will usually tell you to take it once a day at bedtime. If your symptoms of nausea and vomiting are not better, then your doctor may tell you to take it two or three times a day. Your doctor will tell you how and when to take doxylamine and pyridoxine tablets. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take doxylamine and pyridoxine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

    Continue to take doxylamine and pyridoxine even if you feel well. Talk to your doctor about how you are feeling during your treatment. Do not stop taking doxylamine and pyridoxine without talking to your doctor.

    Swallow the tablets whole; do not split, chew, or crush them.

    Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking doxylamine and pyridoxine,

        
  • tell your doctor and pharmacist if you are allergic to doxylamine (Unisom); pyridoxine (vitamin B6); other antihistamine medications including carboxamide (Arbinoxa), clemastine (Tavist), dimenhydrinate (Dramamine), diphenhydramine (Benadryl), and promethazine (Phenergan); any other medications; or any of the ingredients in doxylamine and pyridoxine tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate). Your doctor will probably tell you not to take doxylamine and pyridoxine if you are taking one or more of these medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: medications for colds, hay fever, or allergies; medications for depression; muscle relaxants; narcotic medications for pain; sedatives; sleep medications; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had asthma or other breathing problems, glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); ulcers; intestinal blockage; or difficulty urinating.
  • tell your doctor if you are breast-feeding. You should not breast-feed while taking doxylamine and pyridoxine.
  • you should know that doxylamine and pyridoxine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • avoid alcoholic beverages or products containing alcohol while taking doxylamine and pyridoxine. Alcohol can add to the drowsiness caused by this medication.
  • What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule Do not take more than 4 tablets in a day and do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Doxylamine and pyridoxine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

        
  • dry mouth, nose, and throat
  • drowsiness
  • headache
  • restlessness
  • dizziness
  • muscle pain or weakness
  • stomach pain
  • constipation
  • diarrhea
  • rash
  • Some side effects can be serious. If you experience any of these symptoms, stop taking doxylamine and pyridoxine and call your doctor immediately or get emergency medical treatment:

        
  • vision problems
  • blurred vision
  • dilated pupils (black circles in the centers of the eyes)
  • difficulty urinating or painful urination
  • fast, irregular, or pounding heartbeat
  • shortness of breath
  • confusion
  • seizures
  • Doxylamine and pyridoxine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include:

        
  • restlessness
  • dry mouth
  • dilated pupils (black circles in the centers of the eyes)
  • drowsiness or sleepiness
  • dizziness
  • confusion
  • seizures
  • fast, irregular, or pounding heartbeat
  • difficulty urinating or painful urination
  • What OTHER INFORMATION should I know?

    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

    Selected Revisions: November 15, 2013.