Doxylamine and Pyridoxine

The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women . 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.  A lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.

The combination of doxylamine and pyridoxine comes as a delayed-release (releases the medication in the intestine to delay when the medication will start working) tablet and as an extended-release (long-acting) tablet to take by mouth. Take once daily at bedtime on an empty stomach (at least 1 hour before or 2 hours after a meal) with a full glass of water. If your symptoms do not improve after a few days, you may be told to start taking it twice daily.

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.

Swallow the extended-release and delayed-release 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.

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

Before taking doxylamine and pyridoxine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, phenelzine, selegiline, and tranylcypromine.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking doxylamine and pyridoxine. 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, increased pressure in the eye or 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 breastfeeding. You should not breastfeed 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.
• you should know to avoid alcoholic beverages or products containing alcohol while taking doxylamine and pyridoxine. Alcohol can add to the drowsiness caused by this medication.

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

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 a double dose to make up for a missed one.

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, including blurred vision or 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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). If your medication came with a desiccant canister (small canister that contains a substance that absorbs moisture to keep the medication dry), leave the canister in the bottle.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• restlessness
• dry mouth
• dilated pupils (black circles in the centers of the eyes)
• drowsiness or sleepiness
• dizziness
• confusion
• seizures
• fast, irregular, or pounding heartbeat
• decreased urination
• muscle pain or weakness, dark red or cola-colored urine

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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