Doxylamine and Pyridoxine

The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women whose symptoms 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.

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. 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 the delayed-release tablet two or three times a day, or the extended-release tablet two times a day. . 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.

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 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 delayed-release or extended-release 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 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.
• 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 more than four delayed-release tablets or more than two extended-release tablets in a day. 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
• 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 (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.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately 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
• difficulty urinating or painful urination
• muscle pain or weakness
• buildup of fluid in the body
• 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.

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.

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