DOXYLAMINE/PYRIDOXINE DELAYED-RELEASE - ORAL

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DOXYLAMINE/PYRIDOXINE DELAYED-RELEASE - ORAL

PHONETIC PRONUNCIATION: (dox-ILL-uh-meen/pir-id-OX-een)

COMMON BRAND NAME(S): Diclegis

GENERIC NAME(S): doxylamine succinate/pyridoxine HCl (B6)

Uses

USES: This combination medication (doxylamine with pyridoxine) is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (e.g., pregnancy, poor diet, alcoholism) can result in a lack of this vitamin.


How to use DOXYLAMINE/PYRIDOXINE DELAYED-RELEASE - ORAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth without food as directed by your doctor. If this medication is taken with food, it may take longer for it to start to work but will not decrease the effect. Swallow the medication whole with a full glass of water. Do not crush, chew, or break the tablets. Dosage is based on your medical condition and response to treatment. This medication is usually taken at bedtime to decrease nausea and vomiting in the morning. If nausea persists during the day, additional doses may be prescribed by your doctor. Talk with your doctor about your symptoms and the best dose schedule for you. Do not take more than 4 tablets in a day. Do not stop using this medication or change your dose without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Side Effects

SIDE EFFECTS: Drowsiness, dizziness, blurred vision, stomach upset, diarrhea, constipation, headache, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., confusion, irritability, nervousness), trouble urinating, easy bruising/bleeding, fast/irregular heartbeat. Get medical help right away if you have any very serious side effects, including: seizure. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to doxylamine or pyridoxine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, eye problems (such as glaucoma), heart problems, liver disease, seizures, stomach problems (such as ulcers, blockage), urination problems (such as urinary retention). This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, low blood pressure, confusion, constipation, or trouble urinating. Drowsiness, dizziness, and confusion can increase the risk of falling. This product is safe to use during pregnancy. Pyridoxine passes into breast milk. It is unknown if doxylamine passes into breast milk. However, similar drugs pass into breast milk. Doxylamine may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray). Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: flushing, hallucinations, weakness, shaking (tremor), muscle twitching, loss of consciousness, seizures.

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Faq for DOXYLAMINE/PYRIDOXINE DELAYED-RELEASE - ORAL

Doxylamine/Pyridoxine Delayed-Release is used to treat nausea and vomiting during pregnancy, commonly known as morning sickness.

Doxylamine is an antihistamine that helps to relieve nausea and vomiting. Pyridoxine is a form of vitamin B6 that helps to improve nausea symptoms.

Common side effects of Doxylamine/Pyridoxine Delayed-Release include drowsiness, dry mouth, blurred vision, dizziness, and constipation.

Take Doxylamine/Pyridoxine Delayed-Release exactly as prescribed by your doctor. Typically, it is taken at bedtime. Do not increase or decrease the dosage without consulting your doctor.

It is important to inform your doctor about all the medications you are taking, including over-the-counter drugs, supplements, and herbal products. Some medications may interact with Doxylamine/Pyridoxine Delayed-Release, and your doctor can advise you accordingly.

Yes, Doxylamine/Pyridoxine Delayed-Release is commonly prescribed to treat nausea and vomiting during pregnancy. However, it is always recommended to consult with your healthcare provider before taking any medication during pregnancy.

Doxylamine/Pyridoxine Delayed-Release is not considered addictive when used as directed. However, it may cause drowsiness, so it is important to avoid activities that require alertness until you know how the medication affects you.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for the missed one.

Although rare, allergic reactions to Doxylamine/Pyridoxine Delayed-Release can occur. Seek immediate medical attention if you experience symptoms such as rash, itching, swelling, severe dizziness, or difficulty breathing.

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Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.