Doxylamine and pyridoxine

Doxylamine is an antihistamine that reduces the effects of natural chemical histamine in the body.

Pyridoxine is a form of vitamin B (B6).

Doxylamine and pyridoxine is a combination medicine used to treat nausea and vomiting during pregnancy, sometimes called morning sickness.

Doxylamine and pyridoxine may also be used for purposes not listed in this medication guide.

Take doxylamine and pyridoxine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

doxylamine and pyridoxine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the delayed-release tablet or extended-release tablet whole with a glass of water. Do not crush, break, or chew it. It is best to take doxylamine and pyridoxine on an empty stomach.

Dosing

The dose of doxylamine and pyridoxine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of doxylamine and pyridoxine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of nausea and vomiting during pregnancy:
  • For oral dosage form (delayed-release tablets):
    • Adults—Two tablets taken at bedtime (Day 1). If symptoms are controlled the following day, continue taking two tablets at bedtime. If symptoms persists in the afternoon of Day 2, take two tablets at bedtime and start taking three tablets on Day 3 (one tablet in the morning and two tablets at bedtime). If symptoms are controlled on Day 4, continue taking three tablets daily. Otherwise, take one tablet in the morning, one tablet in the mid-afternoon, and two tablets at bedtime (total of 4 tablets).
    • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (extended-release tablets):
    • Adults—One tablet taken at bedtime (Day 1). If symptoms are controlled the following day, continue taking 1 tablet at bedtime. If symptoms persists on Day 2, take one tablet in the morning and one tablet at bedtime. However, the dose is usually not more than 2 tablets per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of doxylamine and pyridoxine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• If you have an allergy to doxylamine, pyridoxine, or any other part of doxylamine and pyridoxine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you are breast-feeding. Do not breast-feed while you take doxylamine and pyridoxine.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take doxylamine and pyridoxine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take at bedtime if taking once a day.
• Take on an empty stomach.
• Take with a full glass of water.
• Swallow whole. Do not chew, break, or crush.
• If you have trouble swallowing, talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Commonly reported side effects of doxylamine/pyridoxine include: drowsiness. See below for a comprehensive list of adverse effects.

Applies to doxylamine / pyridoxine: oral tablet delayed release, oral tablet extended release

Along with its needed effects, doxylamine / pyridoxine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking doxylamine / pyridoxine:

• Chest discomfort
• decrease in the frequency of urination
• decrease in urine volume
• difficult or labored breathing
• difficult or painful urination
• fast, irregular, pounding, or racing heartbeat or pulse
• swelling of the eyelids, face, lips, hands, or feet

Some side effects of doxylamine / pyridoxine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Unusual drowsiness

Applies to doxylamine / pyridoxine: oral delayed release tablet

Cardiovascular

Postmarketing reports: Palpitation, tachycardia[Ref]

Dermatologic

Postmarketing reports: Hyperhidrosis, pruritus, rash, maculo-papular rash[Ref]

Gastrointestinal

Postmarketing reports: Abdominal distension, abdominal pain, constipation, diarrhea[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity[Ref]

Nervous system

Very common (10% or more): Somnolence (14.3%)
Postmarketing reports: Vertigo, dizziness, headache, migraines, paresthesia, psychomotor hyperactivity[Ref]

Ocular

Postmarketing reports: Blurred vision, visual disturbances[Ref]

Other

Postmarketing reports: Chest discomfort, fatigue, irritability, malaise[Ref]

Psychiatric

Postmarketing reports: Anxiety, disorientation, insomnia, nightmares[Ref]

Renal

Postmarketing reports: Dysuria, urinary retention[Ref]

Respiratory

Postmarketing reports: Dyspnea[Ref]

Some side effects of doxylamine / pyridoxine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.