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Doxylamine and pyridoxine (Oral route)

Pronunciation:

dox-IL-a-meen SUX-i-nate, pir-i-DOX-een hye-droe-KLOR-ide

Brand Names:

  • Diclegis

Dosage Forms:

  • Tablet, Delayed Release
  • Tablet, Extended Release

Classifications:

Therapeutic—

Antiemetic

Pharmacologic—

Doxylamine

Chemical—

Doxylamine

Uses of This Medicine:

Doxylamine and pyridoxine combination is used to treat nausea and vomiting in pregnant women (also called morning sickness) whose symptoms have not been relieved by other therapies. This medicine is a combination of an antihistamine and vitamin B6.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of doxylamine and pyridoxine combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of doxylamine and pyridoxine combination in geriatric patients.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersAAdequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Sodium Oxybate
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acrivastine
  • Altretamine
  • Buprenorphine
  • Bupropion
  • Carbinoxamine
  • Fentanyl
  • Hydrocodone
  • Hydromorphone
  • Meclizine
  • Methadone
  • Morphine
  • Morphine Sulfate Liposome
  • Oxycodone
  • Oxymorphone
  • Suvorexant
  • Tapentadol
  • Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Perampanel

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Asthma or
  • Bladder blockage or
  • Bowel blockage or
  • Glaucoma, narrow angle or
  • Peptic ulcer—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine 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.

This medicine 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 whole with a glass of water. Do not crush, break, or chew it. It is best to take this medicine on an empty stomach.

Dosing—

The dose of this medicine 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 this medicine. 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 oral dosage form (delayed-release tablets):
    • For treatment of nausea and vomiting during pregnancy:
      • 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.

Missed dose—

If you miss a dose of this medicine, 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.

Precautions While Using This Medicine:

It is important that your doctor check your progress while taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your symptoms do not improve or if they become worse, check with your doctor.

You should not use this medicine together with a MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate®. Using these medicines together may cause serious unwanted effects.

This medicine may make you drowsy or sleepy. Make sure you know how to react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

This medicine may cause dry mouth. A dry mouth may also damage your teeth and gums. To help prevent this condition, carefully brush your teeth at least two times a day and have regular visits with your dentist.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine 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:

Incidence not known
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 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:

More common
Unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 11/4/2014

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