Doxylamine and pyridoxine (Oral route)

Pronunciation:

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

Brand Names:

Bonjesta
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 treatments. 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.

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.

Calcium Oxybate
Furazolidone
Iproniazid
Isocarboxazid
Linezolid
Magnesium Oxybate
Methylene Blue
Moclobemide
Nialamide
Phenelzine
Potassium Oxybate
Procarbazine
Rasagiline
Safinamide
Selegiline
Sodium Oxybate
Toloxatone
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.

Acepromazine
Alfentanil
Alprazolam
Altretamine
Amifampridine
Amobarbital
Anileridine
Aripiprazole
Asenapine
Baclofen
Benperidol
Benzhydrocodone
Bromazepam
Bromopride
Buprenorphine
Bupropion
Buspirone
Butabarbital
Cannabidiol
Cannabis
Carbinoxamine
Carisoprodol
Carphenazine
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorpromazine
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Clozapine
Codeine
Cyclobenzaprine
Daridorexant
Dexmedetomidine
Diacetylmorphine
Diazepam
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diphenhydramine
Diphenoxylate
Donepezil
Droperidol
Enflurane
Esketamine
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Flibanserin
Fluphenazine
Flurazepam
Fluspirilene
Fospropofol
Gabapentin
Gabapentin Enacarbil
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxyzine
Isoflurane
Ketamine
Ketazolam
Ketobemidone
Lacosamide
Lemborexant
Levocetirizine
Levorphanol
Lofexidine
Lorazepam
Loxapine
Meclizine
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Metoclopramide
Midazolam
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nicomorphine
Nitrazepam
Nitrous Oxide
Olanzapine
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxycodone
Oxymorphone
Papaveretum
Paregoric
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenobarbital
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Pitolisant
Prazepam
Pregabalin
Primidone
Prochlorperazine
Promazine
Promethazine
Propofol
Quazepam
Quetiapine
Ramelteon
Remifentanil
Remimazolam
Remoxipride
Ropeginterferon Alfa-2b-njft
Scopolamine
Secobarbital
Sertindole
Sufentanil
Sulpiride
Tapentadol
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Tramadol
Trazodone
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Zaleplon
Zolpidem
Zopiclone
Zotepine
Zuranolone

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.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

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:

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

Proper Use of This Medicine:

Take this medicine only as directed. 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 leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the 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 treatment of nausea and vomiting during pregnancy:
- For oral dosage form (delayed-release tablets):
  - Adults—2 tablets taken at bedtime (Day 1). If symptoms are controlled the following day, continue taking 2 tablets at bedtime. If symptoms persist in the afternoon of Day 2, take 2 tablets at bedtime and start taking 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime). If symptoms are controlled on Day 4, continue taking 3 tablets daily. Otherwise, take 1 tablet in the morning, 1 tablet in the mid-afternoon, and 2 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—1 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 1 tablet in the morning and 1 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 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 using this medicine to make sure this medicine is working properly and to check for unwanted effects.

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

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Using these medicines together may cause serious unwanted effects.

This medicine may make you drowsy or sleepy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 using this medicine.

Signs of an overdose include: dizziness or lightheadedness, dry mouth, enlarged pupils, fast, pounding, irregular heartbeat or pulse, feeling of constant movement of self or surroundings, mental confusion, palpitations, restlessness, sensation of spinning, or sleepiness. Call your doctor right away if you notice these symptoms.

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 2 times a day and have regular visits with your dentist.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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: Blurred or loss of vision; burning feeling while urinating; chest discomfort or tightness; decrease in the frequency of urination; decrease in urine volume; difficult or labored breathing; difficult or painful urination; disturbed color perception; double vision; fast, irregular, pounding, or racing heartbeat or pulse; fever; halos around lights; headache, severe and throbbing; hives, itching, skin rash; hoarseness; irritation; joint pain, stiffness, or swelling; night blindness; overbright appearance of lights; redness of the skin; stomach distension or pain; swelling of the eyelids, face, lips, hands, or feet; trouble breathing or swallowing; tunnel vision

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose: Dizziness or lightheadedness; dry mouth; enlarged pupils; fast, pounding, or irregular heartbeat or pulse; feeling of constant movement of self or surroundings; mental confusion; palpitations; restlessness; sensation of spinning; sleepiness

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

Incidence not known: Anxiety; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; confusion about identity, place, and time; constipation; diarrhea; dizziness or lightheadedness; feeling of constant movement of self or surroundings; general feeling of discomfort or illness; headache; increased sweating; irritability; nightmares; sensation of spinning; trouble sleeping; unusual tiredness or weakness

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: 11/16/2023

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