Doxylamine/Pyridoxine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat nausea and vomiting of pregnancy. Take it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• To prevent overdose while you are taking this medicine, ask your pharmacist or healthcare provider before you take any other nonprescription medicine. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihistamine/vitamin B-6

Generic and brand names: doxylamine/pyridoxine, oral; Diclegis

What is this medicine used for?

This medicine is taken by mouth to treat nausea and vomiting of pregnancy when other treatment has not worked.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• Asthma or COPD
• Dementia
• Gastroesophageal reflux disease (GERD), hiatal hernia, or esophagitis (trouble swallowing)
• Glaucoma
• Heart problem such as heart failure, an irregular heartbeat, or a fast heartbeat
• High blood pressure
• Kidney or liver disease
• Mental health problems such as hallucinations or delusions
• Muscle diseases such as myasthenia gravis or Parkinson’s disease
• Nerve problems from diabetes, alcohol abuse, or injury
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

Tell your healthcare provider if you take medicines that can irritate your esophagus such as alendronate (Fosamax) or risedronate (Actonel).

Do not take an MAO inhibitor and this medicine within 14 days of each other.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. Check medicine labels carefully before using two or more medicines at the same time. Other prescription and nonprescription cold and allergy medicines may contain the same kind of medicine, and you may take too much. Ask your healthcare provider or pharmacist about anything you do not understand.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine on an empty stomach with a glass of water. Swallow the tablets whole. Do not crush, chew, or break the tablets. If you cannot swallow the tablets whole, tell your healthcare provider.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222

Symptoms of an acute overdose may include: drowsiness, loss of coordination, restlessness, muscle pain or weakness, trouble urinating, dizziness, enlarged pupils, dry mouth, confusion, fast heartbeat, seizures

What should I watch out for?

Dry mouth and constipation are common side effects of this medicine. If these become bothersome, contact your healthcare provider.

This medicine may cause blurred vision, dizziness, or drowsiness. Do not drive or operate machinery unless you are fully alert and able to see clearly. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine increases the risk of heat stroke because it reduces sweating. Avoid extreme heat, saunas, hot tubs, and exercising too much (especially in hot weather).

This medicine may make your eyes more sensitive to light. Wear sunglasses to help protect your eyes.

This medicine increases the effects of alcohol and other medicines that slow down the nervous system. Do not drink alcohol or take other medicines that make you drowsy unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects such as nervousness or drowsiness. Talk with your healthcare provider about this.

Contact your healthcare provider if your condition does not improve or if it gets worse. Keep appointments for follow up visits.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Clumsiness or numbness in your hands or feet; falling; severe nausea, stomach pain, or vomiting; trouble urinating, fast or irregular heartbeat, trouble breathing, severe drowsiness, confusion, severe restlessness, severe dizziness, seizures.

Other: Dry mouth, constipation, diarrhea, blurred vision, mild dizziness, mild drowsiness, headache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Altretamine (Hexalen)
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), and triazolam (Halcion)
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antipsychotic medicines such as haloperidol (Haldol), olanzapine (Zyprexa), pimozide (Orap), risperidone (Risperdal), and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Qudexy, Topamax, Trokendi)
• Doxepin (Silenor)
• Linezolid (Zyvox)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), and tiotropium (Spiriva)
• Muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other antihistamines such as azelastine (Astelin, Astepro), carbinoxamine (Arbinoxa, Palgic), cetirizine (Zyrtec), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), fexofenadine (Allegra), hydroxyzine (Vistaril), and loratadine (Alavert, Claritin)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), meperidine (Demerol), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), and tapentadol (Nucynta)
• Parkinson’s disease medicines such as benztropine (Cogentin), entacapone (Comtan), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), rasagiline (Azilect), ropinirole (Requip), and trihexyphenidyl
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), pentobarbital (Nembutal), secobarbital (Seconal), suvorexant (Belsomra), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.