Doxylamine and pyridoxine

Doxylamine is an antihistamine that lessens the effects of a natural chemical called histamine in the body.

Pyridoxine is a type of vitamin B (B6).

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

Doxylamine and pyridoxine may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take doxylamine and pyridoxine on an empty stomach with a full glass of water.

Doxylamine and pyridoxine is either taken at bedtime, or at bedtime and in the morning. Follow your doctor's dosing instructions very carefully.

Swallow the capsule or tablet whole and do not crush, chew, or break it.

Call your doctor if your symptoms do not improve, or if they get worse. Severe or ongoing vomiting can cause you to become dehydrated which can lead to serious medical problems.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use doxylamine and pyridoxine.

Store at room temperature away from moisture and heat.

Keep the pills in their original container, along with the packet or canister of moisture-absorbing preservative.

Do not use doxylamine and pyridoxine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not use doxylamine and pyridoxine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use this medicine if you are allergic to doxylamine or pyridoxine, or to other antihistamines such as Benadryl or Dramamine.

Tell your doctor if you have ever had:

• asthma or other breathing disorder;
• glaucoma, increased pressure inside your eye;
• blockage in your digestive tract (stomach or intestines);
• a stomach ulcer; or
• bladder obstruction or other urination problems.

You should not breast-feed while using doxylamine and pyridoxine.

Doxylamine and pyridoxine is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common side effects of doxylamine and pyridoxine may include:

• drowsiness.

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Nausea/Vomiting:

Doxylamine 10 mg-pyridoxine 10 mg delayed-release tablets:-Initial dose: 2 tablets orally once a day at bedtime-Maintenance dose: 2 tablets orally once a day to 4 tablets orally 3 times a day-Maximum dose: 4 tablets/dayDoxylamine 20 mg-pyridoxine 20 mg extended-release tablets:-Initial dose: 1 tablet orally once a day at bedtime-Maximum dose: 2 tablets/dayComments:-Treatment should be taken as prescribed, and should not be taken on an as-needed basis.-Patients should be routinely reassessed for the continued need for treatment.Use: Treatment of nausea and vomiting of pregnancy in patients who do not respond to conservative management

Take the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at the same time.

Do not take more than 2 tablets or capsules in 24 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dry mouth, extreme drowsiness or dizziness, confusion, restless feeling, dilated pupils, rapid heartbeats, seizure (convulsions), or muscle pain or weakness with fever and dark colored urine.

Avoid driving or hazardous activity until you know how doxylamine and pyridoxine will affect you. Your reactions could be impaired.

Avoid drinking alcohol. It can increase drowsiness caused by doxylamine and pyridoxine.

Do not take any medicine without your doctor's advice while you are pregnant.

Using doxylamine and pyridoxine with other medications that cause drowsiness can increase this effect. Consult your doctor before taking opioid medication, a sleeping pill, a muscle relaxant, or medications for anxiety, depression, or seizures.

Other drugs may influence how doxylamine and pyridoxine work, including both prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any new medicines you begin or stop using.