Diclegis

(Doxylamine Succinate/Pyridoxine Hydrochloride)

The active ingredients in Diclegis are doxylamine succinate and pyridoxine hydrochloride. Doxylamine is an antihistamine while pyridoxine is vitamin B6. Although the exact mechanism of action behind Diclegis is unknown, the combination of doxylamine-pyridoxine in pregnant women has been effective in managing nausea and vomiting due to pregnancy.

It is unknown if Diclegis is safe for very severe nausea and vomiting during pregnancy. When nausea and vomiting are this severe, it is termed hyperemesis gravidarum and often requires hospitalization and inpatient treatment.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Diclegis. However, the following is a synopsis of the general guidelines for the use of Diclegis:

• Conservative management of nausea and vomiting during pregnancy is the preferred approach. Other non-medication and diet-related solutions should be tried first before beginning Diclegis.
• Diclegis is typically taken by mouth at bedtime on an empty stomach with a full glass of water. The number of tablets you have to take will depend on your response to the medication. Consult your healthcare provider for more information.
• Take the tablets whole. Do not crush, chew, break, or dissolve tablets.
• Use exactly as prescribed. Do not exceed the recommended dose or duration of use.
• Diclegis can cause drowsiness. Do not drive or operate heavy machinery until you see how Diclegis affects you.
• Diclegis should not be used with alcohol or any medication that helps you fall asleep (such as those in pain medication or cough and cold syrups). Doing so can cause excessive drowsiness that could lead to falls and accidents.

The most common side effects of Diclegis include:

• Drowsiness

Some individuals may experience serious side effects while using Diclegis. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Excessive drowsiness that is interfering with daily activities.
• Signs of an allergic reaction such as difficulty breathing, hives, itchiness, or swelling of the face, eyes, or lips.
• Signs of Diclegis overdose such as restlessness, dry mouth, large pupils, sleepiness, dizziness, confusion, fast heart rate, seizures, fatigue, or muscle pain. You may also have signs of kidney problems such as decreased urination and swelling of the legs, ankles, or feet.
• Worsening symptoms of other medical conditions such as glaucoma, stomach ulcers, intestinal or bladder blockages, and problems urinating.

These are not all of the possible side effects of Diclegis. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Diclegis, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Eye problems such as increased intraocular pressure or narrow-angle glaucoma
• Stomach problems such as stenosing peptic ulcer or pyloroduodenal obstruction (blockage)
• Bladder problems such as urinary bladder-neck obstruction (blockage)
• Are breastfeeding or planning to breastfeed

Do not use Diclegis if you have:

• An allergy to doxylamine succinate or pyridoxine hydrochloride
• An allergy to ethanolamine-derived antihistamines
• You are using a MAOI

It takes 5-7 hours for each medication in Diclegis to reach peak levels in the body which is when you can expect an effect. By the time you wake up, it should help to lessen the nausea. However, each person is different and some may not notice a difference until after this period.

When Diclegis is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• MAOI (monoamine oxidase inhibitors)
• CNS depressants (including sedatives and tranquilizers)

Diclegis delayed-release tablets are available in the following strengths:

• 10 mg doxylamine succinate/10 mg pyridoxine hydrochloride

Diclegis is also available under another brand name known as Bonjesta. Bonjesta is also a delayed-release formulation that contains higher doses of doxylamine-pyridoxine than Diclegis.

Diclegis should be stored at room temperature away from light and out of reach of children. Store Diclegis in its original container and protect tablets from moisture.

Diclegis is manufactured by the pharmaceutical company Duchesnay.

Yes, a generic version of the brand name Diclegis is available.

Diclegis is a temporary medication. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Diclegis.

Diclegis is commonly used in pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Diclegis can pass into the breastmilk and cause harm to the feeding infant. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend how to best feed your infant.