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Pyridoxine & Doxylamine Succinate

Pyridoxine & Doxylamine Succinate

Why is this medication prescribed?

The combination of doxylamine and pyridoxine is used to treat nausea and vomiting in pregnant women whose symptoms have not improved after changing their diet or using other non-medicine treatments. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of certain natural substances in the body that may contribute to nausea and vomiting. Pyridoxine (vitamin B6) is a vitamin. It is given because a lack of pyridoxine in the body may also be a factor in causing nausea and vomiting during pregnancy.

How should this medicine be used?

The combination of doxylamine and pyridoxine comes as a delayed-release (releases the medication in the intestine to delay when the medication will start working) tablet and as an extended-release (long-acting) tablet to take by mouth. It is usually taken on an empty stomach (at least 1 hour before or 2 hours after a meal) with a full glass of water. At first, your doctor will usually tell you to take it once a day at bedtime. If your symptoms of nausea and vomiting are not better, then your doctor may tell you to take the delayed-release tablet two or three times a day, or the extended-release tablet two times a day. . Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take doxylamine and pyridoxine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

  • restlessness
  • dry mouth
  • dilated pupils (black circles in the centers of the eyes)
  • drowsiness or sleepiness
  • dizziness
  • confusion
  • seizures
  • fast, irregular, or pounding heartbeat
  • difficulty urinating or painful urination
  • muscle pain or weakness
  • buildup of fluid in the body
  • dark red or cola-colored urine

Adverse effects and warnings

Reported adverse effects of doxylamine and pyridoxine delayed-release tablets include somnolence, headache, dizziness, dry mouth, and hypersensitivity. According to the package insert, doxylamine and pyridoxine delayed-release tablets are contraindicated in women with known hypersensitivity to doxylamine, other ethanolamine-derivative antihistamines, or pyridoxine. It is also contraindicated in combination with monoamine oxidase inhibitors, which intensify and prolong the adverse central nervous system effects. Monoamine oxidase inhibitors may also prolong and intensify the anticholinergic (drying effects) of such antihistamines as doxylamine. This medication may cause somnolence due to the anticholinergic properties of doxylamine. Use of this medication is not recommended if a woman is concurrently using central nervous system depressants, such as alcohol or sedating medications, including other antihistamines (that may be in cough and cold medications), opiates, or sleep aids. This medication has anticholinergic properties, and should be used with caution in women who have 1) asthma, 2) increased intraocular pressure, 3) narrow-angle glaucoma, 4) stenosing peptic ulcer, 5) pyloroduodenal obstruction, or 6) bladder-neck obstruction.

General Information

Diclegis is a fixed-dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a vitamin B6 analog.

Diclegis is specifically indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Diclegis is supplied as a tablet for oral administration. The recommended dose is two tablets daily at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime).

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