Doxylamine succinate and pyridoxine hydrochloride

What is Doxylamine succinate and Pyridoxine hydrochloride?

• Doxylamine succinate and Pyridoxine hydrochloride (Diclegis; Bonjesta) is a fixed dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a Vitamin B6 analog used for the treatment nausea and vomiting of pregnancy.

Doxylamine

Pyridoxine

What are the uses of this medicine?

• Doxylamine succinate and Pyridoxine hydrochloride (Diclegis; Bonjesta) is used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.

Limitations of Use:

• It is not known if Diclegis is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum. Women with this condition may need to be hospitalized.

How does this medicine work?

• The mechanism of action of Diclegis is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis.
• take monoamine oxidase inhibitors (MAOIs). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including Marplan, Nardil, Emsam, Eldepryl, Zelapar, and Parnate.

What drug interactions can this medicine cause?

• Use of Diclegis is contraindicated in women who are taking monoamine oxidase inhibitors (MAOIs).
• Diclegis should be taken on an empty stomach with a glass of water.
• False positive drug screens for methadone, opiates, and PCP can occur with doxylamine succinate/pyridoxine hydrochloride use.

Is this medicine FDA approved?

FDA approved this drug in the year of 2013.

How should this medicine be used?

Recommended Dosage:

• Initially, take two Diclegis delayed-release tablets orally at bedtime (Day 1).
• If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime.
• However, if symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime).
• If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily.
• Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime).
• The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily.

Administration

• Take Diclegis everyday as prescribed by your healthcare provider. Do not stop taking Diclegis without talking to your healthcare provider first.
• See the following schedule for the usual way you should start taking Diclegis:
• Day 1- Take 2 tablets, by mouth at bedtime.
• Day 2- Take 2 tablets at bedtime. If your nausea and vomiting is better or controlled on Day 2, continue to take 2 tablets every night at bedtime. This will be your usual dose unless your healthcare provider tells you otherwise.
• Day 3- If you still had nausea and vomiting on Day 2, take 3 tablets on Day 3 (1 tablet in the morning and 2 tablets at bedtime).
• Day 4- If your nausea and vomiting was better or controlled on Day 3, continue to take 3 tablets each day (1 tablet in the morning and 2 tablets at bedtime). If you still had nausea and vomiting on Day 3, start taking 4 tablets each day (1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime).
• Do not take more than 4 tablets (1 in the morning, 1 in the mid-afternoon, and 2 at bedtime) in 1 day.
• Take Diclegis on an empty stomach with a glass of water.
• Take Diclegis tablets whole. Do not crush, chew, or break Diclegis tablets before swallowing. If you cannot swallow Diclegis tablets whole, tell your healthcare provider.
• If you take too much Diclegis (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking Diclegis, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride.

This medicine is available in fallowing brand namesː

• Diclegis

What side effects can this medication cause?

The most common side effects of this medicine include:

• somnolence
• drowsiness

Diclegis may cause serious side effects, including drowsiness

What special precautions should I follow?

• Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so.
• Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents.
• Diclegis may cause false positive urine drug screening test for methadone, opiates and PCP.
• Concurrent use with alcohol or other CNS depressants is not recommended.
• Diclegis has anticholinergic properties and, therefore, should be used with caution in women with: asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion and tachycardia.
• At toxic doses, doxylamine exhibits anticholinergic effects, including seizures, rhabdomyolysis, acute renal failure and death.

Management of Overdose

• If treatment is needed, it consists of gastric lavage or activated charcoal, whole bowel irrigation and symptomatic treatment. For additional information about overdose treatment, call a poison control center.

Can this medicine be used in pregnancy?

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

Can this medicine be used in children?

• The safety and effectiveness of Diclegis in children under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6).
• Inactive ingredients: ammonium hydroxide, n-butanol, carnauba wax powder, colloidal silicon dioxide, croscarmellose sodium, D&C Red#27, denatured alcohol, FD&C Blue #2, hypromellose, isopropyl alcohol, magnesium stearate, magnesium trisilicate, methacrylic acid copolymer, microcrystalline cellulose 102, PEG 400, PEG 8000, polysorbate 80, propylene glycol, shellac glaze, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.

Who manufactures and distributes this medicine?

• Distributed by: Duchesnay USA, Inc., Bryn Mawr, PA

What should I know about storage and disposal of this medication?

• Store Diclegis between 68°F to 77°F (20°C to 25°C).
• Keep Diclegis tablets dry, in a tightly closed container, and out of the light.
• Safely throw away medicine that is out of date or no longer needed.
• Keep Diclegis and all medicines out of the reach of children.

• Dailymed label info on Doxylamine succinate and pyridoxine hydrochloride
• FDA Doxylamine succinate and pyridoxine hydrochloride

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