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Diclegis

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Diclegis is a combination of doxylamine succinate (an antihistamine) and pyridoxine (vitamin B6). It is specifically indicated for the management of nausea and vomiting during pregnancy when conservative management fails. The delayed-release tablets provide steady relief for expecting mothers.


Availability
In Stock
Delivery Time
Airmail (14-21 days) | EMS trackable (5-9 days)
Product is shipped in a fully discreet envelope with no content disclosure, including all required documentation inside

Product Sheet

Active Ingredient(s)
Doxylamine Succinate, Pyridoxine
Reference Brand
Xonvea
Manufacturer
Duchesnay
Product Form
Delayed-release tablets
Regulatory Classification
Rx
Primary Category
Morning Sickness Relief
Product Category
Genito-urinary System, Antiemetics, Antihistamine and Vitamin B6 combination
Pharmacological Class
Antihistamine, Vitamin B6 analogue
Manufacturer Description
A medicine specifically developed to manage nausea and vomiting in pregnant women when diet and lifestyle changes haven't worked.
Mechanism of Action
This medication combines an antihistamine that blocks certain natural substances in the body causing nausea, with Vitamin B6, which has been shown to reduce symptoms of morning sickness through unknown mechanisms.
Route of Administration
Oral
Onset Time
4 to 6 hours (delayed release)
Duration
8 to 12 hours
Contraindications
Concurrent use of MAOIs, Known hypersensitivity, Porphyria
Severe Adverse Events
Blurred vision, Difficulty urinating, Rapid heartbeat, Mental confusion
Common Side Effects
Dry mouth, Dry nose, Headache
Uncommon Side Effects
Severe drowsiness, Sleepiness, Stomach upset
Drug Interactions
MAO inhibitors, Alcohol, Sleeping pills, CNS depressants
Pregnancy Safety Warnings
Specifically indicated for use during pregnancy.
Age Restrictions
Approved for use in pregnant adults
Storage Guidelines
Store in a cool, dry place away from children.
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Diclegis FAQ

Can Diclegis be taken while traveling abroad?

Yes, but you should carry a copy of the prescription and the original packaging. Some countries may require proof of prescription for antihistamines, so keeping documentation helps avoid customs delays.

Will Diclegis affect the results of a drug test for work or sports?

Doxylamine is not typically screened for in standard workplace or sports drug tests. However, athletes should check specific league policies, as some governing bodies list antihistamines as prohibited substances when taken in high doses.

What do the imprints on Diclegis tablets look like?

Each 10 mg/10 mg tablet is usually imprinted with the letters “D 10/10” on one side, identifying the dose and brand. Imprint designs can vary by manufacturer and batch.

Are there any special considerations for storing Diclegis in a hot climate?

The medication should be stored below 30 °C. In hot climates, keep the bottle in a climate-controlled area, such as a locked drawer away from windows or a cooler bag, to maintain potency.

How does Diclegis compare with over-the-counter vitamin B6 alone?

Vitamin B6 alone may reduce mild nausea, but the addition of doxylamine provides a sedative effect that improves overall symptom control. Clinical trials have shown the combination to be more effective than either component alone for NVP.

Can Diclegis be used to treat morning sickness after the first trimester?

Yes, it can be prescribed throughout pregnancy if nausea persists, but clinicians often reassess the need in the third trimester and may adjust the dose or discontinue based on symptom severity and fetal considerations.

Is it safe to take Diclegis while breastfeeding?

Small amounts of doxylamine and pyridoxine are excreted in breast milk. Most guidelines consider short-term use compatible with breastfeeding, but a prescriber should weigh maternal benefit against potential infant exposure.

What should I do if I experience severe constipation while on Diclegis?

Increase dietary fibre, hydrate well, and consider a mild stool softener after discussing it with your healthcare provider. Persistent constipation should be evaluated for other causes.

Does the tablet contain any allergens such as lactose or gluten?

The excipients in Diclegis tablets typically include lactose, magnesium stearate, and other standard fillers. Patients with known lactose intolerance or gluten sensitivity should confirm ingredient details with the pharmacy.

What is Diclegis?

Diclegis is a prescription medication that combines two active ingredients - doxylamine succinate and pyridoxine (vitamin B6) - in a single tablet. It belongs to the women’s health therapeutic area and is primarily used to relieve nausea and vomiting during pregnancy, a condition known as nausea and vomiting of pregnancy (NVP).

  • Formulation: Tablet (tab)
  • Strength: 10 mg doxylamine succinate / 10 mg pyridoxine per tablet
  • Regulatory status in the UK: Diclegis is not a UK-licensed product. It may be prescribed off-label under the guidance of a qualified prescriber, with reference to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). In the United States the product is FDA-approved for NVP.

How Diclegis Works in the Body

Diclegis treats NVP through the complementary actions of its two components:

  • Doxylamine succinate is a first-generation antihistamine. It blocks histamine H₁ receptors in the brain, producing a mild sedative effect that can reduce the sensation of nausea. Doxylamine also has anticholinergic activity, which can further diminish the vomiting reflex.

  • Pyridoxine (vitamin B6) participates in neurotransmitter synthesis, particularly the production of serotonin and dopamine, which influence the gut-brain axis. Adequate pyridoxine levels are thought to stabilise the central pathways that trigger nausea.

When taken together, the antihistamine’s calming effect and pyridoxine’s metabolic support provide greater relief than either agent alone. The tablet is designed for oral absorption; peak plasma concentrations are typically reached within 2-4 hours, and the combined effect can last through the night, which is why the medication is usually taken at bedtime.

Conditions Treated by Diclegis

  • Nausea and vomiting of pregnancy (NVP): Diclegis is approved by the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate NVP. In the UK it is commonly prescribed off-label for the same indication when first-line dietary measures are insufficient.

  • Hyperemesis gravidarum (severe NVP): Although not formally approved for hyperemesis gravidarum, clinical guidelines recognise that higher-dose regimens of doxylamine-pyridoxine may be employed under specialist supervision when symptoms are severe.

The medication is not indicated for nausea unrelated to pregnancy, such as chemotherapy-induced nausea, postoperative nausea, or motion sickness, unless a prescriber specifically deems it appropriate.

Evidence-Based Off-Label Uses

  • Post-operative nausea: Small observational studies have explored doxylamine-pyridoxine for nausea after surgery, but evidence remains limited and the use is not standard practice.

  • Chemotherapy-induced nausea: Research to date does not support routine use of doxylamine-pyridoxine for this purpose; anti-emetics with stronger evidence, such as 5-HT₃ antagonists, are preferred.

When used off-label, the same safety considerations and dosing principles apply, and any such use must be supervised by a qualified healthcare professional.

Who Should (and Should Not) Use Diclegis?

Ideal candidates

  • Pregnant individuals experiencing NVP that does not resolve with dietary changes or lifestyle measures.
  • Adults who are not hypersensitive to antihistamines or vitamin B6.

Absolute contraindications

  • Known hypersensitivity to doxylamine succinate, pyridoxine, or any tablet excipients.
  • Use of monoamine oxidase inhibitors (MAOIs) - concurrent therapy is prohibited due to the risk of exaggerated antihistamine effects.

Relative contraindications / cautions

  • Respiratory conditions: Severe asthma, chronic obstructive pulmonary disease (COPD) or a history of bronchospasm may be aggravated by the anticholinergic properties of doxylamine.
  • Glaucoma: Narrow-angle glaucoma can be worsened by antihistamine-induced pupil dilation.
  • Urinary retention or prostatic hypertrophy: Anticholinergic activity may exacerbate these conditions.
  • Pregnancy trimester: Safety data primarily cover the first and second trimesters; use in the third trimester should be reviewed by a prescriber.
  • Breastfeeding: Small amounts of both ingredients pass into breast milk; the decision to continue therapy should balance maternal benefit against potential infant exposure.

Special populations

  • Elderly: Start with the lowest effective dose and monitor for excessive sedation or anticholinergic side effects.
  • Renal or hepatic impairment: No dose adjustment is formally required, but clinicians may prefer a conservative approach and monitor for accumulation of doxylamine.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Drowsiness or mild sedation - reported by most users, especially when first starting therapy.
  • Dry mouth - an anticholinergic effect that can be relieved by sipping water.
  • Mild constipation - may improve with dietary fibre and fluid intake.

These effects are usually transient and lessen as the body adjusts to the medication.

Serious Adverse Events

  • Severe allergic reaction (anaphylaxis): swelling of the face, tongue, or throat, difficulty breathing - requires immediate emergency care.
  • Marked dizziness or confusion - particularly in the elderly, may increase fall risk.
  • Hepatic dysfunction - extremely rare, but enzymes should be checked if prolonged high-dose therapy is considered.

Diclegis does not carry a US “black-box” warning, but the MHRA advises caution in patients with the relative contraindications listed above.

Drug Interactions

  • Central nervous system depressants (e.g., benzodiazepines, opioids, alcohol) - additive sedation; dose reduction of the other agent may be needed.
  • CYP2D6 substrates (e.g., certain antidepressants, beta-blockers) - doxylamine is metabolised partly by CYP2D6; strong inhibitors can raise doxylamine levels.
  • Anticholinergic burden - concurrent use of multiple anticholinergic drugs (e.g., diphenhydramine, tricyclic antidepressants) may amplify dry mouth, urinary retention, or constipation.

When any new medication, herbal product, or supplement is added, the prescriber should review the full list for potential interactions.

Food and Lifestyle Interactions

  • Alcohol: Increases the sedative effect of doxylamine; moderation is advised.
  • Caffeine: May counteract drowsiness but can also worsen nausea; timing should be considered.
  • Driving or operating machinery: Patients should assess their own alertness, especially after the first dose, before engaging in tasks requiring full concentration.

How to Take Diclegis

  • Standard regimen: One tablet (10 mg/10 mg) taken orally at bedtime. If nausea persists after several days, the prescriber may increase the dose to two tablets per day (one at bedtime and one in the early evening), not exceeding four tablets daily.
  • Administration: Swallow the tablet whole with a glass of water. It may be taken with or without food; taking it with a light snack can reduce stomach irritation.
  • Missed dose: If a dose is missed, take it as soon as remembered unless it will be less than 4 hours before the next scheduled dose. Do not double-dose.
  • Overdose: Symptoms may include extreme drowsiness, confusion, dry mouth, flushed skin, and rapid heart rate. Seek urgent medical attention; supportive care is the mainstay. No specific antidote is required.
  • Discontinuation: No tapering is necessary for short-term use. If therapy has been prolonged (several weeks or more), the prescriber may advise a gradual reduction to monitor for rebound nausea.

Monitoring and Follow-Up

  • Symptom control: Patients should report whether nausea and vomiting improve within 3-5 days of therapy. Lack of response may prompt a dosage review or alternative treatment.
  • Adverse effects: Discuss any persistent drowsiness, dry mouth, or visual changes with a healthcare provider.
  • Pregnancy progression: Routine obstetric visits will assess fetal growth and maternal well-being; no specific laboratory monitoring for Diclegis is required.

Storage and Handling

  • Keep tablets in the original container, tightly closed, at room temperature (15-30 °C).
  • Protect from moisture, heat, and direct sunlight.
  • Do not use after the expiry date printed on the pack.
  • Keep out of reach of children; discard unused medication according to local pharmacy guidelines.

Medication-Specific Glossary

Antihistamine
A drug that blocks histamine H₁ receptors, reducing allergy-related symptoms and, in the case of doxylamine, providing mild sedation that can lessen nausea.
Hyperemesis gravidarum
A severe form of pregnancy-related nausea and vomiting that can lead to dehydration, weight loss, and electrolyte imbalance, often requiring hospital care.
Therapeutic Window
The dosage range within which a medication provides clinical benefit without causing unacceptable side effects. For Diclegis, the recommended range is 1-4 tablets daily.
Anticholinergic
A property of some drugs (including doxylamine) that blocks the action of the neurotransmitter acetylcholine, potentially causing dry mouth, urinary retention, and constipation.

Medical Disclaimer

This article provides educational information about Diclegis and is not a substitute for professional medical advice. Treatment decisions, including use for unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Information for Diclegis is sourced from established medical standards and updated frequently. It is provided for general guidance and should be confirmed with a healthcare professional before use.
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