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Doxinate

Doxinate (Doxylamine 10 mg + Vitamin B6 10 mg) — ACOG/NICE/SOGC first-line pharmacological therapy for nausea-vomiting of pregnancy (NVP). FDA Pregnancy Category A.

Lékařsky ověřeno Morgan Ellis — Pharmacy Researcher · 8 years experience Last reviewed: May 2026

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⚡ Quick Answer — What is Doxinate?

Doxinate is a fixed-dose tablet of doxylamine succinate 10 mg + pyridoxine (vitamin B6) 10 mg — the ACOG and FDA-endorsed first-line pharmacotherapy for nausea and vomiting of pregnancy (NVP). The combination is also marketed as Diclegis (US) and Cariban (EU). Doxylamine is a sedating H1-antihistamine; pyridoxine reduces nausea via mechanisms not yet fully understood. Standard regimen: 2 tablets at bedtime, with 1 morning + 1 afternoon doses added if symptoms persist. Onset 4–6 hours, so the bedtime dose targets early-morning sickness. WHO-GMP certified manufacturer.

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💡 First-line for NVP per ACOG (2024) and FDA. Pyridoxine-doxylamine has the strongest evidence base in pregnancy of any antiemetic. The FDA category was upgraded to A in 2013 after a meta-analysis of > 200,000 exposures showed no teratogenic signal. NICE 2024 places it as first-line for NVP after non-pharmacological measures. It is preferred over metoclopramide, ondansetron, and prochlorperazine for first-trimester use.

Proč objednávat z MedsBase

Doxinate is supplied from a výrobce certifikovaného WHO-GMP. Every order ships discreetly worldwide and is covered by our Zárukou opětovného odeslání — if it does not arrive within 20 business days, we reship at no cost. It is the only antiemetic combination with FDA Category A status in pregnancy and is recommended first-line by ACOG, NICE, and the SOGC for nausea and vomiting of pregnancy.

Mechanism

Doxylamine is a first-generation ethanolamine H1-antihistamine with strong central penetration; H1 antagonism in the brainstem vestibular nuclei and CTZ produces antiemetic effect, with the sedation and anticholinergic activity that characterises this antihistamine class. Pyridoxine (vitamin B6) is a cofactor for > 100 enzymes including dopa decarboxylase and glutamate decarboxylase; the precise antiemetic mechanism in pregnancy is unclear but a randomised trial (Sahakian 1991) showed independent benefit at 30 mg/day and the combined product is more effective than either alone.

Indikace

  • Nausea and vomiting of pregnancy (NVP) including hyperemesis gravidarum (initial therapy)
  • Insomnia in pregnancy (off-label, low evidence)

Dose — standard NVP regimen

Day 1: 2 tablets at bedtime. Day 2: 1 morning + 2 bedtime if symptoms persist into next day. Day 3+: 1 morning + 1 afternoon + 2 bedtime (4 tablets/day max). Single doses are insufficient because steady-state takes 2–3 days. Continue until symptoms stable, then taper over a week.

Vedlejší účinky

  • Drowsiness (very common — the bedtime-loaded schedule mitigates this)
  • Dry mouth, blurred vision, urinary hesitancy (anticholinergic)
  • Constipation
  • Dizziness, headache
  • Allergic skin reactions (rare)

Interakce léků

  • Other CNS depressants (alcohol, opioids, benzodiazepines): additive sedation — avoid alcohol entirely in pregnancy.
  • Other anticholinergics: additive dry mouth, constipation, urinary retention.
  • MAO inhibitors: avoid combination.
  • Levodopa: pyridoxine increases peripheral conversion; significant only without carbidopa.

Často kladené dotazy

When in pregnancy can I take Doxinate?

It can be started as early as the first symptoms of NVP appear — typically week 6 of pregnancy. Continue for as long as symptoms persist, usually peaking at weeks 9–12 and resolving by 16–20.

Will it harm the baby?

There is no evidence of teratogenic effect. The FDA upgraded the category to A in 2013 after a large meta-analysis of > 200,000 exposures. It has been used in millions of pregnancies since the 1950s.

Why two tablets at bedtime?

The peak antiemetic effect occurs 4–6 hours after a dose. Loading the bedtime dose targets early-morning sickness, when symptoms are typically worst.

Will it make me sleepy during the day?

Possibly. The bedtime-loaded schedule minimises daytime drowsiness, but the morning and afternoon doses can still cause sleepiness. Do not drive until you know how it affects you.

Can I take it with ondansetron?

Yes, this is a recognised step-up if pyridoxine-doxylamine alone is insufficient. ACOG places ondansetron as second-line in NVP (after week 10) due to a small signal for cleft palate in early use.

When should I worry?

Severe vomiting (> 3 times/day), inability to keep fluids down, weight loss > 5 percent of pre-pregnancy weight, ketones in urine, or signs of dehydration require urgent obstetric review — this is hyperemesis gravidarum and may need admission.

Are non-drug options worth trying first?

Yes. Small frequent meals, ginger, acupressure (P6 wristbands), avoiding triggers (smells, fatty foods), and vitamin B6 monotherapy (10–25 mg three times daily) are recommended starting points and often help mild NVP.

Do I have to stop if my symptoms improve?

You can taper down rather than stop abruptly — many women find that stopping completely allows symptoms to recur. Step down by one tablet every 1–2 days as tolerated.

Skladování

Below 30°C, protect from moisture. Keep out of reach of children.

Co když vynechám dávku?

Take it when you remember unless it is close to the next scheduled dose. Do not double up — that just increases drowsiness.

Other Gastro Health Medications

⚕ Lékařské upozornění. This page is for informational purposes only and does not replace medical advice from a qualified healthcare professional. NVP that prevents fluid intake, causes > 5 percent weight loss, or shows ketonuria is hyperemesis gravidarum and requires obstetric assessment.

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