01Open: this 10 mg tablet is not a US retail NDC
Opened as a 10 mg Motilium letter with no US cash figure. QT and lactation sit in the annotation, not in a price cell.
US cash boards do not carry Motilium as a routine retail tablet. FDA has not approved domperidone for marketing. Compounded or imported stock is a clinician-and-regulator problem, not a coupon problem. This desk will not invent a dollar to look complete.
Health Canada still lists 10 mg tablets. EMA products remain on the market for nausea and vomiting after the 2014 dose-and-duration cut. Those are the sheets this letter annotates.
Nora Lindqvist opens motility mail on cardiac risk and on the missing US NDC, in that order. Dated 21 August 2026. Method: Open, Annotate, Countersign, Seal. [email protected]. Educational desk. No dispense.
Forum carts that price 'Motilium 10 mg x 100' are not a GoodRx line. Treat them as unverified import. Counterfeit antiemetics exist. We will not rank sellers.
If your US clinician is navigating an expanded-access or compounding path for a documented GI indication, that conversation stays in that clinic. The fill rail under this letter links ordinary US chains only to say they are not a Motilium aisle.
02What the Canadian monograph actually measured
A fasting two-way crossover in 24 healthy men compared a generic 10 mg tablet with Motilium 10 mg. Twenty-two completed the statistics. That study exists to show the generic matches the brand, not to give you a Tmax to time against a ferry ride.
Older high-dose kinetic work quoted peaks near 100 ng/mL after 60 mg. Modern labelling forbids that daily load. Do not resurrect 60 mg curves to justify a forum TID-plus-bedtime plan.
Because CYP3A4 is the main N-dealkylation path, a new azole in week one of Motilium is a stop, not a 'watch it.' Grapefruit juice sits on the same contraindication list in the patient pages.
Parkinson patients already take other dopamine-touching drugs. Adding domperidone for nausea can be labelled in Canada and still needs a reconciliation so two peripheral blockers do not stack by accident.
Half-life near 7 hours in healthy kidneys is why TID before meals is plausible for a week and implausible as a silent chronic. When the half-life stretches to 21 hours in severe renal disease, TID is the wrong clock.
03Peripheral D2, prolactin, and why milk is off-label
Domperidone blocks peripheral dopamine receptors in the gut and in the chemoreceptor trigger zone that sits outside a tight blood-brain barrier. That is why acute dystonia is less discussed than with metoclopramide, and why prolactin still rises.
Prolactinoma is a contraindication. So is any situation where pushing gut motility could harm: bleed, mechanical obstruction, perforation.
No regulator licenses Motilium to make milk. Health Canada has reviewed psychiatric withdrawal - insomnia, anxiety, depression - when high-dose or long lactation courses stop suddenly. Most of those cases sat above 30 mg/day and lasted over four weeks. LactMed notes typical study regimens of 10 mg three times daily for 4-10 days and no official galactagogue dose anywhere.
FDA has warned against imported or compounded domperidone for breastfeeding. InfantRisk and LactMed walk that warning. This desk will not provide a pumping protocol or a wean table for milk. QT and milk postscript is the short companion.
If a lactation specialist in a country where the drug is marketed still uses it off-label, that is their consent, ECG, and taper problem. It is not a US cash fill and not a Juvia coupon.
04QT, age over 60, and the 30 mg wall
Age over sixty raises the ventricular-arrhythmia signal in the epidemiology the SmPC quotes. Daily doses above 30 mg do the same. Known long QT, unstable electrolytes, bradycardia, and heart failure are contraindications.
A thorough QT study at 20 mg four times daily (80 mg/day) showed a mean QTc change versus placebo of 3.4 msec (90% CI 1.0-5.9) on day 4. That is below the usual 10 msec regulatory worry line and still not a free pass at labelled 30 mg in older or stacked patients. Post-marketing torsades reports exist, often with other risks piled on.
Stop the tablet and seek care for palpitations, syncope, or seizure. Do not 'finish the box' through a faint.
QT literacy on this site also lives in the vardenafil letter. Different molecule, same request: name the other QT drugs before you start. Do not stack Motilium with a PDE5 on a hunch.
Electrolytes after vomiting are part of the antiemetic visit. Hypokalaemia plus a QT drug is a classic ward mistake.
05The pediatric study that failed its primary endpoint
A multicentre, double-blind program put 292 children aged 6 months to 12 years on oral-rehydration therapy plus either domperidone suspension at 0.25 mg/kg up to three times daily (capped near 30 mg/day) or placebo, for up to 7 days. The SmPC says the study missed its primary efficacy objective. That is why the 10 mg tablet lock stays with adolescents who already weigh 35 kg, and why younger kids do not inherit an adult blister.
Parents sometimes hear 'Motilium drops' from an older relative. Liquid products that remain licensed in some markets come with a measuring device for a reason. Kitchen teaspoons and adult 10 mg tablets are not that device.
Prolactin rise in a child is not a harmless lab curiosity. Galactorrhoea or breast budding on a dopamine antagonist needs a stop and a review, not a dose increase for leftover nausea.
Cardiac risk language is not adults-only. Electrolyte loss from gastroenteritis plus a QT-active antiemetic is a bad pair at any age. Rehydrate first. Drug second, if at all, and only on a licensed pediatric indication.
This desk will not convert 10 mg tablets into a mg/kg liquid on the back of an envelope. If a Nordic clinic still uses a licensed suspension, they own the syringe marks.
06Nausea indication after the 2014 EMA cut
EMA cut the indication to nausea and vomiting. Older dyspepsia and reflux add-on uses were stripped in the referral. The adult oral dose became 10 mg up to three times daily, 30 mg/day maximum. Suppositories at 30 mg twice daily remain in some markets. Treatment should not normally last more than one week.
Adolescents 12 and over must also weigh 35 kg or more for the 10 mg tablet. Efficacy in younger children was not established in the later pediatric gastroenteritis program the SmPC cites. Weight-based 0.25 mg/kg oral liquid remains only where a licensed pediatric product still exists.
People older than 60 should speak with a clinician before Motilium. Epidemiology put higher ventricular-arrhythmia and sudden-death risk on age over 60, daily doses above 30 mg, and QT or CYP3A4 partners.
This is a short antiemetic, not a gastroparesis lifestyle drug. Longer off-label courses need a specialist who owns the QT screen and the stop date. Nausea-role postscript keeps the indication narrow.
Metoclopramide crosses into the CNS more readily and brings tardive risk on long use. It is not a silent Motilium substitute, and Motilium is not a silent metoclopramide substitute. Different labels, different neurologic and cardiac footprints.
07Before-meal timing and the one-week ceiling
Take the tablet before food if you can. Absorption delays when the dose follows a meal. Health Canada patient language still says 15-30 minutes before meals for the 10 mg TID schedule.
Missed a dose? Skip it. Resume the usual clock. Do not double. The Irish SmPC writes that in plain words and the desk keeps it.
Usually the maximum duration should not exceed one week. If nausea lasts longer, the problem is the diagnosis, not a second box of Motilium. Pregnancy, surgical abdomen, raised intracranial pressure, and drug toxicity do not wait on a prokinetic.
Orodispersible 10 mg Fastmelts dissolve on the tongue. Swallow tablets are the lock on this letter. Do not crush a film-coated tablet and call it a Fastmelt.
Severe renal impairment stretches half-life from about 7.4 hours to about 20.8 hours. Repeat-dose frequency falls to once or twice daily and the milligram may need a cut. Moderate or severe hepatic impairment is a contraindication, not a cautious start.
08Health Canada monograph versus FDA silence
Health Canada still markets ten-milligram tablets for GI symptoms, including nausea from some antiparkinson drugs. Maximum recommended daily dose for authorised uses is 30 mg. Lactation is not an authorised use there either.
Protein binding sits around 92-93% in the Canadian monograph. Oral levels in older high-dose work reached on the order of 100 ng/mL after 60 mg, a dose the modern ceiling no longer allows. CYP3A4 runs N-dealkylation; CYP3A4, CYP1A2, and CYP2E1 share aromatic hydroxylation.
FDA silence means no labelled US counselling sheet in the bottle. People who obtain tablets anyway miss the one-week and CYP3A4 sentences unless a clinician prints a foreign SmPC. That gap is a safety problem, not a pricing problem.
Personal import can bypass recall systems. A colour change between unregulated lots is not a brand story; it is an authenticity story. Photograph and stop until a pharmacist or clinician can name the manufacturer.
Swedish and other EU pharmacy supply, where the product is licensed, is a different legal object from a US mailbox blister. This desk will not map customs routes.
09CYP3A4 partners that close the letter
Ketoconazole and erythromycin close this letter. Potent CYP3A4 inhibitors are contraindicated whether or not they also prolong QT. The list on Canadian and EU sheets includes systemic azoles, several macrolides, HIV protease inhibitors, nefazodone, and grapefruit juice.
Ketoconazole interaction work is the historical reason the dose ceiling exists. The combination raised domperidone levels and QT together.
Moderate CYP3A4 inhibitors such as diltiazem and verapamil are 'not recommended' language, not a shrug. QT-prolonging partners are contraindicated except for a narrow apomorphine footnote on some EU texts that is irrelevant to a nausea burst.
Azithromycin appears on some patient lists as a macrolide to flag. When in doubt, hold Motilium during the antibiotic and ask the prescriber. Do not finish both boxes because they came the same week.
Reference centres on this site point at regulators, not at compounding pharmacies.
Stops the desk annotates before any 10 mg tablet
- Potent CYP3A4 inhibitors: contraindicated (azoles, many macrolides, PIs, nefazodone, grapefruit)
- QT-prolonging drugs: contraindicated (EU/HC sheets)
- Moderate CYP3A4 inhibitors (diltiazem, verapamil): avoid
- Known long QT, HF, bad electrolytes: contraindicated
- Moderate or severe hepatic impairment: contraindicated
10What a compounding conversation is not
Compounding talk is a clinician decision in the jurisdiction that allows it. It is not a Juvia product, not a coupon, and not a lactation kit. FDA has told compounding pharmacies not to supply domperidone for breastfeeding.
If a US specialist is using a regulated research or import pathway for refractory GI disease, ask that clinic for the monitoring plan: ECG, electrolytes, interacting drugs, stop date. Bring that paper to any other prescriber you see that month.
Do not price-shop 'Motilium 10 mg' against metoclopramide 10 mg on a US cash board and call them equivalent. Different approvals, different neurologic risk, different cardiac footnotes.
Nora Lindqvist countersigns the educational file. Disclaimer applies. Method page if you want the four stamps without the drug.
Questions: [email protected]. We will send citations. We will not send a supplier.
11Missed dose, renal frequency, hepatic stop
Skip a missed tablet rather than doubling at the next meal. The nausea you are treating is not an excuse to stack 20 mg in one hour.
Severe renal impairment: keep the milligram conversation and cut frequency on repeat dosing. Little unchanged drug leaves in urine, so a single dose is less of a renal math problem than a week of TID.
Moderate or severe liver impairment: do not start. Mild impairment does not need a dose rewrite on the SmPC.
Hypersensitivity to domperidone or a Fastmelt excipient (aspartame on some ODTs) is a stop. Phenylketonuria matters for aspartame melts, not for every film-coated 10 mg tablet.
Parkinson disease nausea from dopaminergics is a labelled Canadian use in some monographs and still sits inside the 30 mg/day and QT rules. Do not add Motilium on top of other peripheral dopamine blockers without a reconciliation.
12Seal this Motilium letter without inventing a dollar
Seal this Motilium letter without inventing a dollar. 10 mg, before meals, up to TID, 30 mg/day, usually one week, QT and CYP3A4 as hard stops, milk as off-label everywhere.
US windows on the rail below are ordinary pharmacies. They are not a Motilium aisle. Each href is that chain only.
21 August 2026, Stockholm Letters desk. Educational annotation. No dispense.
| Pharmacy | Strength / count | How the window works | Official page |
|---|---|---|---|
| Walgreens | 10 mg tablet | Not a routine US retail NDC | Walgreens pharmacy |
| Meijer | 10 mg tablet | No invented Motilium coupon | Meijer pharmacy |
| Safeway | 10 mg tablet | Health Canada / EMA labels, not a US cash board | Safeway pharmacy |
| H-E-B | 10 mg tablet | QT and milk notes still apply | H-E-B pharmacy |
Sources and how this letter was sealed
- EMA / CMDh 2014 domperidone referral: 10 mg up to TID, max 1 week, cardiac risk groups.
- HPRA Motilium Fastmelts 10 mg SmPC: before meals, skip missed dose, hepatic contraindication, QT study 3.4 msec at 80 mg/day.
- Health Canada domperidone product monograph: 10 mg TID, max 30 mg/day, 15-30 min before meals; t1/2 7.4 vs 20.8 h in severe renal impairment; CYP3A4; not authorised for lactation.
- LactMed and InfantRisk: not FDA-approved; no licensed galactagogue dose; FDA warning on import/compounding for milk.
- Health Canada SSR on psychiatric withdrawal after high-dose lactation taper.
Method in brief: open primary sources, annotate against the current FDA label, countersign by Dr. Nora Lindqvist, MD, then seal with a dated review. Full walk-through on the method page and editorial standards.
How to cite this page - Vancouver style
Juvia Pharma Despatch Desk. Motilium 10 mg sits on EU and Canadian labels, not a US cash board [Internet]. Stockholm: Juvia Pharma; 21 August 2026 [cited 2026 Aug 21]. Available from: https://juviapharma.com/letters/domperidone/
