Edone

Approved Uses:

• Treatment of nausea and vomiting of various etiologies (including drug-induced, postoperative, and infectious)
• Gastroparesis, especially diabetic gastroparesis (for symptomatic relief: bloating, early satiety, nausea)
• Gastroesophageal reflux disease (as adjunctive therapy for motility improvement)
• Functional dyspepsia (non-ulcer dyspepsia, chronic bloating)

Clinically Accepted Off-Label Uses:

• Enhancement of lactation in postpartum women via prolactin elevation
• Prevention of nausea and vomiting in patients on dopamine agonists (e.g., in Parkinson’s disease)

রেজিস্টার্ড চিকিৎসকের পরামর্শ ছাড়া ওষুধ সেবন করবেন না।

Adults:

• Standard dose: 10 mg orally, 3 times daily, 15–30 minutes before meals and optionally at bedtime
• Maximum daily dose: 30 mg/day (some regulatory bodies may allow up to 40 mg/day under close supervision)

Elderly:

• Increased risk of cardiac adverse effects; initiate at the lowest effective dose (e.g., 10 mg twice daily)
• Consider ECG monitoring if prolonged use is needed

Pediatrics:

• Not recommended under 12 years due to cardiac risk
• If used off-label:
• 0.25 mg/kg/dose, 3 times daily, before meals
• Maximum: 0.75 mg/kg/day
• Specialist supervision required

Renal Impairment:

• Use with caution; reduce dosing frequency in moderate to severe impairment due to risk of accumulation

Hepatic Impairment:

• Contraindicated in moderate to severe hepatic dysfunction

Administration Notes:

• Take on an empty stomach, 15–30 minutes before meals
• Oral suspension must be shaken well before use
• Do not exceed recommended duration or dose

Domperidone is a peripherally selective dopamine D2 and D3 receptor antagonist. It acts primarily at the chemoreceptor trigger zone (CTZ) in the area postrema, blocking dopamine's emetogenic effects. It also enhances gastrointestinal motility by increasing the frequency and strength of gastric contractions and facilitating gastric emptying. Unlike metoclopramide, domperidone has limited ability to cross the blood–brain barrier, reducing the risk of central nervous system side effects.

• Absorption: Rapid; peak plasma concentration reached in ~30–60 minutes
• Bioavailability: ~15% orally due to significant first-pass metabolism
• Distribution: Volume of distribution ~5.7 L/kg; plasma protein binding ~91–93%
• Metabolism: Extensive hepatic metabolism via CYP3A4; minor glucuronidation
• Excretion:
• ~66% via feces (primarily as metabolites)
• ~33% via urine (only ~10% unchanged)
• Elimination Half-life: ~7–9 hours in healthy adults; prolonged in renal impairment

Pregnancy:

• Limited human data; animal studies show no teratogenicity
• Use only when clearly necessary; avoid in the third trimester due to potential fetal cardiac risks

Lactation:

• Excreted into breast milk in small amounts
• Used off-label to promote lactation (by raising prolactin levels)
• Caution advised; monitor infant for irritability or feeding issues

• Class: Antiemetic, Prokinetic agent
• Subclass: Peripheral dopamine D2 receptor antagonist

• Hypersensitivity to domperidone or excipients
• Known QT prolongation, history of cardiac arrhythmias
• Concomitant use with QT-prolonging drugs or potent CYP3A4 inhibitors (e.g., ketoconazole, erythromycin)
• Prolactinoma or hormone-sensitive tumors
• Moderate to severe hepatic impairment
• Gastrointestinal obstruction, perforation, or bleeding

• Cardiac toxicity: Risk of QT prolongation, torsades de pointes, and sudden cardiac death, especially at high doses or in older adults
• Electrolyte imbalance: Correct hypokalemia, hypomagnesemia before starting treatment
• Prolactin elevation: May cause galactorrhea, gynecomastia, or menstrual irregularities
• Renal impairment: Requires dose adjustment; monitor for accumulation
• Avoid concomitant use with CYP3A4 inhibitors or other QT-prolonging agents
• Use lowest effective dose for shortest duration

Common:

• Dry mouth
• Headache
• Abdominal cramps
• Diarrhea

Less Common:

• Drowsiness
• Rash or pruritus
• Menstrual irregularities

Serious (Rare):

• QT prolongation, arrhythmia, sudden cardiac death
• Gynecomastia, galactorrhea (from elevated prolactin)
• Extrapyramidal symptoms (extremely rare due to poor CNS penetration)
• Anaphylactic reactions (very rare)

• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): Increase plasma levels → ↑QT prolongation risk
• Other QT-prolonging drugs (e.g., amiodarone, haloperidol): Additive cardiac risk
• Levodopa: Domperidone may antagonize its effects; may require dose adjustment
• Anticholinergics: May reduce domperidone’s prokinetic effects
• Alcohol: May increase sedation or adverse GI effects

• Regulatory agencies (e.g., EMA, MHRA) recommend:
• Limiting use to nausea and vomiting only
• Max daily dose ≤30 mg
• Avoid use in patients with cardiac conditions
• Lactation use is off-label but supported in some countries under specialist guidance
• Prolonged use discouraged due to cardiac safety concerns

• Store below 25°C (77°F) in a dry place
• Protect from light and moisture
• Oral suspension: Store in original container; refrigerate if required by product label
• Do not freeze
• Keep out of reach of children
• Discard if tablets become discolored or show signs of deterioration