Apuldon 10 | 1 Strip

✔️ Apuldon (Domperidone) Indications

Gastrointestinal symptoms—often linked to delayed gastric emptying, reflux, or esophagitis:

• Upper-abdominal fullness, bloating/distension, epigastric pain
• Belching, excess gas, and early satiety
• Nausea and vomiting
• Heartburn, with or without sour regurgitation
• Non-ulcer dyspepsia
• Acute nausea/vomiting of functional, organic, infectious, dietary causes, or triggered by radiotherapy, medicines, or migraine.
• Parkinson’s disease: Control of nausea/vomiting caused by dopamine-agonist therapy.
• Radiology: To accelerate barium transit during follow-through studies.

✔️ Dosage & Administration:

Infants (<1 year): only under close medical supervision; neurological adverse effects cannot be fully ruled out.

Liver disease: use with caution.

Severe renal impairment (serum creatinine > 6 mg/100 ml ≈ >0.6 mmol/L): The elimination half-life is prolonged (from ~7.4 to ~20.8 hours), although plasma levels are lower. For repeated dosing, reduce the dosing frequency to once or twice daily, depending on the severity; dose reduction may also be necessary. Review patients on prolonged therapy regularly.

Adults

General use/dyspepsia: 10–20 mg (1–2 tablets or 10–20 ml suspension) every 6–8 hours; max 80 mg/day.

Acute/sub-acute nausea & vomiting: 20 mg (2 tablets or 20 ml suspension) every 6–8 hours.

Children

General use/dyspepsia / acute N&V: 0.2–0.4 mg/kg per dose
(equivalent to 2–4 ml suspension per 10 kg or 0.4–0.8 ml pediatric drops per 10 kg) every 6–8 hours.

In acute nausea/vomiting, the maximum treatment duration is 12 weeks.

✔️ Contraindications

• Known hypersensitivity to domperidone or any component
• Neonates
• Situations where GI stimulation is unsafe: GI bleeding, mechanical obstruction, or perforation
• Prolactin-secreting pituitary tumor (prolactinoma)

✔️ Possible Side Effects | Apuldon 10

Uncommon: transient abdominal cramps

Neurologic (extrapyramidal): rare in young children, exceptional in adults; typically reversible upon stopping

Endocrine: increased prolactin may cause galactorrhea or gynecomastia (rare)

Allergic: rash, urticaria (rare)

In infants (immature blood–brain barrier), neurological effects cannot be completely excluded.

✔️ Drug Interactions

• Anticholinergics may blunt domperidone’s prokinetic/antidyspeptic effect.
• Antacids and antisecretory agents lower oral bioavailability—avoid taking them at the same time as domperidone.
• Metabolized mainly by CYP3A4: strong inhibitors can raise domperidone levels (e.g., azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone).
• As a prokinetic, it could alter absorption of oral drugs (especially sustained-release or enteric-coated forms), though no effect was seen on blood levels of digoxin or paracetamol in stabilized patients.
• Compatible with neuroleptics (no potentiation of their action).
• With dopaminergic agonists (e.g., bromocriptine, levodopa), domperidone reduces peripheral GI side effects (nausea/vomiting) without reducing central efficacy.

✔️ Use in Pregnancy & Lactation

Animal studies (up to 160 mg/kg/day) show no teratogenicity. As with most drugs, use in the first trimester should be considered only if clearly justified by benefit. No evidence to date of increased malformation risk in humans.

Excreted in rat milk; in women, breast-milk levels are ~4× lower than plasma. Potential risk to the newborn is unknown—breastfeeding is not recommended unless the benefits outweigh the risks.

Does not impair alertness.

✔️ Precautions & Warnings

Children: use with great caution due to higher risk of extrapyramidal reactions.

Hepatic impairment: domperidone is extensively metabolized—use cautiously.

✔️ Storage

Store below 30°C, protected from light and moisture. Keep out of reach of children.