Don-A5 mg/ml

Established Uses

• Nausea and vomiting of various causes (excluding chemotherapy-induced and postoperative nausea/vomiting, for which other agents are preferred).
• Symptoms of delayed gastric emptying and dyspepsia, such as epigastric bloating, early satiety, upper abdominal discomfort, belching, and regurgitation of gastric contents.

Guideline-Supported / Adjunct Use

• Relief of nausea and vomiting associated with dopamine-agonist therapy (e.g., levodopa, bromocriptine) in Parkinson’s disease, where Don-A is used as an adjunct because, unlike most anti-dopaminergic antiemetics, it does not readily cross the blood-brain barrier and therefore does not counteract the central effects of dopamine-agonist treatment.
• As an aid during certain radiological (barium) studies to accelerate gastric emptying and small-bowel transit.

Off-Label Use (Not Routinely Recommended)

• Don-A has been used off-label to increase milk supply in breastfeeding mothers (a galactagogue effect via prolactin elevation). Because of the recognized cardiac safety signal described under Precautions and Warnings, this use is not officially approved in most countries and should only be considered under close medical supervision when other measures have failed.

Don-A is not an antibiotic and has no role in treating infections.

Each film-coated tablet contains Domperidone Maleate equivalent to 10 mg domperidone base. Oral suspension is also available, typically containing domperidone equivalent to 5 mg/5 mL. Strength and available dosage forms (tablet, oral suspension, orodispersible tablet, suppository) vary by manufacturer and market; check the product label for the exact strength.

Don-A is a peripherally-acting dopamine D2-receptor antagonist used to relieve nausea, vomiting, and symptoms associated with delayed gastric emptying (functional dyspepsia). It works mainly outside the central nervous system, at the chemoreceptor trigger zone and on the stomach and upper small intestine, which is why it produces fewer of the movement-related (extrapyramidal) side effects seen with centrally-acting antiemetics such as metoclopramide, when used at recommended doses.

Don-A is widely used in Bangladesh and many other countries as a short-term treatment for nausea, vomiting, bloating, and early fullness after meals, and is available in tablet, orodispersible, and oral suspension formulations.

Domperidone Maleate is a dopamine D2-receptor antagonist that blocks dopamine receptors both in the chemoreceptor trigger zone (an area outside the blood-brain barrier that triggers nausea and vomiting) and in the wall of the stomach and duodenum.

• Antiemetic effect: blockade of D2 receptors in the chemoreceptor trigger zone reduces the sensation of nausea and the vomiting reflex.
• Prokinetic effect: blockade of D2 receptors in the gastric wall increases lower esophageal sphincter pressure, enhances gastric and duodenal peristalsis, and accelerates gastric emptying, which relieves bloating, early satiety, and dyspeptic discomfort.

Because Domperidone Maleate has limited ability to cross an intact blood-brain barrier at normal doses, its central nervous system penetration is minimal, resulting in a lower risk of drowsiness and extrapyramidal movement side effects compared with centrally-acting agents; however, it does raise circulating prolactin by blocking D2 receptors in the pituitary gland (outside the blood-brain barrier), and it can affect the heart’s electrical activity (QT interval) as described under Precautions and Warnings.

Take Don-A by mouth 15–30 minutes before meals (and before bedtime if a fourth dose is prescribed). Swallow tablets whole with water; let orodispersible tablets dissolve on the tongue without chewing; shake oral suspension before measuring the dose with the enclosed measuring cup or syringe. Do not exceed the dose or duration advised by your physician.

Clinically Significant Interactions

• QT-prolonging drugs (e.g., certain antiarrhythmics, some antipsychotics, some antidepressants, certain antimalarials, methadone, some fluoroquinolone/macrolide antibiotics): concurrent use with Don-A is contraindicated because of an additive risk of QT prolongation and serious ventricular arrhythmia (see Contraindications).
• Potent CYP3A4 inhibitors (e.g., azole antifungals such as ketoconazole, itraconazole, fluconazole; macrolide antibiotics such as erythromycin, clarithromycin; HIV protease inhibitors): these raise plasma concentrations of Don-A, increasing cardiac risk; concurrent use is contraindicated.
• Anticholinergic drugs: may antagonize the prokinetic (gut motility) effect of Don-A.
• Oral antacids and acid-suppressing drugs (H2-blockers, proton pump inhibitors): may reduce the oral bioavailability of Don-A when taken concurrently; when possible, separate dosing times from antacids.
• Other drugs affecting electrolytes (e.g., diuretics causing hypokalemia/hypomagnesemia): can indirectly increase the risk of QT prolongation with Don-A and should be used with caution, with electrolyte monitoring if co-administration is unavoidable.

Always tell your physician or pharmacist about all prescription drugs, over-the-counter medicines, and herbal products you are taking before starting Don-A.

Most side effects of Don-A are uncommon at recommended doses. Reported adverse effects include:

• Common: dry mouth, headache, transient intestinal cramping, diarrhea.
• Hormonal (due to raised prolactin): galactorrhea (unexpected breast milk production), breast tenderness or enlargement (gynecomastia, including in men), menstrual irregularities.
• Cardiac (uncommon but serious): QT-interval prolongation and, rarely, serious ventricular arrhythmia or sudden cardiac death — risk is higher with doses above 30 mg/day, in patients over 60 years of age, and with concurrent use of interacting drugs (see Precautions and Warnings and Interactions).
• Neurological (rare, mainly at high doses or in young children): extrapyramidal symptoms (abnormal muscle movements), drowsiness.
• Allergic: rash, itching, urticaria; rare severe hypersensitivity reactions.

Seek prompt medical attention for palpitations, fainting, irregular heartbeat, or any severe or persistent reaction while taking Don-A.

Pregnancy: Data on the use of Don-A in human pregnancy are limited. Animal studies have not shown clear teratogenic effects, but human safety data are insufficient to establish safety with confidence. Don-A should be used during pregnancy only if clearly needed and if the anticipated benefit justifies the potential risk to the fetus; a physician should always be consulted before use in pregnancy.

Lactation: Domperidone passes into breast milk in small amounts (milk concentrations are reported to be substantially lower than maternal plasma levels), but because of the cardiac safety signal associated with Don-A (see Precautions and Warnings), routine use to increase milk supply is not officially recommended. If a physician judges that use during breastfeeding is necessary for approved indications, the lowest effective dose for the shortest time should be used, with monitoring of the mother for cardiac symptoms.

Cardiac Risk (Important Safety Information)

Don-A carries a recognized, dose-related risk of QT-interval prolongation and serious ventricular arrhythmia, including rare reports of sudden cardiac death. This risk is a key reason many regulatory authorities have restricted the approved dose, duration, and route of Don-A in recent years. To minimize this risk:

• Use the lowest effective dose for the shortest possible duration (generally no more than one week for acute symptoms, unless a physician determines otherwise after reassessment).
• Use with particular caution in patients over 60 years of age and at doses above 30 mg/day, both of which further increase cardiac risk.
• Avoid in patients with underlying heart disease, electrolyte disturbances, or concurrent use of QT-prolonging drugs or potent CYP3A4 inhibitors (see Contraindications and Interactions).
• Stop Don-A and seek medical attention immediately if palpitations, dizziness, fainting, or irregular heartbeat occur.

Other Precautions

• Hyperprolactinemia: Don-A raises prolactin levels and may cause galactorrhea, gynecomastia, or menstrual irregularities; use with caution in patients with known or suspected prolactin-dependent conditions.
• Hepatic impairment: contraindicated in moderate-to-severe impairment; use with caution and medical supervision in mild impairment.
• Renal impairment: reduce dosing frequency in significant renal insufficiency; monitor for accumulation with repeated dosing.
• Children: the blood-brain barrier is not fully developed in infants and young children, so central nervous system and extrapyramidal side effects are more likely; use only under medical supervision at weight-based doses (see Pediatric Uses).
• Not an antibiotic; Don-A has no role in treating bacterial, viral, or parasitic infections.

Symptoms of Don-A overdose may include drowsiness, disorientation, and extrapyramidal reactions (abnormal, involuntary muscle movements), particularly in children; cardiac effects such as QT prolongation and arrhythmia are also a concern in overdose, given the drug’s known cardiac safety signal.

If an overdose of Don-A is suspected, seek immediate medical attention or contact emergency services / a poison control center. Do not attempt to manage a suspected overdose at home. Management is supportive and should be carried out in a medical facility, which may include close cardiac monitoring, gastric decontamination measures (e.g., activated charcoal) if appropriate and administered promptly by trained personnel, and treatment of extrapyramidal symptoms if they occur; there is no specific antidote.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Elderly (>60 years): increased risk of QT prolongation and cardiac arrhythmia with Don-A; use the lowest effective dose for the shortest duration and monitor closely, especially if other risk factors for QT prolongation are present.
• Children: use only under medical supervision with weight-based dosing; the immature blood-brain barrier increases the risk of central/extrapyramidal side effects; Don-A is contraindicated in neonates. See Pediatric Uses.
• Hepatic impairment: contraindicated in moderate-to-severe impairment; caution required in mild impairment (see Contraindications and Precautions).
• Renal impairment: reduce dosing frequency in significant renal insufficiency (see Dosage and Administration).
• Cardiac disease/electrolyte disturbance: contraindicated in patients with significant structural heart disease, clinically important electrolyte disturbances, or pre-existing QT prolongation.

Don-A should generally be used for the shortest period needed to control symptoms, typically up to about one week for acute nausea, vomiting, or dyspepsia. Longer courses (used historically for chronic dyspepsia or Parkinson’s-related nausea) should only continue if a physician has reassessed the benefit-risk balance, particularly the cardiac risk described under Precautions and Warnings, and determined that continued treatment is warranted; periodic medical review is recommended for any extended use.

Antiemetics; Gastroprokinetic agents; Peripherally-acting dopamine D2-receptor antagonists.

Domperidone Maleate blocks dopamine D2 receptors at the chemoreceptor trigger zone (reducing nausea and vomiting) and in the stomach and duodenal wall (increasing gastric and duodenal motility and lower esophageal sphincter tone, and accelerating gastric emptying). Because it penetrates the intact blood-brain barrier only minimally at normal doses, its effects are largely confined to the periphery, giving it an antiemetic/prokinetic profile with fewer central movement-related side effects than older, centrally-acting dopamine antagonists, at the cost of a recognized cardiac (QT-prolongation) risk that must be actively managed (see Precautions and Warnings).

Don-A may be used in children for nausea, vomiting, and dyspeptic symptoms, but only under medical supervision and at carefully calculated, weight-based doses (see Dosage and Administration), because:

• Don-A is contraindicated in neonates (infants under four weeks of age) due to immature drug metabolism and blood-brain barrier development.
• In infants and young children, the blood-brain barrier is not fully developed, which increases the risk of central nervous system and extrapyramidal side effects compared with older children and adults.
• The same cardiac safety signal (QT prolongation) that applies to adults applies to children, so the lowest effective dose for the shortest necessary duration should always be used.

Safety and efficacy of Don-A for indications and durations outside those specifically studied and labeled in children have not been established; use in children should always follow a physician’s explicit direction rather than self-medication.