Don A 10 is a tablet containing Domperidone Maleate BP equivalent to 10 mg Domperidone. It is manufactured by The ACME Laboratories Ltd. in Bangladesh.

Indications:

Don A 10 is a prokinetic drug used to relieve symptoms associated with:

• Nausea and vomiting: Acute nausea and vomiting of various origins (functional, organic, infectious, dietetic), or those induced by radiotherapy, drug therapy, or migraine. Also used for dopamine-agonist induced nausea and vomiting in Parkinson's disease.
• Dyspeptic symptom complex: Often linked with delayed gastric emptying, gastroesophageal reflux, and esophagitis. Symptoms include:
  • Epigastric fullness, abdominal distension, upper abdominal pain.
  • Belching, flatulence, early satiety.
  • Heartburn, with or without regurgitation of gastric contents into the mouth.
  • Non-ulcer dyspepsia.
• Stimulation of gut motility.

Pharmacology:

Domperidone is a peripheral dopamine receptor blocker. It works by blocking dopamine receptors primarily located in the Chemoreceptor Trigger Zone (CTZ) and in the stomach. This action increases esophageal peristalsis, enhances antral and duodenal peristalsis, facilitates gastric emptying, and regulates contraction of the pylorus. Due to its limited penetration of the blood-brain barrier, it generally has fewer central nervous system (CNS) side effects compared to other dopamine antagonists.

Dosage and Administration:

Don A 10 should be taken 15-30 minutes before meals and, if necessary, before retiring. The maximum period of treatment is generally 12 weeks.

• Adults (including elderly):
  • For nausea and vomiting: 10-20 mg (1-2 tablets) every 4-8 hours. Maximum 80 mg per day.
  • For dyspeptic symptoms: 10 mg (1 tablet) 3 times daily. In some acute conditions (e.g., severe nausea and vomiting), 20 mg (2 tablets) every 6-8 hours daily may be used.
• Children: 0.2-0.4 mg/kg body weight, every 4-8 hours daily. For acute nausea and vomiting, the maximum period of treatment is 12 weeks.

Contraindications:

Don A 10 is contraindicated in:

• Patients with known hypersensitivity to Domperidone or any component of the drug.
• Neonates.
• Situations where gastrointestinal stimulation might be dangerous, such as gastrointestinal hemorrhage, mechanical obstruction, or perforation.
• Patients with a prolactin-releasing pituitary tumor (prolactinoma).
• Moderate to severe hepatic impairment. 
• Patients with known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significantelectrolyte disturbances (hypokalemia, hyperkalemia, hypomagnesemia), or bradycardia, or patients with underlying cardiac diseases such as congestive heart failure.
• Co-administration with QT-prolonging drugs or potent CYP3A4 inhibitors.
• Breastfeeding mothers.

Side Effects:

Most side effects are mild and transient. Common side effects include:

• Headache
• Dryness in mouth
• Stomach pain / Abdominal cramps
• Diarrhea
• Drowsiness
• Dizziness
• Hyperprolactinemia (elevated prolactin levels), which may lead to:
  • Galactorrhea (abnormal milk production)
  • Breast enlargement and soreness
  • Reduced libido

Serious (rare) side effects can include:

• Cardiac arrhythmias, including QTc prolongation and Torsades de Pointes, and sudden cardiac death. The risk is higher with higher doses, in elderly patients, or with pre-existing cardiac conditions.
• Extrapyramidal reactions (involuntary muscle movements, tremor, rigidity), especially in children and young adults, due to an incompletely developed blood-brain barrier.

Precautions and Warnings:

• Use with caution in patients with hepatic impairment, as Domperidone is highly metabolized in the liver.
• Use with caution in patients with kidney disease; dose adjustment may be needed for severe renal impairment.
• Caution is advised in elderly patients and in those with underlying cardiac conditions or a history of heart rhythm disorders.
• Patients should be advised not to drive or operate machinery if they experience dizziness or sleepiness.
• Avoid consuming alcohol as it may cause excessive drowsiness.
• Do not take for longer than 7 days without consulting your doctor.
• If you experience watery diarrhea, fever, or persistent stomach pain, inform your doctor.

Use in Pregnancy and Lactation:

• Pregnancy: The safety of Domperidone during pregnancy has not been definitively established. It is generally not recommended during pregnancy unless the potential benefits outweigh the potential risks, and only under strict medical supervision. Animal studies have not shown teratogenic effects.
• Lactation: Domperidone is secreted in breast milk in small quantities. However, it is contraindicated in nursing mothers due to potential cardiac risks in the infant.

Drug Interactions:

• QT-prolonging drugs: Concomitant use is contraindicated (e.g., some antiarrhythmics, antipsychotics, antidepressants, certain antibiotics like erythromycin, antifungals like ketoconazole, some antimalarials).
• Potent CYP3A4 inhibitors: Concomitant use is contraindicated (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir, indinavir). These drugs can increase Domperidone levels and the risk of cardiac side effects.
• Antacids and H2-receptor antagonists (e.g., cimetidine, ranitidine): Reduce the bioavailability of Domperidone; they should not be taken simultaneously.
• Anticholinergic drugs and opioid analgesics: May antagonize the prokinetic effect of Domperidone.
• Bromocriptine and L-dopa: Domperidone may antagonize the hypoprolactinemic effect of bromocriptine and can suppress the peripheral side effects of L-dopa without counteracting its central effects.

Storage Conditions:

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

Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication.