Pradom 10 mg — Detailed Description

Generic Name: Domperidone Maleate
Brand Name: Pradom 10 mg
Manufacturer: Pristine Pharmaceuticals Ltd.
Dosage Form: Tablet
Strength: 10 mg per tablet
Drug Class: Prokinetic and antiemetic agent

Pharmacological Profile

Pradom contains Domperidone, a peripheral dopamine D2 receptor antagonist. It works primarily by blocking dopamine receptors in the gastrointestinal tract and the chemoreceptor trigger zone (CTZ) in the brain. This action enhances gastrointestinal motility by increasing the movement of food through the stomach and intestines and reduces nausea and vomiting.

Unlike some other antiemetics, domperidone does not readily cross the blood-brain barrier, resulting in fewer central nervous system side effects.

Indications

Pradom 10 mg is commonly prescribed for:

• Nausea and vomiting caused by various conditions, including gastrointestinal disorders, medications, and post-operative states.

• Gastroparesis, where it helps improve gastric emptying.

• Functional dyspepsia and indigestion symptoms.

• Gastritis and associated discomfort.

• Prophylaxis and treatment of nausea and vomiting during pregnancy (under medical supervision).

• Lactation support, as it can increase prolactin secretion to aid milk production in breastfeeding mothers (off-label use).

Dosage and Administration

• Adult Dosage: Usually, 10 mg tablet taken 15 to 30 minutes before meals, 3 to 4 times daily.

• Administration: Tablets should be swallowed whole with water; do not crush or chew.

• Duration: Typically, treatment duration varies depending on the indication and clinical response. Prolonged use should be under medical supervision.

• Special Populations: Dose adjustment may be necessary for patients with liver impairment. Use with caution in elderly patients.

Contraindications

• Hypersensitivity to domperidone or any excipients in the formulation.

• Patients with prolactin-releasing pituitary tumors (prolactinomas).

• Those with known QT prolongation or cardiac arrhythmias.

• Use is contraindicated in patients with gastrointestinal hemorrhage, obstruction, or perforation.

Side Effects

Common side effects include:

• Headache

• Dry mouth

• Abdominal cramps or pain

• Diarrhea

Serious side effects (rare):

• Cardiac arrhythmias (QT prolongation)

• Galactorrhea (unexpected milk flow)

• Gynecomastia (breast enlargement in males)

• Allergic reactions such as rash or itching

Patients experiencing severe side effects should seek immediate medical attention.

Drug Interactions

Domperidone may interact with drugs that prolong the QT interval, such as some antiarrhythmics, antibiotics (macrolides), and antipsychotics, increasing the risk of cardiac arrhythmias.

It can also interact with CYP3A4 inhibitors (e.g., ketoconazole, erythromycin), which may increase domperidone plasma levels and side effects.

Precautions and Warnings

• Use caution in patients with cardiovascular disease or electrolyte imbalances.

• Avoid use in combination with drugs known to prolong QT interval.

• Not recommended for use in children under 12 years without specialist advice.

• Pregnancy and breastfeeding: should be used only if clearly needed and prescribed by a healthcare professional.

• Regular monitoring of cardiac status may be advised for long-term use or in high-risk patients.

Pharmacokinetics

• Absorption: Rapid oral absorption with peak plasma concentrations reached within 30 to 60 minutes.

• Bioavailability: Approximately 15% due to first-pass metabolism.

• Metabolism: Primarily metabolized in the liver.

• Elimination Half-life: About 7 hours.

• Excretion: Mainly via feces and urine.

Storage

• Store in a cool, dry place below 25°C.

• Protect from moisture and light.

• Keep out of reach of children.

Packaging

Available in blister packs of 10, 20, or 30 tablets.