Motilium is prescribed for the treatment of:

• Functional gastrointestinal motility disorders characterized by delayed gastric emptying
• Gastroesophageal reflux disease (GERD) and associated dyspeptic symptoms
• Nausea and vomiting of various etiologies (both central and peripheral origin)
• Prevention and management of chemotherapy-induced and radiation-induced nausea/vomiting
• As an adjunct in radiological contrast studies of the upper gastrointestinal tract

Dosage and Administration Guidelines:

Standard Dosage Regimens: For acute conditions (nausea, vomiting, hiccups):

• Adult patients: 20 mg (2 tablets) 3-4 times daily
• Pediatric patients (5-12 years): 10 mg (1 tablet) 3-4 times daily
• Administration timing: 15-30 minutes before meals and at bedtime as needed

For chronic conditions (dyspepsia, gastric motility disorders):

• Adult patients: 10 mg (1 tablet) 3 times daily (may be increased to 20 mg if necessary)
• Pediatric patients (5-12 years): 5 mg (½ tablet) 3-4 times daily

Special Population Considerations: Pediatric use:

• Not recommended for children under 5 years
• Alternative suspension formulation available for younger patients
• Contraindicated in children weighing less than 35 kg

Renal impairment:

• Requires significant dosage adjustment
• Severe renal insufficiency (creatinine >0.6 mmol/L):
  • Reduce dosing frequency to 1-2 times daily
  • Consider dose reduction
  • Monitor for adverse effects
• Elimination half-life increases from 7.4 to 20.8 hours in severe cases

Important Administration Instructions:

• Must be taken before meals for optimal effect
• Tablets should be swallowed whole with water
• If a dose is missed:
  • Take as soon as remembered
  • Skip if close to next scheduled dose
  • Never double the dose

Contraindications: Absolute contraindications include:

• Hypersensitivity to domperidone or any excipients
• Prolactin-secreting pituitary tumors (prolactinoma)
• Mechanical gastrointestinal obstruction
• Gastrointestinal perforation or hemorrhage
• Severe hepatic impairment
• Pregnancy and breastfeeding (unless absolutely necessary)
• Concomitant use with QT-prolonging medications

Drug Interactions: Significant interactions may occur with:

• Anticholinergic agents (atropine, hyoscine, oxybutynin)
• Opioid analgesics (morphine, codeine)
• CYP3A4 inhibitors (ketoconazole, erythromycin)
• Dopamine antagonists
• QT-prolonging medications

Special Warnings and Precautions: Cardiac considerations:

• Potential risk of QT interval prolongation
• Use with caution in patients with cardiac conditions
• Monitor for arrhythmias

Endocrine effects:

• May cause hyperprolactinemia
• Monitor for:
  • Galactorrhea
  • Gynecomastia
  • Menstrual irregularities

Neurological effects:

• Rare extrapyramidal symptoms possible
• Monitor for movement disorders

Adverse Effects: Common (≥1/100 to <1/10):

• Headache
• Dry mouth
• Abdominal cramps
• Diarrhea

Uncommon (≥1/1,000 to <1/100):

• Hyperprolactinemia-related symptoms
• Dizziness
• Rash

Rare (≥1/10,000 to <1/1,000):

• Extrapyramidal symptoms
• Urticaria
• Angioedema
• Anaphylactic reactions

Use in Special Populations: Pregnancy:

• Category not established
• Use only if potential benefit justifies potential risk
• Avoid during first trimester

Lactation:

• Small amounts excreted in breast milk
• Not recommended unless essential

Elderly:

• Increased risk of adverse effects
• Consider dose reduction

Pharmaceutical Information:

• Active ingredient: Domperidone maleate
• Tablet composition contains lactose
• Not suitable for patients with:
  • Lactose intolerance
  • Galactose intolerance
  • Glucose-galactose malabsorption
  • Galactosemia

Storage Conditions:

• Store at controlled room temperature (20-25°C)
• Protect from moisture and light
• Keep in original packaging
• Store out of reach of children
• Do not use after expiration date

Patient Counseling Information:

• Importance of taking before meals
• Need for regular medical follow-up
• Recognition of adverse effects
• Avoidance of alcohol
• Importance of disclosing all concomitant medications

Monitoring Requirements:

• Regular assessment of treatment efficacy
• Monitoring for adverse effects
• Periodic evaluation of need for continued therapy
• ECG monitoring in high-risk patients

Overdose Management: Symptoms may include:

• Drowsiness
• Disorientation
• Extrapyramidal reactions
• Management:
  • Symptomatic treatment
  • Activated charcoal if recent ingestion
  • ECG monitoring

This comprehensive information should be used in conjunction with professional medical advice. Patients should consult their healthcare provider for personalized treatment recommendations.