Deflux 10 mg

Description

Indications
Deflux is used to treat a variety of conditions, including:

• Dyspeptic symptoms commonly associated with delayed gastric emptying, gastroesophageal reflux, and esophagitis, such as:
  • Epigastric fullness and abdominal distension
  • Upper abdominal pain
  • Eructation (belching), flatulence, and early satiety
  • Nausea and vomiting
  • Heartburn, with or without gastric content regurgitation
  • Non-ulcer dyspepsia
• Acute nausea and vomiting, including those of functional, organic, infectious, dietetic, radiotherapy-induced, or drug-induced origin, as well as nausea induced in migraine.
• Parkinson’s disease: Used to manage nausea and vomiting induced by dopamine agonists.
• Radiological studies: Speeds barium transit during follow-through radiological studies.
  Note: Always follow the advice of a registered healthcare provider when using this medication.

Pharmacology
Deflux contains Domperidone, a dopamine antagonist that works primarily by blocking dopamine receptors in the Chemoreceptor Trigger Zone (CTZ) and the stomach. This action helps regulate gastrointestinal motility. Domperidone’s gastroprokinetic effect aids in restoring the normal motility and tone of the upper gastrointestinal tract, facilitating gastric emptying, enhancing antral and duodenal peristalsis, and regulating pyloric contraction. Additionally, it increases esophageal peristalsis and lower esophageal sphincter pressure, preventing the regurgitation of gastric contents. Due to its minimal penetration of the blood-brain barrier, it avoids central dopaminergic side effects such as psychotropic and neurological reactions.

Dosage and Administration

• Adults:
  • For general use: 10-20 mg (1-2 tablets or 10-20 ml suspension), every 6-8 hours. The maximum recommended dose is 80 mg daily.
  • For dyspeptic symptoms: 10-20 mg (1-2 tablets or 10-20 ml suspension), every 6-8 hours.
  • For acute conditions (e.g., nausea and vomiting): 20 mg (2 tablets or 20 ml suspension), every 6-8 hours.
• Children:
  • For general use: 0.2-0.4 mg/kg body weight (2-4 ml suspension/10 kg or 0.4-0.8 ml pediatric drops/10 kg), every 6-8 hours.
  • For acute nausea and vomiting: 0.2-0.4 mg/kg body weight (2-4 ml suspension/10 kg or 0.4-0.8 ml pediatric drops/10 kg), every 6-8 hours. (Treatment for acute conditions should not exceed 12 weeks).
• Rectal administration (suppositories):
  • Adults: 30-60 mg every 4-8 hours.
  • Children: For those weighing 10-25 kg, a maximum daily rectal dose of 30 mg, divided if necessary. The maximum treatment period is 12 weeks.
    Note: Always follow the advice of a registered healthcare provider when using this medication.

Interactions
Concomitant use of anticholinergic drugs may antagonize Domperidone’s dyspeptic effects. Antacids and antisecretory drugs should not be taken together with Domperidone as they reduce its bioavailability.

• CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone) can increase plasma levels of Domperidone.
• Gastrokinetic effect: Domperidone may affect the absorption of drugs with sustained release or enteric-coated formulations.
• Dopaminergic agonists (e.g., bromocriptine, L-dopa) are not potentiated by Domperidone, though it suppresses their peripheral side effects like nausea and vomiting.

Contraindications

• Known hypersensitivity to Domperidone or any of its ingredients.
• Neonates.
• Gastrointestinal conditions where stimulation might be harmful, such as gastrointestinal hemorrhage, mechanical obstruction, or perforation.
• Prolactin-releasing pituitary tumors (prolactinoma).

Side Effects

• Common side effects: Transient intestinal cramps.
• Rare side effects: Extrapyramidal symptoms, especially in young children, which reverse upon discontinuation of the drug.
• Pituitary effects: Domperidone may increase plasma prolactin levels, potentially causing galactorrhea (milk production) and gynecomastia (breast enlargement) in rare cases.
• Allergic reactions: Rash and urticaria (hives) may occur.
  Note: These side effects are rare and often resolve once the treatment is stopped.

Pregnancy and Lactation

• Pregnancy: Animal studies show no teratogenic effects at doses up to 160 mg/kg/day. However, as with all medications, Domperidone should be used during pregnancy only when the expected benefits outweigh potential risks, particularly during the first trimester.
• Lactation: Domperidone is excreted in breast milk, but concentrations in human milk are about four times lower than in plasma. While it is not known if this is harmful to infants, nursing mothers taking Domperidone should consult their doctor.
• Effects on ability to drive: Domperidone does not impair mental alertness, but may cause dizziness and sleepiness in some individuals.

Precautions and Warnings

• Use with caution in children, as they may be at an increased risk of extrapyramidal reactions due to an underdeveloped blood-brain barrier.
• Liver impairment: Domperidone is metabolized in the liver, so use with caution in patients with liver disorders.
• Renal impairment: In patients with severe renal insufficiency, the drug’s elimination half-life increases, so dosage adjustments may be necessary.

Use in Special Populations

• Infants: Due to immature metabolic and blood-brain barrier functions in infants, Domperidone should be administered with extreme caution and under close medical supervision.
• Hepatic impairment: Caution is required for those with liver disorders.
• Renal impairment: For patients with severe renal insufficiency, dosing may need to be reduced and spaced further apart.

Overdose Effects
Overdosage may result in symptoms such as drowsiness, disorientation, and extrapyramidal reactions, particularly in children. Treatment includes activated charcoal and close observation. In case of extrapyramidal reactions, anticholinergic, antiparkinsonian drugs, or antihistamines with anticholinergic properties may be used.

Therapeutic Class
Motility Stimulants, Dopamine Antagonists, Prokinetic Drugs

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

Chemical Structure

• Molecular Formula: C22H24ClN5O2
• Chemical Structure: Domperidone Maleate (as depicted).

Common Questions about Deflux 10 mg Tablet

• What is Deflux 10 mg Tablet used for?
  Deflux 10 mg Tablet is a dopamine antagonist used primarily for treating nausea and vomiting.
• Quick Tips
  • Deflux 10 mg Tablet helps relieve nausea, vomiting, and indigestion.
  • Take Deflux 10 mg Tablet before meals as directed by your healthcare provider.
  • The medication may cause dizziness or sleepiness. Avoid driving or engaging in activities requiring mental focus until you know how it affects you.
  • Avoid alcohol as it may increase drowsiness.
  • Dry mouth may occur; practice good oral hygiene, stay hydrated, and try sugarless candy.
  • Contact your doctor if you experience watery diarrhea, fever, or persistent stomach pain.
  • Do not take Deflux 10 mg Tablet for more than 7 days without consulting your doctor.