Oxetacaine (10mg/5ml) + Aluminium Hydroxide (300mg/5ml) + Magnesium Trisilicate (150mg/5ml) + Milk Of Magnesia (100mg/5ml) + Simethicone (25mg/5ml)

Clinical Pharmacologist's Monograph

⚠️ Prescription Only: This medicine is Schedule H/H1. Do not self-medicate.

1. Clinical Overview

A comprehensive, multi-ingredient antacid and anti-flatulent suspension indicated for the symptomatic relief of hyperacidity, gastroesophageal reflux disease (GERD), and associated dyspepsia. It combines fast-acting and long-acting antacids with a potent topical anesthetic and a defoaming agent for rapid and sustained relief from pain, burning, and bloating.

OnsetDurationBioavailability
Oxetacaine: 1-3 minutes; Antacids: 5-10 minutes; Simethicone: Immediate.Oxetacaine: 1-2 hours; Antacids: 2-4 hours; Simethicone: Transient.Oxetacaine: Negligible systemic absorption (<1%). Aluminium/Magnesium: <1% absorbed. Simethicone: Not absorbed.

2. Mechanism of Action

1. **Antacids (Aluminium Hydroxide, Magnesium Trisilicate, Magnesium Hydroxide)**: Neutralize gastric hydrochloric acid, raising the intragastric pH. This reduces pepsin activity and provides a physical protective coating (especially Magnesium Trisilicate). 2. **Oxetacaine**: A potent surface anesthetic that blocks sodium channels in neuronal membranes, inhibiting the initiation and conduction of nerve impulses, thereby providing rapid relief from pain and burning sensations in the esophagus and stomach. 3. **Simethicone**: A physiologically inert defoaming agent that reduces the surface tension of gas bubbles, causing them to coalesce and be more easily expelled by belching or passing flatus, relieving bloating and discomfort.

3. Indications & Uses

  • Symptomatic relief of hyperacidity
  • Gastroesophageal Reflux Disease (GERD)
  • Heartburn
  • Acid indigestion
  • Dyspepsia
  • Flatulence and bloating associated with above conditions

4. Dosage & Administration

Adult Dosage: 10 ml (2 teaspoonfuls) 3 to 4 times daily, preferably 20-60 minutes after meals and at bedtime, or as directed by the physician. Maximum: 40 ml per day.

Administration: Shake the bottle well before use. Measure dose accurately with provided measuring cup/spoon. To be taken orally. May be followed with a small amount of water. Do not take with other medications (maintain a 2-hour gap). For optimal effect, take 20-60 minutes after meals and at bedtime.

5. Side Effects

Common side effects may include:

  • Chalky taste
  • Mild constipation or diarrhea (depending on individual sensitivity to aluminium/magnesium balance)
  • White or speckled stools

6. Drug Interactions

DrugEffectSeverity
Tetracyclines (Doxycycline, Tetracycline)Markedly decreased absorption due to chelation by divalent/trivalent cations (Al3+, Mg2+).Major
Fluoroquinolones (Ciprofloxacin, Levofloxacin)Markedly decreased absorption due to chelation.Major
Iron supplementsDecreased absorption of iron.Moderate
DigoxinDecreased absorption of digoxin. Also, hypermagnesemia/hypokalemia can potentiate digoxin toxicity.Moderate
Anticoagulants (Warfarin)Possible altered INR; monitor closely.Moderate
ACE Inhibitors (Captopril, etc.)Decreased absorption.Moderate
Bisphosphonates (Alendronate)Severely decreased absorption.Major
Thyroid hormones (Levothyroxine)Decreased absorption.Moderate
Ketoconazole, ItraconazoleDecreased absorption due to increased gastric pH.Major
Antipsychotics (Phenothiazines), AnticholinergicsDecreased absorption.Moderate

7. Patient Counselling

  • DO shake the bottle well before each use.
  • DO use the measuring device provided.
  • DO take 20-60 minutes after meals and at bedtime for best results.
  • DO maintain a gap of at least 2 hours between this suspension and any other oral medication.
  • DO inform your doctor if you are pregnant, planning pregnancy, or breastfeeding.
  • DO NOT take more than the prescribed dose or for longer than 2 weeks unless advised by your doctor.
  • DO NOT use if you have kidney disease without consulting your doctor.
  • DO NOT give to children under 12 years of age.

8. Toxicology & Storage

Overdose: Symptoms are primarily related to magnesium and aluminium toxicity: severe diarrhea, dehydration, electrolyte imbalance, lethargy, muscle weakness, hypotension, bradycardia, CNS depression, respiratory depression, cardiac arrest. With extreme overdose, aluminium hydroxide can form concretions (bezoars) causing intestinal obstruction.

Storage: Store below 30°C. Protect from light and moisture. Keep the bottle tightly closed. Keep out of reach of children. Do not freeze. Discard any unused suspension 4 weeks after opening the bottle (check manufacturer's instructions).