Diodrox Plus

• Treatment and symptomatic relief of gastroesophageal reflux disease (GERD), including heartburn and acid regurgitation.
• Management of acid indigestion and dyspepsia caused by excess gastric acid.
• Adjunct therapy for gastric and duodenal ulcers to reduce mucosal irritation.
• Relief of symptoms in gastritis and hyperacidity.
• Off-label use includes symptomatic relief of reflux during pregnancy.

• Adults and Adolescents (≥12 years):
• Oral dose: 10–20 mL of oral suspension or equivalent tablet, 3 to 4 times daily, preferably after meals and at bedtime.
• Pediatrics (<12 years):
• Use with caution; safety and efficacy not well established, only under medical supervision.
• Elderly:
• Use standard adult dosing; no specific adjustments necessary.
• Renal or Hepatic Impairment:
• Use cautiously; monitor electrolyte levels. No formal dose adjustment established.
• Administration:
• Shake suspension well before use.
• Administer orally after meals and at bedtime for optimal symptom control.

Sodium alginate interacts with gastric acid to form a viscous gel or “raft” that floats on the surface of stomach contents, creating a physical barrier that prevents acid reflux into the esophagus and protects esophageal mucosa. Sodium bicarbonate and calcium carbonate act as antacids by chemically neutralizing gastric hydrochloric acid, raising gastric pH and reducing acidity. Calcium carbonate additionally provides calcium ions, which can buffer acid and aid in acid neutralization. This combination provides both mechanical protection and rapid acid neutralization, effectively relieving symptoms of heartburn and acid reflux.

• Absorption: Sodium alginate is not absorbed systemically. Sodium bicarbonate and calcium carbonate dissociate into bicarbonate and calcium ions, respectively, with bicarbonate acting locally in the stomach and calcium potentially absorbed systemically.
• Distribution: Acts locally in the gastrointestinal tract. Absorbed calcium distributes in plasma and tissues.
• Metabolism: Sodium alginate is not metabolized. Bicarbonate neutralizes gastric acid chemically. Calcium carbonate may contribute to systemic calcium pools.
• Excretion: Sodium alginate is eliminated unchanged in feces. Excess calcium and sodium ions are primarily excreted via urine.
• Onset of Action: Rapid, typically within minutes after oral administration.
• Half-life: Not applicable to alginate; dependent on systemic handling for calcium and bicarbonate.

• Pregnancy: Generally considered safe; minimal systemic absorption of alginate and safe profile of bicarbonate and calcium carbonate. No evidence of harm to fetus.
• Lactation: Considered safe during breastfeeding due to minimal systemic absorption and local gastrointestinal action.

• Primary Therapeutic Class: Antacid and mucosal protective agent
• Subclass: Alginate-based reflux suppressant combined with carbonate antacids

• Known hypersensitivity to sodium alginate, sodium bicarbonate, calcium carbonate, or any excipients.
• Severe renal impairment or electrolyte imbalance conditions predisposing to hypercalcemia or sodium overload.
• Metabolic alkalosis.

• Use with caution in patients with renal impairment; monitor electrolytes.
• Risk of metabolic alkalosis with prolonged or excessive use.
• Potential for hypercalcemia in predisposed patients with calcium carbonate.
• Discontinue if hypersensitivity or allergic reactions occur.
• Avoid concomitant use with other calcium or sodium-containing products without medical advice.

• Common: Mild gastrointestinal disturbances such as nausea, constipation, flatulence, or diarrhea.
• Uncommon: Abdominal discomfort, bloating.
• Rare: Hypercalcemia, metabolic alkalosis, allergic reactions including rash, pruritus, angioedema.
• Side effects are generally mild and dose-dependent.

• May impair absorption of certain oral drugs (e.g., tetracyclines, fluoroquinolones, iron supplements); separate dosing by at least 2 hours.
• Calcium carbonate may interact with digoxin, thiazide diuretics, bisphosphonates, and other calcium-containing drugs.
• Sodium bicarbonate may alter lithium and salicylate excretion.
• No significant involvement with CYP450 enzymes.
• Alcohol does not affect efficacy or safety significantly.

• Alginate-containing antacid combinations remain recommended for mild to moderate GERD symptom management.
• Recent guidance emphasizes monitoring electrolytes in patients with renal or cardiovascular conditions during long-term use.
• Regulatory agencies advise cautious use in populations at risk for electrolyte imbalances.

• Store at controlled room temperature: 20°C to 25°C (68°F to 77°F).
• Protect from moisture, heat, and direct sunlight.
• Shake well before use if suspension.
• Do not freeze.
• Keep container tightly closed when not in use.