Algisum

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

• Adults and Adolescents (12 years and older):
• Oral dose: 10 to 20 mL of suspension or equivalent tablet formulation, 3 to 4 times daily, preferably after meals and at bedtime.
• Pediatrics (under 12 years):
• Safety and efficacy not well established; use only under medical supervision.
• Elderly:
• Use standard adult dosing; no adjustment typically required.
• Renal/Hepatic Impairment:
• Caution advised in patients with renal impairment due to potassium content; no formal dose adjustment established.
• Administration:
• Shake suspension well before use.
• Administer orally after meals and at bedtime for optimal symptom control.

Sodium alginate reacts with gastric acid to form a viscous gel “raft” that floats on the surface of the stomach contents. This physical barrier prevents acid reflux into the esophagus, reducing mucosal irritation and heartburn symptoms. Potassium bicarbonate acts as an antacid by neutralizing gastric hydrochloric acid, thereby increasing gastric pH and reducing acidity. The combination offers both mechanical protection of the esophageal mucosa and chemical neutralization of acid, resulting in effective symptomatic relief.

• Absorption: Sodium alginate is not absorbed systemically due to its polymeric nature. Potassium bicarbonate dissociates to potassium and bicarbonate ions, which are absorbed systemically.
• Distribution: Acts locally in the gastrointestinal tract; potassium ions are distributed systemically via plasma.
• Metabolism: Sodium alginate is not metabolized; potassium bicarbonate participates in systemic acid-base balance.
• Excretion: Sodium alginate is eliminated unchanged in feces; potassium is excreted primarily via the kidneys.
• Onset of Action: Rapid, usually within minutes of oral administration.
• Half-life: Not applicable to alginate; potassium half-life depends on renal function.

• Pregnancy: Considered relatively safe because of minimal systemic absorption of alginate. Potassium bicarbonate is a natural electrolyte; however, use with caution. No evidence of teratogenicity.
• Lactation: Expected to be safe during breastfeeding due to low systemic exposure and local action.

• Primary Therapeutic Class: Antacid and mucosal protective agent
• Subclass: Alginate-based reflux suppressant and systemic alkalizer

• Known hypersensitivity to sodium alginate, potassium bicarbonate, or any formulation excipients.
• Hyperkalemia or conditions that predispose to elevated potassium levels (e.g., severe renal impairment, Addison’s disease).
• Severe renal dysfunction due to risk of potassium accumulation.

• Monitor serum potassium levels in patients at risk for hyperkalemia, such as those with renal impairment or on potassium-sparing drugs.
• Use caution in patients with cardiovascular disease sensitive to electrolyte imbalances.
• Avoid prolonged or excessive use without medical supervision.
• Discontinue if hypersensitivity reactions occur.
• Avoid concomitant use with other potassium supplements unless monitored.

• Common: Mild gastrointestinal effects such as nausea, flatulence, and diarrhea.
• Uncommon: Abdominal discomfort, constipation.
• Rare: Hyperkalemia, hypersensitivity reactions including rash, pruritus, or angioedema.
• Side effects are typically mild and dose-related.

• May interfere with the absorption of certain oral drugs (e.g., tetracyclines, fluoroquinolones, iron supplements); separate administration by at least two hours.
• Potassium bicarbonate can increase risk of hyperkalemia when combined with potassium-sparing diuretics, ACE inhibitors, ARBs, or NSAIDs.
• No significant interactions involving CYP450 enzymes.
• Alcohol does not significantly affect the safety or efficacy of this combination.

• Alginate-based antacids are endorsed in GERD management guidelines as effective for mild to moderate reflux symptoms.
• Recent safety communications highlight the need for potassium monitoring in patients at risk of hyperkalemia.
• Regulatory bodies such as FDA and EMA recommend caution with potassium-containing antacids in susceptible populations.

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