Gastid

Approved Indications:

• Functional Dyspepsia and Hyperacidity:
  Indicated for the relief of symptoms associated with excess gastric acid, such as epigastric pain, burning sensation, and acid regurgitation.
• Gastroesophageal Reflux Disease (GERD):
  Used for symptomatic relief of heartburn and acid reflux in mild to moderate GERD.
• Peptic Ulcer Disease (PUD):
  Used as adjunctive therapy in the management of gastric and duodenal ulcers to reduce acid-related discomfort and bloating.
• Acute and Chronic Gastritis:
  Provides symptomatic relief from gastric irritation, fullness, and acid-related discomfort.
• Flatulence and Bloating (Gas-related Dyspepsia):
  Treats gas buildup and associated discomfort such as bloating and abdominal pressure.

Clinically Accepted Off-Label Uses:

• Postoperative Flatulence:
  Used to relieve gas retention and abdominal distension following abdominal or pelvic surgeries.
• NSAID-induced Gastric Irritation:
  May be used adjunctively to reduce epigastric discomfort in patients taking nonsteroidal anti-inflammatory drugs.

Adults:

• Recommended Dose:
  5–10 mL of oral suspension or 1–2 chewable tablets (each typically containing Magaldrate 400–480 mg + Simethicone 20–40 mg), taken 1–2 hours after meals and at bedtime, or as directed by a physician.
• Maximum Dose:
  Do not exceed 8 doses (tablets or equivalent volume) per day unless prescribed.

Pediatrics:

• Children >12 years:
  May use adult dosage under medical supervision.
• Children 6–12 years:
  Half the adult dose is usually recommended. Use only on physician’s advice.
• Children <6 years:
  Not recommended unless prescribed; safety data is limited.

Elderly:

• No specific dose adjustment necessary; monitor renal function and bowel habits due to age-related physiological changes.

Renal Impairment:

• Use with caution.
  Avoid prolonged or high-dose use in patients with moderate to severe renal dysfunction due to the risk of accumulation of aluminum and magnesium ions.

Hepatic Impairment:

• No dose adjustment typically required. Use cautiously in advanced hepatic disease to prevent electrolyte imbalances.

Route of Administration:

• Oral (available as chewable tablets and suspension)

Duration of Treatment:

• Short-term use for symptom relief; avoid long-term use unless under medical supervision.

Magaldrate is a non-systemic antacid that reacts with gastric hydrochloric acid to form magnesium and aluminum salts, thereby neutralizing gastric acid and increasing gastric pH. This alleviates acid-induced discomfort and mucosal irritation. Simethicone is a surfactant that reduces the surface tension of gas bubbles in the gastrointestinal tract, allowing gas to coalesce and be expelled more easily. Together, this combination relieves both acid-related symptoms and gas-related bloating or discomfort without altering gastric motility or acid production permanently.

Magaldrate:

• Absorption: Minimally absorbed from the GI tract.
• Distribution: Not systemically distributed in significant amounts.
• Metabolism: Not metabolized; acts locally in the stomach.
• Elimination: Mostly excreted in feces. Trace amounts of absorbed magnesium and aluminum are eliminated renally.
• Onset of Action: 30 minutes
• Duration of Action: 2–3 hours

Simethicone:

• Absorption: Not absorbed systemically.
• Metabolism: Not metabolized.
• Elimination: Excreted unchanged in feces.
• Onset of Action: 15–30 minutes
• Duration of Action: Short-acting; varies depending on gastric emptying.

• Pregnancy:
  Considered safe during pregnancy when used at recommended doses for short durations. Both ingredients have minimal or no systemic absorption. Avoid prolonged high-dose use, especially in the third trimester.
• Lactation:
  Generally safe during breastfeeding. Due to negligible systemic absorption, excretion into breast milk is unlikely. No known adverse effects in breastfed infants.

• Primary Class: Antacid with Anti-Flatulent
• Subclass: Aluminum-Magnesium Antacid + Non-systemic Surfactant
• Generation: Non-absorbable gastrointestinal combination agent

• Hypersensitivity to magaldrate, simethicone, or any formulation excipients
• Severe renal impairment or chronic kidney disease
• Hypophosphatemia
• Bowel obstruction or paralytic ileus
• Alzheimer’s disease or osteomalacia (due to aluminum accumulation risk)

• Renal Dysfunction:
  Risk of accumulation of aluminum and magnesium in patients with impaired renal function. Avoid long-term use.
• Electrolyte Imbalances:
  Long-term use may lead to hypophosphatemia or hypermagnesemia. Monitor serum levels if prolonged therapy is necessary.
• Gastrointestinal Disorders:
  Diarrhea (magnesium component) and constipation (aluminum component) may occur.
• Masking of Serious Conditions:
  Long-term use may mask symptoms of serious gastrointestinal diseases (e.g., malignancy, peptic ulcer disease).
• Drug Absorption Interference:
  May impair the absorption of several oral medications. Administer other drugs at least 2–4 hours apart.

Gastrointestinal:

• Common:
• Diarrhea (magnesium-related)
• Constipation (aluminum-related)
• Flatulence
• Abdominal bloating or discomfort
• Less Common:
• Nausea
• Metallic taste
• Belching

Metabolic:

• Rare (usually in renal impairment):
• Hypermagnesemia (muscle weakness, hypotension, cardiac arrhythmias)
• Hypophosphatemia (fatigue, bone pain, weakness)
• Aluminum toxicity (neurological symptoms)

• Tetracyclines and Quinolones:
  Chelation may reduce antibiotic absorption → Separate by 2–4 hours.
• Iron Supplements:
  Reduced bioavailability → Administer at least 2 hours apart.
• Levothyroxine:
  Decreased absorption → Administer at least 4 hours apart.
• Digoxin and Isoniazid:
  Reduced absorption → Monitor serum levels; space dosing apart.
• Enteric-coated drugs:
  May dissolve prematurely in altered pH → Avoid simultaneous administration.

Enzyme System Involvement:

• No CYP450 interaction; all interactions are due to physicochemical binding in the gastrointestinal tract.

• No major recent updates from FDA or EMA.
• Simethicone-containing antacid combinations continue to be recommended for short-term use in functional dyspepsia and gas-related symptoms.
• Clinical guidelines for GERD and dyspepsia favor antacid use for intermittent symptom relief rather than long-term therapy.

• Temperature: Store at 20°C to 25°C (68°F to 77°F). Short excursions between 15°C and 30°C are acceptable.
• Humidity & Light Protection: Store in a dry place, away from excessive moisture and direct light.
• Handling Instructions:
• Shake suspension well before use.
• Do not freeze.
• Store in original packaging.
• Keep out of reach of children.
• Use within the shelf life printed on the label.