Relief of symptoms associated with acid indigestion, heartburn, gastric hyperacidity, and sour stomach.
Treatment of peptic ulcer disease and gastroesophageal reflux disease (GERD) symptoms by neutralizing gastric acid.
Relief from dyspepsia and gas-related discomfort including bloating and flatulence.
Off-label Uses:
Adjunctive therapy to reduce gastric irritation in gastritis.
Management of abdominal discomfort associated with excess gas production.
Dosage & Administration
Formulation: Oral suspensions, chewable tablets, or tablets combining antacids and antiflatulent agents.
Adults and Adolescents (12 years and older):
Typical dose: 400–600 mg aluminium hydroxide, 400–600 mg magnesium hydroxide, and 40–80 mg simethicone per dose.
Administer 1–4 times daily, typically 1–3 hours after meals and at bedtime.
Chew tablets thoroughly or shake suspensions well before use.
Pediatrics (under 12 years): Use only under medical supervision; safety not well established.
Elderly: Same dosing as adults; monitor renal function due to aluminium and magnesium content.
Renal Impairment: Use with caution; dose adjustments may be needed to prevent toxicity.
Hepatic Impairment: No specific dose adjustments necessary.
Duration: Use for symptomatic relief; prolonged use under medical supervision.
Mechanism of Action (MOA)
Aluminium Hydroxide and Magnesium Hydroxide: Both act as inorganic antacids by chemically neutralizing gastric hydrochloric acid. Aluminium hydroxide reacts to form aluminium chloride and water, increasing gastric pH and reducing acidity, while magnesium hydroxide forms magnesium chloride and water, also raising gastric pH. This neutralization decreases irritation of the gastric and esophageal mucosa, alleviating symptoms of hyperacidity. Magnesium hydroxide additionally produces a mild laxative effect, counterbalancing aluminium hydroxide's constipating properties.
Simethicone: Acts as an antiflatulent by decreasing the surface tension of gas bubbles in the gastrointestinal tract. This causes the coalescence of smaller gas bubbles into larger ones, facilitating their elimination through belching or passage per rectum, thereby reducing bloating and discomfort.
Pharmacokinetics
Absorption: Aluminium and magnesium ions are minimally absorbed; simethicone is not absorbed systemically and acts locally in the gut.
Distribution: Localized gastric action; negligible systemic distribution for all components.
Metabolism: Aluminium and magnesium are inorganic and not metabolized; simethicone is inert and passes unchanged through the GI tract.
Elimination: Aluminium and magnesium are primarily renally excreted if absorbed; simethicone is excreted unchanged in feces.
Onset of Action: Symptomatic relief typically occurs within minutes to one hour after administration.
Duration: Effects last approximately 1–3 hours, depending on dose and gastric conditions.
Pregnancy Category & Lactation
Pregnancy: Generally considered Category C; topical use of aluminium and magnesium hydroxides is low risk with minimal systemic absorption; simethicone is considered safe in pregnancy due to lack of absorption. Use only if clearly needed.
Lactation: Considered compatible with breastfeeding; low systemic absorption suggests minimal risk to infant.