Acedone-Z

• Approved Indications:
• Symptomatic relief of acid indigestion, heartburn, and sour stomach due to gastric hyperacidity.
• Treatment of peptic ulcer disease as an adjunct to reduce gastric acidity.
• Management of gastroesophageal reflux disease (GERD) symptoms.
• Relief from dyspepsia and gastritis-related discomfort.
• Off-label Uses:
• Adjunctive therapy to neutralize gastric acid in conditions like gastritis or Zollinger-Ellison syndrome.
• Used in combination with other medications to reduce stomach irritation.

• Formulations: Oral suspensions, chewable tablets, or tablets.
• Adults and Adolescents (12 years and older):
• Typical dose: 400–600 mg aluminium hydroxide combined with 400–600 mg magnesium hydroxide per dose.
• Administer 1–4 times daily, usually 1–3 hours after meals and at bedtime.
• Chew tablets thoroughly before swallowing or shake suspensions well before use.
• Pediatrics (under 12 years): Safety not well established; use only under medical advice.
• Elderly: Same as adults; monitor renal function due to potential accumulation.
• Renal Impairment: Use with caution; dose adjustment may be required to avoid aluminium or magnesium toxicity.
• Hepatic Impairment: No specific dose adjustments necessary.
• Duration: Use for symptomatic relief; prolonged use should be under medical supervision.

Aluminium hydroxide and magnesium hydroxide are inorganic antacids that neutralize gastric acid through a direct chemical reaction. Aluminium hydroxide reacts with hydrochloric acid in the stomach to form aluminium chloride and water, raising gastric pH and reducing acidity. Magnesium hydroxide similarly neutralizes hydrochloric acid forming magnesium chloride and water. The combined effect rapidly increases gastric pH, reducing irritation of the gastric mucosa, providing symptomatic relief from acid-related discomfort. Magnesium hydroxide also exhibits a mild laxative effect, balancing the constipating effect of aluminium hydroxide.

• Absorption: Both aluminium and magnesium ions are minimally absorbed systemically; most action is local in the stomach.
• Distribution: Systemic exposure is low; absorbed ions distribute mainly in extracellular fluids.
• Metabolism: Not metabolized; these are inorganic compounds.
• Elimination: Aluminium and magnesium are primarily eliminated via the kidneys.
• Onset of Action: Effects generally begin within minutes of oral administration.
• Duration: Action typically lasts 1 to 3 hours depending on gastric acidity and dosage.

• Pregnancy: Classified as Category C; generally considered safe for use during pregnancy when used as directed due to minimal systemic absorption, but only if benefits outweigh risks.
• Lactation: Considered compatible with breastfeeding; negligible systemic absorption suggests low risk to the infant.

• Primary Class: Antacid
• Subclass: Inorganic antacid combination (Aluminium and Magnesium compounds)

• Known hypersensitivity to aluminium hydroxide, magnesium hydroxide, or any formulation components.
• Severe renal impairment or failure due to risk of aluminium and magnesium accumulation.
• Presence of gastrointestinal obstruction.
• Conditions with hypermagnesemia or hyperaluminemia.

• Use cautiously in patients with renal impairment to avoid accumulation and toxicity.
• Prolonged use may cause electrolyte imbalances, especially hypophosphatemia (aluminium) or hypermagnesemia (magnesium).
• Aluminium compounds may interfere with absorption of certain drugs (e.g., tetracyclines, digoxin).
• Monitor for signs of aluminium toxicity (encephalopathy, bone disease) in long-term use.
• Magnesium hydroxide may cause diarrhea; aluminium hydroxide may cause constipation; the combination helps balance these effects.

• Common:
• Gastrointestinal: constipation (due to aluminium), diarrhea (due to magnesium), nausea, abdominal cramps.
• Less Common:
• Electrolyte disturbances (hypophosphatemia, hypermagnesemia).
• Rare:
• Aluminium toxicity symptoms with chronic use or renal impairment (encephalopathy, osteomalacia).
• Allergic reactions such as rash or urticaria.

• May reduce absorption of concomitantly administered drugs such as:
• Tetracycline and fluoroquinolone antibiotics
• Iron supplements
• Digoxin
• Phenytoin
• Interaction may result in reduced efficacy of these drugs; separate administration by 2 hours is recommended.
• May alter urinary pH affecting excretion of weak acids or bases.
• Avoid co-administration with other magnesium or aluminium-containing compounds to prevent toxicity.

• Updated clinical guidelines emphasize cautious use in patients with renal impairment due to risk of aluminium and magnesium accumulation.
• Recommendations stress patient education on proper dosing intervals to avoid drug interactions.
• Newer formulations focus on balancing aluminium and magnesium ratios to minimize side effects.
• No significant changes in approved indications or dosing reported recently.

• Store at 20°C to 30°C (68°F to 86°F) in a tightly closed container.
• Protect from moisture, excessive heat, and direct sunlight.
• Shake suspensions well before use.
• Keep out of reach of children.