Almasil MS

 (400 mg+400 mg+30 mg)/5 ml Oral Suspension
United Pharmaceuticals Ltd.
200 ml bottle: ৳ 55.00
Indications
  • Approved Indications:
    • 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.
Therapeutic Class
  • Primary Classes:
    • Antacid (Aluminium Hydroxide + Magnesium Hydroxide)
    • Antiflatulent (Simethicone)
  • Subclass: Inorganic antacid combination with defoaming agent
Contraindications
  • Known hypersensitivity to aluminium hydroxide, magnesium hydroxide, simethicone, or any excipients.
  • Severe renal impairment due to risk of aluminium and magnesium accumulation.
  • Intestinal obstruction or severe gastrointestinal conditions where gas accumulation is contraindicated.
Warnings & Precautions
  • Use cautiously in patients with renal impairment to prevent aluminium and magnesium toxicity.
  • Prolonged use may cause electrolyte imbalances or adverse gastrointestinal effects.
  • Monitor for signs of aluminium toxicity (encephalopathy, osteomalacia) during long-term use.
  • Avoid use on broken or irritated mucosa.
  • Simethicone generally well tolerated but discontinue if hypersensitivity occurs.
Side Effects
  • Common:
    • Gastrointestinal: constipation (aluminium), diarrhea (magnesium), nausea, abdominal discomfort.
  • Less Common:
    • Electrolyte disturbances, including hypophosphatemia and hypermagnesemia.
  • Rare:
    • Allergic reactions such as rash or urticaria.
    • Aluminium toxicity in long-term or impaired renal function cases.
Drug Interactions
  • May reduce absorption of drugs such as:
    • Tetracyclines, fluoroquinolones, iron supplements, digoxin, and phenytoin.
  • Recommend separating administration of these drugs and antacids by at least 2 hours.
  • No significant systemic interactions with simethicone due to lack of absorption.
  • Concomitant use with other magnesium- or aluminium-containing agents may increase toxicity risk.
Recent Updates or Guidelines
  • Guidelines emphasize caution in renal impairment to avoid aluminium and magnesium accumulation.
  • Continued recommendation for separating antacid and interacting drug dosing times to maintain efficacy.
  • Simethicone inclusion supports symptomatic relief from gas-related discomfort alongside acid neutralization.
  • No major changes in approved indications or dosing protocols recently.
Storage Conditions
  • Store at 20°C to 30°C (68°F to 86°F).
  • Protect from moisture, heat, and direct sunlight.
  • Shake suspensions well before use.
  • Keep containers tightly closed and out of reach of children.
Available Brand Names