Not scheduled (OTC)

Oral

• Oral suspension: 200 mg/5 mL (often combined with magnesium hydroxide and/or simethicone)

• Chewable tablets: 250 mg, 300 mg, 500 mg (often in combination)

• Sachets: Combination products (e.g., aluminium hydroxide + magnesium hydroxide + oxetacaine)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Dyspepsia / Gastric Hyperacidity / Peptic Ulcer Disease (Short-term Symptomatic Relief)

ORAL SUSPENSION (Adults):

Parameter Recommendation

Starting dose 5–10 mL (equivalent to ~200–400 mg aluminium hydroxide)

Titration May increase frequency based on symptom response

Usual maintenance dose 10 mL 1–2 hours after meals and at bedtime (3–4 times daily)

Maximum dose 60 mL/day (total elemental aluminium should not exceed 1.5 g/day)

CHEWABLE TABLETS (Adults):

Parameter Recommendation

Starting dose 500 mg aluminium hydroxide

Titration May increase to 1000 mg based on symptom response

Usual maintenance dose 500–1000 mg 1–2 hours after meals and at bedtime

Maximum dose Elemental aluminium should not exceed 1.5 g/day

Clinical Notes:

• Effect enhanced when taken 1–2 hours postprandially

• Often used in combination with magnesium hydroxide to balance GI side effects (constipation vs diarrhoea)

• Duration: Short-term use only; reassess if symptoms persist >2 weeks

1. Gastroesophageal Reflux Disease (GERD) — Mild / Intermittent

ADULTS:

Parameter Recommendation

Starting dose 10 mL suspension or 500 mg tablet as needed

Titration Not applicable (PRN use)

Usual maintenance dose 10–15 mL or 500–1000 mg after meals and at bedtime

Maximum dose 60 mL/day (suspension)

Clinical Notes:

• Typically used in combination with magnesium hydroxide ± simethicone for improved efficacy

• Duration: Short-term use only (≤2 weeks); not suitable for maintenance therapy

• Refer for PPI/H2RA therapy if symptoms persist

1. Duodenal Ulcer — Adjunct to Standard H. pylori Eradication Regimen

ADULTS:

Parameter Recommendation

Starting dose 500 mg four times daily

Titration May increase to 1000 mg four times daily based on symptom severity

Usual maintenance dose 500–1000 mg QID (includes bedtime dose)

Maximum dose 4000 mg/day

Clinical Notes:

• Used in addition to primary anti-H. pylori therapy (PPI + antibiotics)

• Duration: 4–8 weeks

• Role: Provides mucosal protection and symptomatic relief

Secondary Indications – Adults (Off-label)

Indication Dose Duration Specialist Only Evidence Basis

Phosphate binder in Chronic Kidney Disease — OFF-LABEL 500–600 mg with meals (TDS) Short-term only (<4 weeks) Yes Indian nephrology specialist practice; declining use due to safer alternatives (sevelamer, calcium acetate); requires aluminium level monitoring

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: Symptomatic Relief of Acid-related Dyspepsia (Short-term)

6–12 years 5 mL suspension (200 mg/5 mL) after meals May increase frequency to TDS based on response 5–10 mL TDS after meals 30 mL/day

12 years 10 mL suspension after meals As per adult dosing 10 mL TDS after meals 60 mL/day

Clinical Notes:

• Use shortest duration required; avoid prolonged use

• Risk of aluminium accumulation with chronic use

• Avoid in paediatric patients with renal impairment

Secondary Indications – Paediatrics (Off-label)

Indication Dose Duration Specialist Only Evidence Basis

Phosphate control in paediatric CKD — OFF-LABEL 50–150 mg/kg/day in divided doses with meals Short-term (2–4 weeks maximum) Yes — Paediatric nephrology mandatory WHO EML (supportive); Indian nephrology practice

Safety Monitoring for Off-label Use:

• Serum aluminium levels

• Serum phosphate and calcium

• Signs of aluminium toxicity

⚠️ Not recommended in infants <6 months of age; aluminium toxicity reported with chronic use in this age group.

• Severe renal impairment (eGFR <30 mL/min)

• Known hypersensitivity to aluminium compounds or formulation excipients

• Hypophosphataemia

• Gastrointestinal obstruction

• Dialysis patients without specialist monitoring (risk of aluminium toxicity)

• Appendicitis or acute surgical abdomen

• Use cautiously in elderly and children (increased risk of aluminium accumulation)

• Prolonged use may lead to hypophosphataemia and constipation

• May interfere with absorption of other oral medications — stagger dosing

• Impaired renal function increases risk of neurotoxicity

• Chronic use may cause aluminium bone disease (osteomalacia)

• Patients with dehydration or fluid restriction

Parameter Recommendation

Overall safety Generally considered safe for short-term, occasional use

Preferred alternatives Calcium carbonate or sucralfate if long-term antacid therapy needed

When to use Acute symptomatic relief; avoid chronic use

Monitoring GI symptoms; serum phosphate if prolonged use

Parameter Recommendation

Breastfeeding compatibility Compatible; negligible systemic absorption

Preferred alternatives Calcium-based antacids or sucralfate for long-term needs

Expected drug levels in milk Negligible

Infant monitoring None generally required; monitor if high maternal doses used chronically

Parameter Recommendation

Starting dose Lower end of dose range (5 mL suspension or 250–500 mg tablet)

Titration Titrate slowly; reassess frequently

Extra risks Aluminium accumulation (due to age-related renal decline), constipation, hypophosphataemia, cognitive effects with chronic use

Clinical note Consider alternatives for long-term therapy; screen renal function before use

Interacting Drug Mechanism/Effect Recommendation

Tetracyclines (e.g., doxycycline) Chelation → decreased antibiotic absorption Separate administration by ≥2 hours

Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) Chelation → decreased antibiotic absorption and efficacy Separate administration by ≥2 hours (preferably 4 hours)

Thyroxine (levothyroxine) Reduced absorption → therapeutic failure Administer thyroxine at least 4 hours apart

Iron supplements Chelation → reduced iron absorption Separate by 2–4 hours

Isoniazid Reduced absorption Separate by at least 2 hours

Mycophenolate Reduced absorption Avoid co-administration; separate by at least 2 hours

Interacting Drug Effect Recommendation

H2 blockers, PPIs Minor reduction in antacid efficacy when co-administered Generally not clinically significant

Digoxin Potentially reduced absorption Separate doses by 2 hours; monitor digoxin levels if symptomatic

Ketoconazole, Itraconazole Reduced antifungal absorption (require acidic environment) Separate by 2 hours; consider alternative antifungal

Calcium supplements Increased risk of constipation or alkalosis Use with caution; monitor symptoms

Sodium valproate May displace protein binding slightly Monitor if narrow therapeutic window

• Constipation (most common)

• Abdominal discomfort

• Nausea

• Altered taste

• Flatulence (especially with simethicone-containing combinations)

• Aluminium bone disease (osteomalacia) — with prolonged use, especially in renal impairment

• Hypophosphataemia — with excessive or prolonged use

• Aluminium-induced encephalopathy — particularly in patients with renal failure; presents as confusion, speech disturbance, myoclonus

• Intestinal obstruction — rare; mostly in overdose or immobile patients

⚠️ Serious toxicity requires immediate drug discontinuation and hospitalisation.

Phase Parameters

Baseline Renal function (serum creatinine, eGFR), especially in elderly, CKD, and children

During short-term use (<2 weeks) Symptomatic response; bowel habits

Prolonged use (>2 weeks) Serum phosphate (every 2–4 weeks); serum aluminium levels (if CKD or off-label use as phosphate binder)

Chronic users Monitor for signs of aluminium toxicity (bone pain, cognitive changes); periodic electrolytes and renal function

• Digene® (Aluminium hydroxide + Magnesium hydroxide + Simethicone)

• Gelusil®

• Mucaine® (includes oxetacaine)

• Acidon®

• Kremil-S®

Note: Most formulations in India are fixed-dose combinations (FDCs) with magnesium hydroxide and/or simethicone.

Note: Listed in NLEM India 2022; available in government supply

• Use aluminium-containing antacids for quick symptomatic relief only; not suitable for maintenance therapy in GERD or peptic ulcer disease

• Always screen renal function before initiating prolonged therapy (>2 weeks)

• Do not co-administer with other oral medications within 2 hours — significant drug absorption interference

• Combination products with magnesium hydroxide are preferred due to constipation concerns with aluminium alone

• Declining use as phosphate binder in CKD due to availability of safer alternatives (sevelamer, lanthanum, calcium acetate)

• Counsel patients about constipation and encourage adequate hydration and fibre intake

Aluminium Hydroxide; antacid; dyspepsia; GERD; peptic ulcer; phosphate binder; renal-caution; elderly-caution; drug interactions; OTC; NLEM India

RxIndia v1.0 — 30 Jan 2026

• CDSCO product inserts

• Indian Pharmacopoeia

• NLEM India 2022

• API Textbook of Medicine

• AIIMS Adult and Paediatric Formularies

• Indian Society of Nephrology resources

• WHO EML (supportive for paediatric phosphate binding — off-label)