Schedule H

Oral

• Tablet: 25 mg

• Tablet: 50 mg

• Tablet: 100 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Type 2 Diabetes Mellitus (Adjunct to diet and exercise, targeting postprandial hyperglycaemia)

Parameter Dosing Details

Starting dose 25 mg orally three times daily with the first bite of each main meal

Titration Increase to 50 mg TID after 4–8 weeks based on glycaemic response and GI tolerability

Usual maintenance dose 50 mg three times daily

Maximum dose 100 mg three times daily (300 mg/day)

Clinical Notes:

• Must be taken with the first bite of each meal for optimal efficacy

• Primarily reduces postprandial glucose excursions; minimal effect on fasting glucose

• Expected HbA1c reduction: 0.3–0.8%

• Not suitable as monotherapy if HbA1c is significantly above target (>1.5% above goal)

• Gastrointestinal adverse effects are dose-dependent and often improve with continued use

• May be combined with metformin, sulfonylureas, or insulin

Secondary Indications – Adults (Off-label, if any):

Not applicable. No documented off-label uses with accepted clinical evidence in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India):

Not applicable. No approved paediatric indications in India.

Secondary Indications – Paediatric (Off-label, if any):

Not applicable. Insufficient safety and efficacy data in paediatric population.

Age Restriction Statement:

NOT RECOMMENDED below 18 years of age. Use only in exceptional circumstances under paediatric endocrinology supervision at tertiary care centres.

Dialysis Contraindicated; miglitol accumulates and is not effectively dialysed

Additional Notes:

• Miglitol is primarily excreted unchanged by the kidneys

• Plasma levels increase substantially in moderate-to-severe renal impairment

• Monitor renal function periodically in elderly and those with borderline function

Note: Miglitol acts locally in the gut and undergoes minimal hepatic metabolism; systemic exposure is low.

• Known hypersensitivity to miglitol or any excipient

• Inflammatory bowel disease (Crohn's disease, ulcerative colitis)

• Colonic ulceration

• Partial or complete intestinal obstruction

• Predisposition to intestinal obstruction

• Chronic intestinal diseases with marked maldigestion or malabsorption

• Severe renal impairment (eGFR <30 mL/min/1.73m²)

• Diabetic ketoacidosis

• Elderly patients (higher susceptibility to GI adverse effects; assess renal function)

• Patients with irritable bowel syndrome or other functional GI disorders

• Concurrent use with sulfonylureas or insulin (risk of hypoglycaemia; treat with glucose, not sucrose)

• Conditions that may deteriorate with increased intestinal gas (hernias, intestinal strictures)

• Febrile illness, surgery, or trauma (may require temporary switch to insulin)

Parameter Details

Safety Limited human data; not formally classified in India

Overall recommendation Not recommended during pregnancy

Preferred alternatives Insulin is first-line; metformin may be used under specialist guidance

When may be used Only if insulin/metformin not feasible and benefit clearly outweighs risk; specialist supervision essential

Monitoring Maternal glycaemic control (fasting and postprandial), fetal growth scans

Parameter Details

Compatibility Not recommended; insufficient human data

Drug levels in milk Unknown; small amounts detected in animal studies

Preferred alternatives Insulin (does not enter milk); metformin (low milk transfer)

Infant monitoring If exposure occurs: feeding patterns, GI discomfort, weight gain

Parameter Recommendation

Starting dose 25 mg once or twice daily with meals

Titration Slow; increase at 4–8 week intervals based on tolerance

Maximum dose Individualise; often limit to 50 mg TID due to GI intolerance

Special concerns Higher risk of GI adverse effects (flatulence, diarrhoea); age-related renal decline may cause accumulation

Additional monitoring Renal function every 6–12 months; assess for dehydration if diarrhoea occurs

Interacting Drug Effect Management

Digestive enzyme preparations (pancreatin, amylase) Reduced efficacy of miglitol due to enhanced carbohydrate digestion Avoid concomitant use

Activated charcoal Adsorbs miglitol; reduces efficacy Avoid concomitant use (except in overdose management)

Sulfonylureas / Insulin Increased risk of hypoglycaemia Monitor closely; treat hypoglycaemia with oral glucose (dextrose), NOT sucrose

Interacting Drug Effect Management

Digoxin Minor reduction in digoxin bioavailability Monitor digoxin levels if clinically indicated

Intestinal adsorbents (kaolin, cholestyramine) May impair local action of miglitol Separate administration by ≥2 hours

Neomycin (oral) Enhanced GI adverse effects; additive effect on carbohydrate malabsorption Avoid combination if possible; monitor for severe diarrhoea

Propranolol Minor reduction in propranolol bioavailability reported Usually clinically insignificant; monitor if beta-blocker response appears reduced

• Flatulence (very common; dose-related)

• Abdominal bloating and distension

• Diarrhoea

• Abdominal pain or cramping

• Borborygmi (increased bowel sounds)

• Soft stools or increased frequency of bowel movements

Note: GI adverse effects typically diminish with continued therapy and adherence to diet.

Adverse Effect Clinical Notes

Hepatic dysfunction Rare; elevated transaminases reported; discontinue if unexplained hepatic enzyme elevation occurs

Severe GI symptoms May lead to dehydration, electrolyte imbalance, or therapy discontinuation

Hypoglycaemia (in combination therapy) When combined with sulfonylureas or insulin; requires treatment with glucose (NOT sucrose)

Intestinal obstruction (ileus) Very rare; more likely in patients with predisposing conditions; discontinue immediately

Phase Parameters to Monitor

Baseline HbA1c, fasting and postprandial glucose, renal function (creatinine, eGFR), liver function tests

After initiation/dose change GI tolerability within 2–4 weeks; postprandial glucose levels; symptoms of hypoglycaemia if on combination therapy

Long-term (chronic use) HbA1c every 3–6 months; renal function annually (more frequently in elderly); LFTs if hepatic symptoms develop

Clinical monitoring Compliance with timing of administration; dietary adherence; hypoglycaemia symptoms

• Mignar (Zydus Cadila)

• Miglitab (Micro Labs)

• Elitol (Eris Lifesciences)

• Miglitor (Torrent)

(Note: Brand availability may vary by region; confirm with local distributors)

Notes:

• Not listed under NLEM 2022

• Not under NPPA price control

• Prices vary across brands and retail outlets

1. Timing is critical: Miglitol must be taken with the first bite of each meal; taking it before or after meals significantly reduces efficacy.

1. Hypoglycaemia management: When used with sulfonylureas or insulin, treat hypoglycaemia with oral glucose (dextrose tablets, glucose powder) — NOT table sugar, fruit juice, or sucrose-containing foods, as disaccharide absorption is delayed.

1. GI tolerability strategy: Start low (25 mg TID) and titrate slowly; GI symptoms often improve over 4–8 weeks with continued use and dietary carbohydrate moderation.

1. Limited HbA1c impact: Expect modest reduction (0.3–0.8%); not suitable as monotherapy for patients significantly above glycaemic targets.

1. Avoid in GI disease: Contraindicated in inflammatory bowel disease and intestinal obstruction; increased gas production may worsen symptoms in patients with hernias.

1. Renal caution: Unlike acarbose, miglitol is systemically absorbed and renally excreted; avoid in eGFR <30 mL/min/1.73m².

Miglitol; Type 2 diabetes; alpha-glucosidase inhibitor; postprandial hyperglycaemia; GI intolerance; renal-caution; pregnancy-avoid; elderly-caution; hypoglycaemia-glucose-only

RxIndia v1.0 — 10 Jan 2025

• CDSCO approved product information

• Indian Pharmacopoeia 2018

• National Formulary of India (NFI 2021)

• API Textbook of Medicine

• ICMR Guidelines for Management of Type 2 Diabetes (2023)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• AIIMS Standard Treatment Guidelines

• Harrison's Principles of Internal Medicine

• NLEM 2022 (miglitol — not listed)