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Authoritative Clinical Reference
Schedule H
Oral
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Type 2 Diabetes Mellitus — adjunct to diet, lifestyle, and/or other oral antidiabetics
May be used as monotherapy or in combination with metformin, sulfonylureas, or insulin for control of postprandial hyperglycaemia.
Parameter Recommendation
Starting dose 0.2 mg orally three times daily, taken immediately before each main meal
Titration After 4–8 weeks, may increase based on postprandial glucose response and tolerability
Usual maintenance dose 0.2–0.3 mg three times daily with main meals
Maximum dose 0.3 mg three times daily (0.9 mg/day total)
Clinical notes Must be taken immediately before meals for optimal efficacy; specifically targets postprandial glucose excursions; less effective if fasting hyperglycaemia is the predominant problem; particularly useful in patients consuming high-carbohydrate diets (common in Indian dietary patterns)
Administration Note: Tablet should be taken with the first bite of food for maximum effect on carbohydrate absorption.
Secondary Indications — Adults (Off-label)
Not applicable — No documented off-label indications in Indian guidelines or specialist practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications
Not applicable — Voglibose is NOT approved for use in children or adolescents below 18 years of age. Safety and efficacy have not been established in the paediatric population.
Secondary Indications — Paediatrics (Off-label)
Not applicable — No established off-label paediatric indications in Indian practice.
Age Restriction: Not recommended below 18 years of age. Use only under paediatric endocrinologist supervision in exceptional circumstances with documented justification.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
30 No dose adjustment required (minimal systemic absorption)
<30 Use with caution; limited data available; consider alternative agents
Haemodialysis Limited data; use with caution if required
Peritoneal dialysis Limited data; use with caution if required
Note: Voglibose acts locally in the gut with minimal systemic absorption (<5%), hence renal impairment has limited impact on drug levels. However, altered gut motility in advanced CKD may affect tolerability.
| Severity | Recommendation |
|---|---|
| Mild impairment | No dose adjustment required |
| Moderate impairment | Use with caution; monitor liver function tests periodically |
| Severe impairment | Avoid — potential for hepatic enzyme elevation; limited safety data |
Parameter Recommendation
Risk category Safety not established; limited human and animal data
Preferred alternatives Insulin (first choice); metformin (widely used in Indian obstetric practice under specialist guidance)
When it may be used Only if potential benefit clearly outweighs risk — requires specialist diabetologist/obstetrician input
What to monitor Maternal glycaemic control (fasting and postprandial glucose); fetal growth via ultrasound
Parameter Recommendation
Compatibility Probably compatible; minimal systemic absorption expected
Expected drug levels in milk Likely negligible (due to poor systemic absorption)
Preferred alternatives Insulin (no transfer to infant); metformin (low milk levels, generally acceptable)
What to monitor in infant GI symptoms such as bloating, loose stools, or diarrhoea; feeding adequacy; weight gain
Parameter Recommendation
Starting dose 0.2 mg three times daily with meals
Titration Slow — increase only after assessing tolerability over 4–8 weeks
Key risks Higher incidence of GI adverse effects (flatulence, diarrhoea); hypoglycaemia risk when combined with sulfonylureas or insulin; dehydration if diarrhoea occurs
Monitoring Postprandial glucose; symptoms of GI intolerance; signs of hypoglycaemia if on combination therapy
Interacting Drug Mechanism / Effect Action
Sulfonylureas (glimepiride, gliclazide, glipizide) Additive hypoglycaemic effect Monitor blood glucose closely; may need to reduce sulfonylurea dose; treat hypoglycaemia with oral glucose (dextrose), NOT sucrose
Insulin Additive hypoglycaemic effect Monitor blood glucose closely; may need to reduce insulin dose; treat hypoglycaemia with oral glucose (dextrose), NOT sucrose
Digestive enzyme preparations (pancreatin, amylase, diastase) Reduce efficacy of voglibose by enhancing carbohydrate digestion Avoid combination — negates therapeutic effect
Activated charcoal May adsorb voglibose and reduce absorption Avoid concurrent administration
Interacting Drug Mechanism / Effect Action
Antacids (aluminium/magnesium hydroxide) May theoretically reduce voglibose activity Separate administration if possible; monitor glycaemic response
Acarbose / Miglitol Additive GI adverse effects; no additional glycaemic benefit Avoid co-administration — no therapeutic rationale
Neomycin (oral) May enhance glucose-lowering effect; additive GI effects Monitor for hypoglycaemia and increased GI symptoms
Cholestyramine May reduce absorption of voglibose Separate doses by at least 2 hours
Note: GI adverse effects are dose-related and typically diminish with continued use over 4–8 weeks as gut flora adapts.
Adverse Effect Clinical Significance
Hepatic dysfunction Rare; elevated transaminases reported; discontinue if ALT/AST >3× ULN or if jaundice develops
Ileus / Intestinal obstruction Rare but serious; requires immediate discontinuation and surgical evaluation if suspected
Severe hypoglycaemia Only when combined with sulfonylureas or insulin; must be treated with oral glucose (dextrose), NOT sucrose (sucrose digestion is inhibited by voglibose)
Pneumatosis cystoides intestinalis Very rare; discontinue immediately if suspected
| Timing | Parameters |
|---|---|
| Baseline | (before initiation) Liver function tests (ALT/AST), renal function, fasting and postprandial blood glucose, HbA1c |
| After initiation / dose change | Postprandial glucose after 1–2 weeks; assess GI tolerability |
Long-term maintenance HbA1c every 3 months initially, then every 6 months if stable; LFTs every 3–6 months during first year, then annually; periodic assessment of GI symptoms
Monotherapy:
Fixed-Dose Combinations (commonly available):
| Brand Name | Composition | Manufacturer |
|---|---|---|
| * | Voglibose + Metformin: Volibo M, Vogliboz M, | Vogli M |
| * | Voglibose + Glimepiride: Volibo G, | Voglistar G |
| * | Voglibose + Metformin + Glimepiride: Volibo GM, | Vogli Plus |
| Formulation | Approximate Price (per tablet) |
|---|---|
| Voglibose 0.2 mg tablet ₹4–₹8 per tablet | |
| Voglibose 0.3 mg tablet ₹6–₹11 per tablet | |
| FDC with Metformin ₹4–₹10 per tablet (varies by metformin strength) |
NPPA Status: Voglibose monotherapy is not included in NLEM 2022. FDCs containing metformin may fall under DPCO price control; verify current NPPA ceiling prices.
Voglibose; alpha-glucosidase inhibitor; type 2 diabetes; postprandial hyperglycaemia; GI side effects; renal-safe; oral antidiabetic; Schedule H
RxIndia v1.0 — 05 Apr 2025
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