Glimepiride Uses, Dosage, Side Effects & Price | DrugsAtlas
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Therapeutic Class
Antidiabetic
Subclass
Sulfonylurea (second-generation)
Speciality
Endocrinology
Schedule (India)
Schedule H
Routes
Oral
Formulations
- Tablets: 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg
- Fixed-dose combinations (FDCs): Glimepiride + Metformin (1/500 mg, 1/1000 mg, 2/500 mg, 2/1000 mg); Glimepiride + Metformin + Pioglitazone; Glimepiride + Metformin + Voglibose
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Type 2 Diabetes Mellitus (T2DM) — Monotherapy or Combination Therapy
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
1 mg once daily with breakfast (0.5 mg in elderly/frail) |
|
Titration
|
Increase by 1 mg every 1–2 weeks based on fasting plasma glucose response |
|
Usual maintenance dose
|
1–4 mg once daily |
|
Maximum dose
|
6 mg once daily (8 mg rarely used in Indian practice) |
Key Clinical Notes:
- Administer with first main meal of the day (preferably breakfast)
- Best suited for lean, insulinopenic T2DM patients with preserved beta-cell function
- When combining with insulin: reduce insulin dose by 30–50% at initiation to prevent hypoglycaemia
- ICMR 2022 recommends SGLT2 inhibitors or DPP-4 inhibitors over sulfonylureas in patients with obesity, cardiovascular disease, or CKD
Use in Combination with Metformin
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
1 mg once daily (add to existing metformin) |
|
Titration
|
Increase by 1 mg every 2 weeks based on FPG/HbA1c |
|
Usual maintenance dose
|
1–2 mg once daily |
|
Maximum dose
|
4 mg once daily in combination |
Key Clinical Notes:
- Higher hypoglycaemia risk than metformin monotherapy; counsel patient on recognition and management
- FDC tablets improve adherence but reduce dose flexibility
Use in Combination with Insulin
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
1 mg once daily |
|
Titration
|
Increase cautiously every 2–4 weeks |
|
Usual maintenance dose
|
1–2 mg once daily |
|
Maximum dose
|
4 mg once daily |
Key Clinical Notes:
- Reduce basal insulin dose by 30–50% when adding glimepiride
- Significant hypoglycaemia risk; ensure strict glucose monitoring
- Consider this combination only when other oral agents insufficient
Secondary Indications — Adults (Off-label, if any)
Not applicable.
No validated off-label adult indications exist for glimepiride in Indian clinical practice.
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Type 2 Diabetes Mellitus in Paediatric Population:
| Parameter | Recommendation |
|---|---|
| Approval status |
NOT APPROVED in India for patients <18 years
|
| Minimum age for off-label use | ≥12 years (under specialist supervision only) |
| Starting dose | 0.5 mg once daily with breakfast |
| Titration | Increase by 0.5–1 mg every 2–4 weeks |
| Maximum dose | 2 mg once daily |
Safety Monitoring Requirements:
- Frequent capillary blood glucose monitoring (minimum twice daily initially)
- HbA1c every 3 months
- Weight monitoring (sulfonylureas promote weight gain)
- Educate caregivers on hypoglycaemia recognition and management
- Keep glucose tablets/juice accessible at all times
Key Clinical Notes:
- Use only under paediatric endocrinologist supervision
- Metformin remains first-line in paediatric T2DM as per IAP guidelines
- Consider only when metformin alone inadequate or contraindicated
- NOT recommended in children <12 years or in Type 1 Diabetes
Secondary Indications — Paediatrics (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| MODY (Maturity-Onset Diabetes of the Young) — HNF1A/HNF4A subtypes | 0.5–1 mg once daily | Long-term |
OFF-LABEL; Specialist only. Evidence: Case series; genetic confirmation required before use. Very sensitive to sulfonylureas — start very low.
|
Renal Adjustments
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| ≥60 | No dose adjustment required |
| 45–59 | Start at 0.5 mg once daily; titrate cautiously with close glucose monitoring |
| 30–44 | Start at 0.5 mg once daily; maximum 2 mg/day; high hypoglycaemia risk |
| <30 | Avoid use — prolonged hypoglycaemia risk due to accumulation of active metabolites |
| Haemodialysis | Avoid use |
| Peritoneal dialysis | Avoid use |
Key Clinical Notes:
- Active metabolites (M1, M2) renally excreted; accumulate in renal impairment
- DPP-4 inhibitors (linagliptin) or short-acting insulin preferred in advanced CKD
Hepatic adjustment
Contraindications
- Type 1 diabetes mellitus
- Diabetic ketoacidosis (with or without coma)
- Hyperosmolar hyperglycaemic state
- Severe renal impairment (eGFR <30 ml/min/1.73m²)
- Severe hepatic impairment (Child-Pugh C)
- Hypersensitivity to glimepiride, other sulfonylureas, or sulfonamide derivatives
- Pregnancy
- Lactation
Cautions
- Elderly patients — increased hypoglycaemia risk and delayed recognition
- G6PD deficiency — haemolytic anaemia reported with sulfonylureas (rare)
- Adrenal or pituitary insufficiency — impaired counter-regulatory response
- Malnutrition, irregular meal patterns, or alcohol intake
- Patients fasting for religious or medical reasons
- Acute illness, trauma, or perioperative period (consider temporary insulin switch)
- Concurrent use of other hypoglycaemic agents
- Shift workers with inconsistent meal timings
- History of sulfonamide allergy — cross-reactivity possible (use with caution)
Pregnancy
| Parameter | Recommendation |
|---|---|
|
Risk category
|
Not recommended; crosses placenta |
|
Fetal risks
|
Neonatal hypoglycaemia, macrosomia |
|
Preferred alternative
|
Insulin (all trimesters) as per ICMR and FOGSI guidelines |
|
Preconception
|
Discontinue at least 1 month prior to planned conception and switch to insulin |
|
If inadvertent exposure
|
Monitor fetal growth (ultrasound); prepare for neonatal glucose monitoring post-delivery |
|
Monitoring
|
Fetal growth, amniotic fluid; neonatal blood glucose in first 24–48 hours |
Lactation
| Parameter | Recommendation |
|---|---|
|
Compatibility
|
Not compatible with breastfeeding |
|
Milk excretion
|
Excreted in breast milk (animal data); potential risk to infant |
|
Preferred alternatives
|
Insulin (safe); Metformin (acceptable if breastfeeding-compatible needed) |
|
If inadvertent exposure
|
Monitor infant for hypoglycaemia (poor feeding, lethargy, jitteriness, seizures), weight gain |
Elderly
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
0.5 mg once daily with breakfast |
|
Titration
|
Slow; increase by 0.5 mg every 2–4 weeks |
|
Maximum dose
|
2 mg once daily in frail elderly |
|
Special risks
|
Prolonged hypoglycaemia (may persist >24 hours), atypical hypoglycaemia presentation (confusion, falls, focal neurological deficits), reduced renal reserve, cognitive impairment masking symptoms |
|
Monitoring
|
Regular capillary glucose; assess renal function every 6 months; fall risk assessment |
Major drug interactions
| Interacting Drug | Effect | Mechanism | Management |
|---|---|---|---|
|
Fluconazole / Miconazole
|
Severe hypoglycaemia | CYP2C9 inhibition → increased glimepiride levels | Avoid combination or reduce glimepiride dose by 50%; intensive glucose monitoring |
|
Rifampicin
|
Reduced glycaemic efficacy | CYP2C9 induction → increased glimepiride clearance | May need to increase glimepiride dose or switch to alternative antidiabetic during TB treatment |
|
Beta-blockers (non-selective)
|
Masked hypoglycaemia symptoms | Block adrenergic warning signs (except sweating) | Prefer cardioselective beta-blockers; educate patient on atypical symptoms |
|
Warfarin
|
Enhanced hypoglycaemia + altered anticoagulation | Protein binding displacement | Monitor INR and glucose closely |
|
Sulfonamide antibiotics (e.g., Cotrimoxazole)
|
Severe hypoglycaemia | CYP2C9 inhibition + protein displacement | Avoid if possible; close glucose monitoring if used |
Moderate drug interactions
| Interacting Drug | Effect | Management |
|---|---|---|
|
ACE inhibitors / ARBs
|
May enhance hypoglycaemic effect | Monitor glucose; may need dose reduction |
|
NSAIDs (ibuprofen, diclofenac)
|
Increased hypoglycaemia risk | Protein displacement; monitor glucose |
|
Pioglitazone
|
Additive hypoglycaemia + weight gain | Monitor weight and glucose; may need to reduce glimepiride |
|
Isoniazid
|
May reduce sulfonylurea efficacy | Monitor HbA1c; adjust dose as needed |
|
Glucocorticoids
|
Antagonise glucose-lowering effect | Monitor FPG/PPG; may need temporary dose increase or insulin |
|
Thiazide diuretics
|
May worsen glycaemic control | Monitor glucose; adjust antidiabetic therapy |
|
Alcohol
|
Unpredictable glucose effects; disulfiram-like reaction rare | Advise moderation; monitor glucose |
|
Clarithromycin / Erythromycin
|
May increase glimepiride levels | CYP3A4 inhibition (minor pathway); monitor glucose |
Common Adverse effects
- Hypoglycaemia (dose-dependent; most common)
- Weight gain (1–3 kg typical over first year)
- Nausea, epigastric discomfort
- Headache
- Dizziness
- Photosensitivity rash
- Mild gastrointestinal upset
Serious Adverse effects
| Adverse Effect | Notes |
|---|---|
|
Severe/prolonged hypoglycaemia
|
May require IV dextrose infusion and hospitalisation; can persist >24 hours especially in elderly/renal impairment |
|
Cholestatic jaundice
|
Rare; discontinue immediately; monitor LFTs |
|
Stevens-Johnson syndrome / TEN
|
Rare hypersensitivity; immediate discontinuation required |
|
Haemolytic anaemia
|
Rare; especially in G6PD deficiency |
|
Thrombocytopenia / Agranulocytosis
|
Rare; monitor if unexplained bleeding or infections |
|
Hyponatraemia (SIADH)
|
Rare; reported with sulfonylureas |
Monitoring requirements
| Timing | Parameters |
|---|---|
|
Baseline
|
HbA1c, fasting plasma glucose, renal function (serum creatinine, eGFR), LFTs, weight |
|
After initiation / dose change (1–2 weeks)
|
Fasting and post-prandial glucose; assess for hypoglycaemia symptoms |
|
Every 3 months
|
HbA1c, weight, hypoglycaemia frequency |
|
Every 6–12 months
|
Renal function, LFTs, complete blood count (if on long-term therapy) |
|
As needed
|
Capillary glucose during illness, fasting, or if symptoms of hypoglycaemia |
Brands in India
| Brand Name | Manufacturer | Strengths Available |
|---|---|---|
| Amaryl | Sanofi | 1 mg, 2 mg, 3 mg, 4 mg |
| Glimy | USV | 1 mg, 2 mg |
| Glimer | Torrent | 1 mg, 2 mg, 4 mg |
| Zoryl | Intas | 1 mg, 2 mg, 3 mg, 4 mg |
| Glimestar | Mankind | 1 mg, 2 mg |
| Glimpid | USV | 1 mg, 2 mg |
Common FDC Brands:
| Gemer | Glimepiride + Metformin | Sun Pharma |
|---|---|---|
| Glycomet-GP | Glimepiride + Metformin | USV |
| Zoryl-M | Glimepiride + Metformin | Intas |
| Amaryl-M | Glimepiride + Metformin | Sanofi |
| Trivolib | Glimepiride + Metformin + Voglibose | Sun Pharma |
Price range (INR)
| Formulation | Approximate Price (per tablet) |
|---|---|
| Glimepiride 1 mg | ₹1.50–6 |
| Glimepiride 2 mg | ₹2–8 |
| Glimepiride 3 mg | ₹3–9 |
| Glimepiride 4 mg | ₹4–12 |
| FDC with Metformin | ₹4–15 (varies by composition and brand) |
NPPA Status: Glimepiride included in NLEM 2022; FDCs with metformin under price control.
Government Supply: Available through public health facilities and Jan Aushadhi stores at subsidised rates.
Clinical pearls
- Patient selection matters: Best suited for lean, non-obese T2DM patients with preserved beta-cell function; avoid in overweight patients where metformin, SGLT2 inhibitors, or GLP-1 agonists offer metabolic advantages.
- Start low, go slow: Most Indian patients respond to 1–2 mg/day; dose escalation beyond 4 mg rarely provides additional benefit and increases hypoglycaemia risk.
- Meal timing is critical: Always counsel patients to take with breakfast and never skip meals; avoid use in shift workers or those with erratic eating patterns.
- Hypoglycaemia education is essential: Teach patients and caregivers to recognise symptoms and carry glucose tablets/sweets; ensure contact numbers for emergencies.
- Reassess at 3 months: If HbA1c not improving despite adequate dose (4 mg) and compliance, reconsider diagnosis (LADA, secondary diabetes) or switch drug class rather than escalating further.
- Perioperative and sick-day management: Temporarily switch to insulin during acute illness, surgery, or fasting states to avoid hypoglycaemia or uncontrolled hyperglycaemia.
Version
RxIndia v1.1 — 09 Jul 2025
Reference
- CDSCO approved prescribing information
- Indian Pharmacopoeia
- National List of Essential Medicines (NLEM 2022)
- API Textbook of Medicine (11th Edition)
- ICMR Guidelines for Management of Type 2 Diabetes (2022)
- AIIMS Diabetes Treatment Protocols
- IAP Guidelines for Paediatric Diabetes
- Product inserts: Amaryl® (Sanofi), Glimy® (USV)
- Goodman & Gilman's The Pharmacological Basis of Therapeutics
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Clinical Responsibility
This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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