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Glimepiride Uses, Dosage, Side Effects & Price | DrugsAtlas

Authoritative Clinical Reference

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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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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