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Authoritative Clinical Reference
Schedule H
Oral
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
When diet and exercise alone are insufficient for glycaemic control, particularly when Metformin is contraindicated or not tolerated
Parameter Recommendation
Starting dose 5 mg once daily orally
Titration Not required
Usual maintenance dose 5 mg once daily
Maximum dose 5 mg once daily
Clinical Notes:
In combination with Metformin, Sulfonylurea, Thiazolidinedione, or Insulin when monotherapy is insufficient
Parameter Recommendation
Starting dose 5 mg once daily orally
Titration Not required
Usual maintenance dose 5 mg once daily
Maximum dose 5 mg once daily
Clinical Notes:
Secondary Indications — Adults (Off-label, if any)
Not applicable. No documented off-label indications in Indian practice.
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Not applicable.
Secondary Indications — Paediatric doses (Off-label, if any)
Not applicable. No off-label paediatric use documented in Indian practice.
Statement: Not recommended in children or adolescents under 18 years due to lack of safety and efficacy data. No paediatric trials conducted in Indian population.
| eGFR (ml/min/1.73m²) | Recommendation |
|---|---|
| ≥60 | (Normal/Mild impairment) 5 mg once daily — no adjustment |
| 30–59 | (Moderate impairment) 5 mg once daily — no adjustment |
| 15–29 | (Severe impairment) 5 mg once daily — no adjustment |
| <15 | or Dialysis (ESRD) 5 mg once daily — no adjustment required |
Clinical Notes:
| Severity | Recommendation |
|---|---|
| Mild impairment (Child-Pugh A) | No dose adjustment required |
| Moderate impairment (Child-Pugh B) | No dose adjustment required; use with caution |
| Severe impairment (Child-Pugh C) | Avoid use — insufficient safety data available |
Parameter Details
Overall safety Limited human data; animal studies do not indicate direct teratogenicity
Recommendation Not recommended; use only if benefit clearly outweighs risk under specialist supervision
Preferred alternatives Insulin (first-line); Metformin (if appropriate for gestational diabetes)
If used (specialist only) Monitor maternal glycaemic control closely
Monitoring FBG, PPBG, HbA1c; fetal growth surveillance via ultrasound
Parameter Details
Compatibility Unknown — insufficient human lactation data
Excretion in milk Unknown whether excreted in human breast milk
Recommendation Avoid use; switch to preferred alternatives
Preferred alternatives Insulin; Metformin (if appropriate)
Infant monitoring (if used) Feeding behaviour, weight gain, signs of hypoglycaemia
Parameter Recommendation
Starting dose 5 mg once daily (same as adults)
Titration Not required
Special considerations Monitor renal function periodically; assess hypoglycaemia risk if on SU/insulin
Additional risks Polypharmacy interactions; increased sensitivity to hypoglycaemia
Interacting Drug Effect Management
Rifampicin ↓ Evogliptin exposure (strong CYP3A4 inducer) Avoid combination if possible; if unavoidable, monitor glycaemic control closely
Other DPP-4 inhibitors Duplicate therapy; no added efficacy, increased adverse effect risk Avoid concurrent use
Sulfonylureas ↑ Risk of hypoglycaemia Reduce SU dose when initiating Evogliptin
Insulin ↑ Risk of hypoglycaemia Reduce insulin dose; monitor glucose closely
Interacting Drug Effect Management
Digoxin Possible minor alteration in digoxin levels Monitor digoxin levels if clinically indicated; interaction generally not significant
Other CYP3A4 inducers (Carbamazepine, Phenytoin, Phenobarbital) May reduce Evogliptin efficacy Monitor glycaemic control during concurrent use
Ketoconazole / Itraconazole (CYP3A4 inhibitors) May increase Evogliptin levels Clinical significance unclear; monitor for adverse effects
Common antimicrobials (Amoxicillin, Azithromycin) No clinically relevant interaction No dose adjustment needed
Adverse Effect Notes
Acute pancreatitis Rare; discontinue immediately if suspected (persistent severe abdominal pain radiating to back)
Severe hypersensitivity reactions Angioedema, anaphylaxis (rare) — discontinue permanently
Bullous pemphigoid Rare; discontinue if blistering skin lesions develop
Hepatic dysfunction Rare; monitor LFTs if symptoms of hepatotoxicity appear (jaundice, dark urine, fatigue)
| Timing | Parameters |
|---|---|
| Baseline | HbA1c, FBG, PPBG, serum creatinine, eGFR, LFTs |
After initiation (4–12 weeks) Blood glucose monitoring; assess for hypoglycaemia symptoms if on SU/insulin
3 months HbA1c to evaluate glycaemic response
Long-term HbA1c every 3–6 months; annual renal and hepatic function assessment
If pancreatitis suspected Serum amylase, lipase; abdominal imaging if indicated
Single-ingredient (Evogliptin 5 mg):
Note: FDC formulations with Metformin may be available — verify with regional suppliers.
| Formulation | Approximate Price (per tablet) |
|---|---|
| Evogliptin 5 mg tablet ₹10–₹18 per tablet |
Note: Not currently listed under NLEM (2022); prices not NPPA-controlled.
evogliptin; DPP-4 inhibitor; type 2 diabetes; T2DM; renal-safe; CKD-friendly; once daily; no titration; weight-neutral; India formulary
RxIndia v1.0 — 01 Jun 2025
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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