| Category: |
Antidiabetic Agent / Antihyperglycemic Agent
|
| Product information: |
- Generic Name:Empagliflozin
- CompositionEach film-coated tablet contains:
Empagliflozin 10 mg tablets
Empagliflozin 25 mg tablets
- Therapeutic Class: Antidiabetic Agent / Antihyperglycemic Agent
- Pharmacological Class:SGLT2 (Sodium-Glucose Co-Transporter 2) Inhibitor
- Presentation: 10 x 10’S tablet
- Pregnancy Category: Category C (FDA)
- Lactation:Avoid use.
|
| INDICATIONS: |
- Type 2 Diabetes Mellitus (T2DM)
- Heart Failure with Reduced Ejection Fraction (HFrEF)
- Chronic Kidney Disease (CKD)
- Cardiovascular Risk Reduction
|
| MECHANISM OF ACTION: |
Glucose is filtered by glomerulus
↓
Reabsorbed by SGLT2 in proximal renal tubule
↓
[Empagliflozin inhibits SGLT2]
↓
↓ Renal glucose reabsorption
↑ Urinary glucose excretion (glucosuria)
↓
↓ Blood glucose levels
↓
Improved glycemic control & calorie loss
|
| Pharmacokinetics: |
Absorption: Oral bioavailability ~78%
Peak Plasma (Tmax): ~1.5 hours (fasting)
Half-life (t½):~12.4 hours
Metabolism: Mainly glucuronidation (UGT2B7, UGT1A9)
Excretion: 54% feces (unchanged), 41% urine
|
| Dosage Information: |
Tablets to be taken once daily in the morning, with or without food.
|
| Type 2 Diabetes: |
starting dose 10 mg once daily if tolerated maximum dose can be increased to 25 mg once daily
|
| Heart Failure: |
starting dose 10 mg once daily
|
| Chronic Kidney Disease: |
starting dose 10 mg once daily
Note: Dose may vary depending upon patient condition.
|
| Side Effects: |
Common Side Effects:
-
-
- Genital infections (fungal)
- Urinary tract infections (UTIs)
- Increased urination
Dehydration
- Hypoglycemia (with insulin/sulfonylureas)
- Thirst, constipation, nausea
Serious Side Effects:
-
- Diabetic ketoacidosis (even with normal glucose)
- Fournier’s gangrene (rare)
- Acute kidney injury
- Severe urinary tract infection
- Hypotension
- Allergic reactions (rash, angioedema)
|
| Contraindications: |
- Hypersensitivity to empagliflozin
- Severe renal impairment (eGFR <30 mL/min/1.73 m²)
- End-stage renal disease (ESRD) or dialysis
- Diabetic ketoacidosis (DKA)
|
| Drug Interaction : |
- Diuretics: Increased risk of dehydration and hypotension
- Insulin/Secretagogues: Risk of hypoglycemia (monitor glucose)
- ACE inhibitors / ARBs: Enhanced risk of volume depletion
- Lithium: May decrease lithium levels (monitor closely)
|
