Medicine Information

Glycema

Name: Glycema
Brand: Glycema
Rating: 4.5 (117 reviews)

Tablet10 mgAnti-diabetic (SGLT2 inhibitor)ATC: A10BK03

Generic Name

Empagliflozin

Manufacturer

Example Pharma Ltd.

Country

Bangladesh

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
glycema 10 mg tablet	৳ 30.00	৳ 300.00

Description

Overview of the medicine

Empagliflozin (Glycema) is an oral medication used to treat type 2 diabetes mellitus, heart failure, and chronic kidney disease. It helps lower blood glucose by increasing glucose excretion in urine and provides cardiovascular and renal benefits.

Uses & Indications

To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.

To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.

To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (HFrEF).

To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD).

Dosage

Adults

Initial dose is 10 mg once daily, taken in the morning, with or without food. May be increased to 25 mg once daily if additional glycemic control is needed and tolerated, or for specific cardiovascular/renal indications.

Elderly

No dose adjustment required based on age alone, but monitor renal function carefully due to age-related decline in kidney function and increased risk of volume depletion.

Renal_impairment

Not recommended to initiate if eGFR is < 30 mL/min/1.73m². If already on treatment and eGFR declines to < 30 mL/min/1.73m², continue with 10 mg once daily. For eGFR < 20 mL/min/1.73m², empagliflozin is not recommended.

How to Take

Oral. Take once daily in the morning, with or without food. Swallow the tablet whole with water.

Mechanism of Action

Empagliflozin inhibits the sodium-glucose co-transporter 2 (SGLT2) in the renal proximal tubules, reducing glucose reabsorption and increasing urinary glucose excretion. This leads to lower blood glucose levels, osmotic diuresis, and natriuresis.

Pharmacokinetics

Onset

Glucose-lowering effect seen within hours of administration.

Excretion

Approximately 41% excreted in urine and 54% in feces, mainly as unchanged drug or glucuronide conjugates.

Half life

Approximately 12.4 hours.

Absorption

Rapidly absorbed, peak plasma concentration (Cmax) reached within 1.5 hours after oral administration. Absolute bioavailability is approximately 78%.

Metabolism

Primarily metabolized by glucuronidation via uridine 5'-diphospho-glucuronosyltransferases UGT1A8, UGT1A3, UGT1A9, and UGT2B7.

Side Effects

Contraindications

Known hypersensitivity to empagliflozin or any excipients in the formulation.
Patients with severe renal impairment (eGFR < 30 mL/min/1.73m²), end-stage renal disease (ESRD), or on dialysis.

Drug Interactions

Lithium

Empagliflozin may decrease lithium levels due to increased urinary excretion. Lithium levels should be monitored if co-administered.

Diuretics (e.g., Loop and Thiazide diuretics)

Increased risk of dehydration and hypotension. Close monitoring of volume status and renal function is recommended.

Insulin and Insulin Secretagogues (e.g., Sulfonylureas)

Increased risk of hypoglycemia when co-administered. A lower dose of insulin or secretagogue may be required.

Storage

Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.

Overdose

In case of an overdose, symptomatic treatment should be initiated. Management involves supportive measures, including monitoring of fluid status, electrolytes, and glucose levels. Empagliflozin is not dialyzable.

Pregnancy & Lactation

Not recommended during the second and third trimesters of pregnancy due to potential adverse effects on fetal renal development. Avoid during breastfeeding as animal studies show excretion into milk and potential harm to the infant.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

1 x 10 tablets3 x 10 tablets

Shelf Life

36 months

Availability

Pharmacies, Hospitals

Approval Status

Approved by FDA and DGDA

Patent Status

Generics available

Clinical Trials

Empagliflozin has been extensively studied in large-scale clinical trials such as EMPA-REG OUTCOME, EMPEROR-Reduced, EMPEROR-Preserved, and EMPA-KIDNEY, demonstrating significant benefits in reducing cardiovascular mortality, heart failure hospitalizations, and kidney disease progression.

Lab Monitoring

Renal function (eGFR) should be assessed before initiation and periodically during treatment.
Blood glucose levels should be monitored regularly.
Electrolytes should be monitored in patients at risk of volume depletion or electrolyte imbalances.
Lipid profile (periodically).

Doctor Notes

Prior to initiation, assess renal function (eGFR). Do not initiate if eGFR is < 30 mL/min/1.73m².
Educate patients on the signs and symptoms of volume depletion, urogenital mycotic infections, and diabetic ketoacidosis (even with near-normal glucose levels).
Consider temporary discontinuation in situations associated with acute illness (e.g., severe infection), surgery, prolonged fasting, or conditions predisposing to ketoacidosis.
Monitor for signs of Fournier's gangrene and discontinue immediately if suspected.

Patient Guidelines

Stay well hydrated, especially during illness or in hot weather, to prevent dehydration.
Report any symptoms of urinary tract infections (e.g., painful urination, frequent urination, lower abdominal pain) or genital yeast infections (e.g., itching, burning, discharge).
Be aware of symptoms of diabetic ketoacidosis (e.g., nausea, vomiting, abdominal pain, excessive thirst, rapid breathing, unusual fatigue) and seek immediate medical attention if they occur.
Report any tenderness, redness, or swelling in the genital or perineal area immediately, as these could be signs of Fournier's gangrene.

Missed Dose Advice

If a dose is missed, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Driving Precautions

Glycema has no or negligible influence on the ability to drive and use machines. However, patients should be advised to take precautions to avoid hypoglycemia, particularly when used in combination with insulin or sulfonylureas, which can affect driving ability.

Lifestyle Advice

Follow a balanced diet and engage in regular physical activity as advised by your healthcare provider to manage diabetes and improve overall health.
Maintain good personal hygiene, especially in the genital area, to reduce the risk of infections.