Xenia 25
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Xenia 25 is a sodium-glucose cotransporter-2 (SGLT2) inhibitor containing 25 mg of empagliflozin. It is marketed by USV Private Limited. Empagliflozin reduces blood glucose levels by inhibiting glucose reabsorption in the kidneys, leading to increased urinary glucose excretion. The 25 mg dose of empagliflozin in clinical trials has shown enhanced glycemic efficacy and additional cardiovascular and renal protective effects.
Xenia 25 is approved for:
- Improving glycemic control in adults with type 2 diabetes mellitus.
- Reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
Empagliflozin 25 mg is rapidly absorbed, reaching peak plasma concentration (Tmax) in approximately 1.5 hours. It undergoes metabolism primarily through glucuronidation (via UGT2B7, UGT1A3, UGT1A8, UGT1A9) and is excreted in urine (54.4%) and feces (41.2%).
Common side effects include urinary tract infections, increased urination, and genital infections. The 25 mg dose is also associated with greater urinary glucose excretion (~78 g/day), modest weight loss, and reduction in systolic blood pressure.
Xenia 25 is available in oral tablet form and is approved in multiple countries worldwide.
Xenia 25 contains empagliflozin, an SGLT2 inhibitor that lowers blood glucose by increasing glucose excretion through the kidneys.
● Receptor Selectivity: Selective inhibition of SGLT2.
● Physiological Effect: Lowers blood glucose levels and reduces cardiovascular risks.
● Onset of Action: Within hours.
● Duration of Action: 24 hours.
● Tmax: 1.5 hours.
● Cmax: 687 nmol/L (25 mg dose).
Xenia 25 which is composed of empagliflozin can be uses as follows:
● Take orally once daily in the morning.
● May be taken with or without food.
● Swallow tablet whole with water; do not crush or chew.
Xenia 25 containing empagliflozin 25mg can be used
● Treatment of type 2 diabetes mellitus as monotherapy or in combination with other antidiabetic agents.
● Reduction in cardiovascular mortality in patients with type 2 diabetes and established cardiovascular disease.
● May offer benefits in patients with mild to moderate renal impairment (eGFR ≥45 mL/min/1.73 m²).
Xenia 25 which contains empagliflozin 25mg can help to
● Enhanced glycemic control with greater HbA1c reduction than the 10 mg dose.
● Improved cardiovascular outcomes including reduced cardiovascular death.
● Modest weight loss and systolic blood pressure reduction.
● Sustained urinary glucose excretion (~78 g/day).
Xenia 25 which contains empagliflozin 25mg is approved for use in the following clinical indications
● Type 2 diabetes mellitus.
● Cardiovascular disease risk reduction in diabetic patients.
Dosage and administration of Xenia 25 is as follows
● Oral Tablets: Swallow whole with water, once daily in the morning, with or without food.
● The dosage and duration of treatment should be as per the clinical judgment of the treating physician.
● 25 mg.
● Xenia 25 is available in the form Oral solid tablet.
● To be used alongside appropriate dietary modifications for diabetes management.
● Fluid intake should be maintained to reduce dehydration risk.
● Dietary plans should be tailored individually.
Xenia 25 may be contradicted in the following
● Hypersensitivity to empagliflozin or any of its excipients.
● Severe renal impairment (eGFR < 30 mL/min/1.73 m²).
Xenia 25 containing empagliflozin should be used with certain warnings and precautions
● Monitor renal function regularly; avoid initiation in patients with eGFR < 45 mL/min/1.73 m².
● Increased risk of urinary and genital infections.
● May cause volume depletion—caution in elderly or patients on diuretics.
● Discontinue temporarily during illness, fasting, or surgery to avoid ketoacidosis.
● Increases LDL-C levels—monitor lipid profile.
Alcohol Warning
There is no sufficient scientific evidence regarding the use and safety of Xenia 25 in concurrent use with alcohol. However, alcohol can increase the risk of ketoacidosis and should be avoided or used with caution.
Breast Feeding Warning
There is no sufficient scientific evidence regarding the use and safety of Xenia 25 during breastfeeding. Animal data shows empagliflozin is present in milk and may pose a risk to developing kidneys. Consult a healthcare provider before use.
Pregnancy Warning
There is no sufficient scientific evidence regarding the use and safety of Xenia 25 during pregnancy. Animal studies showed adverse renal effects during late gestation. Consult a healthcare provider before use.
Food Warning
There is no sufficient scientific evidence regarding the use and safety of Xenia 25 in concurrent use with any particular food. However, food has minimal impact on drug efficacy.
Adverse reactions related to Xenia 25 can be categorized as
- Common: Urinary tract infections, increased urination (polyuria, nocturia), genital mycotic infections (especially in females).
- Less Common: Hypotension, dehydration, dyslipidemia, nausea, increased LDL-C.
- Rare: Diabetic ketoacidosis (DKA), acute kidney injury, severe hypersensitivity reactions, urosepsis, and pyelonephritis.
The clinically relevant drug interactions of Xenia 25 is briefly summarized here
- Diuretics: May enhance volume depletion.
- Insulin/Secretagogues: Increased risk of hypoglycemia.
- Urine Glucose Test: May show positive glucose results.
The use of Xenia 25 should be prudent in the following group of special populations
- Elderly: Increased risk of volume depletion and UTIs; monitor closely.
- Renal Impairment: Not recommended for eGFR < 45 mL/min/1.73 m²; contraindicated if <30.
- Hepatic Impairment: No dose adjustment required.
- Pediatrics: Safety and efficacy not established in patients under 18 years.
The physician should be vigilant about the knowledge pertaining to the identification and treatment of overdosage of Xenia 25
In case of overdose, initiate supportive treatment. Removal via hemodialysis has not been studied. Monitor for signs of dehydration and hypotension.
- Pharmacodynamics: Inhibits SGLT2 in the kidney, increasing urinary glucose excretion.
- Pharmacokinetics:
- Absorption: Tmax of 1.5 hours.
- Distribution: 86.2% plasma protein binding.
- Metabolism: Primarily by UGT enzymes.
- Elimination: 54.4% in urine, 41.2% in feces.
Xenia 25 contains empagliflozin. Some of the clinical studies related to empagliflozin include the following
● Glycemic Control: In monotherapy and combination therapy trials, empagliflozin significantly reduced HbA1c, fasting plasma glucose, and body weight compared to placebo.
● Cardiovascular Benefits: In patients with type 2 diabetes and established cardiovascular disease, empagliflozin reduced the risk of cardiovascular death by 38% (EMPA-REG OUTCOME trial).
● No mutagenicity or carcinogenicity observed at therapeutic doses.
● No impairment of fertility in animal models.
● High-dose animal studies showed reversible renal changes during developmental stages.
● Patients should adhere to prescribed dosing and dietary guidelines.
● Monitor for dehydration, especially in elderly or those on diuretics.
● Report signs of urinary or genital infections promptly.
● Seek immediate medical attention if symptoms of ketoacidosis occur (e.g., nausea, vomiting, abdominal pain, fatigue, or difficulty breathing).
● Inform healthcare provider of all medications being taken to avoid interactions.
