Xenia 10
Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Xenia 10 is a sodium-glucose cotransporter-2 (SGLT2) inhibitor containing 10 mg of empagliflozin. It is marketed by USV Private Limited. Empagliflozin works by reducing renal glucose reabsorption, leading to increased urinary glucose excretion. In clinical studies, empagliflozin has also been shown to reduce blood pressure and body weight as secondary benefits.
Xenia 10 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 is absorbed with a peak plasma concentration (Tmax) of 1.5 hours. The mean Cmax is approximately 259 nmol/L for the 10 mg dose. It is primarily metabolized via glucuronidation by UGT enzymes (UGT2B7, UGT1A3, UGT1A8, UGT1A9) and excreted in urine (54.4%) and feces (41.2%).
Common side effects include urinary tract infections, increased urination, and genital infections. Additional benefits include a reduction in systolic blood pressure by up to 2.6–4.1 mmHg (placebo-adjusted) and modest weight loss.
Xenia 10 is available in oral tablet form.
Xenia 10 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: 259 nmol/L (10 mg dose).
Xenia 10 which us composed of empagliflozin can be uses as follows:
- Take orally once daily in the morning, with or without food.
- Swallow whole with water.
- Do not crush or chew.
Xenia 10 containing empagliflozin 10mg can be used
- In the treatment of type 2 diabetes mellitus.
- Reduces the risk of cardiovascular mortality in patients with type 2 diabetes and cardiovascular disease.
- Can also lead to reduction in HbA1c, fasting plasma glucose, body weight, and systolic blood pressure.
Xenia 10 which contains empagliflozin 10mg can help to
● Helps lower blood sugar levels through increased glucose excretion.
● Provides cardiovascular benefits including reduced risk of cardiovascular death.
● Associated with modest weight loss and reduction in blood pressure.
Xenia 10 which contains empagliflozin 10mg 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 10 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.
● 10 mg.
Xenia 10 is available in the form of Oral solid tablet.
● Should be used in the treatment of diabetes with appropriate dietary modifications.
● The dietary restriction should be individualized as per patient requirements.
● Maintain adequate fluid intake to minimize dehydration risk.
Xenia 10 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 10 containing empagliflozin should be used with certain warnings and precautions
- Use with caution in renal impairment (eGFR < 60 mL/min/1.73 m²).
- Increased risk of genital mycotic infections and urinary tract infections.
- May cause hypotension, especially in elderly, those on diuretics, or with low systolic BP.
- Temporarily discontinue during acute illness, fasting, or surgery to reduce risk of ketoacidosis.
- Monitor renal function regularly during treatment.
Alcohol Warning
There is no sufficient scientific evidence regarding the use and safety of Xenia 10 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 10 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 10 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 10 in concurrent use with any particular food. However, food has minimal impact on drug efficacy.
Adverse reactions related to Xenia 10 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 10 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 10 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 10
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 10 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.
