The chemical name of Empagliozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3 furanyl]oxy]phenyl]methyl]phenyl]-, (1S).
CLINICAL PHARMACOLOGY:
Mechanism of action: Sodium-glucose co-transporter 2 (SGLT2) is the predominant transporter responsible for the reabsorption of glucose from the glomerular ¬ltrate back into the circulation. Empagliozin is an inhibitor of SGLT2. By inhibiting SGLT2, Empagliozin reduces renal reabsorption of -ltered glucose and lowers the renal threshold for glucose, thereby increases urinary glucose excretion. Pharmacokinetics: Empagliozin may be administered with or without food. The apparent steady-state volume of distribution of Empagliozin is estimated to be 73.8 L. The primary route of metabolism of Empagli zin in humans is glucuronidation by the uridine 5′-diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, and UGT1A9. The apparent terminal elimination half-life of Empagliozin is estimated to be 12.4 h and apparent oral clearance is 10.6 L/h.
INDICATIONS
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
DOSAGE & ADMINISTRATION:
The recommended dose of Empagliozin is 10 mg once daily in the morning, taken with or without food. In patients tolerating Empagliozin, the dose may be increased to 25mg. Patients with Renal Impairment: Assessment of renal function is recommended before initiation of Empagliozin and periodically after that. Empagliozin should not be initiated in patients with an eGFR less than 45 mL/min/1.73 m2. No dose adjustment is needed in patients with an eGFR greater than or equal to 45 mL/min/1.73 m2. Empagliozin should be discontinued if eGFR is less than 45 mL/min/1.73 m2
PRECAUTIONS & WARNINGS:
Empagliozin (Jemvesta) causes intravascular volume contraction. Symptomatic hypotension may occur after initiating Empagliozin, particularly in patients with renal impairment, the elderly, those with low systolic blood pressure, and those on diuretics. If you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a dierent odor to your urine or sweat, contact a doctor or the nearest hospital straight away. These symptoms could be a sign of “diabetic ketoacidosis” – a rare, but serious, sometimes life-threatening problem.
Empagliozin (Jemvesta) causes intravascular volume contraction and can cause renal impairment. Empagliozin increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Renal function abnormalities can occur after initiating Empagliozin (Jemvesta). Renal function should be evaluated before initiation of Empagliozin and monitored periodically after that. Insulin and insulin secretagogues are known to cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with Empagliozin.
SIDE EFFECTS:
Empagliozin (Jemvesta) can cause serious side effects, including: Dehydration {dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up (orthostatic hypotension)}. Vaginal yeast infection {symptoms of a vaginal yeast infection include vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching}. Yeast infection of the penis (balanitis or balanoposthitis) (symptoms of yeast infection of the penis include redness, itching, or swelling of the penis, a rash of the penis, foul smelling discharge from the penis, or pain in the skin around the penis.