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Ertoxa 15
Ziska Pharmaceuticals Ltd.
Generic: Ertugliflozin
Medicine Overview of Ertoxa 15mg Tablet
বাংলা
English
Indication
Type 2 Diabetes Mellitus
Administration
Take in the morning qDay, with or without food
Adult Dose
Type 2 Diabetes Mellitus
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Recommended starting dose is 5 mg PO qDay in the morning
If starting dose tolerated and additional glycemic control is needed, increase dose to maximum of 15 mg qDay
Hepatic impairment
Mild-to-moderate: No dosage adjustment necessary
Severe: Not recommended
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
eGFR ?60 mL/min/1.73 m²: No dosage adjustment necessary
eGFR <30 mL/min/1.73 m²: Contraindicated
End-stage renal disease or dialysis: Contraindicated
eGFR 30-60 mL/min/1.73 m²
Initiation of ertugliflozin not recommended
Continued use not recommended with persistent eGFR 30-60 mL/min/1.73 m²
Contraindication
Hypersensitivity
Severe renal impairment, end-stage renal disease, or dialysis
Mode of Action
Selective sodium-glucose transporter-2 (SGLT2) inhibitor
SGLT-2 inhibition lowers the renal glucose threshold (ie, the plasma glucose concentration, which exceeds the maximum glucose reabsorption capacity of the kidney); lowering the renal glucose threshold results in increased urinary glucose excretion
Precaution
Causes intravascular volume contraction; symptomatic hypotension may occur after initiating, particularly in patients with renal impairment, with low systolic blood pressure, on diuretics, or who are elderly Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been reported; before initiating, consider factors that may predispose patient to ketoacidosis, including pancreatic insulin deficiency from any cause, caloric restriction, and alcohol abuse; monitor for ketoacidosis and temporarily discontinue in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting owing to acute illness or surgery) Renal impairment may occur owing to intravascular volume contraction; before initiating, consider factors that may predispose patients...
... Show moreSide Effect
>10%
Female genital mycotic infections (9.1-12.2%)
1-10%
Volume depletion adverse effects (1.9-4.4%)
Male genital mycotic infections (3.7-4.2%)
Urinary tract infections (4-4.1%)
Headache (2.9-3.5%)
Vaginal pruritus (2.4-2.8%)
Increased urination (2.4-2.7%)
Nasopharyngitis (2-2.5%)
Back pain (1.7-2.5%)
Renal adverse effects (1.3-2.5%)
Weight decreased (1.2-2.4%)
Thirst (1.4-2.7%)
Pregnancy Category Note
Pregnancy Based on animal data showing adverse renal effects, not recommended during the second and third trimesters of pregnancy Data are limited in pregnant women and are not sufficient to determine a drug-associated risk of adverse developmental outcomes; there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy Animal data In animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy; doses ~13 times the maximum clinical dose caused renal pelvic and tubule dilatations and...
... Show moreInteraction
Hypoglycemia risk increased with insulin and insulin secretagogues (eg, sulfonylureas); a lower dose of insulin or insulin secretagogue may be required
Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors, as SGLT2 inhibitors, increase urinary glucose excretion and lead to positive urine glucose tests; use alternative methods to monitor glycemic control
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