قرص پگلینو 10 میلی گرم

Paglino®

Paglino® oral tablets (Empagliflozin) for the management of type 2 diabetes mellitus, heart failure, and chronic kidney disease

Description

The antidiabetic medicine Empagliflozin, sold under the brand name Paglino®, is manufactured by Arvand Pharmed Company. It is used as monotherapy as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus and to reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease. Empagliflozin has been shown to reduce the risk of hospitalization and cardiovascular death in patients with heart failure or chronic kidney disease.

Product information

Paglino® is an oral antidiabetic agent and it is produced in two doses of 10 mg and 25 mg by Arvand Pharmed Company. Paglino® is indicated as an adjunct to diet and exercise to improve glycemic control in patients with Type 2 Diabetes Mellitus (T2DM) and to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease. This medication is used to reduce the risk of cardiovascular death plus hospitalization in adults with Heart Failure (HF) and to reduce the risk of sustained decline in eGFR, End-Stage Kidney Disease (ESRD), cardiovascular death, and hospitalization in adults with Chronic Kidney Disease (CKD) at risk of progression.

General Product Information

• Pharmacologic Category

Antidiabetic Agent, Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor

• Dosage Forms & Strengths

Tablet, Oral: 10 mg, 25 mg

• Mechanism of Action

By inhibiting Sodium-Glucose cotransporter 2 (SGLT2) in the proximal renal tubules, empagliflozin reduces the reabsorption of filtered glucose from the tubular lumen. SGLT2 is the main site of filtered glucose reabsorption; reduction of filtered glucose reabsorption result in increased urinary excretion of glucose, thereby reducing plasma glucose concentrations. Empagliflozin also reduces sodium reabsorption and increases the delivery of sodium to the distal tubule, which may lower both preload and afterload of the heart and downregulate sympathetic activity.

• Use: Labeled Indications

- Diabetes mellitus, type 2, treatment

As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years of age with type 2 diabetes mellitus; risk reduction of cardiovascular mortality in adults with type 2 diabetes mellitus and established cardiovascular disease.

- Chronic kidney disease

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

- Heart failure

Risk reduction of cardiovascular mortality and hospitalization for heart failure in adults with heart failure.

• Dosing: Kidney Impairment

o Adult

- eGFR ≥30 mL/minute/1.73 m2:

No dosage adjustment is necessary.

- eGFR <30 mL/minute/1.73 m2:

- Chronic kidney disease: No dosage adjustment necessary for eGFR ≥20 mL/minute/1.73 m2; therapy was not initiated in patients with an eGFR <20 mL/minute/1.73 m2.

- Diabetes mellitus, type 2, treatment: It is not recommended for glycemic control; however, in patients previously established on empagliflozin, some experts continue to use off label as a treatment for diabetic kidney disease; renal and heart failure benefits have been shown in patients with an eGFR ≥20 mL/minute/1.73 m2.

- Heart failure: Benefits of Empagliflozin have been shown in patients with an eGFR ≥20 mL/minute/1.73 m2.

- Hemodialysis and peritoneal dialysis: Avoid use.

o Pediatric:

Children ≥10 years and Adolescents: Oral:

- eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

- eGFR 30 to <60 mL/minute/1.73 m2: There are no pediatric-specific recommendations in the manufacturer's labeling; in pediatric trials, patients with eGFR <60 mL/minute/1.73 m2were excluded.

- eGFR <30 mL/minute/1.73 m2: Use not recommended. 

• Dosing: Liver Impairment: Adult

No dosage adjustment is necessary. 

• Administration: Adult

Oral: Administer once daily in the morning, with or without food.

 Surgical procedures: Consider temporary discontinuation of therapy at least 3 days prior to surgery; ensure risk factors for ketoacidosis are resolved prior to reinitiating therapy.

• Contraindications

- Hypersensitivity (e.g., angioedema) to empagliflozin or any component of the formulation.

- In hemodialysis and peritoneal dialysis

• Warnings/Precautions

o Special populations:

- Older adults: The risk of intravascular volume depletion may be increased in patients ≥75 years of age.

o Other warnings/precautions:

- Appropriate use: Not for use in patients with diabetic ketoacidosis or for glycemic control in patients with type 1 diabetes mellitus. Not for use in the treatment of chronic kidney disease in patients with polycystic kidney disease, or in those who currently require or have a recent history of immunosuppressive therapy for kidney disease.

- Hospitalized patients: Use of SGLT2 inhibitors is not routinely recommended for glycemic control in hospitalized patients.

- Surgical procedures: Consider temporary discontinuation of therapy at least 3 days prior to surgery; ensure risk factors for ketoacidosis are resolved prior to reinitiating therapy.

• Drug Interactions

Risk D: Consider therapy modification

- Insulins: SGLT2 Inhibitors may enhance the hypoglycemic effect of Insulins. Management: Consider a decrease in insulin dose when initiating therapy with a sodium-glucose cotransporter 2 inhibitor and monitor patients for hypoglycemia. 

- Sulfonylureas: SGLT2 Inhibitors may enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a SGLT2 inhibitor and monitor patients for hypoglycemia. 

• Pregnancy and Breastfeeding Considerations

Information related to the use of empagliflozin in pregnancy and breastfeeding is limited. It is not recommended using empagliflozin during the second and third trimesters of pregnancy and breastfeeding.

FAQ

- What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

- What should I avoid while taking Paglino?

Avoid drinking alcohol.

Avoid getting up too fast from a sitting or lying position.

- What other drugs will affect Paglino?

Tell your doctor about all your other prescription and over-the-counter medicines, vitamins, and herbal products, especially insulin or other oral diabetes medicines.

- How long does it take for Paglino to work?

Results can differ for everyone. It’s important to take it daily as directed by your healthcare provider.

References

1. Empagliflozin: Drug information. UpToDate database, 8/2024.

2. Empagliflozin. FDA Label, Revised: 9/2023.