Dapazin Tablet

Dapazin 5 tablet: Each film coated tablet contains Dapagliflozin INN 5 mg. Dapazin10 tablet: Each film coated tablet contains Dapagliflozin INN 10 mg.

PHARMACOLOGY

Dapazin (Dapagliflozin) helps lower blood glucose levels by helping the body to filter more excess glucose out of the blood. Sodium-glucose co transporter 2 (SGLT2), expressed in the proximal renal tubules, is responsible for the majority of the re-absorption of filtered glucose from the tubular lumen. Dapagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, Dapagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

INDICATION

Dapazin (Dapagliflozin) is indicated
• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
• To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction (NYHAclass II-IV).
• To reduce the risk of sustained eGFR decline, end stage kidney disease cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.
Limitation of Use: Dapagliflozin is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Dapagliflozin is not recommended for use to improve glycemic control in adults with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m2.

DOSAGE AND ADMINISTRATION

• To improve glycemic control, the recommended starting dose is 5 mg once daily, taken in the morning, with or without food.
• Dose can be increased to 10 mg once daily for additional glycemic control.
• For all other indications, the recommended starting dose is 10 mg orally once daily.
• Patients with eGFR less than 25, initiation is not recommended, however patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death and hHF (Hospitalization for heart failure).

SIDE-EFFECT

Dapagliflozin may cause female genital mycotic infections, nasopharyngitis and urinary tract infections.

DRUG INTERACTION

Hypoglycemic Agents: May enhance the adverse/toxic effect of other hypoglycemic agents.
Hypotensive Agents: May enhance the adverse/toxic effect of other hypotensive agents.
Loop Diuretics: May diminish the hypoglycemic effect of hypoglycemic agents.
MAO Inhibitors: May enhance the hypoglycemic effect of hypoglycemic agents.
Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of hypoglycemic agents.

USE IN PREGNANCY AND LACTATION

Pregnancy: There are no adequate well controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to fetus.
Nursing mother: Discontinue Dapazin or discontinue nursing.

OVER DOSAGE

There were no reports of overdose during the clinical development program for Dapagliflozin.

STORAGE

Store in a cool (below 300) and dry place. Keep away from light and out of reach of children.

COMMERCIAL PACK

Dapazin 5 tablet: Each box containing 2 X 14’s tablet in Alu-Alu blister strips. Dapazin 10 tablet: Each box containing 1 X 14’s tablet in Alu-Alu blister strips.

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