Dapatab Tablet
Dapagliflozin propanediol
10 mg
Ibn Sina Pharmaceutical Ind. Ltd.
| Pack size | 20's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 20.00 AED |
Available as:
Indications
Dapatab Tablet is used for:
Type 2 diabetes mellitus, Heart Failure, Chronic Kidney Disease
Adult Dose
Oral
Type 2 Diabetes Mellitus
Improve glycemic control
Indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus (T2DM)
Initial: 5 mg once daily in AM
May increase to 10 mg once daily in patients tolerating 5 mg/day who require additional glycemic control
Reduce the risk of hospitalization for heart failure
Indicated to reduce hospitalization risk for heart failure in adults with T2DM and established cardiovascular disease (CVD) or multiple CV risk factors
10 mg PO once daily in AM
Heart Failure
Indicated to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with HF (NYHA class II-IV) with reduced ejection fraction
10 mg once daily.
Chronic Kidney Disease
Indicated to reduce risk of sustained eGFR decline, end-stage kidney disease (ESKD), cardiovascular death, and hospitalization for HF in adults with chronic kidney disease (CKD) who are at risk of progression
10 mg PO qDay
Child Dose
Safety and effectiveness in pediatric patients under 18 years of age have not been established.
Renal Dose
Renal impairment
eGFR>45mL/min/1.73 m2: No dosage adjustment required
eGFR 25 to <45 mL/min/1.73 m2
T2DM: Not recommended
HF or CKD: No dosage adjustment required
eGFR <25 mL/min/1.73 m2
Initiation not recommended
Patients with HF or CKD may continue 10 mg/day to reduce risk of eGFR decline, ESKD, CV death, and HF hospitalization
Administration
Administer in the morning, with or without food
Contra Indications
Hypersensitivity to dapagliflozin propanediol or to any of the excipients. Moderate to severe renal impairment; end-stage renal disease; active bladder cancer. Pregnancy (2nd & 3rd trimester) & lactation.
Precautions
Ketoacidosis in Patients with Diabetes Mellitus: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis regardless of blood glucose level. If suspected, discontinue Dapagliflozin, evaluate and treat promptly. Before initiating Dapagliflozin, consider risk factors for ketoacidosis. Patients on Dapagliflozin may require monitoring
and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis.
Volume depletion: Before initiating Dapagliflozin, assess volume status and renal function in the elderly, patients with renal impairment or low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy.
Urosepsis and Pyelonephritis: Evaluate for signs and symptoms of urinary tract infections and treat promptly, if indicated.
Hypoglycemia: Consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia when used in combination with
Dapagliflozin.
Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases have occurred in patients with diabetes, both females and males. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment.
Genital Mycotic Infections: Monitor and treat if indicated.
MONITORING PARAMETERS
Monitor renal function before treatment, and at least annually thereafter.
When used for Type 1 diabetes mellitus, patients should monitor ketone levels before starting and during treatment (blood ketone levels are preferred to urine)
Monitor vol status & electrolytes.
Pregnancy-Lactation
Pregnancy
Based on animal data showing adverse renal effects drug is not recommended during second and third trimesters of pregnancy
Limited data in pregnant women are not sufficient to determine drug-associated risk for major birth defects or miscarriage; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
In animal studies, adverse renal pelvic and tubule dilatations, that were not fully reversible, were observed in rats when administered during a period of renal development corresponding to late second and third trimesters of human pregnancy, at all doses tested
Clinical considerations
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications; poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia related morbidity
Lactation
There is no information regarding presence of dapagliflozin in human milk, effects on breastfed infant, or on milk production; drug is present in milk of lactating rats; however, due to species-specific differences in lactation physiology, clinical relevance of these data are not clear
Since human kidney maturation occurs in utero and during first 2 years of life when lactational exposure may occur, there may be risk to developing human kidney; because of potential for serious adverse reactions in breastfed infants, advise women that therapy is not recommended while breastfeeding
Interactions
Hypoglycemia may occur w/ concomitant use w/ insulin & insulin secretagogues eg sulfonylureas.
Decrease in Cmax & AUC w/ rifampin. Increase in Cmax & AUC w/ mefenamic acid.
Increased thiazide & loop diuretic effects;
May increase risk of dehydration & hypotension. Pioglitazone.
Adverse Effects
Side effects of Dapagliflozin propanediol :
>10%
Renal impairment
1-10%
Female genital mycotic infections (6.9-8.4%),Urinary tract infection (4.3-5.7%),Increased urination (2.9-3.8%),Male genital mycotic infections (2.7-2.8%),Dyslipidemia (2.1-2.5%),Constipation (1.9-2.2%),Discomfort with urination (2.6-2.1%),Extremity pain (1.7-2%),Volume depletion
<1%
Hypersensitivity (0.3%)
Mechanism of Action
Dapagliflozin is a highly potent, selective, and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that improves glycemic control in patients with type 2 diabetes mellitus by reducing renal glucose reabsorption leading to urinary excretion of excess glucose (glucuresis).
Note
Dapatab 10 mg Tablet manufactured by Ibn Sina Pharmaceutical Ind. Ltd.. Its generic name is Dapagliflozin propanediol. Dapatab is availble in Bangladesh.
Farmaco BD drug index information on Dapatab Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.