Dapaglip 10 Tablet
Dapagliflozin propanediol
10 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 20's Pack |
|---|---|
| Unite Price | 30.00 BDT |
Indications
Dapaglip 10 Tablet is used for:
Type 2 diabetes mellitus
Adult Dose
Diabetes Mellitus Type 2
Selective sodium-glucose transporter-2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control with type 2 diabetes mellitus
Initial: 5 mg PO qDay; take in am with or without food
May increase to 10 mg qDay in patients tolerating 5 mg/day who have an eGFR ?60 mL/min/1.73 m² and require additional glycemic control
Indicated as monotherapy, as initial therapy with metformin, or as an add-on to other oral glucose-lowering agents, including metformin, glimepiride, sitagliptin, and insulin
Hepatic impairment
Mild or moderate: No dosage adjustment required
Severe: Not studied
Child Dose
Renal Dose
Renal impairment
eGFR ?60 mL/min/1.73 m²: No dosage adjustment required
eGFR <60 mL/min/1.73 m²: Do not initiate
Not recommended with eGFR that declines persistently between 30 to <60 mL/min/1.73 m²
eGFR <30 mL/min/1.73 m²: Contraindicated
Administration
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
CV disease; history of hypotension. Monitor vol status & electrolytes. UTI. Childn. Elderly.
Lactation: Unknown whether distributed in human breast milk; breast feeding women should discontinue dapagliflozin or nursing taking into account the importance of the drug to the mother
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.
Side 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%)
Mode 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
Dapaglip 10 10 mg Tablet generic name is Dapagliflozin propanediol. Dapaglip 10 10 mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Dapaglip 10 is availble in all over Bangladesh.
Mes BD drug index information on Dapaglip 10 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.