Introduction
Dapaglip 10 is used alone or in combination with other medicines to treat type 2 diabetes mellitus. It helps control the high blood sugar levels seen in diabetes. This reduces the chances of serious complications of diabetes and also helps prevent heart disease.
Dapaglip 10 can be taken with or without food at any time of day but you should try to take it at the same time every day. The dose will be decided by your doctor. Do not stop taking it without asking your doctor. If you do, your blood sugar levels may increase and put you at risk of serious complications like kidney damage and blindness. This medicine is only part of a treatment program that should include a healthy diet, regular exercise and weight reduction as advised by your doctor.
The most common side effects of this medicine include nausea, frequent urge to urinate, increased thirst, urinary tract infections, hypoglycemia (low blood sugar levels) and genital tract infection. It may cause the body to lose too much water. Drinking plenty of fluids to prevent dehydration. Some people may develop fungal infections in the genital area. Maintaining good hygiene can help prevent this.
Before taking this medicine, inform your doctor if you have any kidney or liver problems or a urinary tract infection or if you are on water pills (diuretics). Pregnant or breastfeeding women should also consult their doctor before taking it. Avoid excessive alcohol intake while taking it as this may increase the risk of developing some side effects. Monitor your blood sugar levels regularly while taking this medicine.
Side effects of Dapaglip 10
Common
- Nausea
- Frequent urge to urinate
- Genital fungal infection
- Increased thirst
- Urinary tract infection
How to use Dapaglip 10
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Dapaglip 10 may be taken with or without food, but it is better to take it at a fixed time.
How Dapaglip 10 works
Dapaglip 10 is an antidiabetic medication. It works by removing excess sugar from your body through urine.
What if you forget to take Dapaglip 10?
If you miss a dose of Dapaglip 10, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Indication
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
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
Contraindication
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.
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).
Precaution
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
Side Effect
>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%)
Pregnancy Category Note
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
Interaction
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.