Medication info
Plogli Tablets 10 mg (Dapagliflozin Propanediol Hydrate)

Plogli Tablets 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Yellow, film-coated tablets that are convex on both sides in a rhomboid shape
Packaging
28 tablets/box [(14 tablets/PTP×2)]
Approval status
Active

MFDS item code 202202918 · Approved 2022.07.14 · Insurance code 663608640

Summary

Main use
Treatment for controlling blood sugar in Type 2 diabetes and reducing cardiovascular risks in chronic heart failure and chronic kidney disease
Who takes it
Adults · Children
Adult dose
For treatment of Type 2 diabetes as monotherapy and in combination therapy, the recommended dosage is 10 mg orally once daily. In initial combination therapy with metformin, the dosage is 5 mg or 10 mg orally once daily. Chronic heart failure and chronic kidney disease patients also receive 10 mg orally once daily. The medication can be taken at any time during the day, regardless of food intake, and tablets should be swallowed whole.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years; therefore, it is not administered.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment for controlling blood sugar in Type 2 diabetes and reducing cardiovascular risks in chronic heart failure and chronic kidney disease

  • Type 2 diabetes
  • poor blood sugar control
  • cardiovascular diseases
  • cardiovascular risk factors
  • chronic heart failure
  • hospitalizations due to heart failure
  • emergency visits due to heart failure
  • chronic kidney disease
  • reduced estimated glomerular filtration rate
  • end-stage kidney disease
View approved original text

This medication is used in conjunction with dietary and exercise regimens to help control blood sugar levels in patients with Type 2 diabetes. It also assists in reducing the risk of death or hospitalization due to cardiovascular disease in patients with chronic heart failure. In patients with chronic kidney disease, it is utilized to reduce the risk of declining kidney function and cardiovascular-related mortality. The effectiveness is enhanced when used alongside standard therapies for each condition. Due to these characteristics, this medication is used to improve the treatment and health management of patients with diabetes, heart failure, and kidney disease.

How to take

Adult dose

For treatment of Type 2 diabetes as monotherapy and in combination therapy, the recommended dosage is 10 mg orally once daily. In initial combination therapy with metformin, the dosage is 5 mg or 10 mg orally once daily. Chronic heart failure and chronic kidney disease patients also receive 10 mg orally once daily. The medication can be taken at any time during the day, regardless of food intake, and tablets should be swallowed whole.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years; therefore, it is not administered.

Precautions

This medication should not be administered to certain patients. First, patients who are allergic to the active ingredient or additives of this medication should not use it. Second, it is contraindicated in patients with Type 1 diabetes or diabetic ketoacidosis. Third, patients with lactose intolerance or hereditary lactose degradation disorders should also avoid taking this medication. Fourth, patients undergoing dialysis should not use this medication. This medication should be administered with caution in patients with decreased kidney function or reduced fluid volume. As this medication may lower blood pressure or reduce blood volume, elderly patients or those with weak kidney function, as well as patients taking diuretics, may face an increased risk of hypotension or kidney damage. Therefore, it is essential to check the fluid status and kidney function before prescribing it to such patients, and blood pressure and kidney function should be monitored continuously during treatment. Also, in patients with significantly diminished kidney function, the blood sugar control effect may be reduced, so caution is advised. Taking this medication may lead to genital infections frequently. Women, or patients with a history of genital infections, should be cautious as they are at a higher risk of recurrent infections. Additionally, hypoglycemic symptoms may occur, especially when taken with diabetes medications such as insulin or sulfonylureas. Thus, it is important to be aware of hypoglycemic symptoms, and dose adjustments for diabetes medications may be necessary. This medication may cause side effects such as fluid volume reduction, dehydration, hypotension, etc., so if any of these symptoms appear, you should consult a healthcare professional immediately. Moreover, serious metabolic disorders such as diabetic ketoacidosis may rarely occur; thus, caution is required since ketoacidosis can develop even when blood sugar levels are not high. If symptoms such as vomiting, abdominal pain, shortness of breath, or fatigue occur, you should seek immediate medical attention. This medication may also cause severe urinary tract infections, such as urinary tract infection and pyelonephritis, so if you experience pain during urination or fever, please seek medical care promptly. Additionally, this medication can rarely lead to a severe infection called perineal necrosis, so if you develop pain, swelling, or redness in the genital or perineal area, you should inform a healthcare facility immediately. Women who are pregnant or breastfeeding are advised not to take this medication. If pregnancy is confirmed, the medication should be stopped immediately, and it is also safer not to use it while nursing. Elderly patients or those with reduced kidney function may require further caution while taking this medication, as the risks of fluid volume reduction and hypotension are higher, so they should follow healthcare professionals' directions. This medication can interact with other drugs, so it is crucial to inform your doctor or pharmacist of any medications currently being taken. Caution should be exercised when taken with diuretics, insulin, sulfonylureas, etc., as the risk of hypoglycemia or dehydration may increase. During the course of this medication, glucose may be detected in the urine, so this should be considered when interpreting urine test results. There is no specific antidote for overdose, so treatment should be tailored to the symptoms, and you should follow the healthcare professionals' directions. Finally, this medication does not significantly affect driving or machine operation, but caution is advised when symptoms of hypoglycemia are present. This medication is not used in children, as its safety and efficacy in this age group have not been established.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blistering, skin peeling, pain in the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress associated with cough+fever, jaundice (yellowing of the skin or eyes), severe malaise, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache,

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, low back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, decreased initial renal creatinine clearance, dyslipidemia, increased serum creatinine, increased blood urea, weight loss, dyspepsia, nausea, diarrhea, vomiting,

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is best kept at room temperature between 1 and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained and degradation can be prevented.

Appearance and packaging

Appearance

Yellow, film-coated tablets that are convex on both sides in a rhomboid shape

Package unit

28 tablets/box [(14 tablets/PTP×2)]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.