Medication info
Glyflo Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Glyflo Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Yellow, biconvex, diamond-shaped film-coated tablet
Packaging
30 tablets/bottle, 90 tablets/bottle
Approval status
Active

MFDS item code 202204126 · Approved 2022.11.16 · Insurance code 649606220

Summary

Main use
Blood sugar control in type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication for monotherapy and add-on therapy with insulin or other antihyperglycemic drugs is 10 mg once daily. When used together with insulin or insulin secretagogues such as sulfonylureas, the dose of insulin or insulin secretagogues may be lowered to reduce the risk of hypoglycemia. For those with no previous experience of diabetes medication, the initial recommended dose when used in combination with metformin is
Child dose
Safety and efficacy in pediatric patients under 18 years have not been established, hence its use is not recommended.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Blood sugar control in type 2 diabetes and reduction of cardiovascular risk

View approved original text

This medication helps patients with type 2 diabetes control their blood sugar more effectively. It can be used alone or in combination with other medications alongside dietary and exercise therapy. It is particularly applicable to patients whose blood sugar is not adequately controlled and who have cardiovascular diseases or risk factors. Thus, it aids not only in blood sugar management but also in considering the possibility of cardiovascular events. Therefore, it is effectively used for blood sugar control and the prevention of complications in type 2 diabetes.

How to take

Adult dose

The recommended dose of this medication for monotherapy and add-on therapy with insulin or other antihyperglycemic drugs is 10 mg once daily. When used together with insulin or insulin secretagogues such as sulfonylureas, the dose of insulin or insulin secretagogues may be lowered to reduce the risk of hypoglycemia. For those with no previous experience of diabetes medication, the initial recommended dose when used in combination with metformin is

Child dose

Safety and efficacy in pediatric patients under 18 years have not been established, hence its use is not recommended.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients allergic to this medication, patients with type 1 diabetes, diabetic ketoacidosis, congenital disorders like lactose intolerance, and patients undergoing dialysis. In patients with reduced fluid volume or impaired kidney function, this medication should be used with caution. It may lower blood pressure or affect kidney function, so fluid status and kidney function should be carefully monitored before and after administration. Side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, and ketoacidosis may occur while taking this medication. In particular, women or patients with a history of infections may experience genital infections more frequently. Additionally, while this medication helps with blood sugar control, its effectiveness may be reduced in patients with severely impaired kidney function. Pregnant or breastfeeding women are advised not to take this medication and should discontinue it immediately if pregnancy is confirmed. This medication may interact with other drugs, so when used in conjunction with diuretics or insulin, dosage adjustments may be necessary to reduce the risk of hypoglycemia or dehydration. In case of overdose, there is no specific antidote, so appropriate treatment based on symptoms should be sought, and methods for removing this medication through dialysis are not known. Finally, care should be taken while driving or operating machinery during the course of this medication, especially when taken with insulin or sulfonylureas, to always be aware of the risk of hypoglycemia. The safety and efficacy of this medication in children have not been established, making its use inadvisable in this population. It is important to always follow the instructions of a physician or pharmacist and consult immediately if any abnormal symptoms occur.

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, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), severe malaise, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urine

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, thirst, dizziness, constipation, dry mouth, lumbar pain, dysuria, polyuria, nocturia, interstitial nephritis, elevated hematocrit, decreased early treatment kidney creatinine clearance, dyslipidemia, elevated serum creatinine, elevated blood urea, weight loss, rash, angioedema, edema, itching, sweating, hives, chest pain, fatigue

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air and moisture. It is best to keep the medication at room temperature between 1 and 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

30 tablets/bottle, 90 tablets/bottle

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

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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.