Medication info

Huons Dapagliflozin 5mg (Dapagliflozin Monohydrate Blend)

Prescription medicationTablet경구Expired
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›7.635mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Yellow, biconvex, film-coated tablet with a round shape
Packaging
28 tablets/box [(7 tablets/PTP×4)]
Approval status
Expired

MFDS item code 202005364 · Approved 2020.07.23

This product's status changed to Expired on 2025.07.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults · Children
Adult dose
The recommended dose for this medication as monotherapy and in combination with other antidiabetic agents, such as insulin, is 10mg once daily. In the case of initial combination therapy with metformin, the initial recommended doses are 5mg or 10mg once daily. This medication can be orally administered at any time of the day regardless of food intake. The tablet should be swallowed whole.
Child dose
The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. There are no related data.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control for patients with type 2 diabetes
View approved original text

This medication is used in conjunction with diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It can also be administered as monotherapy, and if blood sugar control is challenging, it can be used in combination with other diabetes medications such as metformin, sulfonylureas, insulin, and sitagliptin to enhance its effectiveness. It allows for a variety of treatment experiences and combinations tailored to the individual patient, supporting appropriate blood sugar management. This medication is used to improve blood sugar control.

How to take

Adult dose

The recommended dose for this medication as monotherapy and in combination with other antidiabetic agents, such as insulin, is 10mg once daily. In the case of initial combination therapy with metformin, the initial recommended doses are 5mg or 10mg once daily. This medication can be orally administered at any time of the day regardless of food intake. The tablet should be swallowed whole.

Child dose

The efficacy and safety of dapagliflozin in children under 18 years of age have not been established. There are no related data.

Precautions

This medication should not be used in patients who are hypersensitive to the active ingredients or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. This medication contains anhydrous lactose, which should not be given to patients with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients undergoing dialysis should not use this medication. Patients with reduced fluid volume or renal impairment should use this medication cautiously, as it may cause hypotension or rapid changes in kidney function. Especially in older patients or those taking diuretics and with poor kidney function, blood pressure and kidney function should be monitored frequently. This medication contains Yellow No. 4 and Yellow No. 5 dyes, so patients allergic or hypersensitive to these components should exercise caution. This medication may increase the risk of genital infections and urinary tract infections; if related symptoms appear, immediate treatment should be sought. Due to the risk of hypoglycemia, dosage adjustments may be required when used with insulin or sulfonylureas. During treatment, symptoms such as dizziness, dry mouth, constipation, back pain, and dysuria may occur; if unusual symptoms persist, consult a physician. It is advisable for pregnant or breastfeeding women to avoid this medication and to discontinue it immediately if pregnancy is confirmed. There is no specific antidote for overdose, so it is important to receive symptom-appropriate treatment. This medication does not significantly affect driving or machine operation, but caution is necessary due to potential hypoglycemic symptoms. Store this medication out of reach of children and in its original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blistering, peeling skin, oral/ocular mucous membrane pain, shortness of breath or difficulty breathing, asthma attacks, abnormal respiratory patterns with cough + fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning headache, seizures, consciousness confusion, visual disturbances, paralysis, and urination difficulties.

Mild side effects

Vulvitis, balanitis and associated genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar itching, genital itching, increased hematocrit, reduced creatinine clearance in the initial stages of treatment, dyslipidemia, elevated blood creatinine, increased blood urea, weight loss, urticaria, cold sweat, dermatitis, and dry skin.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Yellow, biconvex, film-coated tablet with a round shape

Package unit

28 tablets/box [(7 tablets/PTP×4)]

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

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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.