Medication info
Daplo Tablets 10mg (Dapagliflozin Propanediol Hydrate)

Daplo Tablets 10mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Yellow, biconvex, rhomboid film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202300410 · Approved 2023.01.31 · Insurance code 645907350

Summary

Main use
Effect on blood sugar control in type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 10mg once daily for use as monotherapy and in additional combination therapy with insulin and other hypoglycemic agents. For initial combination therapy, if the patient has not previously experienced diabetes medication treatment, co-administration with metformin at 5mg once daily or 10mg once daily is recommended. The administration method allows for oral intake once daily 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 have not been established. There is no relevant data.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Effect on blood sugar control in type 2 diabetes and reduction of cardiovascular risk

  • Type 2 diabetes
  • blood sugar control disorder
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used in conjunction with dietary and exercise therapies to assist in blood sugar control for patients with type 2 diabetes. It can be administered alone or in combination with other medications. Notably, for patients with type 2 diabetes whose blood sugar is not adequately controlled and who have cardiovascular disease or risk factors, it is important to refer to an expert's advice regarding the risk of adverse cardiovascular events. This medication is utilized to improve blood sugar control and aid in diabetes management.

How to take

Adult dose

The recommended dosage for this medication is 10mg once daily for use as monotherapy and in additional combination therapy with insulin and other hypoglycemic agents. For initial combination therapy, if the patient has not previously experienced diabetes medication treatment, co-administration with metformin at 5mg once daily or 10mg once daily is recommended. The administration method allows for oral intake once daily 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 have not been established. There is no relevant data.

Precautions

This medication should not be used in individuals who are allergic to the active ingredient or excipients, patients with type 1 diabetes, those with diabetic ketoacidosis, individuals with genetic disorders affecting lactose breakdown, and patients undergoing dialysis. It should be used cautiously in patients with low fluid volume or impaired kidney function, and blood pressure and kidney function should be carefully monitored before and after administration. This medication may cause side effects including genital infections, urinary tract infections, hypoglycemia, dehydration symptoms, dizziness, dry mouth, weight loss, and so on, and infections may occur more easily, especially in women or those with a prior history of infection. In severe cases, rare complications such as diabetic ketoacidosis or Fournier's gangrene may occur, so if symptoms like pain, swelling, or redness around the genital area arise, immediate consultation with healthcare professionals is necessary. This medication may increase the risk of hypoglycemia when used in conjunction with drugs that can induce hypoglycemia, such as insulin or sulfonylureas, so dosing adjustments may be required for these medications. Pregnant or breastfeeding women are advised not to use this medication and should discontinue immediately if pregnancy is confirmed. During the use of this medication, the status of fluid volume should be checked periodically, and if symptoms of dehydration or hypotension occur, temporary cessation of administration may be necessary. In case of overdose, there is no specific antidote, so symptomatic treatment should be sought, and appropriate supportive treatment should be received at a hospital if necessary. This medication does not significantly affect the ability to drive or operate machinery, but caution should be observed for symptoms of hypoglycemia when used in combination with other hypoglycemic agents. Finally, this medication should not be used in children as safety and efficacy have not been established.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, urinary volume changes

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, hypoglycemia, dehydration, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, genital itching, increased hematocrit, decreased renal creatinine clearance at the initiation of treatment, dyslipidemia, elevated serum creatinine, increased blood urea nitrogen, weight loss, chest pain, weakness, pain, edema, foreign body sensation, facial edema, facial pain, warmth

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. It is advisable to store it at room temperature between 1°C and 30°C. This helps to maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Yellow, biconvex, rhomboid film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]

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.