Medication info
Dapaglu Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Dapaglu Tablet 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
(주)일화
Appearance
Yellow, biconvex, diamond-shaped film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202203754 · Approved 2022.10.05 · Insurance code 640904380

Summary

Main use
Effects of blood sugar control in type 2 diabetes and cardiovascular risk reduction
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents. If used in conjunction with insulin or insulin secretagogues like sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. If there is no previous experience with diabetes medication treatment, the starting dose is 5 mg once daily or 10 mg once daily when combined with metformin.
Child dose
The efficacy and safety of dapagliflozin in patients under 18 years of age have not been established. There is no relevant data.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

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

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

This medication is used to help control blood sugar levels in patients with type 2 diabetes. It can be prescribed either alone or in combination therapy along with dietary and exercise therapy. In particular, for patients who do not have sufficient blood sugar control and have cardiovascular diseases or risk factors, it should be taken under the guidance of an expert considering its impact on the occurrence of cardiovascular events. This medication can assist in blood sugar management and reduce the risk of associated complications.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and additional combination therapy with insulin or other blood glucose-lowering agents. If used in conjunction with insulin or insulin secretagogues like sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to reduce the risk of hypoglycemia. If there is no previous experience with diabetes medication treatment, the starting dose is 5 mg once daily or 10 mg once daily when combined with metformin.

Child dose

The efficacy and safety of dapagliflozin in patients under 18 years of age have not been established. There is no relevant data.

Precautions

This medication should not be used in patients who have had allergic reactions to the active ingredient or additives. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis, nor to patients with genetic lactose metabolism disorders. It is safer not to administer this drug to patients undergoing dialysis. Patients with reduced fluid volume or poor kidney function should use this medication with caution, ensuring to check fluid status and kidney function before administration. This medication can lower blood pressure, so patients at risk of hypotension, the elderly, or those taking diuretics should be careful. Patients with allergies to the dye components in this medication should also take it cautiously. Taking this medication may increase the risk of genital infections or urinary tract infections, so if any infection symptoms appear, immediate consultation with medical personnel is advised. There is a risk of hypoglycemia, so when taken with insulin or blood sugar-lowering medications, blood sugar changes should be closely monitored. Symptoms of dehydration or hypotension due to decreased fluid volume may occur, requiring adequate fluid intake and symptom observation. Serious metabolic abnormalities such as ketoacidosis may occur; therefore, if symptoms such as vomiting, abdominal pain, or difficulty breathing arise, immediate hospital visit is necessary. Patients with decreased kidney function may find this medication less effective, and there is a possibility of worsening kidney function, thus regular checks are needed. It is recommended that women who are pregnant or breastfeeding do not use this medication. In case of overdose, there are no specific antidotes, and treatment should be given according to symptoms; do not increase dosage without doctor's instructions. This medication does not significantly affect driving or operating machinery, but caution is needed due to the risk of hypoglycemia. This medication should be kept out of reach of children and stored in its original container to ensure safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes, severe lethargy throughout the body, sudden and very severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly decreased urine output

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
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  • dysuria
  • polyuria
  • nocturia
  • increased hematocrit
  • dyslipidemia
  • increased blood urea
  • weight loss
  • increased blood creatinine
  • rash
  • angioedema
  • gastroesophageal reflux disease
  • upper abdominal pain
  • diverticulitis
  • intestinal perforation
  • acute pancreatitis
  • chronic pancreatitis
  • hyperglycemia
  • sensory disturbances
  • cerebral infarction
  • nerve compression

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 contact with air or moisture, preferably at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and ensure safe use.

Appearance and packaging

Appearance

Yellow, biconvex, diamond-shaped film-coated tablet

Package unit

30 tablets/bottle, 300 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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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.