Medication info
Dapasingul Tablets 10 mg (Dapagliflozin Propanediol Hydrate)

Dapasingul Tablets 10 mg (Dapagliflozin Propanediol Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Yellow, bi-convex, diamond-shaped film-coated tablet
Packaging
PTP - 28 tablets/box [(7 tablets/PTP x 4)], bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202202088 · Approved 2022.05.18 · Insurance code 648604450

Summary

Main use
Effectiveness in blood glucose control for type 2 diabetes and reduction of cardiovascular risk
Who takes it
Adults
Adult dose
Take 10 mg once a day for monotherapy and additional combination therapy. For initial combination therapy, take 5 mg or 10 mg once a day. Regardless of food intake, take orally once a day at any time and swallow the tablet whole.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Effectiveness in blood glucose control for type 2 diabetes and reduction of cardiovascular risk

  • Type 2 diabetes
  • blood glucose control abnormalities
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medicine is used alongside dietary management and exercise therapy to help control blood glucose levels in patients with type 2 diabetes. It can be administered alone or in combination with other medications. It is particularly beneficial for patients whose blood glucose is not adequately controlled, as well as those with or at risk for cardiovascular diseases. Clinical trials recommend consulting professional information regarding the impact of this drug on cardiovascular events. Overall, this drug is effectively used in the treatment of type 2 diabetes.

How to take

Adult dose

Take 10 mg once a day for monotherapy and additional combination therapy. For initial combination therapy, take 5 mg or 10 mg once a day. Regardless of food intake, take orally once a day at any time and swallow the tablet whole.

Precautions

This medicine should not be used in patients with a history of allergic reactions to the active ingredients or excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. The drug contains lactose, and should not be used in patients with hereditary conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. It should also not be administered to patients undergoing renal dialysis. Use with caution in patients with reduced fluid volume or poor kidney function, as blood pressure drop or worsening kidney function may occur; the patient's condition should be monitored before and after administration. In patients with moderate to severe reduced kidney function, blood glucose control efficacy may decrease, and this medication is not recommended for patients with very low kidney function. This medication may increase the risk of genital infections and urinary tract infections, so immediate treatment is necessary upon symptoms of infection. When used with insulin or sulfonylureas, which have a risk of hypoglycemia, pay attention to symptoms of low blood sugar, and adjust the dosage of those medications if necessary. There can be signs of dehydration or hypotension due to reduced fluid volume, so caution is needed, especially in elderly patients or those taking diuretics. Diabetic ketoacidosis may occur; if symptoms such as vomiting, abdominal pain, or difficulty breathing appear, inform medical personnel immediately. Pregnant or breastfeeding women should avoid using this medicine, and if pregnancy is confirmed, discontinuation should occur. The safety and efficacy for children have not been established, and it should not be used in pediatric patients. In the event of an overdose, appropriate treatment depending on symptoms is required, and since there is no specific antidote, medical personnel's instructions should be followed. This medication does not significantly affect driving or operating machinery, but caution is necessary in cases where there is a risk of hypoglycemia.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, abnormal breathing with cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, interstitial nephritis, increased hematocrit, reduced renal creatinine clearance at the beginning of treatment, dyslipidemia, increased serum creatinine at the beginning of treatment, elevated blood urea, weight loss, lightheadedness, herpes simplex, pruritus, hives, cold sweats, chest pain,

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

Storage

This medicine should be stored in a tightly closed container to avoid exposure to air and moisture. It is recommended to maintain storage temperature between 1 to 30 degrees Celsius. This will help preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow, bi-convex, diamond-shaped film-coated tablet

Package unit

PTP - 28 tablets/box [(7 tablets/PTP x 4)], bottle - 30 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.