Medication info
Dapagliflozin SM Prolonged-release Tablet 10/100/1000 mg (Dapagliflozin, Sitagliptin, Metformin)

Dapagliflozin SM Prolonged-release Tablet 10/100/1000 mg (Dapagliflozin, Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletDapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Yellow to deep yellow, oval-shaped prolonged-release film-coated tablets with both sides convex
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202403108 · Approved 2024.12.31 · Insurance code 648105170

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
Dapagliflozin 10 mg, Sitagliptin 100 mg, and prolonged-release Metformin Hydrochloride should be administered based on each patient's current treatment regimen, efficacy, and tolerability, without exceeding 2000 mg. This medication is taken once daily in the evening with meals, and if dose adjustment of Metformin Hydrochloride is required, it is adjusted stepwise. Patients should take 1 prolonged-release tablet of 10/100/1000 mg once daily.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to assist in blood sugar control in patients with type 2 diabetes when used in conjunction with dapagliflozin, sitagliptin, and metformin. When taken alongside dietary and exercise therapy, it can effectively improve blood sugar levels. This helps manage diabetes and contributes to maintaining a healthy lifestyle.

How to take

Adult dose

Dapagliflozin 10 mg, Sitagliptin 100 mg, and prolonged-release Metformin Hydrochloride should be administered based on each patient's current treatment regimen, efficacy, and tolerability, without exceeding 2000 mg. This medication is taken once daily in the evening with meals, and if dose adjustment of Metformin Hydrochloride is required, it is adjusted stepwise. Patients should take 1 prolonged-release tablet of 10/100/1000 mg once daily.

Precautions

This medication is a diabetes treatment that combines three components: sitagliptin, dapagliflozin, and metformin. Firstly, the sitagliptin component can rarely cause serious allergic reactions. If you notice symptoms such as skin rash, difficulty breathing, or facial swelling after taking it, you should immediately stop taking the medication and consult a physician. Additionally, acute pancreatitis, a condition involving inflammation of the pancreas, may occur, so if you experience severe abdominal pain, vomiting, or fever, you should visit a hospital right away. Next, metformin can rarely cause severe metabolic disorder known as lactic acidosis. If sudden difficulty in breathing, muscle pain, weakness, or abdominal pain occurs, you must inform your healthcare provider immediately. This medication should not be used in patients with moderate or severe renal impairment or in cases of dehydration, severe infection, acute myocardial infarction, sepsis, or acute heart failure. Particularly before and after any imaging procedures using contrast agents, it is advisable to temporarily discontinue use due to the risk of worsening renal function and lactic acidosis, as well as to pause the medication before and after surgical procedures for safety. During treatment, symptoms such as low blood pressure and decreased fluid volume may occur, so watch for dizziness and signs of dehydration. Elderly patients or those with compromised renal function should be monitored more closely. Moreover, this medication may increase the risk of genital and urinary tract infections, and proper treatment should be sought if any signs of infection arise. When used in conjunction with other medications for blood sugar control, the risk of hypoglycemia may increase. Immediate action should be taken if symptoms of hypoglycemia such as cold sweat, trembling, headache, or confusion arise. Routine evaluations of liver and kidney function should be conducted while taking this medication, and if any signs of abnormality appear, you must inform healthcare personnel immediately. If you experience fever, pain in the genital or perineal area, redness, or swelling during treatment, it could indicate serious perineal necrosis disease, and immediate treatment should be sought. Finally, it is advisable to avoid alcohol consumption during treatment with this medication. If fluid volume decreases, dehydration, or acute illness occur, temporarily discontinuing the medication and consulting a physician is recommended.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, breathing difficulties accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headache, seizures, disorientation, vision disturbances, paralysis, urinary changes.

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, decreased fluid volume, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, interstitial nephritis, vulvar pruritus, genital pruritus, dyslipidemia, increased serum creatinine, headache, diarrhea, abdominal pain, nausea, vomiting, dyspepsia, hunger, itching, cold sweat, chest pain, asthenia, fatigue, edema.

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow to deep yellow, oval-shaped prolonged-release film-coated tablets with both sides convex

Package unit

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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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.