Medication info
Hyusiga Duo Sustained Release Tablet 10/1000 mg (Dapagliflozin, Metformin)

Hyusiga Duo Sustained Release Tablet 10/1000 mg (Dapagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletDapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Yellow, oval-shaped, bilayered, biconvex, sustained-release film-coated tablet
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300360 · Approved 2023.01.27 · Insurance code 670402400,670609310

Summary

Main use
Blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The dosage of this medication should be individualized based on the patient's current treatment, efficacy, and tolerance, not exceeding the maximum recommended dosage of 10 mg of dapagliflozin and 2000 mg of sustained-release metformin. Generally, it is administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of sustained-release metformin once daily, which can be given as two tablets of 5 mg/1000 mg. It is used as an initial therapy.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • blood sugar control abnormalities
  • cardiovascular diseases
  • cardiovascular risk factors
View approved original text

This medication is used to improve blood sugar control in adult patients with type 2 diabetes when administered alongside dietary and exercise regimens. It is particularly applicable to type 2 diabetes patients who are not sufficiently controlled and have cardiovascular diseases or risk factors. However, the impact related to the occurrence of cardiovascular events should be referred to in professional information. Overall, this medication is utilized as a therapeutic agent that assists in diabetes management.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment, efficacy, and tolerance, not exceeding the maximum recommended dosage of 10 mg of dapagliflozin and 2000 mg of sustained-release metformin. Generally, it is administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of sustained-release metformin once daily, which can be given as two tablets of 5 mg/1000 mg. It is used as an initial therapy.

Precautions

This medication consists of two components and is primarily used for blood sugar control in type 2 diabetes patients. Before taking this medication, it is essential to verify that renal function is normal, and it should not be prescribed to patients with severe renal impairment. This medication should not be used in cases of acute illness affecting renal function, such as severe infections, dehydration, cardiovascular issues, acute myocardial infarction, or sepsis. Women who are pregnant or breastfeeding should not take this medication, and it is contraindicated in patients with certain genetic disorders such as lactase deficiency. This medication can rarely cause serious metabolic complications such as lactic acidosis, so patients and caregivers must immediately inform healthcare professionals if symptoms such as malaise, muscle pain, difficulty breathing, or abdominal pain occur. When used in combination with insulin or sulfonylurea medications, there may be an increased risk of hypoglycemia, necessitating close monitoring of blood sugar changes and dosage adjustments as needed. This medication may cause reduced fluid volume and hypotension, so elderly patients or those on diuretics should regularly check blood pressure and fluid status. There is an increased risk of genital and urinary tract infections, and if any infection symptoms appear, treatment should be sought immediately, with further caution advised for patients with a history of recurrent infections. It is advisable not to use this medication in patients with hepatic dysfunction, and if symptoms of hepatic functional abnormalities occur, immediate consultation with a healthcare provider is necessary. Excessive alcohol consumption should be avoided while taking this medication, and if any abnormal symptoms such as sudden weight loss, fever, or pain or swelling around the genital area occur, immediate medical care should be sought. Before undergoing surgery or radiological iodine contrast examinations, this medication should be discontinued for a specified period, and administration should resume only after confirming normal kidney function. Elderly patients often experience renal function decline, so dose adjustments and regular renal function tests are necessary, and the risk of vitamin B12 deficiency should also be periodically checked. The safety and efficacy of this medication have not been established in children, so it should not be administered to pediatric patients. In the event of overdose, immediate medical action is required, and in the case of the metformin component, drug removal through dialysis is possible, following the healthcare provider's instructions. This medication does not significantly affect the ability to drive or operate machinery, but caution is needed if symptoms such as dizziness occur. Finally, this medication should be kept out of the reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe allergic reactions, severe skin adverse reactions, respiratory issues, hepatic abnormalities (jaundice), severe neurological symptoms, severe edema or urination abnormalities, diabetic ketoacidosis, urosepsis and pyelonephritis, acute kidney injury and renal dysfunction, Guillain-Barré syndrome, bacterial pneumonia, acute cholecystitis, atrial fibrillation, perineal necrosis

Mild side effects

Vulvitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, elevated serum creatinine at the start of treatment, increased serum urea, dyslipidemia, weight loss, diarrhea, nausea/vomiting, decreased vitamin B12, abdominal pain, dyspepsia, abdominal discomfort, abdominal pain, gastric issues

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

Storage

This medication should be kept in a sealed container to prevent air exposure, and the storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. This storage method helps in maintaining the medication's efficacy and preventing degradation.

Appearance and packaging

Appearance

Yellow, oval-shaped, bilayered, biconvex, sustained-release film-coated tablet

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.

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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.