Medication info
Dapaem Sustained Release Tablet 10/1000 mg

Dapaem Sustained Release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Yellow, oval, biconvex film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202106874 · Approved 2021.10.12 · Insurance code 645210650

Summary

Main use
Effect on glycemic control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally taken once daily with the evening meal. The maximum dose is 1 daily dose of 10 mg of dapagliflozin and 2000 mg of sustained release metformin, taken as 2 tablets of 5 mg/1000 mg. If there is no previous experience with diabetes treatment, an initial regimen of 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily is recommended. To reduce gastrointestinal side effects of metformin, dosage should be up-titrated gradually.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Effect on glycemic control in type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • poor glycemic control
  • cardiovascular disease
  • cardiovascular risk factors
View approved original text

This medication is used in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. It is particularly recommended for patients who are not sufficiently controlled with current treatment and have cardiovascular disease or risk factors, hence consulting a specialist regarding the cardiovascular impact of dapagliflozin is advised. This medication is used to improve glycemic control in type 2 diabetes patients.

How to take

Adult dose

This medication is generally taken once daily with the evening meal. The maximum dose is 1 daily dose of 10 mg of dapagliflozin and 2000 mg of sustained release metformin, taken as 2 tablets of 5 mg/1000 mg. If there is no previous experience with diabetes treatment, an initial regimen of 1 tablet of 5 mg/500 mg or 10 mg/500 mg once daily is recommended. To reduce gastrointestinal side effects of metformin, dosage should be up-titrated gradually.

Precautions

This medication is used in the treatment of diabetes and helps regulate blood sugar levels. It can rarely result in a serious metabolic complication known as lactic acidosis, and should not be used if kidney function is poor or in cases of severe infection or dehydration. Care should be taken when using alongside other diabetes medications due to the risk of hypoglycemia, particularly with insulin or sulfonylureas, whereby dosage adjustment may be required. It should not be administered to patients with moderate to severe renal dysfunction, severe liver dysfunction, acute heart disease or severe infection, women who are pregnant or breastfeeding, and patients undergoing dialysis. Administration should be temporarily suspended before and after surgery or imaging tests involving iodine contrast agents, and caution is necessary in patients with reduced fluid volume or risk of hypotension. Regular monitoring of kidney function and fluid status is essential during treatment, and any unusual symptoms should prompt immediate consultation with healthcare professionals. This medication can cause side effects such as genital infections, urinary tract infections, hypoglycemia, reduced fluid volume, headache, dizziness, dyspepsia, and other ailments, warranting caution. Elderly patients or those with compromised renal function are at a higher risk of side effects, thus requiring dosage adjustments and regular check-ups. During pregnancy or breastfeeding, this medication should not be used, and if pregnancy is confirmed, it should be discontinued immediately. In cases of overdose, immediate treatment is necessary, and some components may be removed via dialysis. While this medication does not significantly affect driving or operating machinery, caution is warranted in case of dizziness or similar symptoms. Keep this medication out of the reach of children and store in its original container to prevent quality deterioration or misuse.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, rapid deterioration of renal function, acute kidney injury, urosepsis, pyelonephritis, perineal necrosis, acute cholecystitis, atrial fibrillation, Guillain-Barré syndrome, ketoacidosis, severe allergic reactions (including hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe cutaneous adverse reactions (with severe rashes accompanied by fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes), respiratory problems (shortness of breath or

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), loss of fluid volume (including dehydration, hypovolemia, hypotension), dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, reduced creatinine clearance at initiation of treatment, dyslipidemia, early increases in blood

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 or moisture. It is best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature. Storing it this way will help maintain its efficacy for a longer period.

Appearance and packaging

Appearance

Yellow, oval, biconvex film-coated tablet

Package unit

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.