Viewing nowCombinationDamec Extended Release Tablets 10/1000 Milligrams
Dapagliflozin citric acid 14.7mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
Bionex Co., Ltd.

MFDS item code 202106882 · Approved 2021.10.13 · Insurance code 643105650
Effect on glycemic control in type 2 diabetes and prevention of cardiovascular events
This medication is used to assist in glycemic control for adult patients with type 2 diabetes when combined with dapagliflozin and metformin. When taken in conjunction with dietary and exercise therapy, it can effectively manage blood sugar levels. Notably, caution is required for patients with cardiovascular diseases or risk factors where pre-existing glycemic control is inadequate, concerning the occurrence of cardiovascular events. This medication improves the glycemic status of diabetes patients and helps in preventing complications.
The dosage of this medication should be individualized based on the patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended doses of dapagliflozin 10 mg and sustained-release metformin 2000 mg. This medication is generally administered once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/sustained-release metformin 2000 mg, taken as 2 tablets of 5 mg/1000 mg. In cases where previous diabetes medication treatment experience is absent and adequate glycemic control is difficult with monotherapy: When initiated as initial therapy in a patient without previous diabetes treatment experience, the recommended starting dose is 1 tablet once daily of either 5 mg/500 mg or 10 mg/500 mg. Gradually adjust the dosage to reduce gastrointestinal side effects of metformin. For patients on metformin treatment, the recommended dose of dapagliflozin is 10 mg once daily, and this dosage should provide a dose equivalent to the amount of metformin being taken or a therapeutically close appropriate dose. When converting from immediate-release to sustained-release metformin, blood sugar control should be closely monitored, and dosage adjustments should be made as necessary. For patients switching to this medication from combined therapy with dapagliflozin and metformin, the starting dosage can be based on the existing dosing amounts for both medications. When converting from immediate-release to sustained-release metformin, blood sugar control should be closely monitored, and dosage adjustments should be made as necessary. When used in combination with insulin or insulin secretagogues like sulfonylureas, lower doses of insulin or insulin secretagogues may be considered to mitigate the risk of hypoglycemia. The safety and efficacy of this medication in patients switched from other hypoglycemic agents have not been specifically evaluated. Changes in glycemic control can occur, necessitating careful monitoring of any modifications within the treatment for type 2 diabetes. This medication should be swallowed whole and should not be crushed, cut, or chewed. Occasionally, the inactive ingredients of this medication may be excreted in the stool in the form of soft hydrates resembling tablets. Renal impairment No dose adjustments are necessary for patients with mild renal impairment. For patients with an estimated GFR (eGFR) between 45 mL/min/1.73 m² and below 60 mL/min/1.73 m² without other symptoms that could increase the risk of lactic acidosis, the starting dose containing the active ingredient metformin hydrochloride is 500 mg once daily, with a maximum daily dose of 1000 mg. The use of this medication is not recommended in patients with an eGFR below 45 mL/min/1.73 m². If the estimated GFR falls below 45 mL/min/1.73 m², the use of this medication must be immediately discontinued. Renal function should be assessed every 3-6 months. Elderly patients Metformin is excreted via the kidneys, and the elderly are more prone to renal function decline, so this medication should be used with caution as age increases (refer to the precautions regarding the administration to elderly patients).
This medication can very rarely cause serious lactic acidosis, so renal function and general health status must be confirmed before use. When used with other diabetes medications, there may be a risk of hypoglycemia, necessitating careful monitoring of blood sugar levels. Patients with moderate to severe renal impairment, severe infections, dehydration, or acute cardiovascular diseases should not use this medication. Before surgery or radiographic iodine contrast examinations, this medication should be discontinued for a period, and restarts should only occur after confirming normal renal function. Women who are pregnant or breastfeeding should not take this medication, and caution is warranted for use in children and the elderly. During treatment with this medication, regular checks for symptoms of hypoglycemia, dehydration, infection, and so forth are necessary, and immediate medical consultation is warranted in case of any abnormal symptoms. Long-term use may reduce vitamin B12 levels; therefore, regular blood tests are recommended. Alcohol intake may increase the risk of side effects; therefore, excessive drinking should be avoided while on this medication. This medication may increase the risk of genital and urinary infections, so personal hygiene should be monitored, and immediate treatment sought if infection symptoms appear. Patients with decreased fluid volume or risk of hypotension should frequently monitor blood pressure and fluid status, and dose adjustments may be necessary if needed. This medication can interact with other drugs; therefore, inform healthcare professionals of any other medications being taken. In the case of overdose, immediately visit a healthcare facility for appropriate treatment; this medication may be removed via dialysis. Caution is necessary when driving or operating machinery, as dizziness and other symptoms may occur.
Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty in breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes, profound fatigue, sudden severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, markedly reduced urine output
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature, which helps maintain the medication's effectiveness for a longer duration.
Yellow, dual convex, egg-shaped film-coated tablet
30 tablets/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
Viewing nowCombinationDapagliflozin citric acid 14.7mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
Bionex Co., Ltd.
CombinationDapagliflozin citric acid 14.7mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
HK Inno.N Co., Ltd.
CombinationDapagliflozin citric acid 7.35mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
HK inno.N Co., Ltd.
Dapagliflozin citric acid 14.7mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
Poonglim Pharmaceutical Co., Ltd.
Dapagliflozin citric acid 7.35mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
Punglim Muhak Co., Ltd.
CombinationDapagliflozin citric acid 14.7mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
Korea Prime Pharmaceutical Co., Ltd.
Dapagliflozin citric acid 7.35mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
Korea Prime Pharmaceutical Co., Ltd.
CombinationDapagliflozin citric acid 14.7mg · Metformin Hydrochloride 1000mg
Tablet · Prescription medication · Combination
KS Pharm Co., Ltd.
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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For anything that needs medical judgment, consult a doctor or pharmacist.
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.