Medication info

Damet Sustained Release Tablet 10/500 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Dapagliflozin citric acid›14.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
Pink, bilaterally convex, oval-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202204074 · Approved 2022.11.10

This product's status changed to Approval withdrawn on 2023.10.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effect on blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally administered once a day with the evening meal. The maximum dosage is one time daily dapagliflozin 10 mg/sustained release metformin 2000 mg, which can be given as 2 tablets of 5 mg/1000 mg. If there is no prior experience with diabetes medication, initial therapy involves administering once daily 1 tablet of 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted incrementally

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

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

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

This medication is used in combination with dapagliflozin and metformin as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. In particular, for patients with insufficient glycemic control who have cardiovascular diseases or risk factors, reference to expert guidance regarding the impact of dapagliflozin on the occurrence of cardiovascular events should be considered. This medication helps manage blood sugar safely and effectively, providing a positive aid in diabetes treatment.

How to take

Adult dose

This medication is generally administered once a day with the evening meal. The maximum dosage is one time daily dapagliflozin 10 mg/sustained release metformin 2000 mg, which can be given as 2 tablets of 5 mg/1000 mg. If there is no prior experience with diabetes medication, initial therapy involves administering once daily 1 tablet of 5 mg/500 mg or 10 mg/500 mg. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted incrementally

Precautions

This medication can very rarely cause a serious condition called lactic acidosis, so it is important to be aware of this symptom. Additionally, caution should be exercised as the risk of hypoglycemia may be increased when used in conjunction with other diabetes medications such as insulin or sulfonylureas. It should not be used in patients with moderate to severe renal impairment or acute renal damage, or it should be used with caution in such cases. In situations where the physical condition is rapidly changing, such as heart disease, dehydration, severe infections, or pre-and post-surgical conditions, it may be necessary to temporarily stop administering this medication. Women who are pregnant or breastfeeding should not take this medication, and women who may become pregnant need to be cautious. This medication may increase the risk of genital and urinary tract infections, so if infection symptoms appear, consult a healthcare provider immediately. Patients at risk for reduced fluid volumes or hypotension should regularly check their blood pressure and fluid status, and may need to discontinue use. It is advisable to avoid alcohol consumption while taking this medication, as excessive drinking can increase the risk of side effects. If blood sugar control fails or abnormal symptoms appear, notify your healthcare provider immediately, and be vigilant about symptoms of hypoglycemia. Elderly patients or patients with impaired renal function should pay particular attention to dosage adjustments and renal monitoring. This medication has not been established as safe and effective in children, so it is not used in this population. When storing the medication, keep it out of reach of children and store it in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, diabetic ketoacidosis, urosepsis, pyelonephritis, acute kidney injury, renal dysfunction, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash with fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes), breathing problems (shortness of breath or difficulty breathing, asthma attack, cough with fever accompanying respiratory anomalies), liver abnormalities (hepatic abnormalities due to medication effects)

Mild side effects

Hypoglycemia, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, elevated hematocrit, initial treatment reduction in renal creatinine clearance, dyslipidemia, initial treatment increase in blood creatinine, elevated blood urea, weight loss, diarrhea, nausea/vomiting, epigastric pain, dyspepsia, abdominal discomfort, abdominal pain, gastric ulcer, irritable bowel syndrome, toothache, headache, sensory abnormality, tremor

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. Storing it this way helps maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

Pink, bilaterally convex, oval-shaped 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.