Medication info

Daploem Sustained Release Tablets 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Anhydrous Lactose Mixture›15.27mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Pink, biconvex, oval-shaped sustained release film-coated tablet
Packaging
30 tablets/box [(6 tablets/PTP) * 5], 30 tablets/bottle
Approval status
Active

MFDS item code 202301893 · Approved 2023.06.21

Summary

Main use
Effectiveness for blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
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, given as two tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is one tablet once daily of either 5 mg/500 mg or 10 mg/500 mg. Dosing should be adjusted gradually to minimize gastrointestinal side effects from metformin.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Effectiveness for blood sugar control in type 2 diabetes and prevention of cardiovascular events

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

This medication is used in combination with dapagliflozin and metformin to assist with dietary and exercise regimens to improve blood sugar control in adults with type 2 diabetes. It can also be prescribed for patients with cardiovascular diseases or risk factors among those whose blood sugar is inadequately controlled. However, the impact of dapagliflozin on cardiovascular events should be referenced against expert guidelines. This medication effectively aids in improving blood sugar control.

How to take

Adult dose

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, given as two tablets of 5 mg/1000 mg. When used as initial therapy, the recommended starting dosage is one tablet once daily of either 5 mg/500 mg or 10 mg/500 mg. Dosing should be adjusted gradually to minimize gastrointestinal side effects from metformin.

Precautions

This medication may cause rare side effects such as severe lactic acidosis, so it should not be administered to patients with impaired kidney function, severe infections, or dehydration. Additionally, caution should be exercised for the risk of hypoglycemia when used in conjunction with insulin or sulfonylurea medications. Patients with moderate to severe renal impairment, those with acute myocardial infarction or heart failure, and those scheduled for surgery should consult their physician before administration. This medication is not to be used in pregnant or breastfeeding women, or patients with specific genetic issues like lactose intolerance. Symptoms of fluid volume decrease or hypotension may occur during treatment, so blood pressure and renal function should be monitored regularly. There is an increased risk of genital infections or urinary tract infections, so medical attention should be sought immediately upon the appearance of related symptoms. Vitamin B12 levels may decrease; thus, blood vitamin B12 levels should be checked with long-term use. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided. This medication does not significantly affect driving or machinery operation, but dizziness may occur, so caution is advised. Keep out of reach of children and store in the original container.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • renal impairment
  • perineal necrosis
  • severe allergic reactions
  • severe skin reactions
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  • respiratory issues
  • liver anomalies (jaundice)
  • serious neurological symptoms
  • severe edema or urinary abnormalities
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • atrial fibrillation
  • acute cholecystitis

Mild side effects

Vulvovaginitis, balanitis, and related genital infections, urinary tract infections, hypoglycemia (when used with insulin or sulfonylureas), reduced fluid volume (dehydration, hypovolemia, hypotension), thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, reduced initial renal creatinine clearance, dyslipidemia, elevated serum creatinine, elevated blood urea,

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 contact with air or moisture. The storage temperature should ideally be maintained at room temperature between 1°C and 30°C. Proper storage will help maintain the medication’s efficacy and safety.

Appearance and packaging

Appearance

Pink, biconvex, oval-shaped sustained release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP) * 5], 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.