Medication info
Dapa M Sustained Release Tablets 5/1000 mg

Dapa M Sustained Release Tablets 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin citric acid›7.35mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Dark pink, double convex, egg-shaped film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202106875 · Approved 2021.10.12 · Insurance code 645210660

Summary

Main use
Effect on 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 therapy, efficacy, and tolerability, without exceeding the maximum recommended dose of 10 mg of dapagliflozin and 2000 mg of sustained-release metformin. This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of sustained-release metformin once daily, administered as 2 tablets of 5 mg/1000 mg.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

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

This medication is used in combination with dapagliflozin and metformin, along with dietary and exercise therapy, to assist in controlling blood sugar levels in adult patients with type 2 diabetes. Particularly for patients whose blood sugar is not adequately controlled and who have cardiovascular disease or risk factors, refer to professional information regarding the impact of this medication on the occurrence of cardiovascular events. It is effectively used to improve blood sugar control.

How to take

Adult dose

The dosage of this medication should be individualized based on the patient's current therapy, efficacy, and tolerability, without exceeding the maximum recommended dose of 10 mg of dapagliflozin and 2000 mg of sustained-release metformin. This medication is generally administered once daily with the evening meal. The maximum dosage is 10 mg of dapagliflozin/2000 mg of sustained-release metformin once daily, administered as 2 tablets of 5 mg/1000 mg.

Precautions

This medication is used to treat diabetes and helps to control blood sugar levels. It may rarely cause a serious condition known as lactic acidosis, so caution should be exercised especially in patients with poor kidney function, heart disease, infections, etc. When used with other diabetes medications, hypoglycemic symptoms may occur, necessitating dose adjustments and symptom monitoring. This medication should not be used in patients with moderate to severe renal impairment, dehydration, severe infections, acute myocardial infarction, etc. If undergoing a radiographic examination with contrast agents, this medication should be discontinued for at least 48 hours prior to the examination and should only be resumed once kidney function is confirmed to be normal after the examination. If surgery is planned, this medication should also be temporarily discontinued 48 hours before surgery and resumed only after confirming that kidney function is normal after surgery. Women who are pregnant or may become pregnant, as well as nursing mothers, should not use this medication. Elderly patients or those with weak kidney function require dosage adjustments and monitoring of kidney function, and should be cautious if there is a high risk of hypotension or dehydration. During the use of this medication, genital infections or urinary tract infections may occur, and if symptoms of infection appear, immediate consultation with a physician is necessary. Vitamin B12 deficiency may occur, so it is advisable to check vitamin B12 levels during prolonged use. Excessive alcohol intake can increase the risk of side effects from this medication, so it should be avoided. Caution is required when driving or operating machinery as dizziness may occur. This medication should be stored out of the reach of children and kept in its original container for safety. If any unusual symptoms or discomfort occur while taking this medication, healthcare personnel should be notified immediately.

Side effects and when to seek care immediately

Serious side effects

  • Lactic acidosis
  • severe hypoglycemia
  • severe allergic reaction
  • severe skin reactions
  • breathing difficulty
  • dyspnea
  • jaundice
  • sudden and severe headache
  • seizures
  • confusion
Show 13 more
  • visual disturbances
  • paralysis
  • severe edema
  • urinary abnormalities
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • renal impairment
  • perineal necrosis
  • Guillain-Barré syndrome
  • acute cholecystitis
  • atrial fibrillation

Mild side effects

  • Hypoglycemia
  • decreased fluid volume
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
  • dysuria
  • polyuria
  • nocturia
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  • itching of the vulva
  • itching of the genitals
  • increased hematocrit
  • decreased creatinine clearance
  • dyslipidemia
  • increased serum creatinine
  • elevated blood urea
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased/deficiency of vitamin B12
  • Guillain-Barré syndrome
  • bacterial pneumonia
  • sialadenitis
  • tendinitis
  • chest pain
  • thermal burns
  • wrist pain

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a well-closed container. It is best stored at room temperature, between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance and packaging

Appearance

Dark pink, double convex, egg-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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.