Medication info
Dapa Plus Extended Release Tablet 10/1000 mg

Dapa Plus Extended Release Tablet 10/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)씨엠지제약
Appearance
Yellow, oval, bilaterally convex, extended-release film-coated tablets
Packaging
30 tablets/box [6 tablets/PTP x 5]
Approval status
Active

MFDS item code 202300243 · Approved 2023.01.12 · Insurance code 648604500

Summary

Main use
Effectiveness in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events
Who takes it
Adults
Adult dose
This medicine is typically administered once daily with the evening meal. The maximum dose is dapagliflozin 10 mg / extended-release metformin 2000 mg once daily, administered as 2 tablets of 5 mg / 1000 mg. For those with no previous experience of diabetes medication treatment, the initial regimen should be 1 tablet of 5 mg / 500 mg or 10 mg / 500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

Effectiveness in controlling blood sugar levels in type 2 diabetes and preventing cardiovascular events

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

This medicine is used as a combination of dapagliflozin and metformin as an adjunct to diet and exercise to improve blood sugar control in adult patients with type 2 diabetes. It is specifically used in patients with type 2 diabetes who have inadequate blood sugar control and who have cardiovascular disease or risk factors. When administered, it is important to manage carefully based on information from cardiovascular-related clinical trials. This medicine effectively improves blood sugar control and helps in the health management of patients.

How to take

Adult dose

This medicine is typically administered once daily with the evening meal. The maximum dose is dapagliflozin 10 mg / extended-release metformin 2000 mg once daily, administered as 2 tablets of 5 mg / 1000 mg. For those with no previous experience of diabetes medication treatment, the initial regimen should be 1 tablet of 5 mg / 500 mg or 10 mg / 500 mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

Precautions

This medicine is used to treat diabetes and helps control blood sugar levels. Rarely, this medicine may cause a condition known as severe lactic acidosis, which can occur due to excessive accumulation of lactic acid in the body and can lead to dangerous situations, so caution is necessary. Additionally, when used with insulin or sulfonylureas, there is a risk of hypoglycemia, so blood sugar levels should be closely monitored. Patients with allergies to this medicine's active ingredients or excipients, severely decreased kidney function, dehydration, severe infections, heart disease, liver dysfunction should not take this medicine. Women who are pregnant or breastfeeding should not use this medicine, and patients scheduled for tests involving radiological contrast agents should discontinue its use. Patients with decreased fluid volume or weakened kidney function should carefully assess their condition before taking this medicine, and regularly monitor blood pressure and kidney function during treatment. This medicine may increase urination and lower blood pressure, therefore, additional caution is needed for patients at risk of hypotension or the elderly. During treatment, genital infections or urinary tract infections may occur, so if infection symptoms appear, immediate consultation with a healthcare professional is needed. This medicine may lower vitamin B12 levels, so if taken for a prolonged period, regular checks of vitamin B12 levels are recommended. Excessive alcohol intake may increase the risk of side effects from this medicine, hence avoiding alcohol while taking this medicine is recommended. In case of overdose, immediate medical attention is necessary, especially for patients with decreased kidney function. While on this medicine, dizziness may occur during driving or machine operation, so caution is advised. Keep out of reach of children and store in the original container to prevent misuse or degradation of quality.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, severe hypoglycemia, severe allergic reactions (history of hypersensitivity), acute kidney injury, severe neurological symptoms (Guillain-Barré syndrome, facial paralysis), severe edema, acute cholecystitis, atrial fibrillation, perineal necrosis, urinary sepsis and pyelonephritis, severe skin adverse reactions (severe rash, blisters, skin peeling, mucosal pain), severe liver abnormalities (jaundice), ketoacidosis, difficulty breathing, severe swelling accompanied by elevated blood pressure

Mild side effects

Vulvovaginitis, balanitis and associated genital infections, urinary tract infections, fungal infections, hypoglycemia, dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, dyslipidemia, increased serum creatinine, elevated blood urea, weight loss, headache, sensory disturbances, tremor, upper abdominal pain, indigestion, abdominal discomfort, diarrhea, irritable bowel syndrome, salivary gland swelling, dental pain, headache, sensations

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

Storage

This medicine must be stored in a tightly sealed container to prevent air and moisture from entering. It is important to maintain storage temperatures between 1 degree and 30 degrees at room temperature to safely preserve the efficacy of the medicine.

Appearance and packaging

Appearance

Yellow, oval, bilaterally convex, extended-release film-coated tablets

Package unit

30 tablets/box [6 tablets/PTP x 5]

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.