Medication info
DapaRome Sustained Release Tablet 10/1000 Milligrams

DapaRome Sustained Release Tablet 10/1000 Milligrams

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

MFDS item code 202300241 · Approved 2023.01.12 · Insurance code 645306860

Summary

Main use
Effective 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 dose is 10mg of dapagliflozin/2000mg of sustained-release metformin once daily, taken as 2 tablets of 5mg/1000mg. The recommended starting dose for initial therapy is one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Effective 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 as a combination therapy of dapagliflozin and metformin to help control blood sugar levels in adults with type 2 diabetes. It is administered as an adjunct to diet and exercise to effectively improve blood sugar levels in patients whose blood sugar control is difficult. It can also be cautiously used in patients with cardiovascular diseases or risk factors among those who find it hard to manage blood sugar levels. This medication contributes to maintaining patient health by assisting in blood sugar management.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The maximum dose is 10mg of dapagliflozin/2000mg of sustained-release metformin once daily, taken as 2 tablets of 5mg/1000mg. The recommended starting dose for initial therapy is one tablet of 5mg/500mg or 10mg/500mg once daily. To reduce gastrointestinal side effects of metformin, the dosage should be adjusted gradually.

Precautions

This medication is to help control blood sugar levels and should not be administered to patients with impaired renal function or specific health conditions. It can rarely cause a serious condition called lactic acidosis, so caution is needed in patients with decreased renal function or conditions such as severe infection, dehydration, or acute myocardial infarction. When taken with insulin or sulfonylureas, the risk of hypoglycemia may increase, so dosage adjustments may be necessary. This medication should not be used during pregnancy or breastfeeding, and its safety in children has not been established. While taking this medication, genital infections or urinary tract infections may occur, so immediate consultation with healthcare providers is required if symptoms appear. Patients with low blood pressure or reduced fluid volume may develop symptoms of hypotension or dehydration, so regular monitoring of blood pressure and renal function before and during treatment is necessary. This medication can lower vitamin B12 levels, so long-term users should monitor for vitamin B12 deficiency. Excessive alcohol consumption may increase the risk of side effects from this medication, so it is advisable to avoid alcohol intake while on this medication. Before and after surgery or tests using iodine contrast agents, this medication should be discontinued for a certain period and resumed only after checking kidney function. In case of overdose, immediate medical attention should be sought, and this medication should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, acute kidney injury and renal dysfunction, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash with fever, blistering, skin peeling, pain in the mouth/eyes), respiratory problems (shortness of breath or difficulty breathing, asthma attacks, cough accompanied by abnormal breathing and fever), liver problems (jaundice of the skin or eyes, systemic lethargy)

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when used with sulfonylureas or insulin), dry mouth, dizziness, constipation, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, reduced initial renal creatinine clearance, dyslipidemia, elevated serum creatinine at the start of treatment, increased blood urea, weight loss

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. Avoid storing in excessively hot or cold places, ideally at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, double-sided convex, oval-shaped sustained-release film-coated tablet

Package unit

PTP - 30 tablets/box [(6 tablets/PTP) × 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.