Medication info
Trudapa M Controlled Release Tablet 10/500 mg (Dapagliflozin, Metformin)

Trudapa M Controlled Release Tablet 10/500 mg (Dapagliflozin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Dapagliflozin Bis L-proline›15.63mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)보령
Appearance
Pink, oval-shaped, bilayered, film-coated tablet
Packaging
Box - 30 tablets/box [6 tablets (Alu-Alu)x5], Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202108079 · Approved 2021.12.23 · Insurance code 641908050

Summary

Main use
Blood glucose control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
This medication is generally taken once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. The recommended starting dose when used as initial therapy is once daily 5 mg/500 mg or 10 mg/500 mg 1 tablet. This medication should be swallowed whole and must not be crushed, cut, or chewed.

Ingredients

Manufacturer
(주)보령

Efficacy & effects

Blood glucose control in type 2 diabetes and prevention of cardiovascular events

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

This medication is used to assist adults with type 2 diabetes who do not achieve adequate blood glucose control despite proper dietary and exercise regimens by taking dapagliflozin and metformin concomitantly, thereby providing more effective blood glucose management. Special care is necessary for patients with cardiovascular disease or those with cardiovascular risk factors to ensure safe use, and detailed information can be confirmed through consultation with a healthcare professional. This medication is used to improve blood glucose management in diabetes patients.

How to take

Adult dose

This medication is generally taken once daily with the evening meal. The maximum dosage is once daily dapagliflozin 10 mg/extended-release metformin 2000 mg, administered as 2 tablets of 5 mg/1000 mg. The recommended starting dose when used as initial therapy is once daily 5 mg/500 mg or 10 mg/500 mg 1 tablet. This medication should be swallowed whole and must not be crushed, cut, or chewed.

Precautions

This medication is used for the treatment of diabetes and should not be administered to patients with impaired kidney function or certain acute illnesses. Though rare, this medication may cause a serious condition called lactic acidosis, so patients should be vigilant for symptoms. Additionally, hypoglycemia may occur if used in conjunction with insulin or sulfonylureas, so blood glucose levels should be monitored carefully. Patients with compromised kidney function, the elderly, or those with depleted fluid volume should consult with a physician before use, and kidney function and blood pressure should be periodically monitored during treatment. This medication may increase the risk of genital and urinary infections, so any symptoms of infection should be reported to a healthcare provider immediately. Dehydration or hypotension may occur during use, so adequate fluid intake is essential, and precautions should be taken if symptoms develop. Women who are pregnant or possibly pregnant, as well as nursing mothers, should avoid using this medication, and if they are currently using it, they should discontinue use and consult their physician. Consumption of alcohol may increase the risk of side effects from this medication, so excessive drinking should be avoided while taking it. This medication may lower vitamin B12 levels, so it is advisable to check vitamin B12 status if taken for an extended period. It is recommended to discontinue use for a period before and after surgery, and to resume after kidney function has recovered. In case of overdose, immediate medical attention should be sought. Finally, this medication should be stored out of reach of children and kept in its original container to prevent misuse and degradation.

Side effects and when to seek care immediately

Serious side effects

Lactic acidosis, severe hypoglycemia, acute kidney injury and renal dysfunction, severe allergic reactions (urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin reactions (severe rash accompanied by fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes), respiratory issues (shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever), liver issues (yellowing of skin or eyes, general malaise)

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • hypoglycemia
  • decreased fluid volume
  • dizziness
  • constipation
  • dry mouth
  • back pain
  • dysuria
Show 18 more
  • polyuria
  • nocturia
  • vulvar itching
  • genital itching
  • dyslipidemia
  • elevated serum creatinine
  • elevated blood urea
  • weight loss
  • diarrhea
  • nausea/vomiting
  • decreased/deficient vitamin B12
  • abdominal pain
  • indigestion
  • abdominal discomfort
  • abdominal pain
  • gastric ulcers
  • irritable bowel syndrome
  • saliva

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to retain its effectiveness over time.

Appearance and packaging

Appearance

Pink, oval-shaped, bilayered, film-coated tablet

Package unit

Box - 30 tablets/box [6 tablets (Alu-Alu)x5], Bottle - 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.