Medication info
Dapagliflozin and Sitagliptin Tablets 10/100 mg

Dapagliflozin and Sitagliptin Tablets 10/100 mg

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Bright yellow film-coated oblong tablet
Packaging
Box - 28 tablets/box [7 tablets/Alu-Alu x 4], Box - 30 tablets/box [10 tablets/Alu-Alu x 3]
Approval status
Active

MFDS item code 202200054 · Approved 2022.01.04 · Insurance code 645210670

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication may be administered as one tablet orally once daily regardless of meals to patients taking 100 mg of Sitagliptin and 10 mg of Dapagliflozin. The tablet should be swallowed whole.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to assist in blood sugar control for patients with type 2 diabetes taking Sitagliptin and Dapagliflozin together. When combined with diet and exercise therapy, it can effectively improve blood sugar levels. This contributes to smoother blood sugar management and helps prevent complications of diabetes. In other words, this medication is used to enhance blood sugar control in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

This medication may be administered as one tablet orally once daily regardless of meals to patients taking 100 mg of Sitagliptin and 10 mg of Dapagliflozin. The tablet should be swallowed whole.

Precautions

This medication contains Sitagliptin and Dapagliflozin, both of which are used in the treatment of diabetes. First, Sitagliptin can rarely induce severe allergic reactions, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck appear within three months of administration, it should be discontinued immediately and a doctor consulted. Additionally, Sitagliptin may cause acute pancreatitis; hence, if symptoms like abdominal pain, vomiting, or fever occur, inform a healthcare professional immediately. Dapagliflozin can lead to decreased blood pressure or kidney function disorder by reducing the body’s fluid level, so patients with impaired kidney function, the elderly, or those on diuretics should confirm their fluid status and kidney function before taking this medication, and monitor periodically during treatment. This medication is not safe for patients with a history of hypersensitivity, those with type 1 diabetes, or patients undergoing dialysis. Dapagliflozin may increase the risk of urinary tract infections and genital infections, and immediate treatment is required if infection symptoms appear. Moreover, serious metabolic abnormalities known as diabetic ketoacidosis may occur; thus, if symptoms such as vomiting, abdominal pain, shortness of breath, or fatigue occur, immediate medical attention should be sought. When this medication is taken in conjunction with insulin or sulfonylureas, the risk of hypoglycemia may increase, requiring frequent blood sugar checks and dosage adjustments as necessary. Women who are pregnant or breastfeeding are advised not to use this medication, especially avoiding Dapagliflozin while breastfeeding. Elderly patients may have reduced kidney function, so it is important to regularly test kidney function before and during use. In case of overdose, there is no specific antidote; thus, appropriate treatment should be provided according to symptoms, and Sitagliptin can be partially removed by hemodialysis. Finally, this medication does not significantly impact driving or operating machinery, but caution is advised for the risk of hypoglycemia when used with insulin or sulfonylureas.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice, extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision problems, paralysis, urination.

Mild side effects

  • Headache
  • diarrhea
  • vomiting
  • dyspepsia
  • constipation
  • thirst
  • back pain
  • altered taste
  • drowsiness
  • itching
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  • weakness
  • fatigue
  • palpitations
  • insomnia
  • decreased appetite
  • weight loss
  • genital infection
  • urinary tract infection
  • dysuria
  • polyuria
  • nocturia
  • increased serum creatinine
  • increased serum urea
  • dyslipidemia
  • hives
  • cold sweat
  • chest pain
  • facial swelling
  • facial pain
  • warmth
  • fever
  • hunger
  • joint pain
  • musculoskeletal pain
  • limb pain
  • proximal myopathy.

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 air and moisture from entering. It is recommended to maintain storage temperatures between 1 to 30 degrees Celsius. This can help preserve the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Bright yellow film-coated oblong tablet

Package unit

Box - 28 tablets/box [7 tablets/Alu-Alu x 4], Box - 30 tablets/box [10 tablets/Alu-Alu x 3]

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.