Medication info
Sitagliptin and Dapagliflozin Tablets 10/100 mg (Dapagliflozin Propanediol Monohydrate, Sitagliptin Phosphate Monohydrate)

Sitagliptin and Dapagliflozin Tablets 10/100 mg (Dapagliflozin Propanediol Monohydrate, Sitagliptin Phosphate Monohydrate)

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
Beige oval film-coated tablets
Packaging
30 tablets/PTP [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202300036 · Approved 2023.01.03 · Insurance code 647304510

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication can be administered as one tablet once daily for patients receiving 100 mg of sitagliptin and 10 mg of dapagliflozin, regardless of meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
에이치엘비제약(주)

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

View approved original text

This medication is used to help effectively manage blood sugar levels in patients with type 2 diabetes, in conjunction with dietary and exercise regimens. It is particularly suitable for use of both sitagliptin and dapagliflozin together, helping to manage blood glucose levels more stably. This contributes to smoother diabetes management and reduces the risk of complications. If taken safely and consistently, positive effects on blood sugar control can be expected.

Dosage and Administration

Adult dosage

This medication can be administered as one tablet once daily for patients receiving 100 mg of sitagliptin and 10 mg of dapagliflozin, regardless of meals. The tablet should be swallowed whole.

Precautions

This medication can cause allergic reactions, so patients with hypersensitivity should not use it. During treatment, serious pancreatic diseases such as acute pancreatitis may occur, so if symptoms like abdominal pain or vomiting arise, consult a physician immediately. It is contraindicated in patients with type 1 diabetes, diabetic ketoacidosis, and those undergoing dialysis. Patients with impaired renal function or at risk of decreased fluid volume should use this medication with caution, and kidney function and blood pressure should be monitored regularly. As this medication has blood sugar-lowering effects, the risk of hypoglycemia may increase when taken with insulin or sulfonylureas, so dosage adjustments may be necessary. The risk of genital infections or urinary tract infections may increase, so treatment should be sought immediately if infection symptoms occur. Elderly patients or those with liver dysfunction should also use this medication with caution, and regular health status monitoring is recommended. Women who are pregnant or breastfeeding should not take this medication, and if pregnancy is confirmed, use should be discontinued immediately. Symptoms such as decreased fluid volume, hypotension, or ketoacidosis may occur during treatment, and if any abnormal symptoms arise, immediate consultation with healthcare professionals is necessary. In case of overdose, seek medical attention immediately for appropriate treatment, as there is no specific antidote and symptomatic treatment based on the symptoms is necessary. This medication is not recommended for children, as its safety and efficacy have not been established in this population. If driving or operating machinery during treatment, caution is advised due to the risk of hypoglycemia.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin disease, acute pancreatitis, hemorrhagic pancreatitis, necrotizing pancreatitis, severe rash with high fever, blisters, epidermal peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory distress, jaundice (yellowing of the skin or eyes).

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • diarrhea
  • thirst
  • hypoglycemia
  • dizziness
  • back pain
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  • dysuria
  • polyuria
  • nocturia
  • itching of the external genitalia
  • itching of the genitals
  • rash
  • pruritus
  • cold sweat
  • dermatitis
  • dry skin
  • hyperkeratosis
  • skin lesions
  • flank pain
  • myalgia
  • limb discomfort
  • muscle cramps
  • musculoskeletal discomfort
  • osteopenia
  • trauma
  • bruising
  • vascular headache
  • orthostatic hypotension
  • palpitations
  • insomnia
  • tinnitus
  • and others.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Beige oval film-coated tablets

Package unit

30 tablets/PTP [10 tablets/PTP 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.