Medication info
Dapagliflozin/ Sitagliptin Tablets 10/100 mg

Dapagliflozin/ Sitagliptin Tablets 10/100 mg

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

MFDS item code 202300188 · Approved 2023.01.10 · Insurance code 649702980

Summary

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

Ingredients

Manufacturer
주식회사 노바엠헬스케어

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used alongside dietary and exercise therapy to assist blood sugar control in patients with type 2 diabetes. The two ingredients, sitagliptin and dapagliflozin, act together to lower blood sugar more effectively. This helps maintain stable blood sugar levels and is beneficial for diabetes management. Patients can expect better results by using this medication in conjunction with regular dietary management and exercise. This medication is used to improve blood sugar control.

Dosage and Administration

Adult dosage

For patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, one tablet may be taken once daily regardless of meals. The tablet should be swallowed whole.

Precautions

This medication contains two ingredients: sitagliptin and dapagliflozin. First, sitagliptin can rarely cause serious allergic reactions, so if symptoms such as rash, difficulty breathing, or swelling of the face or lips occur, discontinue use immediately and consult a doctor. Sitagliptin can also cause acute pancreatitis, a condition where inflammation occurs in the pancreas; thus, if symptoms such as abdominal pain, vomiting, or nausea arise, careful observation is necessary, and medical attention should be sought. Next, dapagliflozin may lead to lower blood pressure or worsen kidney function in patients with impaired kidney function or fluid depletion, so it is essential to routinely monitor blood pressure and kidney function before and during administration. This medication can also increase the risk of genital infections and urinary tract infections, so prompt treatment is required if symptoms of infection appear. Dapagliflozin can cause severe metabolic acidosis known as ketoacidosis, which can occur even if blood sugar is not high; symptoms may include nausea, vomiting, abdominal pain, fatigue, and difficulty breathing. Inform healthcare professionals immediately if these symptoms occur. This medication should not be used in patients with type 1 diabetes, those with diabetic ketoacidosis, or patients on dialysis, and should not be administered to patients with hypersensitivity to the drug or its excipients. Elderly patients or those with reduced kidney function should use this medication with particular caution, and adjustments in dosage may be necessary if used with other blood sugar-lowering agents like insulin or sulfonylureas due to the risk of hypoglycemia. Pregnant or breastfeeding women are advised not to use this medication, and if pregnancy is confirmed, it should be discontinued immediately. In the case of overdose, there is no specific antidote, and appropriate treatment should be provided based on symptoms, although some ingredients may be removed by dialysis. Finally, while taking this medication, caution should be exercised regarding hypoglycemic symptoms when driving or operating machinery, and it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • anaphylaxis
  • angioedema
  • severe hypersensitivity reactions
  • Stevens-Johnson syndrome
  • exfoliative skin disorders
  • acute pancreatitis
  • fatal hemorrhagic pancreatitis
  • necrotizing pancreatitis
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  • difficulty breathing
  • asthma attacks
  • shortness of breath
  • rash
  • blisters
  • peeling skin
  • pain in oral/eye mucous membranes
  • yellowing of the skin or eyes (jaundice)
  • extreme lethargy
  • sudden and severe headaches
  • thunderclap headache
  • seizures

Mild side effects

  • Headache
  • upper respiratory infection
  • rhinitis
  • constipation
  • vomiting
  • dizziness
  • weight loss
  • thirst
  • back pain
  • pain during urination
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  • polyuria
  • nocturia
  • pruritus of the external genitals
  • itching
  • cold sweat
  • elevated serum creatinine
  • dyspepsia
  • diarrhea
  • nausea
  • abdominal pain
  • hunger
  • palpitations
  • insomnia
  • tinnitus
  • edema
  • vascular headache
  • orthostatic hypotension
  • myalgia
  • arthralgia
  • musculoskeletal pain
  • drowsiness
  • taste disturbances
  • fainting
  • anxiety disorders
  • urinary incontinence
  • muscle weakness
  • eating

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

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.