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)이든파마
Appearance
Beige oval film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP X 3)]
Approval status
Active

MFDS item code 202300293 · Approved 2023.01.18 · Insurance code 628902220

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
Sitagliptin 100 mg and Dapagliflozin 10 mg, taken once daily as 1 tablet regardless of meal. The tablet should be swallowed whole.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps control blood sugar levels in patients with type 2 diabetes by using Sitagliptin and Dapagliflozin together. It is used to effectively improve blood sugar levels in conjunction with dietary restrictions and exercise therapy. Therefore, it serves as an important adjunctive treatment in the management of type 2 diabetes.

Dosage and Administration

Adult dosage

Sitagliptin 100 mg and Dapagliflozin 10 mg, taken once daily as 1 tablet regardless of meal. The tablet should be swallowed whole.

Precautions

This medication may cause severe allergic reactions due to the Sitagliptin component; if an allergic reaction is suspected, discontinue use immediately and consult a doctor. This medication can cause severe side effects such as acute pancreatitis, marked by inflammation of the pancreas, so if symptoms such as abdominal pain, nausea, or vomiting occur during use, notify healthcare personnel immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and in patients undergoing dialysis. In patients with decreased fluid volume or renal function issues, this medication may cause symptomatic hypotension or worsen renal function, so renal function and fluid status should be carefully assessed before and during use. This medication may increase the risk of genital and urinary infections, so rapid treatment should be sought if infection symptoms develop. As there is a risk of hypoglycemia, blood glucose levels must be carefully monitored and dosing adjusted if used in conjunction with insulin or sulfonylureas. Elderly patients are at higher risk for renal function decline and decreased fluid volume; hence, more caution is needed when taking this medication, and regular monitoring of renal function is recommended. Pregnant or lactating women should avoid using this medication, and it should be discontinued immediately if pregnancy is confirmed. If abnormal symptoms such as skin blisters, rash, or severe joint pain occur during use, notify a doctor immediately. In the case of overdose, no specific antidote is available, so appropriate treatment should be administered based on symptoms. While this medication does not greatly affect driving or machine operation, caution is advised as hypoglycemic symptoms may occur. The safety and efficacy of this medication in children have not been established, so it is advised not to administer it to patients under 18 years of age.

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 fever, blisters, skin peeling, pain in oral/ocular mucous membranes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headache, lightning-like headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Headache
  • dizziness
  • nausea
  • diarrhea
  • constipation
  • dry mouth
  • back pain
  • dysuria
  • polyuria
  • nocturia
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  • itching
  • cold sweat
  • chest pain
  • weakness
  • fatigue
  • pain
  • swelling
  • hunger
  • vaginal discharge
  • menstrual irregularities
  • fever
  • foreign body sensation
  • facial swelling
  • facial pain
  • warmth
  • sweating abnormalities
  • flank pain
  • muscle fiber pain
  • limb discomfort
  • muscle cramps
  • musculoskeletal discomfort
  • osteoporosis
  • muscle weakness
  • joint pain
  • musculoskeletal pain
  • limb pain
  • myalgia
  • osteoarthritis.

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness and safety of the medication for a prolonged period.

Appearance and packaging

Appearance

Beige oval film-coated tablets

Package unit

30 tablets/box [(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.