Medication info
Dapalcita Tablet 10/100mg (Dapagliflozin, Sitagliptin)

Dapalcita Tablet 10/100mg (Dapagliflozin, Sitagliptin)

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

MFDS item code 202300369 · Approved 2023.01.30 · Insurance code 645702900

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
Patients taking sitagliptin 100 mg and dapagliflozin 10 mg may take 1 tablet once daily with or without meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
삼아제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to help control blood sugar in patients with type 2 diabetes. It is especially effective for those who are also following dietary and exercise therapies and is suitable for combination therapy with sitagliptin and dapagliflozin. This helps to manage blood sugar levels more effectively.

Dosage and Administration

Adult dosage

Patients taking sitagliptin 100 mg and dapagliflozin 10 mg may take 1 tablet once daily with or without meals. The tablet should be swallowed whole.

Precautions

This medication is a diabetes treatment combining two active ingredients that assist in blood sugar control. The first ingredient inhibits glucose reabsorption in the kidneys, increasing glucose excretion in the urine, resulting in lower blood sugar levels. However, this process can reduce body fluid levels, which may lower blood pressure, thus patients with dehydration or low blood pressure should exercise caution. Additionally, this ingredient can increase the risk of kidney damage in patients with reduced kidney function or the elderly, so kidney function should be carefully monitored before and after administration. If symptoms of reduced fluid volume occur, discontinuation of the medication may be necessary, and there is also a risk of developing a serious metabolic disorder known as diabetic ketoacidosis, so patients should consult healthcare professionals immediately if symptoms occur. The second ingredient stimulates insulin secretion and helps control blood sugar. This ingredient may cause allergic reactions, or rarely, severe pancreatitis in some patients, so patients should notify their doctors immediately if they experience skin rashes or abdominal pain. This medication may increase the risk of hypoglycemia, so when taken with other glucose-lowering agents such as insulin or sulfonylureas, blood sugar levels should be closely monitored, and dosage adjustments may be necessary. This medication is not to be used in specific patients, such as those allergic to the components or patients with type 1 diabetes or those undergoing dialysis. It is recommended that pregnant or lactating women avoid using this medication, especially during breastfeeding, as it may affect the infant. While taking this medication, the possibility of infections, particularly genital and urinary tract infections, may arise, so prompt treatment should be sought upon the appearance of related symptoms. Elderly patients or those with decreased kidney function have a higher risk of adverse effects while on this medication, hence regular health checks are necessary. Finally, care should be taken when driving or operating machinery during treatment, as the risk of accidents due to hypoglycemia exists.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin disease, acute pancreatitis, hemorrhagic pancreatitis, necrotizing pancreatitis, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or breathing difficulty, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice)

Mild side effects

  • Vulvitis
  • balanitis
  • fungal infections
  • urinary tract infections
  • hypoglycemia
  • thirst
  • dizziness
  • constipation
  • dry mouth
  • back pain
Show 26 more
  • dysuria
  • polyuria
  • nocturia
  • elevated serum creatinine
  • weight loss
  • paresthesia
  • headache
  • nasopharyngitis
  • dyspepsia
  • nausea
  • diarrhea
  • itching
  • hives
  • cold sweats
  • chest pain
  • asthenia
  • fatigue
  • pain
  • edema
  • menstrual irregularities
  • vaginal discharge
  • hair loss
  • dermatitis
  • dry skin
  • allergic dermatitis
  • contact dermatitis

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should ideally be maintained at room temperature between 1 degree and 30 degrees Celsius. This will help to preserve the effectiveness and safety of the medication over time.

Appearance and packaging

Appearance

Beige oval film-coated tablet

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.