Medication info
Sildapa Tablets 10/100 mg (Dapagliflozin, Sitagliptin)

Sildapa Tablets 10/100 mg (Dapagliflozin, Sitagliptin)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.6mg / 1 tabletDapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Yellow oval film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202204006 · Approved 2022.11.04 · Insurance code 643508660

Summary

Main use
Improves blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This drug can be administered to patients taking 100 mg of sitagliptin and 10 mg of dapagliflozin, at a dosage of one tablet once daily, regardless of meals. The tablet should be swallowed whole.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Improves blood sugar control in type 2 diabetes

View approved original text

This drug is used to assist in blood sugar control for patients with type 2 diabetes who require combination therapy with sitagliptin and dapagliflozin. It is administered as an adjunct to meal and exercise therapy to help improve blood sugar management.

Dosage and Administration

Adult dosage

This drug can be administered to patients taking 100 mg of sitagliptin and 10 mg of dapagliflozin, at a dosage of one tablet once daily, regardless of meals. The tablet should be swallowed whole.

Precautions

This drug contains two ingredients, dapagliflozin and sitagliptin, and is used for the treatment of type 2 diabetes. First, the sitagliptin component may cause allergic reactions, so if symptoms such as skin rash, shortness of breath, or swelling of the face or neck occur, use should be discontinued immediately. In addition, there is a risk of acute pancreatitis, which is inflammation of the pancreas, so if abdominal pain, vomiting, or severe indigestion occurs, consult a doctor immediately. Next, this drug should not be used by patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. The dapagliflozin component may cause reduced body fluid or low blood pressure; thus, patients with dehydration or at risk for hypotension need to undergo thorough testing before taking this medication, and symptoms should be closely monitored during use. Particularly, patients with decreased kidney function or the elderly should exercise additional caution. While taking this drug, the risk of infection may increase, particularly urinary tract or genital infections, hence attention to cleanliness is essential, and immediate treatment is necessary if infection symptoms occur. Hypoglycemia may occur, so when taking it along with insulin or other hypoglycemic agents, blood glucose levels should be checked frequently, and appropriate measures should be taken if hypoglycemic symptoms arise. Pregnant or breastfeeding women are advised to avoid using this medication, and if planning to become pregnant or confirmation of pregnancy occurs, it is necessary to consult a doctor. Elderly patients should regularly test their kidney function to monitor for potential declines. In case of overdose, there are no specific antidotes, so appropriate treatment should be received based on the symptoms, and monitoring at a hospital may be required if necessary. Finally, safety and efficacy in children have not been established, so it should not be taken by anyone under 18 years of age, and when stored, it should be kept out of reach of children.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • severe hypersensitivity reactions
  • anaphylaxis
  • angioedema
  • Stevens-Johnson syndrome
Show 14 more
  • exfoliative dermatitis
  • acute pancreatitis
  • hemorrhagic or necrotizing pancreatitis
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • acute kidney injury
  • worsening kidney function
  • rash
  • severe skin adverse reactions
  • liver abnormalities (jaundice)
  • sudden and severe headache
  • seizures
  • loss of consciousness

Mild side effects

  • Vulvovaginitis
  • balanitis
  • urinary tract infection
  • fungal infection
  • reduced body fluid
  • thirst
  • hypoglycemia
  • dizziness
  • constipation
  • dry mouth
Show 28 more
  • back pain
  • dysuria
  • polyuria
  • nocturia
  • headache
  • decreased appetite
  • nausea
  • diarrhea
  • vomiting
  • sensory impairment
  • paresthesia
  • indigestion
  • weakness
  • hunger
  • itching
  • hives
  • cold sweat
  • edema
  • facial swelling
  • facial pain
  • warmth
  • flu-like symptoms
  • menstrual irregularities
  • vaginal discharge
  • hair loss
  • dermatitis
  • dry skin
  • allergy

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture, and safely stored at a temperature between 1 to 30 degrees Celsius. This storage method helps maintain the drug's efficacy and prevents degradation.

Appearance and packaging

Appearance

Yellow oval film-coated tablets

Package unit

30 tablets/bottle

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.