Medication info
Sidapflo Tablets 10/100 mg

Sidapflo Tablets 10/100 mg

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
영진약품(주)
Appearance
Bright yellow rectangular film-coated tablets
Packaging
Box - 28 tablets/box [(7 tablets/PTP (Alu-Alu) x 4)], Box - 30 tablets/box [(10 tablets/PTP (Alu-Alu) x 3)]
Approval status
Active

MFDS item code 202200048 · Approved 2022.01.04 · Insurance code 642405120

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication can be administered at 1 tablet once daily, regardless of meals, to patients receiving sitagliptin 100 mg and dapagliflozin 10 mg. The tablet should be swallowed whole.

Ingredients

Manufacturer
영진약품(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This drug is designed as an adjunct to diet and exercise to help effectively control blood sugar for patients with type 2 diabetes. Sitagliptin and dapagliflozin work together to help improve blood sugar levels, enhancing patients' blood sugar management. Therefore, this medication is used to improve blood sugar control in type 2 diabetes.

Dosage and Administration

Adult dosage

This medication can be administered at 1 tablet once daily, regardless of meals, to patients receiving sitagliptin 100 mg and dapagliflozin 10 mg. The tablet should be swallowed whole.

Precautions

This medication contains sitagliptin and dapagliflozin and is used in the treatment of diabetes. Before use, it should not be taken if there is a known allergy to any of the ingredients or if a hypersensitivity reaction has occurred previously. In particular, serious allergic reactions such as anaphylaxis or angioedema may occur, so if such symptoms are suspected, the medication should be discontinued immediately and a doctor should be consulted. This medication may cause serious side effects such as pancreatitis, characterized by inflammation of the pancreas, so if symptoms like abdominal pain, vomiting, or nausea appear during treatment, medical personnel should be informed immediately. Dapagliflozin can lead to decreased fluid volume and impaired kidney function, so close caution is particularly needed for patients with poor kidney function or those taking diuretics. Patients with low blood pressure or at risk of reduced fluid volume should consult medical personnel before using this medication and should regularly monitor their blood pressure and kidney function during treatment. Serious metabolic abnormalities, such as diabetic ketoacidosis, may occur; therefore, patients taking this medication should carefully observe for symptoms of ketoacidosis such as abdominal pain, vomiting, and difficulty breathing. This medication may increase the risk of genital and urinary tract infections, so immediate treatment should be sought upon appearance of infection symptoms. Elderly patients or those with decreased kidney function require dosage adjustments and kidney function testing, and patients undergoing dialysis should not take this medication. The risk of hypoglycemia may increase when taken with other antidiabetic agents such as insulin or sulfonylureas, so dosage adjustments may be necessary. Women who are pregnant or breastfeeding should avoid taking this medication, and it should be stopped immediately if pregnancy is confirmed. If symptoms such as skin rash, hives, severe joint pain, or blistering skin conditions occur during treatment, medical personnel should be informed immediately. In the case of overdose, there is no specific antidote, and symptomatic treatment should be administered as needed, with dialysis treatment considered if necessary. Patients should be cautious of hypoglycemic symptoms during driving or operating machinery, and the medication should be stored 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, anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin disease, severe rash with high fever, blisters, peeling skin, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe reactions

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • dry mouth
  • dizziness
  • constipation
  • back pain
  • dysuria
  • polyuria
Show 22 more
  • nocturia
  • elevated hematocrit
  • increased serum creatinine
  • dyslipidemia
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • upper respiratory tract infections
  • nasopharyngitis
  • headache
  • itching
  • sweating
  • edema
  • fever
  • foreign body sensation
  • facial swelling
  • facial pain
  • warmth
  • flu-like symptoms
  • weakness
  • fatigue

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is safe to store at room temperature, which is between 1 degree and 30 degrees Celsius, avoiding extremes of temperature.

Appearance and packaging

Appearance

Bright yellow rectangular film-coated tablets

Package unit

Box - 28 tablets/box [(7 tablets/PTP (Alu-Alu) x 4)], Box - 30 tablets/box [(10 tablets/PTP (Alu-Alu) 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.