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

Dapasitin Tablet 10/100 mg (Dapagliflozin, Sitagliptin)

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)테라젠이텍스
Appearance
Yellow circular film-coated tablet
Packaging
For oral use - 28 tablets/PTP
Approval status
Active

MFDS item code 202301736 · Approved 2023.06.02 · Insurance code 698504810

Summary

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

Ingredients

Manufacturer
(주)테라젠이텍스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps improve blood sugar control in patients with type 2 diabetes when used in conjunction with diet and exercise therapy by administering sitagliptin and dapagliflozin together.

Dosage and Administration

Adult dosage

For patients taking sitagliptin 100 mg and dapagliflozin 10 mg, the recommended dose is one tablet daily regardless of meals. The tablet should be swallowed whole.

Precautions

This medication contains sitagliptin and dapagliflozin and is used for diabetes treatment. Firstly, the sitagliptin ingredient may cause rare but serious allergic reactions; thus, patients should seek immediate medical attention if symptoms such as skin rash, difficulty breathing, or swelling of the face or lips occur within three months of administration. Moreover, sitagliptin may cause acute pancreatitis, and if symptoms like abdominal pain, nausea, or vomiting arise, patients should stop taking the medication immediately and consult a doctor. This medication is not to be administered to patients who are allergic to the main ingredients or excipients, patients with type 1 diabetes, diabetic ketoacidosis patients, those on dialysis, and specific genetic lactose-intolerant patients. Dapagliflozin may cause hypotension or kidney impairment in patients with decreased body fluid volume or poor kidney function, so these patients must have their kidney function and fluid status thoroughly assessed before administration and monitored closely during treatment. Sitagliptin is excreted through the kidneys, thus requiring dose adjustment in patients with impaired kidney function. Patients with an allergy to the yellow dye No. 5 included in this medication should use it with caution. While taking this medication, symptoms such as genital infections, urinary tract infections, hypoglycemia, dehydration symptoms, and ketoacidosis may occur, so patients should inform medical personnel immediately if any such symptoms arise. In particular, dapagliflozin may have a weight-reducing effect in patients with poorly controlled blood glucose. Rare cases of severe infections around the genitals (perineal necrotizing fasciitis) have been reported in diabetic patients, and if symptoms such as fever, pain, or swelling appear, immediate treatment is necessary. Pregnant or breastfeeding women are advised not to use this medication. Elderly patients or those with decreased kidney function should evaluate their kidney function before treatment and should regularly monitor their kidney status during treatment. This medication may increase the risk of hypoglycemia when used with other glucose-lowering agents, requiring dose adjustments of insulin or sulfonylureas. In case of overdose, immediate consultation with medical personnel and appropriate treatment should be sought; dialysis removal is limited. Lastly, the safety and efficacy of this medication have not been confirmed for children; thus it should not be used in patients under 18 years of age. Patients should be cautious of hypoglycemic symptoms while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

  • Anaphylaxis
  • angioedema
  • Stevens-Johnson syndrome
  • exfoliative skin disorders
  • acute pancreatitis
  • hemorrhagic pancreatitis
  • necrotizing pancreatitis
  • severe allergic reactions
  • severe skin adverse reactions
  • difficulty breathing
Show 13 more
  • asthma attacks
  • respiratory issues
  • yellowing of the skin or eyes
  • jaundice
  • liver abnormalities
  • sudden and severe headaches
  • thunderclap headaches
  • seizures
  • confusion in consciousness
  • vision abnormalities
  • paralysis
  • severe neurological symptoms
  • significantly reduced urine output

Mild side effects

  • Vulvovaginitis
  • balanitis
  • genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • constipation
  • back pain
  • dysuria
Show 27 more
  • polyuria
  • nocturia
  • itching
  • hives
  • diaphoresis
  • headache
  • dizziness
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • vaginal discharge
  • chest pain
  • fatigue
  • weakness
  • hunger
  • fever
  • facial swelling
  • facial pain
  • edema
  • genital itching
  • menstrual irregularities
  • musculoskeletal pain
  • arthralgia
  • myalgia
  • myasthenia
  • palpitations

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, and the storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. In other words, avoid storing it in overly hot or cold places; keeping it at a stable temperature will preserve its effectiveness well.

Appearance and packaging

Appearance

Yellow circular film-coated tablet

Package unit

For oral use - 28 tablets/PTP

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.

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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.