Medication info
Dapagliflozin Plus Tablet 10/100 mg

Dapagliflozin Plus Tablet 10/100 mg

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
Bright yellow oval film-coated tablet
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 202200050 · Approved 2022.01.04 · Insurance code 651206000

Summary

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

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is recommended as an adjunct to diet and exercise for improving blood sugar control in patients with type 2 diabetes. It helps effectively lower blood sugar levels by the combined action of sitagliptin and dapagliflozin. This helps to maintain stable blood sugar levels and aids in the management of diabetes. Patients are encouraged to take it consistently and make efforts to improve their lifestyle. This medication is used to enhance blood sugar control.

Dosage and Administration

Adult dosage

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

Precautions

This medication contains the ingredients sitagliptin and dapagliflozin, which help control blood sugar. When taking this medication, allergic reactions may occur, so if symptoms such as skin rash, swelling, or difficulty breathing appear, discontinue use immediately and consult a physician. Additionally, it may cause acute pancreatitis, which is inflammation of the pancreas, so if abdominal pain, vomiting, or severe abdominal discomfort occurs after taking it, visit a hospital immediately. This medication is not safe for patients with impaired kidney function or those undergoing dialysis, and dosage adjustment is necessary in cases of mild renal impairment. Blood pressure may decrease due to decreased fluid volume during use, so elderly patients or those taking diuretics should be cautious of dehydration symptoms or dizziness. This medication may increase the risk of genital infections and urinary tract infections, so appropriate treatment should be received if infection symptoms appear. Serious metabolic disturbances called diabetic ketoacidosis may occur, so if symptoms such as nausea, vomiting, abdominal pain, or difficulty breathing occur during use, inform a physician immediately. Women who are pregnant or breastfeeding are advised not to take this medication, and if planning for pregnancy or pregnancy is confirmed, consult a physician. This medication has not established safety and efficacy in children under 18 years of age, so it should not be used. During use, symptoms of hypoglycemia may appear, so especially when taking insulin or sulfonylurea medications together, blood sugar should be monitored carefully. In the case of overdose, there are no specific antidotes, so appropriate treatment should be received based on symptoms, and dialysis treatment may be considered if necessary. Finally, this medication does not significantly impact driving or operating machinery, but caution is needed due to the risk of hypoglycemia. Keep the medication out of the reach of children and store it in its original container.

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 high fever, blisters, peeling of skin, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthmatic attack, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • hypoglycemia
  • dry mouth
  • constipation
  • back pain
  • dysuria
  • nocturia
Show 22 more
  • elevated hematocrit
  • increased serum creatinine
  • dyslipidemia
  • dizziness
  • headache
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • itching
  • sweating
  • dermatitis
  • xerosis
  • hyperkeratosis
  • arthralgia
  • musculoskeletal pain
  • limb pain
  • weakness
  • myalgia
  • osteoarthritis
  • cough
  • ho

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree Celsius and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

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.