Medication info

Penmix Sitagliptin Tablets (Sitagliptin Phosphate Monohydrate · Dapagliflozin Propanediol Monohydrate)

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

MFDS item code 202300260 · Approved 2023.01.16

Summary

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

Ingredients

Manufacturer
(주)펜믹스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is designed to help patients with type 2 diabetes manage their blood sugar levels more effectively. In particular, sitagliptin and dapagliflozin work together to support dietary and exercise regimens, enabling stable management of blood sugar levels. Maintaining good blood sugar control can also reduce the risk of complications, so regular use is important. This medication is intended for improving blood sugar control.

Dosage and Administration

Adult dosage

For patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, one tablet may be administered once daily regardless of meals. The tablet should be swallowed whole.

Precautions

This medication contains sitagliptin phosphate monohydrate and dapagliflozin propanediol monohydrate. First, the sitagliptin component can rarely cause severe allergic reactions; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur within three months of starting treatment, usage should be immediately stopped and a healthcare professional consulted. Additionally, sitagliptin can cause acute pancreatitis, an inflammation of the pancreas, so if symptoms such as abdominal pain, nausea, or vomiting occur, healthcare professionals should be notified immediately. This medication should not be used in patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. The dapagliflozin component may cause low blood pressure or impaired kidney function due to decreased body fluid levels. Therefore, patients with poor kidney function, elderly patients, and those on diuretics should carefully check their kidney function and fluid status before administration, and periodically monitor blood pressure and kidney function during treatment. This medication may increase the risk of genital and urinary infections; if symptoms of infection, such as itching, pain, or increased discharge, occur, consult a doctor immediately. Moreover, serious metabolic imbalances known as diabetic ketoacidosis may arise, so if symptoms such as vomiting, abdominal pain, difficulty breathing, or fatigue occur, immediate medical attention is required. This medication is not recommended for use during pregnancy, and should be immediately discontinued if pregnancy is confirmed. It is also advisable for breastfeeding women not to use this medication. Safety and efficacy in children under 18 have not been established, so it should not be used in this population. While taking this medication, there is a risk of hypoglycemia when used in conjunction with insulin or sulfonylureas, so patients should be vigilant for signs of low blood sugar and adjust the doses of those medications if necessary. In case of overdose, visit a medical institution immediately for appropriate treatment, and dialysis may be somewhat helpful. Finally, while this medication does not significantly affect driving or machine operation, caution should be taken due to the possible occurrence of hypoglycemia.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, acute pancreatitis, pancreatitis, Stevens-Johnson syndrome, bullous pemphigoid, acute renal failure, deterioration of kidney function, necrotizing fasciitis (Fournier's gangrene), acute kidney injury, urinary sepsis, and pyelonephritis, severe hypoglycemia, diabetic ketoacidosis, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), neurological symptoms, severe edema or abdominal swelling.

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • dry mouth
  • dizziness
  • constipation
  • dry mouth
  • low back pain
  • dysuria
Show 26 more
  • polyuria
  • nocturia
  • headache
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • abdominal discomfort
  • edema
  • itching
  • hives
  • diaphoresis
  • weakness
  • fatigue
  • fever
  • pain
  • facial edema
  • musculoskeletal pain
  • myalgia
  • arthralgia
  • insomnia
  • palpitations
  • decreased appetite
  • vaginal discharge
  • menstrual irregularities
  • elevated triglycerides.

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, ideally at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Beige oval film-coated tablet

Package unit

30 tablets/PTP [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.