Medication info

Januduo Tablet 10/100 mg

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

MFDS item code 202300386 · Approved 2023.01.30

Summary

Main use
Improvement in blood glucose control for type 2 diabetes
Who uses it
Adults
Adult dosage
The recommended dosage for this medication is one tablet daily, taken without regard to meals, for patients receiving sitagliptin 100 mg and dapagliflozin 10 mg. The tablet should be swallowed whole.

Ingredients

Manufacturer
(주)킴스제약

Efficacy & effects

Improvement in blood glucose control for type 2 diabetes

View approved original text

This medication is used to help control blood glucose levels in patients with type 2 diabetes by combining sitagliptin and dapagliflozin. It supports effective management of blood glucose levels when taken alongside dietary and exercise strategies. Thus, this medication is utilized as a therapeutic agent to aid in the improvement of blood glucose control.

Dosage and Administration

Adult dosage

The recommended dosage for this medication is one tablet daily, taken without regard to meals, for patients receiving sitagliptin 100 mg and dapagliflozin 10 mg. The tablet should be swallowed whole.

Precautions

This medication can rarely cause serious allergic reactions, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, you should stop taking it immediately and consult a doctor. This medication carries a risk of pancreatitis, inflammation of the pancreas, so if severe abdominal pain, vomiting, or fever develops, promptly inform a healthcare professional. This medication is not to be used in patients with allergies to specific components, type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. It should be used cautiously in patients with reduced fluid volume or impaired kidney function, as there could be a risk of blood pressure drops or worsening kidney function requiring regular monitoring. This medication may cause hypoglycemia, so especially when taken with insulin or sulfonylurea medications, careful monitoring of blood glucose levels may be necessary and dose adjustments may be needed. There may be an increased risk of genital infections or urinary tract infections, so if symptoms of infection arise, immediate treatment should be sought, particularly in patients with a history of infections. This medication is not recommended for use in pregnant or breastfeeding women, and should be discontinued if pregnancy is confirmed. In elderly patients, there may be reduced kidney function, making dose adjustments and monitoring of kidney function vital, along with careful attention to fluid volume and low blood pressure. There is no specific antidote for overdose, so appropriate treatment based on symptoms should be received, and dialysis may be considered if needed. While taking this medication, caution is advised when driving or operating machinery due to the risk of hypoglycemia. This medication should be stored in its original container and kept in a secure place out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, respiratory problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Hypoglycemia
  • headache
  • upper respiratory infection
  • pharyngitis
  • diarrhea
  • nausea
  • indigestion
  • vomiting
  • constipation
  • dizziness
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  • weight loss
  • urinary tract infection
  • genital itching
  • balanitis
  • genital infections
  • rash
  • itching
  • cold sweat
  • urticaria
  • increased blood creatinine
  • abdominal pain
  • abdominal discomfort
  • menstrual irregularities
  • cough
  • difficulty breathing
  • palpitations
  • insomnia
  • facial swelling
  • weakness
  • fatigue
  • joint pain
  • musculoskeletal pain
  • limb pain
  • myalgia
  • allergy

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

Storage

This medication should be stored in a sealed container to prevent exposure to air and moisture, and it is important to keep it at room temperature between 1°C and 30°C. Storing it this way helps maintain the medication's effectiveness and safety.

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.