Medication info
Janubifor Tablets 10/100 mg

Janubifor Tablets 10/100 mg

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

MFDS item code 202300202 · Approved 2023.01.11 · Insurance code 658204700

Summary

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

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps effectively control blood sugar levels in patients with type 2 diabetes by taking Sitagliptin and Dapagliflozin together. It shows better effects when combined with dietary control and exercise therapy and is used to stabilize blood sugar levels.

Dosage and Administration

Adult dosage

This medication can be administered to patients receiving 100 mg of Sitagliptin and 10 mg of Dapagliflozin as one tablet once daily regardless of meals. The tablet should be swallowed whole.

Precautions

This medication contains Sitagliptin and Dapagliflozin and is used for diabetes treatment. First, severe allergic reactions may occur while taking this medication, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck appear, you should immediately stop taking it and consult a physician. Additionally, serious side effects such as pancreatitis, which causes inflammation of the pancreas, have been reported, so if you experience abdominal pain, nausea, or vomiting, you should visit a healthcare facility immediately. This medication should not be used in patients with type 1 diabetes or those undergoing dialysis, nor should it be administered to individuals with a history of allergy to the main ingredients or excipients. Patients with impaired kidney function or the elderly require dose adjustments and kidney function tests, and periodic checks of blood pressure and fluid status are necessary due to risks of hypotension and dehydration. During treatment, attention should be paid to symptoms of hypoglycemia, and especially when taken in conjunction with insulin or sulfonylureas, there may be an increased risk of hypoglycemia, necessitating dose adjustments. The Dapagliflozin component may increase the risk of genital infections and urinary tract infections, so prompt treatment is necessary if symptoms of infection occur. Pregnant women or those planning to become pregnant should avoid using this medication, and breastfeeding women are also advised against its use. During treatment, it is important to maintain adequate hydration, and if symptoms of decreased fluid volume appear, immediate consultation with healthcare personnel is necessary. Finally, the safety and efficacy of this medication in children have not been established, and renal function monitoring is important in the elderly. If abnormal symptoms occur during treatment, it is necessary to inform a physician immediately and take appropriate measures.

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 fever, blisters, skin peeling, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe malaise, sudden and severe headache, thunderclap headache, seizures, confusion, visual abnormalities, paralysis, urination

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • dizziness
  • dry mouth
  • back pain
  • dysuria
  • polyuria
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  • nocturia
  • itching of the vulva
  • pruritus
  • cold sweat
  • weight loss
  • muscle fiber pain
  • limb discomfort
  • muscle cramps
  • musculoskeletal discomfort
  • side pain
  • myalgia
  • osteopenia
  • arthralgia
  • musculoskeletal pain
  • limb pain
  • muscle weakness
  • palpitations
  • insomnia
  • dyspepsia
  • nausea
  • diarrhea
  • decreased appetite
  • next-day syndrome
  • taste disturbance
  • drowsiness
  • sleep disturbances

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is best to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Beige oval film-coated tablets

Package unit

30 tablets/TP[10 tablets/TP×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.