Medication info
Januflo Met Extended Release Tablets 5/50/1000 mg (Dapagliflozin, Sitagliptin, Metformin)

Januflo Met Extended Release Tablets 5/50/1000 mg (Dapagliflozin, Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletSitagliptin Phosphate Hydrate›64.25mg / 1 tabletDapagliflozin Propanediol Hydrate›6.15mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Orange oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202401790 · Approved 2024.07.24 · Insurance code 694004300

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dosage for this medication in diabetes therapy is 10 mg of dapagliflozin and 100 mg of sitagliptin, while the extended-release metformin hydrochloride should not exceed 2000 mg, considering each patient's current therapy, efficacy, and tolerability. This medication is to be taken once daily in the evening with meals, and dose adjustments for metformin hydrochloride should be made incrementally as needed. 10/100/1

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication is used together with dapagliflozin, sitagliptin, and metformin to help control blood glucose in patients with type 2 diabetes. It serves as an adjunct to diet and exercise for those who require additional support and can effectively improve blood glucose levels. Therefore, it is recommended for patients with type 2 diabetes who are struggling with blood glucose management.

How to take

Adult dose

The recommended dosage for this medication in diabetes therapy is 10 mg of dapagliflozin and 100 mg of sitagliptin, while the extended-release metformin hydrochloride should not exceed 2000 mg, considering each patient's current therapy, efficacy, and tolerability. This medication is to be taken once daily in the evening with meals, and dose adjustments for metformin hydrochloride should be made incrementally as needed. 10/100/1

Precautions

This medication contains three components: sitagliptin, dapagliflozin, and metformin. First, the component sitagliptin can rarely cause a serious allergic reaction. If symptoms such as skin rash or difficulty breathing occur within 3 months of administration, the use of the medication should be immediately discontinued and a physician consulted. Additionally, sitagliptin may pose a risk of acute pancreatitis, a form of inflammation of the pancreas; therefore, if abdominal pain, nausea, or vomiting arises, it should be immediately reported to a healthcare professional. Next, the dapagliflozin component carries risks of hypotension or kidney injury, especially in patients with impaired kidney function or low fluid volume. Kidney function should be thoroughly evaluated before administration, and blood pressure and kidney status should be carefully monitored during treatment. This component may also increase the risk of genital infections and urinary tract infections, necessitating prompt treatment for any signs of infection. Rarely, severe infections in the perineal area can occur; immediate medical attention is required if pain or swelling is experienced. Moreover, this medication can trigger severe metabolic disorders, known as diabetic ketoacidosis, which may present symptoms such as vomiting, abdominal pain, and difficulty breathing, even when blood sugar levels are not significantly elevated. Lastly, the metformin component, although rarely, can lead to a life-threatening condition known as lactic acidosis. Patients with impaired kidney function, heart or liver disease, or dehydration should not take this medication, and excessive alcohol intake should also be avoided. During treatment with this medication, it is important to regularly check kidney function, liver function, and vitamin B12 levels. Symptoms of hypoglycemia may occur; thus, meals should not be skipped, and caution should be exercised during exercise or when combining with other antihyperglycemic agents to prevent hypoglycemia. Additionally, if surgery is planned or if an individual is facing severe infection or dehydration, it is advisable to temporarily discontinue the medication. It is also recommended to halt administration around the time of diagnostic tests using radiographic contrast agents. This medication should not be used in certain patients, so it is crucial to accurately inform healthcare professionals about one’s health status and adhere to prescribed treatment.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, shortness of breath, cold sweats, paleness, severe allergic reactions.
  • Severe rash with fever, blisters, skin peeling, pain of oral/eye mucosa, severe skin reactions.
  • Trouble breathing or wheezing, asthma attacks, respiratory abnormalities accompanying cough + fever.
  • Jaundice (yellowing of the skin or eyes), profound lethargy, liver abnormalities (jaundice).
  • Sudden and severe headache.

Mild side effects

  • Vulvovaginitis
  • balanitis and related genital infections
  • urinary tract infections
  • fungal infections
  • dry mouth
  • dizziness
  • constipation
  • back pain
  • dysuria
  • polyuria
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  • nocturia
  • interstitial nephritis
  • dyslipidemia
  • elevated serum creatinine
  • weight loss
  • headache
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • itching
  • cold sweats
  • abnormal sweating eczema
  • nummular eczema
  • eczema
  • hyperkeratosis
  • skin lesions
  • myofibrosis
  • muscle cramps
  • musculoskeletal discomfort
  • osteoporosis

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, ideally at room temperature between 1 and 30 degrees Celsius. By storing it this way, the medication's effectiveness can be maintained for a longer period.

Appearance and packaging

Appearance

Orange oval extended-release film-coated tablet

Package unit

30 tablets/bottle

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.

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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.