Medication info
Glucita Duo Sustained Release Tablet 50/500 mg

Glucita Duo Sustained Release Tablet 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한올바이오파마(주)
Appearance
Bright blue, oval sustained release film-coated tablet with a convex front and back
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202202018 · Approved 2022.05.13 · Insurance code 655605460

Summary

Main use
Improvement in blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
The 100/1000 mg sustained release tablet of this medication should be taken once a day, with 1 tablet at a time. For patients taking the 50/500 mg sustained release tablet or the 50/1000 mg sustained release tablet, the recommended dose is 2 tablets at a time, once a day. 1. For patients not currently receiving treatment with metformin: The initial dosage of this medication involves a total daily amount of sitagliptin 100 mg and metformin 1000 mg. Gradually increase the dosage as needed.

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

Improvement in blood glucose control in type 2 diabetes

View approved original text

This medication has been developed to effectively assist patients with type 2 diabetes in controlling their blood glucose levels. It is particularly useful in managing glucose levels when used alongside dietary and exercise therapies. The two components, sitagliptin and metformin, work together to enhance blood glucose control, helping to reduce the risk of diabetes-related complications. Therefore, this medication is used to improve blood glucose control in patients with type 2 diabetes.

How to take

Adult dose

The 100/1000 mg sustained release tablet of this medication should be taken once a day, with 1 tablet at a time. For patients taking the 50/500 mg sustained release tablet or the 50/1000 mg sustained release tablet, the recommended dose is 2 tablets at a time, once a day. 1. For patients not currently receiving treatment with metformin: The initial dosage of this medication involves a total daily amount of sitagliptin 100 mg and metformin 1000 mg. Gradually increase the dosage as needed.

Precautions

This medication contains sitagliptin and metformin, and is used to assist in blood glucose control in patients with type 2 diabetes. The sitagliptin component can rarely cause severe hypersensitivity reactions, such as anaphylaxis, angioedema, or serious skin disorders; caution is especially needed during the first three months of treatment. Additionally, acute pancreatitis may occur, so if symptoms such as abdominal pain, nausea, or vomiting appear, consult a physician immediately. The metformin component can lead to a serious metabolic disorder called lactic acidosis, which can be life-threatening, thus, patients with impaired kidney function or liver function should not take this medication. This medication should not be administered to patients with moderate to severe renal impairment, severe infection or dehydration, acute heart failure or myocardial infarction, and to women who are pregnant or breastfeeding. During treatment, kidney function should be regularly monitored to ensure there are no abnormalities, and if dehydration or severe vomiting or diarrhea occurs, medication should be stopped immediately, and a doctor should be consulted. It is important to avoid alcohol consumption during treatment, as excessive drinking may increase the risk of lactic acidosis. Moreover, caution is needed if meal sizes are irregular or insufficient, if vigorous exercise is performed, or if other drugs are combined, as it may increase the risk of hypoglycemia. If treated with insulin or sulfonylurea medications alongside this medication, symptoms of hypoglycemia may appear, thus dosage adjustments of those medications may be necessary. During treatment, side effects such as diarrhea, nausea, headaches, and upper respiratory infections may occur. If symptoms such as severe joint pain or skin blisters appear, inform a physician immediately. If surgery is planned or has been performed, this medication should be stopped at least 48 hours prior and should be resumed only after kidney function has returned to normal. Elderly patients are at a higher risk of kidney function deterioration, so it is important to adjust medication dosage and undergo regular kidney function tests. This medication is not indicated for use in patients under 18, as safety and efficacy have not been sufficiently proven in this age group. In case of overdose, seek medical attention immediately for appropriate treatment, and if necessary, the drug can be removed via hemodialysis. Regular blood tests and kidney function monitoring should be performed during treatment to assess health status, and if symptoms or abnormalities occur, immediate consultation with healthcare professionals is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, anaphylaxis, angioedema, severe hypersensitivity reactions including Stevens-Johnson syndrome, hemorrhagic or necrotizing pancreatitis which includes acute pancreatitis, acute kidney injury, lactic acidosis, severe hypoglycemia, severe blistering drug eruptions, elevated liver enzymes, acute kidney injury (occasionally requiring dialysis), deterioration of kidney function, acute kidney injury, severe edema, edema associated with raised blood pressure, severe and disability-associated arthralgia, severe neurological symptoms (such as seizures)

Mild side effects

Diarrhea, upper respiratory infections, headaches, nausea, vomiting, abdominal pain, nasopharyngitis, constipation, myalgia, limb pain, back pain, pruritus, thrombocytopenia, rhabdomyolysis, severe and disability-associated arthralgia

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will ensure the medication's effectiveness is safely maintained.

Appearance and packaging

Appearance

Bright blue, oval sustained release film-coated tablet with a convex front and back

Package unit

28 tablets/bottle, 56 tablets/bottle, 200 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.