Medication info
Sitagliptin/Metformin Extended-Release Tablet 50/500 mg

Sitagliptin/Metformin Extended-Release Tablet 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Bright blue, oval-shaped extended-release film-coated tablet, convex on both sides
Packaging
28 tablets/bottle, 56 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 202202039 · Approved 2022.05.16 · Insurance code 649606190

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is taken once a day in the evening with meals, gradually increasing the dosage. To maintain the extended-release properties, do not split, crush, chew, or dissolve the tablets, but swallow them whole. The 100/1000 mg extended-release tablet is taken once a day, with one tablet at a time. The 50/500 mg or 50/1000 mg extended-release tablets are taken once a day, with two tablets at the same time. 1. For patients currently treated with Metformin.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

View approved original text

This medication is used to help control blood sugar levels in patients with type 2 diabetes. When taken with dietary measures and exercise, it helps effectively improve blood glucose levels. Sitagliptin and Metformin work together to effectively manage blood sugar levels. Therefore, this medication is used to enhance blood sugar control.

How to take

Adult dose

This medication is taken once a day in the evening with meals, gradually increasing the dosage. To maintain the extended-release properties, do not split, crush, chew, or dissolve the tablets, but swallow them whole. The 100/1000 mg extended-release tablet is taken once a day, with one tablet at a time. The 50/500 mg or 50/1000 mg extended-release tablets are taken once a day, with two tablets at the same time. 1. For patients currently treated with Metformin.

Precautions

This medication contains two components used for diabetes treatment: Sitagliptin and Metformin. Firstly, Sitagliptin can cause severe allergic reactions or skin diseases in some patients; if such symptoms occur, discontinue use immediately and consult a doctor. Additionally, there is a risk of pancreatitis, which is inflammation of the pancreas, so if symptoms like abdominal pain or vomiting appear during use, it should be carefully monitored and the medication should be discontinued if necessary. Metformin can rarely cause a serious condition called lactic acidosis, which can lead to dangerous situations due to lactic acid accumulation in the body. Therefore, it should not be used in cases of impaired kidney function, liver disease, dehydration, or severe infections. Particularly, patients with moderate to severe renal impairment should not take this medication during conditions like acute heart failure, myocardial infarction, or sepsis. Before and after tests using iodine contrast agents, this medication should be temporarily discontinued due to risks of renal function worsening and lactic acidosis, and should only be resumed after confirming normal kidney function. This medication should not be prescribed for pregnant or nursing women, children under 18 years, or patients with certain severe metabolic conditions. While taking this medication, there is a risk of hypoglycemia or lactic acidosis due to irregular eating, intense exercise, or interactions with other drugs, so caution is needed. Regular monitoring of kidney function, blood tests, and vitamin B12 levels is advisable, and it is best to avoid alcohol consumption. Moreover, it is safe to discontinue use for a certain period before and after surgery. Symptoms of hypoglycemia may occur, so blood glucose levels should be monitored carefully, especially when taken along with other hypoglycemic agents such as insulin or sulfonylureas. If severe joint pain, skin rash, difficulty breathing, or other unusual symptoms occur, notify a doctor immediately, as these symptoms may improve after stopping the medication. In case of overdose, immediate medical attention is necessary, and some components can be removed by hemodialysis. This medication should be taken cautiously according to the patient's condition, and regular check-ups and consultations with healthcare professionals during treatment are important.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, rash, skin vasculitis, exfoliative skin diseases such as Stevens-Johnson syndrome, severe hypersensitivity reactions, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, acute pancreatitis, acute renal failure, liver abnormalities (jaundice), elevated liver enzymes, severe and disabling arthralgia, blistering dermatitis, severe lactic acidosis

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory tract infection
  • nasopharyngitis
  • headache
  • hypoglycemia
  • myalgia
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis

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

Storage

Store this medication in a tightly closed container to prevent air and moisture from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Bright blue, oval-shaped extended-release film-coated tablet, convex on both sides

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.

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.