Medication info
Sinubim XR Coated Tablets 50/500 mg (Sitagliptin, Metformin)

Sinubim XR Coated Tablets 50/500 mg (Sitagliptin, Metformin)

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

MFDS item code 202201964 · Approved 2022.05.11 · Insurance code 647805470

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is taken once daily with dinner to reduce gastrointestinal adverse reactions caused by metformin, with gradual dose escalation. To maintain the extended-release properties, do not split, crush, chew, or break tablets; swallow whole. The 100/1000 mg extended-release tablet is taken once daily, with one tablet per dose. The 50/500 mg or 50/1000 mg extended-release tablets are taken once daily, with two tablets per dose.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication combines sitagliptin and metformin to help control blood glucose levels in patients with type 2 diabetes who are on a diet and exercise regimen. It effectively improves blood sugar levels and assists in diabetes management.

How to take

Adult dose

This medication is taken once daily with dinner to reduce gastrointestinal adverse reactions caused by metformin, with gradual dose escalation. To maintain the extended-release properties, do not split, crush, chew, or break tablets; swallow whole. The 100/1000 mg extended-release tablet is taken once daily, with one tablet per dose. The 50/500 mg or 50/1000 mg extended-release tablets are taken once daily, with two tablets per dose.

Precautions

This medication is a diabetes treatment that contains two ingredients: sitagliptin and metformin. First, sitagliptin can rarely cause serious allergic reactions. Symptoms such as anaphylaxis, angioedema, or severe skin disorders may occur, so if these symptoms appear, discontinue use immediately and consult a doctor. Additionally, sitagliptin may induce acute pancreatitis, which is inflammation of the pancreas, and if symptoms such as abdominal pain, vomiting, or severe discomfort in the abdomen occur, seek medical attention immediately. Metformin can cause a rare complication known as lactic acidosis, a serious condition in which lactic acid builds up in the body, presenting symptoms like muscle pain, difficulty breathing, fatigue, and abdominal pain. If these symptoms occur, discontinue medication and consult a healthcare professional immediately. This medication should not be administered to patients with significantly impaired kidney function, acute heart failure, acute myocardial infarction, severe infections, dehydration, acute metabolic acidosis, or to women who are pregnant or breastfeeding. Patients scheduled for surgery should temporarily stop taking this medication 48 hours prior to surgery and resume only after confirming normal kidney function post-surgery. Care should be taken if taking other medications that can increase or decrease blood sugar levels, especially in combination with insulin or sulfonylureas, as the risk of hypoglycemia may increase. Gastrointestinal symptoms such as diarrhea, nausea, vomiting, and headaches may occur during treatment, and if these symptoms persist, consult a healthcare professional. Elderly patients may experience decreased kidney function, so regular kidney function tests and appropriate dose adjustments are important. As vitamin B12 levels may decrease, regular blood tests to monitor vitamin B12 status are advisable during long-term use. During treatment, excessive alcohol consumption should be avoided, as alcohol can increase the risk of lactic acidosis. Finally, this medication should not be used in pediatric patients under the age of 18, as safety and efficacy have not been established. If atypical symptoms occur while taking this medication, consult a doctor immediately and adhere to the prescribed dosage and administration.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, Stevens-Johnson syndrome, exfoliative skin disorders, severe allergic reactions, severe rash and blisters accompanied by high fever, desquamation, mucosal pain in the mouth/eyes, acute pancreatitis, acute renal failure, difficulty breathing, severe swelling, swelling accompanied by elevated blood pressure, jaundice (yellowing of the skin or eyes), liver abnormalities, sudden and severe headache, thunderclap headache, seizures.

Mild side effects

Diarrhea, upper respiratory infection, headache, nausea, vomiting, abdominal pain, nasopharyngitis, constipation, muscle pain, limb pain, back pain, pruritus, thrombocytopenia, rhabdomyolysis, hypoglycemia, elevated liver enzymes, increased white blood cell count, decreased vitamin B12 levels, severe joint pain accompanied by disability

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 and moisture, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

Bright blue, oval-shaped, biconvex, extended-release film-coated tablet

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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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.