Medication info

Sitameron Tablets 50/1000 Milligrams

Prescription medicationApproval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›Strength being verifiedMetformin Hydrochloride›Strength being verified
Manufacturer / importer
동국제약(주)
Appearance
Dark red oval film-coated tablets
Packaging
PTP - 28 tablets/box [(14 tablets/PTP*2)], PTP - 56 tablets/box [(14 tablets/PTP*4)]
Approval status
Approval withdrawn

MFDS item code 201505846 · Approved 2015.08.20

This product's status changed to Approval withdrawn on 2023.08.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is generally taken twice daily with food, and the dosage is gradually increased to minimize gastrointestinal side effects associated with metformin. 1. Patients who are not currently being treated with metformin: This drug 50/500 mg should be taken twice a day, 1 tablet per dose; it can be increased to 50/1000 mg, taking 1 tablet twice daily. 2. Patients already receiving metformin:

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Difficulty controlling blood sugar levels in patients with type 2 diabetes
View approved original text

This medication is used to help control blood sugar levels in patients with type 2 diabetes. It is helpful for those who find it difficult to control blood sugar levels with monotherapy when first taking diabetes medications. Additionally, it can be administered when metformin or sitagliptin monotherapy is insufficient, or when replacing combinatorial therapy of both medications. If there is a lack of effectiveness with combination therapy of metformin and sulfonylurea, or metformin and thiazolidinedione, this drug can be combined to improve blood glucose control. When insulin and metformin do not adequately control blood sugar levels, this medication can be used in conjunction to assist with management. This effectively improves blood glucose control in type 2 diabetes patients.

Dosage and Administration

Adult dosage

This medication is generally taken twice daily with food, and the dosage is gradually increased to minimize gastrointestinal side effects associated with metformin. 1. Patients who are not currently being treated with metformin: This drug 50/500 mg should be taken twice a day, 1 tablet per dose; it can be increased to 50/1000 mg, taking 1 tablet twice daily. 2. Patients already receiving metformin:

Precautions

This medication is composed of sitagliptin and metformin and is used for diabetes treatment. During the intake of this drug, severe allergic reactions may occur; therefore, if symptoms such as hives, rashes, difficulty breathing, or swelling of the face or neck occur, it is necessary to stop taking the medication immediately and consult a doctor. This medication can cause a serious side effect called pancreatitis, which is inflammation of the pancreas; thus, if symptoms such as abdominal pain, nausea, vomiting, or fever occur, it is crucial to visit a healthcare institution immediately. Patients with poor kidney function or acute heart disease, severe infections, or dehydration should not use this medication, especially those with reduced kidney function should avoid or stop administration. Patients with acute or chronic liver disease should also avoid taking this medication for safety, and if liver function abnormality symptoms arise, they should consult a physician immediately. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Regular monitoring of kidney function and blood tests is important while using this drug, including checking vitamin B12 levels. Excessive alcohol consumption, rapid weight loss, or nutritional imbalance increases the risk of serious side effects such as hypoglycemia or lactic acidosis, hence caution is advised. If surgery is planned, the intake of this medication should be discontinued 48 hours before the procedure, and it should be resumed only after confirming that kidney function is normal post-surgery. When used with other hypoglycemic agents or insulin, this medication may increase the risk of hypoglycemia, so it is essential to be aware of hypoglycemic symptoms and possibly adjust doses of other medications as needed. In case of overdose, immediate notification to healthcare personnel is required, and blood dialysis or other treatments may be necessary. If blisters develop on the skin or severe joint pain occurs during treatment, consult a physician immediately as these symptoms may necessitate discontinuation of the medication. Finally, during the intake of this medication, it is important to maintain a regular eating and exercise routine, and to monitor blood glucose and kidney function through regular examinations.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema, anaphylaxis, Stevens-Johnson syndrome, severe allergic reactions
  • Acute pancreatitis, fatal or non-fatal hemorrhagic pancreatitis
  • Acute renal failure, worsening of kidney function
  • Respiratory distress
  • Severe and disabling arthralgia
  • Bullous pemphigoid
  • Thrombocytopenia
  • Severe hypoglycemia
  • Acute renal failure
  • Respiratory distress
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  • Unstable angina
  • Lactic acidosis (severe metabolic acidosis)
  • Elevated liver enzymes, jaundice (symptoms suggestive of liver dysfunction)
  • Seizures, consciousness confusion

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infections
  • nasopharyngitis
  • headache
  • hypoglycemia
  • constipation
  • myalgia
Show 10 more
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
  • itching
  • dizziness
  • decreased appetite
  • dermatitis
  • weight loss
  • arthralgia

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 air exposure, at a temperature between 1 to 30 degrees Celsius. This provides optimal maintenance of the drug's effectiveness.

Appearance and packaging

Appearance

Dark red oval film-coated tablets

Package unit

PTP - 28 tablets/box [(14 tablets/PTP*2)], PTP - 56 tablets/box [(14 tablets/PTP*4)]

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.