Medication info

Sitabaem Tablets 50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
Pink oval film-coated tablets
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202200227 · Approved 2022.01.12

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication is determined considering the treatment regimen, efficacy, and tolerability of the patient not exceeding the maximum daily recommended dosage of sitagliptin 100 mg and metformin 2000 mg. Generally, it is taken twice daily with meals, and the dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients not receiving metformin treatment: The initial dose is 1 tablet of 50/500 mg taken twice a day.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

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

This medicine is used as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes. It is effective for patients who are starting diabetes medication for the first time or who have difficulty controlling blood sugar with metformin or sitagliptin alone. Additionally, it helps in treatment when sufficient blood sugar control is not achieved with combination therapy of metformin and sulfonylureas, or metformin and thiazolidinediones. It also improves blood sugar control when there is difficulty in achieving control with insulin and metformin combination therapy. In summary, this medication is effectively used to improve blood sugar control in patients with type 2 diabetes who have difficulty controlling blood sugar with various single or combination therapies.

How to take

Adult dose

The dosage of this medication is determined considering the treatment regimen, efficacy, and tolerability of the patient not exceeding the maximum daily recommended dosage of sitagliptin 100 mg and metformin 2000 mg. Generally, it is taken twice daily with meals, and the dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients not receiving metformin treatment: The initial dose is 1 tablet of 50/500 mg taken twice a day.

Precautions

This medicine is used for the treatment of diabetes and contains two ingredients: sitagliptin and metformin. Caution is advised for hypersensitivity reactions when taking this medication. Rarely, severe allergic reactions may occur, and if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck appear, discontinue immediately and consult a doctor. Additionally, there is a risk of acute pancreatitis (inflammation of the pancreas), so if symptoms such as abdominal pain, nausea, vomiting, or fever occur, seek medical attention immediately. The metformin component can rarely cause lactic acidosis, a serious metabolic disorder, manifested by symptoms such as muscle pain, difficulty breathing, fatigue, and abdominal pain. Inform healthcare professionals immediately if these symptoms occur. This medication should not be used in patients with severely impaired renal function, acute heart failure, severe infections, or dehydration. Furthermore, it is advisable to temporarily discontinue this medication before and after tests using radiocontrast agents to protect kidney function and to resume only after kidney function returns to normal. It is safest for pregnant or breastfeeding women to avoid taking this medication. During treatment, regular monitoring of kidney function and blood tests should be done, especially for older adults or those with slightly impaired renal function, who should be monitored more often. Due to the risk of hypoglycemia, it is advisable to eat regularly and avoid prolonged fasting or excessive exercise. Hypoglycemia symptoms may occur when taken with other antidiabetic agents or insulin, so blood sugar levels should be monitored closely. The risk of lactic acidosis increases when taken with alcohol, so alcohol consumption should be avoided. It may be necessary to discontinue this medication for a certain period before and after surgery, so consult with healthcare professionals. If severe joint pain or skin blisters appear while taking this medication, inform a doctor immediately and receive treatment. Some patients may experience side effects such as diarrhea, nausea, vomiting, headache, upper respiratory tract infections, rhinitis, constipation, muscle pain, limb pain, back pain, itching, thrombocytopenia, peripheral edema, hypoglycemia, decreased appetite, pruritus, dizziness, and weight loss, and if symptoms are severe, consult with healthcare professionals. In case of overdose, seek emergency treatment immediately; if necessary, drug removal may be performed via dialysis. Finally, during the use of this medication, regular blood sugar testing and health condition monitoring should be carried out to ensure safe and effective treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, severe allergic reactions, rash, severe skin adverse reactions, Stevens-Johnson syndrome, severe rash with fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, acute pancreatitis, liver abnormalities (jaundice), acute renal failure, severe edema or urinary abnormalities, severe pain in joints with disability, bullous pemphigoid, serious neurological effects

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • headache
  • upper respiratory tract infection
  • rhinitis
  • constipation
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • peripheral edema
  • hypoglycemia
  • decreased appetite
  • itching
  • dizziness
  • weight loss

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 or moisture from entering, and it should be kept at room temperature between 1 to 30 degrees Celsius. This ensures the medication's efficacy is maintained and prevents deterioration.

Appearance and packaging

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP x 3)]

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.