Medication info
Sidiphen Extended Release Tablet 50/1000 mg

Sidiphen Extended Release Tablet 50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Bright green oval extended-release film-coated tablet
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300597 · Approved 2023.02.17 · Insurance code 645907430

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The 100/1000 mg extended-release tablet should be taken once daily, with one tablet at a time. Patients taking the 50/500 mg extended-release tablet or the 50/1000 mg extended-release tablet should take two tablets at a time once daily. 1. For patients not currently treated with metformin: The initial dosage is a total daily amount of sitagliptin 100 mg and metformin 1000 mg. If necessary, metformin dosage can be adjusted to a maximum daily limit.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to assist in blood sugar control for patients with type 2 diabetes through the combination of sitagliptin and metformin. It is prescribed as an adjunct to diet and exercise to effectively improve blood glucose levels. This supports diabetes management and enhances the patient's health status.

How to take

Adult dose

The 100/1000 mg extended-release tablet should be taken once daily, with one tablet at a time. Patients taking the 50/500 mg extended-release tablet or the 50/1000 mg extended-release tablet should take two tablets at a time once daily. 1. For patients not currently treated with metformin: The initial dosage is a total daily amount of sitagliptin 100 mg and metformin 1000 mg. If necessary, metformin dosage can be adjusted to a maximum daily limit.

Precautions

This medication consists of two components, sitagliptin and metformin, both of which are used in diabetes treatment. Firstly, sitagliptin can cause rare but severe allergic reactions, so if symptoms such as hives, rash, or difficulty breathing occur, use should be stopped immediately. Additionally, there is a risk of acute pancreatitis, which can cause inflammation of the pancreas, so careful monitoring is required if severe abdominal pain or vomiting occurs, and medication should be discontinued if necessary. Metformin can cause a rare complication called lactic acidosis, which is very dangerous and can be accompanied by symptoms such as muscle pain, difficulty breathing, fatigue, and abdominal pain. Especially patients with reduced kidney function, liver dysfunction, severe infection, or dehydration should not take this medication. This drug should not be administered to patients with severe kidney impairment, acute heart failure, acute myocardial infarction, or to pregnant or breastfeeding women. Moreover, during the use of this medication, regular meals and appropriate exercise should be maintained, as sudden decreases in meal size or intense exercise can increase the risk of hypoglycemia. There is an increased risk of hypoglycemia when this medication is used in combination with other blood glucose-lowering agents, so dosage adjustment may be necessary when taken with insulin or sulfonylureas. Gastrointestinal side effects such as diarrhea, nausea, vomiting, headache may occur during use; if symptoms are severe or persistent, consultation with a healthcare professional is recommended. Regular monitoring of liver and kidney functions is necessary, particularly for elderly patients or those with weak kidney function. Before and after surgery, this medication should be discontinued for a period of time, and it should only be resumed after the postoperative condition stabilizes and kidney function is confirmed to be normal. Lastly, excessive alcohol consumption should be avoided during this medication period, as alcohol can increase the risk of lactic acidosis, a side effect of this drug. If any abnormal symptoms or discomfort arise during the use of this drug, it is important to inform a healthcare professional immediately and receive appropriate care.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • exfoliative skin disease
  • Stevens-Johnson syndrome
  • acute pancreatitis
  • lactic acidosis
  • acute renal failure
  • severe and debilitating arthralgia
  • bullous pemphigoid
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  • severe hypoglycemia
  • severe edema

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • arthralgia
  • myalgia
  • limb pain
  • back pain
  • interstitial lung disease
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  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • diarrhea
  • nausea
  • abdominal pain
  • bullous pemphigoid
  • peripheral edema
  • hypoglycemia

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a sealed container. It is best to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Bright green oval extended-release film-coated tablet

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 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.