Medication info

Promet XR Extended Release Tablet 50/500 Milligrams

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

MFDS item code 202201968 · Approved 2022.05.11 · Insurance code 654005920

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage should be determined based on each patient's current therapeutic regimen, efficacy, and tolerability, without exceeding a maximum daily dose of sitagliptin 100 mg and metformin 2000 mg. This medication should be taken once daily with the evening meal, with gradual dose increments. The extended-release tablet should be swallowed whole and not split or crushed. For the 100/1000 mg extended-release tablet, take 1 tablet once daily. For the 50/500 mg or 50/1000 mg extended-release tablets, take 2 tablets once daily.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

View approved original text

This medication is used alongside diet and exercise to assist in blood sugar control for patients with type 2 diabetes. Sitagliptin and metformin work together to effectively lower blood sugar and improve blood sugar control. Therefore, consistent treatment and use of this medication can provide good results in blood sugar management.

How to take

Adult dose

The dosage should be determined based on each patient's current therapeutic regimen, efficacy, and tolerability, without exceeding a maximum daily dose of sitagliptin 100 mg and metformin 2000 mg. This medication should be taken once daily with the evening meal, with gradual dose increments. The extended-release tablet should be swallowed whole and not split or crushed. For the 100/1000 mg extended-release tablet, take 1 tablet once daily. For the 50/500 mg or 50/1000 mg extended-release tablets, take 2 tablets once daily.

Precautions

This medication contains two components and is primarily used for the treatment of type 2 diabetes. First, one component of this medication is sitagliptin, which can rarely cause serious allergic reactions. These reactions may include anaphylaxis, angioedema, and Stevens-Johnson syndrome, which can cause severe skin damage. If such symptoms are suspected, discontinue use of this medication immediately and consult a physician. Additionally, sitagliptin may cause acute pancreatitis, which indicates inflammation of the pancreas. If symptoms such as abdominal pain, vomiting, or severe indigestion occur during use, notify healthcare professionals immediately. Second, the other component of this medication, metformin, can rarely cause a serious metabolic disorder called lactic acidosis. This condition involves an abnormally high level of lactic acid in the blood, with symptoms including fatigue, muscle pain, shortness of breath, and abdominal pain. If these symptoms occur, discontinue use of the medication immediately and seek medical attention. This medication should not be used in patients with severely impaired kidney function, acute myocardial infarction, heart failure, severe infections, liver dysfunction, pregnant and breastfeeding women. Moreover, this medication should be temporarily discontinued before and after surgery, and can be resumed once the patient’s condition is stable and kidney function is confirmed to be normal. Regular kidney function tests should be performed during the use of this medication, with special attention required for elderly patients or those with compromised kidney function. Hypoglycemic symptoms may occur, so particularly when taken in conjunction with insulin or sulfonylurea agents, blood sugar changes should be carefully monitored. During the use of this medication, excessive alcohol consumption should be avoided, as alcohol may increase the risk of side effects from this medication. Finally, patients taking this medication should have regular blood tests and kidney function tests, as vitamin B12 levels may decrease, necessitating supplementation if needed.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, rash, Stevens-Johnson syndrome, cutaneous vasculitis, exfoliative skin disease, pancreatitis (including lethal/non-lethal hemorrhagic or necrotizing pancreatitis), acute pancreatitis, elevated liver enzymes, acute renal failure, worsening kidney function, lactic acidosis, severe swelling (edema), hypoglycemia (including severe), hives, severe allergic reactions, severe skin reactions, respiratory problems, liver disturbances (jaundice), severe

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
Show 8 more
  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • severe joint pain with disability
  • severe hypoglycemia
  • vitamin B12 deficiency

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture from entering. It is best to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage can help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Light blue, oval-shaped, bilaterally convex 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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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.