Medication info

Metformin and Sitagliptin Tablet 50/1000 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›Strength being verifiedMetformin Hydrochloride›Strength being verified
Manufacturer / importer
광동제약(주)
Appearance
Dark red oval film-coated tablet
Packaging
Company packaging unit
Approval status
Approval withdrawn

MFDS item code 201506303 · Approved 2015.09.01

This product's status changed to Approval withdrawn on 2023.07.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is generally taken twice daily with food, with a gradual increase in dosage to reduce gastrointestinal side effects caused by metformin. 1. Patients not currently treated with metformin: Take this medication 50/500 mg twice a day, one tablet at a time, and may increase to 50/1000 mg twice a day, one tablet at a time. 2. Patients currently receiving metformin:

Ingredients

Manufacturer
광동제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
View approved original text

This medication is an adjunct to diet and exercise to help control blood sugar in patients with type 2 diabetes. If individuals who have not previously taken diabetes medications find it difficult to control their blood sugar, this medication can be used alone. It is also administered when blood sugar control is inadequate with monotherapy of either metformin or sitagliptin, or when replacing the combination therapy of both medications. If blood sugar is not controlled with a combination of metformin and sulfonylurea, sulfonylurea can be combined with this medication. Similarly, if the combination of metformin and thiazolidinedione is ineffective, this medication can be used together with thiazolidinedione. Lastly, if control is lacking with combination therapy of insulin and metformin, this medication can be used concurrently with insulin to improve blood sugar control.

Dosage and Administration

Adult dosage

This medication is generally taken twice daily with food, with a gradual increase in dosage to reduce gastrointestinal side effects caused by metformin. 1. Patients not currently treated with metformin: Take this medication 50/500 mg twice a day, one tablet at a time, and may increase to 50/1000 mg twice a day, one tablet at a time. 2. Patients currently receiving metformin:

Precautions

This medication is used for the treatment of diabetes and helps to control blood sugar. Severe allergic reactions can occur during the use of this medication, so if symptoms such as skin rash, hives, difficulty breathing, or swelling of the face or neck occur, it should be stopped immediately and medical advice should be sought. There is a risk of serious pancreatic inflammation known as pancreatitis, so any symptoms including abdominal pain, nausea, vomiting, or fever should be reported to a healthcare professional immediately. Patients with poor kidney function or heart problems may face risks when taking this medication, so it must be used only after consulting with a doctor. The use of this medication should be temporarily stopped before and after examinations using iodine contrast agents, and resumption should only occur after confirming normal kidney function. It is safer for women who are pregnant or may become pregnant, as well as nursing mothers, to avoid this medication. Irregular meals, vigorous exercise, and concurrent use with certain medications can increase the risk of side effects such as hypoglycemia or lactic acidosis, requiring careful monitoring. This medication may cause gastrointestinal disturbances (diarrhea, nausea, vomiting, abdominal pain) and headaches, as well as cold symptoms. When taken with other antihyperglycemic agents, hypoglycemic symptoms may occur, thus blood sugar levels should be frequently monitored and dosage adjustments made as necessary. Lactic acidosis, a rare but very serious side effect, can happen; symptoms such as sudden muscle aches, shortness of breath, fatigue, or abdominal pain require immediate medical consultation. Long-term use of this medication may result in decreased Vitamin B12 levels, hence regular blood tests are recommended. Before surgery, this medication should be discontinued and restarted only after the patient's condition has stabilized. Elderly patients may have reduced kidney function, so regular kidney function monitoring and the lowest effective dose should be administered. In case of overdose, immediate medical care should be sought, and in some cases, blood dialysis may be necessary. Alcohol consumption during the use of this medication is best avoided, and any unusual symptoms associated with the medication should be discussed with a physician immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • anaphylaxis
  • Stevens-Johnson syndrome
  • severe skin reactions
  • rash with fever
  • blisters
  • skin peeling
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  • oral/ocular mucosal pain
  • respiratory issues
  • yellowing of the skin or eyes (jaundice)
  • extreme fatigue
  • liver abnormalities (jaundice)
  • sudden and severe headaches
  • thunderclap headache
  • seizures
  • confusion
  • vision disturbances
  • paralysis.

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infections
  • nasopharyngitis
  • headaches
  • hypoglycemia
  • constipation
  • muscle pain
Show 8 more
  • limb pain
  • back pain
  • itching
  • dizziness
  • decreased appetite
  • thrombocytopenia
  • dermatitis
  • weight loss

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

Storage

This medication should be stored in a sealed container that does not allow air to enter and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way can maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Dark red oval film-coated tablet

Package unit

Company packaging unit

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.