Medication info
Combiglyze XR 5/1000 mg

Combiglyze XR 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletSaxagliptin Hydrate›5.29mg / 1 tablet
Manufacturer / importer
한국아스트라제네카(주)
Appearance
Pink, double convex, capsule-shaped film-coated tablet
Packaging
28 tablets (7 tablets × 4) / box
Approval status
Active

MFDS item code 201202806 · Approved 2012.04.12 · Insurance code 650700910

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. For patients who are not currently treated with Metformin and require Saxagliptin 5 mg, it is recommended to take Saxagliptin 5 mg/Metformin 500 mg extended-release tablets once daily, with gradual dose adjustment to minimize gastrointestinal side effects associated with Metformin. For patients already undergoing Metformin treatment, Saxagliptin 5 mg is administered once daily, and the dosage may need to be adjusted based on the Metformin being taken.

Ingredients

Importer
한국아스트라제네카(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication helps patients with type 2 diabetes improve their blood glucose control as a complement to dietary and exercise therapy. It is used to enhance blood glucose levels effectively through the combined action of Saxagliptin and Metformin. In other words, it aids in smoother blood glucose management to assist in diabetes treatment.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. For patients who are not currently treated with Metformin and require Saxagliptin 5 mg, it is recommended to take Saxagliptin 5 mg/Metformin 500 mg extended-release tablets once daily, with gradual dose adjustment to minimize gastrointestinal side effects associated with Metformin. For patients already undergoing Metformin treatment, Saxagliptin 5 mg is administered once daily, and the dosage may need to be adjusted based on the Metformin being taken.

Precautions

This medication contains Metformin and Saxagliptin and is primarily used for the treatment of type 2 diabetes. During treatment with this medication, there is a risk of a rare but fatal metabolic complication called lactic acidosis, so patients with poor kidney function should not use it. Patients with moderately reduced kidney function or acute renal impairment should not use this medication. Additionally, patients who have had hypersensitivity reactions to this medication or to biguanide class medications, as well as those with metabolic acidosis such as lactic acidosis or diabetic ketoacidosis, should avoid taking this medication. This medication should also not be used in patients who have rapidly worsening kidney function due to conditions such as cardiovascular collapse, acute myocardial infarction, or sepsis. If iodinated contrast agents used in radiological examinations are administered intravenously, there is a risk of worsening kidney function; therefore, use of this medication should be stopped at least 48 hours before such tests, and resumed only after kidney function is confirmed to be normal. Patients scheduled for surgery and those with restrictions on food and fluid intake should stop taking this medication 48 hours before surgery and should not resume until kidney function has recovered post-surgery. Pregnant women, women who may become pregnant, and nursing mothers should also avoid taking this medication. While on this medication, hypoglycemic symptoms may occur; therefore, dose adjustments may be necessary when used in combination with insulin or sulfonylureas to reduce the risk of hypoglycemia. Side effects such as diarrhea, nausea, vomiting, headache, and upper respiratory infections may occur, and in rare cases, signs of acute pancreatitis or heart failure may develop, so any unusual symptoms should be reported immediately to a healthcare professional. Moreover, this medication may lower vitamin B12 levels, so regular monitoring of vitamin B12 levels is recommended for long-term use. Alcohol consumption may increase the risk of side effects from this medication, so excessive drinking should be avoided while on this medication. Elderly patients have a higher likelihood of reduced kidney function, so regular kidney function tests should be conducted and caution should be exercised while taking this medication. In case of overdose, appropriate treatment and possibly dialysis may be necessary for drug removal, so adhering to the prescribed dose is crucial. Keep this medication out of reach of children and store it in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • facial swelling
  • anaphylaxis
  • angioedema
  • exfoliative skin symptoms
  • bullous pemphigoid
  • acute pancreatitis
  • severe joint pain with disability
  • severe hypoglycemia
  • lactic acidosis
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  • sudden and severe headache
  • seizures
  • confusional state
  • visual disturbances
  • paralysis
  • breathing difficulties
  • dyspnea
  • asthma attack
  • chest tightness
  • severe swelling (edema)
  • acute kidney injury
  • cardiovascular collapse (shock)
  • acute myocardial infarction
  • sepsis

Mild side effects

  • Headache
  • upper respiratory infection
  • urinary tract infection
  • sinusitis
  • abdominal pain
  • gastroenteritis
  • vomiting
  • diarrhea
  • nausea/vomiting
  • lymphopenia
Show 22 more
  • increased serum creatinine
  • increased serum creatine phosphokinase
  • decreased vitamin B12
  • dyspepsia
  • loss of appetite
  • constipation
  • hyperglycemia
  • neuropathy
  • dizziness
  • lightheadedness
  • chest pain
  • ineffective medication
  • asthenia
  • skeletal pain
  • arthritis
  • arthralgia
  • back pain
  • frequent urination
  • cystitis
  • cold
  • emphysema
  • lung disease

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 degree and 30 degrees Celsius. This will help safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Pink, double convex, capsule-shaped film-coated tablet

Package unit

28 tablets (7 tablets × 4) / box

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.