Medication info
Pioglitazone and Sitagliptin Tablets 100/15 mg (Sitagliptin Phosphate Hydrate, Pioglitazone Hydrochloride)

Pioglitazone and Sitagliptin Tablets 100/15 mg (Sitagliptin Phosphate Hydrate, Pioglitazone Hydrochloride)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tabletPioglitazone Hydrochloride›16.53mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Pink oval film-coated tablet
Packaging
Bottle package - 30 tablets/bottle, Bottle package - 100 tablets/bottle
Approval status
Active

MFDS item code 202302364 · Approved 2023.08.08 · Insurance code 646005720

Summary

Main use
Improvement in blood sugar control for Type 2 diabetes
Who uses it
Adults
Adult dosage
This medication may be administered once daily, regardless of meals, as one tablet containing 100 mg of Sitagliptin and either 15 mg or 30 mg of Pioglitazone for patients with Type 2 diabetes.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Improvement in blood sugar control for Type 2 diabetes

View approved original text

This medication is designed to help patients with Type 2 diabetes control their blood sugar levels, used in conjunction with diet and exercise therapy. It aids in improving blood sugar levels through the effective combination of Sitagliptin and Pioglitazone. Therefore, this medication is used to enhance blood sugar control in patients with Type 2 diabetes.

Dosage and Administration

Adult dosage

This medication may be administered once daily, regardless of meals, as one tablet containing 100 mg of Sitagliptin and either 15 mg or 30 mg of Pioglitazone for patients with Type 2 diabetes.

Precautions

This medication contains Sitagliptin and Pioglitazone and is used for the treatment of Type 2 diabetes. Patients with a history of allergic reactions should not use this medication, especially those with a history of severe hypersensitivity reactions such as anaphylaxis or angioedema should not be administered this drug. Patients with heart failure or a history of heart failure should also not take this medication, as the Pioglitazone component can cause fluid retention and worsen heart failure. This medication is contraindicated in patients with active bladder cancer or a history of bladder cancer due to the reported risk of bladder cancer occurrence, thus caution is required. Patients with severely impaired liver function and those with severe renal impairment should not take this medication. In particular, Sitagliptin is excreted through the kidneys, so dosage adjustments are necessary based on renal function. For patients with diabetic ketoacidosis, diabetic coma, Type 1 diabetes patients, patients pre- and post-surgery, and those with severe infections or trauma, insulin treatment is recommended instead of this medication. Women who are pregnant or could become pregnant should not take this medication, and premenopausal women should take necessary contraceptive measures as this medication may increase the likelihood of becoming pregnant. While taking this medication, pancreatitis symptoms (severe abdominal pain, nausea, vomiting, etc.) should be observed closely, and if such symptoms are suspected, immediate consultation with a physician is necessary. Furthermore, this medication has a risk of hypoglycemia, so it is essential to frequently check blood sugar levels, especially when combined with insulin or sulfonylureas, and to be aware of symptoms of hypoglycemia. The component Pioglitazone may cause weight gain and edema, and if edema worsens or symptoms of heart failure appear, a physician should be informed. If symptoms of liver dysfunction (fatigue, loss of appetite, jaundice, etc.) occur, liver function tests should be performed immediately and the medication should be discontinued if there are signs of severe liver injury. If any unusual symptoms such as severe joint pain or skin blisters occur while taking this medication, immediate consultation with a physician is necessary. Finally, this medication may interact with various drugs, so if you are taking other medications, you must inform your doctor or pharmacist, especially as dosage adjustments may be needed when combined with CYP2C8 inhibitors or inducers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, mouth/eye mucous membrane pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities along with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, altered consciousness, vision changes, paralysis, urination issues

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • dyspepsia
  • diarrhea
  • nausea
  • myalgia
  • limb pain
  • back pain
  • constipation
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  • dizziness
  • increased triglycerides
  • elevated low-density lipoprotein
  • hyperglycemia
  • loss of appetite
  • gastritis
  • pruritus
  • chest pain
  • fatigue
  • weakness
  • vomiting
  • tremors
  • chills
  • abdominal pain
  • discomfort in the epigastrium
  • numbness
  • muscle rigidity
  • discomfort in the head
  • elevated liver enzymes
  • joint pain
  • knee abnormality
  • weakness of arms
  • proteinuria
  • elevated serum creatinine
  • anxiety

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 ingress, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the efficacy of the medication.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

Bottle package - 30 tablets/bottle, Bottle package - 100 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.