Medication info
Pioglerone 15mg (Pioglitazone Hydrochloride)

Pioglerone 15mg (Pioglitazone Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Pioglitazone Hydrochloride›16.53mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
White round tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 200703876 · Notified 2007.04.03 · Insurance code 643100820

Summary

Main use
Improvement of Type 2 Diabetes (blood sugar control)
Who takes it
Adults · Children
Adult dose
This medication is administered orally once a day regardless of meals. As a monotherapy, it is initiated at 15 mg once a day, and if sufficient effect is not achieved, the dose may be increased to 30 mg once daily. For combination therapy, the initial dose is 15 mg once a day, and can be used with sulfonylureas, metformin, and insulin. The maximum recommended dose should not exceed 30 mg once daily.
Child dose
There is no experience in children under 18 years; therefore, administration is not recommended.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Improvement of Type 2 Diabetes (blood sugar control)

  • Type 2 diabetes
View approved original text

This medication is used as an adjunct to dietary and exercise regimens for blood sugar control in patients with Type 2 diabetes. It can be administered as a monotherapy or in combination with sulfonylureas, metformin, or insulin when other oral hypoglycemic agents are ineffective. Additionally, nutritional counseling, weight loss, and exercise should be implemented, as these therapeutic efforts are critical for maintaining the drug's effectiveness and achieving optimal results. This medication is used to improve effective blood sugar control.

How to take

Adult dose

This medication is administered orally once a day regardless of meals. As a monotherapy, it is initiated at 15 mg once a day, and if sufficient effect is not achieved, the dose may be increased to 30 mg once daily. For combination therapy, the initial dose is 15 mg once a day, and can be used with sulfonylureas, metformin, and insulin. The maximum recommended dose should not exceed 30 mg once daily.

Child dose

There is no experience in children under 18 years; therefore, administration is not recommended.

Precautions

This medication helps to control blood sugar levels in patients with Type 2 diabetes and works by improving insulin resistance. During the course of treatment, caution is advised as this medication can put stress on the heart, particularly in patients with congestive heart failure or a history of congestive heart failure. Patients should be closely monitored for symptoms of heart failure such as sudden weight gain, shortness of breath, and swelling during treatment. This medication can cause fluid retention, which may worsen congestive heart failure; therefore, it should be used cautiously in patients with cardiovascular disease or swelling. Patients with active bladder cancer or a history of bladder cancer should not take this medication, and any symptoms such as hematuria or urinary disorders should be reported to a doctor immediately. Patients with impaired liver function or severe kidney dysfunction should also exercise caution while taking this medication. Women who are pregnant or may become pregnant should avoid this medication, and premenopausal women should use appropriate contraceptive methods as ovulation may be stimulated. This medication does not lower blood sugar levels when given alone and is effective only in the presence of insulin, hence it is not suitable for patients with Type 1 diabetes or diabetic ketoacidosis. Regular blood glucose and liver function tests should be conducted during treatment, and if any unusual symptoms arise, medical consultation is advised. Moreover, the risk of hypoglycemia may increase when this medication is used in conjunction with other hypoglycemic agents or insulin, so caution is necessary when combining therapies. Elderly patients or those with diminished kidney and liver function require careful monitoring while taking this medication. In the case of overdose, there is no specific antidote; thus, appropriate treatment based on symptoms is vital. Lastly, this medication has not been established for safety and effectiveness in children and should not be used in this population. This medication should be stored out of the reach of children and kept in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Congestive heart failure, symptoms and signs of heart failure (excessive and rapid weight changes, breathlessness, swelling), severe swelling, bladder cancer, liver impairment and liver failure, jaundice, severe allergic reactions (hives, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor), severe skin adverse reactions (severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa), breathing problems (shortness of breath or difficulty breathing)

Mild side effects

  • Upper respiratory infection
  • headache
  • sinusitis
  • myalgia
  • pharyngitis
  • abdominal bloating
  • weight gain
  • hypoglycemia
  • urinary tract infection
  • back pain
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  • dizziness
  • diarrhea
  • elevated serum creatine kinase (CK)
  • hypertension
  • pruritus
  • decreased appetite
  • constipation
  • upper abdominal pain
  • chest pain
  • fatigue
  • weakness
  • dyspepsia
  • nausea
  • chest discomfort
  • tremor
  • chills
  • gastrointestinal disorders
  • abdominal pain
  • epigastric discomfort
  • numbness
  • muscle stiffness
  • headache discomfort
  • elevated liver enzymes
  • worsening liver disease

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

Storage

This medication should be stored in a container that can block light and air, and precautions should be taken to avoid exposure to moisture. Additionally, it is recommended to store it at temperatures between 15 to 30 degrees Celsius, especially around room temperature of approximately 25 degrees.

Appearance and packaging

Appearance

White round tablet

Package unit

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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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.