Medication info

Samsung Pioglitazone Tablets 15 mg (Pioglitazone Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Pioglitazone Hydrochloride›Strength being verified
Manufacturer / importer
삼성제약(주)
Appearance
White round tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201805174 · Approved 2018.12.19

This product's status changed to Approval withdrawn on 2023.08.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of type 2 diabetes (blood sugar control)
Who uses it
Adults · Children
Adult dosage
This medication should be taken orally once a day regardless of meals. In monotherapy, it is initiated at 15 mg once daily, and if efficacy is insufficient, the dose can be increased to 30 mg once daily. In combination therapy, 15 mg is administered once daily alongside sulfonylureas, metformin, or insulin, with the maximum recommended dose not to exceed 30 mg once daily.
Children's dosage
Use in children under 18 years of age is not recommended due to lack of experience.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of type 2 diabetes (blood sugar control)

  • Blood sugar control issues in patients with type 2 diabetes
View approved original text

This medication is used as an adjunct to dietary and exercise therapy for blood sugar control in patients with type 2 diabetes. It can be administered as a monotherapy, but if there is no blood sugar improvement with other oral hypoglycemic agents, it is used in combination with sulfonylureas, metformin, or insulin. Furthermore, patients with type 2 diabetes are required to follow nutritional counseling and weight loss, as well as maintaining a regular exercise regimen, as these efforts are crucial not only for initial treatment but also for sustaining the effectiveness of drug therapy. This medication effectively improves blood sugar control in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

This medication should be taken orally once a day regardless of meals. In monotherapy, it is initiated at 15 mg once daily, and if efficacy is insufficient, the dose can be increased to 30 mg once daily. In combination therapy, 15 mg is administered once daily alongside sulfonylureas, metformin, or insulin, with the maximum recommended dose not to exceed 30 mg once daily.

Children's dosage

Use in children under 18 years of age is not recommended due to lack of experience.

Precautions

This medication is primarily used for blood sugar control in patients with type 2 diabetes. This medication may place a burden on the heart, and should not be used in patients with heart failure or a history of heart failure. Particularly, if symptoms or signs of heart failure appear, immediate medical attention should be sought, and if necessary, the administration of this medication should be stopped or the dosage reduced. Moreover, this medication can cause fluid retention, potentially worsening edema or heart failure, so patients with edema or heart disease should be closely monitored. Patients with active bladder cancer or a history of bladder cancer, liver impairments, severe kidney disorders, and diabetic ketoacidosis should not receive this medication. Women who are pregnant or may become pregnant, as well as certain genetically lactose intolerant patients should also refrain from taking this medication. When used in combination with other hypoglycemic agents, the risk of hypoglycemia may increase, so one should be well-informed about hypoglycemia symptoms and appropriate responses. During treatment, regular monitoring of liver function tests and blood sugar control status is necessary, and if unusual symptoms such as weight gain, edema, or shortness of breath appear, immediate consultation with a physician is advised. Some premenopausal women may experience ovulation as a result of this medication, so it is recommended to use appropriate contraceptive methods during treatment. This medication is taken once daily regardless of meals, and in case of a missed dose, care should be taken not to double the dose the next day. Finally, the safety and efficacy in children have not been established, and caution should be exercised in elderly patients. It is important to promptly consult a physician or pharmacist if any unusual symptoms or suspicious signs occur during the course of treatment.

Side effects and when to seek care immediately

Serious side effects

Congestive heart failure, edema, symptoms of heart failure (dyspnea, edema), urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes accompanied by high fever, blisters, mucosal pain in the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough+fever, jaundice, liver abnormalities, sudden and very severe headaches, lightning-like headache

Mild side effects

  • Upper respiratory infections
  • headaches
  • sinusitis
  • muscle pain
  • pharyngitis
  • abdominal distension
  • weight gain
  • hypoglycemia
  • urinary tract infections
  • back pain
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  • dizziness
  • diarrhea
  • elevated serum creatine kinase levels
  • hypertension
  • itching
  • tremors
  • chest pain
  • fatigue
  • weakness
  • dyspepsia
  • nausea
  • cough
  • chest discomfort
  • gastrointestinal diseases
  • epigastric discomfort
  • numbness
  • muscle stiffness
  • headache discomfort
  • elevated liver enzymes
  • joint pain
  • knee abnormalities
  • arm weakness
  • proteinuria
  • anxiety

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 moisture-laden areas should be avoided. The storage temperature should be maintained between 15 degrees and 30 degrees, ideally around 25 degrees.

Appearance and packaging

Appearance

White round tablets

Package unit

30 tablets/bottle, 300 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.