Medication info

Actosmet Tablets 15/850 Milligrams

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Pioglitazone Hydrochloride›16.53mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
White to grayish-white elongated convex film-coated tablets, with '15/850' on one side and '4833M' on the other side.
Packaging
56 tablets (14 tablets/PTP packaging x 4)
Approval status
Approval withdrawn

MFDS item code 200802021 · Approved 2008.02.21

This product's status changed to Approval withdrawn on 2025.03.19. 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
The doses of pioglitazone should not exceed 30mg and metformin should not exceed 2500mg based on effectiveness and tolerability, which should be individualized. Initial dosing should be based on the patient's current treatment regimen, starting with 1 tablet per day based on the current dose of metformin or pioglitazone in monotherapy. The dose should be gradually adjusted according to treatment response. Patients transitioning from combination therapy should start at their existing dosing levels.

Ingredients

Importer
(주)셀트리온제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used as an adjunct to diet and exercise to help control blood sugar in patients with type 2 diabetes. By taking pioglitazone and metformin together, it effectively helps improve blood sugar levels. Thus, it is a suitable treatment for patients who require blood sugar management.

Dosage and Administration

Adult dosage

The doses of pioglitazone should not exceed 30mg and metformin should not exceed 2500mg based on effectiveness and tolerability, which should be individualized. Initial dosing should be based on the patient's current treatment regimen, starting with 1 tablet per day based on the current dose of metformin or pioglitazone in monotherapy. The dose should be gradually adjusted according to treatment response. Patients transitioning from combination therapy should start at their existing dosing levels.

Precautions

This medication contains metformin and pioglitazone and is primarily used for the treatment of type 2 diabetes. Metformin is excreted by the kidneys, so regular kidney function tests are necessary, as there is a risk of a serious side effect called lactic acidosis in patients with impaired renal function. Lactic acidosis is a rare complication that occurs when lactic acid accumulates abnormally, with symptoms including fatigue, muscle pain, difficulty breathing, and abdominal pain; if any of these symptoms occur, consult a physician immediately. In patients with impaired liver function or those who consume alcohol excessively, the risk of lactic acidosis is increased, so caution is required. Pioglitazone can cause fluid retention, which may worsen heart failure; if symptoms of heart failure such as sudden weight gain, difficulty breathing, or edema occur, seek medical attention promptly. This medication should not be used in specific patient groups such as those with severe heart failure, severe renal impairment, or active bladder cancer. This medication should be administered cautiously to patients with irregular eating habits, those engaged in vigorous exercise, or those taking interacting medications, as there is a risk of hypoglycemia, requiring frequent monitoring of blood sugar levels. Also, it is not used for pregnant or breastfeeding women or pediatric patients, as safety has not been established. Regularly monitor blood sugar, kidney function, liver function, and hematological tests while taking this medication to detect and manage any abnormal signs early. In case of overdose, inform medical personnel immediately to receive appropriate supportive care; metformin can be removed by hemodialysis. Finally, if acute diseases, surgeries, or dehydration occur during treatment, temporarily discontinue use and consult with medical professionals.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, hypoglycemia, acute renal function deterioration, cardiopulmonary disease, sepsis, severe allergic reactions, congestive heart failure, worsening heart failure, cardiac adverse reactions, severe heart failure, liver failure, liver abnormalities (jaundice), severe edema, urinary disorders, bladder cancer, severe neurological symptoms, symptoms related to lactic acidosis (hyperventilation, muscle pain, fatigue, confusion), hypoglycemia, pulmonary embolism, cardiovascular collapse, acute myocardial infarction, hypoxia, pulmonary function impairment.

Mild side effects

  • Upper respiratory tract infection
  • diarrhea
  • nausea
  • headache
  • urinary tract infection
  • sinusitis
  • dizziness
  • lower extremity edema
  • weight gain
  • muscle pain
Show 14 more
  • dental disorders
  • worsening diabetes
  • pharyngitis
  • anemia
  • dyspepsia
  • insomnia
  • dry mouth
  • constipation
  • abdominal distension
  • gastroesophageal reflux disease
  • aerophagia
  • increased serum creatinine
  • increased blood urea nitrogen
  • abnormal blood glucose.

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

Storage

This medication can be deteriorated by air or moisture, so it must be stored in a tightly closed container. It is best to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to grayish-white elongated convex film-coated tablets, with '15/850' on one side and '4833M' on the other side.

Package unit

56 tablets (14 tablets/PTP packaging x 4)

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.

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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.