Medication info
Ketosmet Tablet 15/850 mg

Ketosmet Tablet 15/850 mg

Prescription medicationTablet
Ingredient · strength
Metformin Hydrochloride›850mg / 1 tabletPioglitazone Hydrochloride›16.53mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
White to grayish-white oval film-coated tablets
Packaging
30 tablets (10 tablets/PTP*3)
Approval status
Active

MFDS item code 201705673 · Approved 2017.07.14 · Insurance code 671705340

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
The initial dose of this medication should be based on the patient's current treatment regimen. 1. Patients who do not achieve adequate blood sugar control with monotherapy of metformin or pioglitazone: The dose should be based on the current dosage of metformin or pioglitazone being taken. This medication should be initiated at 1 tablet once daily, and dosage adjusted gradually based on the adequacy of treatment response. 2. Patients transitioning from combination therapy of pioglitazone and metformin.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps patients with type 2 diabetes manage blood sugar levels more effectively when combined with diet and exercise. The two components, pioglitazone and metformin, work together to stabilize blood sugar levels. Therefore, it is suitable for individuals who have difficulties managing blood sugar and aids in diabetes treatment.

Dosage and Administration

Adult dosage

The initial dose of this medication should be based on the patient's current treatment regimen. 1. Patients who do not achieve adequate blood sugar control with monotherapy of metformin or pioglitazone: The dose should be based on the current dosage of metformin or pioglitazone being taken. This medication should be initiated at 1 tablet once daily, and dosage adjusted gradually based on the adequacy of treatment response. 2. Patients transitioning from combination therapy of pioglitazone and metformin.

Precautions

This medication consists of two components, with the first component being a drug that helps lower blood sugar levels. This medication should not be used in patients with impaired kidney function or liver dysfunction, severe heart failure, those with bladder cancer, and in pregnant or breastfeeding women. Additionally, it should be discontinued in cases of acute renal failure, serious infections, severe trauma, and pre- or post-surgical states. This medication can cause a rare but serious side effect known as lactic acidosis. Lactic acidosis occurs when there is an excessive buildup of lactic acid in the body, which can present symptoms such as vomiting, abdominal pain, muscle pain, difficulty breathing, and weakness. If these symptoms occur, you should immediately inform your doctor and discontinue the medication. Moreover, this medication may worsen heart failure; therefore, patients with heart disease should use it with caution and should also monitor for symptoms such as weight gain or edema. It is advisable to avoid alcohol while taking this medication. Alcohol can increase the impact of the drug on lactic acid metabolism, raising the risk of side effects. If taken alongside other diabetes medications for blood sugar control, hypoglycemia may occur, so blood sugar levels should be monitored frequently, and medication dosages adjusted as necessary. Regular blood tests and kidney function tests should be conducted while taking this medication, and monitoring of vitamin B12 levels is also recommended. Furthermore, this medication may interact with certain drugs, so it's essential to inform your doctor or pharmacist about any other medications you are currently taking. If undergoing surgery or tests using contrast agents, the medication should be temporarily discontinued and resumed only after confirming normal kidney function. Elderly patients or those with compromised kidney function should particularly adjust the dosage carefully and monitor kidney function frequently. Finally, this medication has not been confirmed to be safe and effective in pediatric patients, so it is not used in children.

Side effects and when to seek care immediately

Serious side effects

Severe lactic acidosis, hypoglycemia, symptoms and signs of heart failure (including excessive weight gain, difficulty breathing, and edema), severe heart failure, acute kidney function deterioration, acute myocardial infarction, sepsis, cardiovascular collapse (shock), liver dysfunction, liver damage (including jaundice), severe skin adverse reactions (high fever and severe rash, blisters, skin peeling, mucosal pain), bladder cancer, severe neurological symptoms (headache, seizures, altered consciousness, visual disturbances, paralysis).

Mild side effects

  • Upper respiratory tract infection
  • diarrhea
  • nausea
  • headache
  • urinary tract infection
  • sinusitis
  • dizziness
  • leg edema
  • weight gain
  • muscle pain
Show 19 more
  • dental disorders
  • worsening diabetes
  • pharyngitis
  • anemia
  • indigestion
  • insomnia
  • dry mouth
  • constipation
  • abdominal bloating
  • gastroesophageal reflux disease
  • intestinal gas
  • increased blood creatinine
  • increased blood urea
  • decreased vision
  • macular edema
  • fractures
  • hypoglycemia
  • reduced vitamin B12
  • increased ovulation.

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. The appropriate storage temperature is room temperature between 1°C and 30°C, avoiding extremely hot or cold places.

Appearance and packaging

Appearance

White to grayish-white oval film-coated tablets

Package unit

30 tablets (10 tablets/PTP*3)

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.