Medication info
Sitaphol M Tablet 50/850 mg

Sitaphol M Tablet 50/850 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
(주)마더스제약
Appearance
Dark pink oval film-coated tablet
Packaging
56 tablets/box[(14 tablets/PTP×4)], 200 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202204572 · Approved 2022.12.21 · Insurance code 622804970

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally taken twice a day with food, and the dosage is gradually increased to minimize gastrointestinal side effects caused by metformin. 1. For patients who are not currently treated with metformin: Take this medication at 50/500 mg twice daily, with 1 tablet per dose, and it can be titrated to 50/1000 mg twice daily, with 1 tablet per dose. 2. For patients currently treated with metformin:

Ingredients

Manufacturer
(주)마더스제약

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication is used to assist in blood glucose control for patients with type 2 diabetes. When taken alongside dietary and exercise therapies, it effectively controls blood sugar levels to maintain a healthy glucose level. The combination of sitagliptin and metformin enhances the efficacy of lowering blood glucose. Therefore, it is suitable for patients with type 2 diabetes who need blood sugar management.

How to take

Adult dose

This medication is generally taken twice a day with food, and the dosage is gradually increased to minimize gastrointestinal side effects caused by metformin. 1. For patients who are not currently treated with metformin: Take this medication at 50/500 mg twice daily, with 1 tablet per dose, and it can be titrated to 50/1000 mg twice daily, with 1 tablet per dose. 2. For patients currently treated with metformin:

Precautions

This medication contains sitagliptin and metformin, which are used to help control blood sugar levels. Serious allergic reactions may occur while taking this medication; discontinue immediately and consult a physician if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck appear. There is a risk of acute pancreatitis, which is inflammation of the pancreas, so notify healthcare professionals immediately if symptoms such as abdominal pain, nausea, or vomiting occur. Patients with decreased kidney function, severe infections, dehydration, acute myocardial infarction, or heart failure should not take this medication. The medication should be temporarily discontinued before tests using iodine contrast agents, and usage should resume only after kidney function is confirmed to be normal post-examination. Women who are pregnant or may become pregnant, as well as nursing mothers, are advised not to take this medication. There is a risk of hypoglycemia with this medication; caution is especially needed when taken with other antidiabetic agents or insulin, and appropriate measures should be taken immediately if symptoms of hypoglycemia occur. The metformin component can rarely cause a serious metabolic disorder known as lactic acidosis, so immediate medical attention should be sought if sudden fatigue, muscle pain, difficulty breathing, or abdominal pain occur during treatment. Patients with impaired liver function or excessive alcohol consumption should exercise caution when using this medication due to increased risks. While taking this medication, regular blood tests and kidney function tests should be performed, and vitamin B12 levels should be monitored periodically. Patients scheduled for surgery should discontinue this medication 48 hours prior to surgery and resume only after confirming that kidney function has returned to normal following the procedure. The safety and efficacy of this medication have not been established in children under 18 years of age and its use is not recommended. In elderly patients, kidney function may decline, so dose adjustments and regular kidney function monitoring are necessary. In case of overdose, immediate hospital treatment should be sought, and the sitagliptin component may be partially removed through hemodialysis. Alcohol consumption should be avoided while taking this medication, as the risk of lactic acidosis may be increased when taken with alcohol. This medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, cutaneous vasculitis, severe cutaneous adverse reactions including Stevens-Johnson syndrome, acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure (sometimes requiring dialysis), dyspnea, worsening kidney function due to acute myocardial infarction, cardiovascular collapse (shock), sepsis, severe hypoglycemia (including confusion, seizures), severe edema, edema with hypertension

Mild side effects

  • Headache
  • upper respiratory tract infection
  • nasopharyngitis
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • constipation
  • weakness
  • pruritus
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  • thrombocytopenia
  • myalgia
  • limb pain
  • back pain
  • itching
  • dizziness
  • decreased appetite
  • weight loss
  • hypoglycemia
  • arthralgia

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

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy over time.

Appearance and packaging

Appearance

Dark pink oval film-coated tablet

Package unit

56 tablets/box[(14 tablets/PTP×4)], 200 tablets/bottle, 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.

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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.