Medication info
Sildapamil Extended Release Tablets 5/50/750 mg

Sildapamil Extended Release Tablets 5/50/750 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Phosphate Hydrate›64.3mg / 1 tabletDapagliflozin Propanediol Hydrate›6.2mg / 1 tabletMetformin Hydrochloride›750mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Pale yellow oval-shaped extended release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202301625 · Approved 2023.05.22 · Insurance code 643508700

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
For antidiabetic therapy, the recommended dosage of this medication is dapagliflozin at 10 mg, sitagliptin at 100 mg, and the extended release metformin hydrochloride should not exceed 2000 mg, determined based on each patient's current treatment regimen, efficacy, and tolerability. This medication should be taken with dinner once daily to reduce gastrointestinal side effects caused by metformin hydrochloride, and the dosage of metformin should be adjusted incrementally if necessary.

Ingredients

Manufacturer
한미약품(주)

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. It is particularly effective when used in combination with dapagliflozin, sitagliptin, and metformin, and better results can be expected when combined with dietary and exercise therapy. This medication helps to manage blood glucose levels stably, aiding in the treatment of diabetes.

How to take

Adult dose

For antidiabetic therapy, the recommended dosage of this medication is dapagliflozin at 10 mg, sitagliptin at 100 mg, and the extended release metformin hydrochloride should not exceed 2000 mg, determined based on each patient's current treatment regimen, efficacy, and tolerability. This medication should be taken with dinner once daily to reduce gastrointestinal side effects caused by metformin hydrochloride, and the dosage of metformin should be adjusted incrementally if necessary.

Precautions

This medication contains sitagliptin, dapagliflozin, and metformin, which are used for the treatment of diabetes. First, the sitagliptin component can rarely cause serious allergic reactions, so if sudden rashes, difficulty breathing, or swelling of the face or neck occur after taking the medication, discontinue use immediately and seek medical care. Additionally, acute pancreatitis, which is inflammation of the pancreas, can occur, so if symptoms like abdominal pain, vomiting, or nausea arise, it is important to visit a hospital promptly. Next, the dapagliflozin component can reduce body fluid volume, potentially lowering blood pressure, thus caution is necessary for patients at risk of dehydration or hypotension. There is an increased risk of genital and urinary tract infections, so prompt treatment is necessary if any symptoms of infection are present. Also, very rarely, serious perineal necrosis, which is damage to skin and tissues, may occur; therefore, if pain, swelling, or redness appears around the genital area, consult medical personnel immediately. The metformin component can very rarely cause lactic acidosis, a serious metabolic disturbance; thus, if symptoms such as severe fatigue, difficulty breathing, or abdominal pain arise, immediate treatment is necessary. Patients with poor liver function or decreased kidney function should limit the use of this medication and undergo regular kidney and liver function tests. Additionally, there is a risk of hypoglycemia, so blood glucose changes should be monitored carefully if meals are skipped or irregular, if vigorous exercise is performed, or if insulin or other diabetes medications are used concurrently. This medication should not be administered to patients who are pregnant or have severe infections, heart failure, or acute myocardial infarction. While taking this medication, it is important to closely observe any changes in health status and to consult a doctor immediately if abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, anaphylaxis, angioedema, Stevens-Johnson syndrome, exfoliative skin disease, high fever, severe rash, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, and sudden and severe headaches.

Mild side effects

  • Hypoglycemia
  • nasopharyngitis
  • upper respiratory tract infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • vomiting
  • weakness
  • chest pain
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  • fatigue
  • pain
  • swelling
  • foreign body sensation
  • facial swelling
  • facial pain
  • warmth
  • flu-like symptoms
  • itching
  • rash
  • cold sweat
  • myalgia
  • limb pain
  • back pain
  • dyspepsia
  • nausea
  • diarrhea
  • vomiting
  • increased serum triglycerides
  • allergic dermatitis
  • contact dermatitis
  • hair loss
  • dry skin
  • sensory decrease
  • sensory abnormalities
  • drowsiness
  • and dry mouth.

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The optimal storage temperature is between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the efficacy of the medication for a longer duration and ensure safe usage.

Appearance and packaging

Appearance

Pale yellow oval-shaped extended release film-coated 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.