Empagliflozin and Sitagliptin and Metformin Hydrochloride Extended-Release Tablets 25/100/1000 mg

Adult dose

In antidiabetic therapy, the recommended dosage of this medication should not exceed the maximum daily dosages of each component, which are empagliflozin 25 mg, sitagliptin 100 mg, and extended-release metformin hydrochloride 2000 mg. The dosage is determined based on each patient's current treatment regimen, efficacy, and tolerability. This medication should be taken once daily in the evening with food to reduce gastrointestinal adverse reactions due to metformin hydrochloride, and the dosage may need adjustments if required.

This medication contains three components: sitagliptin, empagliflozin, and metformin hydrochloride. Firstly, the sitagliptin component may cause severe allergic reactions, albeit rarely. Such reactions can appear within 3 months after starting the medication; if symptoms such as skin rash, difficulty breathing, or swelling of the face or throat occur, you should discontinue the medication immediately and seek medical attention. Additionally, it may cause acute pancreatitis, an inflammation of the pancreas, so symptoms like abdominal pain, nausea, or vomiting should be observed closely during treatment. The metformin hydrochloride component may cause lactic acidosis, which is a rare but very serious metabolic disorder. Symptoms can include difficulty breathing, muscle pain, weakness, and abdominal pain. It is particularly advisable for patients with impaired kidney function, liver impairment, severe dehydration, or ongoing infections to avoid this medication. This drug should not be administered to patients with type 1 diabetes, acute or chronic kidney disorders, acute heart failure, myocardial infarction, or patients scheduled for surgery with severe infections. Regular kidney function tests should be conducted during treatment, particularly in elderly patients and those with slightly impaired kidney function who may require more frequent monitoring. There is a risk of hypoglycemia associated with this medication; therefore, caution should be taken for patients on insulin or sulfonylureas to observe symptoms of low blood sugar and respond promptly if they appear. Moreover, this medication may lead to dehydration or low blood pressure, so intake should be temporarily discontinued and a physician consulted if symptoms such as diarrhea, vomiting, or fever lead to fluid loss. Increased occurrences of genital infections or urinary tract infections may occur, so prompt treatment is necessary if related symptoms appear. Caution is advised while driving or operating machinery due to the risk of hypoglycemia, and it is recommended to avoid alcohol consumption during treatment. The tablets should be swallowed whole and not chewed or crushed; it is normal for the tablet coating to appear in the stool. It is essential to consult healthcare professionals immediately if any unusual symptoms or discomfort occur during treatment.

Serious side effects

• Hives
• angioedema
• anaphylaxis
• Stevens-Johnson syndrome
• exfoliative skin conditions
• acute pancreatitis
• lactic acidosis
• severe allergic reactions
• severe skin reactions
• liver abnormalities (jaundice)

Mild side effects

• Indigestion
• abdominal pain
• vaginal infection
• weight loss
• thirst
• rash
• hypoglycemia
• headache
• upper respiratory tract infection
• pharyngitis

This medication should be stored in a tightly sealed container to protect it from air and moisture. The appropriate storage temperature is between 1 to 30 degrees Celsius (33.8 to 86 degrees Fahrenheit). Avoid extremely hot or cold locations and keep it in a cool place away from direct sunlight.

Appearance

Round, biconvex, yellow film-coated extended-release tablets

Package unit

30 tablets/bottle