Diabex XR Extended-Release Tablet 1000 mg (Metformin Hydrochloride)

Adult dose

The typical initial dose is 500mg of Metformin Hydrochloride Extended-Release Tablet once daily with the evening meal. A week later, blood sugar levels should be measured to adjust the dosage, and when increasing the dose, it should be increased by 500mg weekly, up to a maximum of 2000mg daily, also taken with the evening meal. If adequate blood sugar control is not achieved after maximum daily dosing of 2000mg, consider 1000mg twice daily, with both doses taken with meals.

This medication may rarely cause a serious condition called lactic acidosis, which can lead to death. Caution is necessary when used in conjunction with insulin or sulfonylureas, as severe hypoglycemia may occur. This medication should not be used in patients with moderate to severe renal impairment or those in acute conditions such as dehydration, serious infections, or acute myocardial infarction. It should be discontinued before and after tests involving acute heart failure or radiologic iodine contrast agents and may only be resumed after renal function is confirmed to be normal. Patients allergic to this medication’s components or to biguanide class medications should not use it. It is not indicated for patients with type 1 diabetes or a history of lactic acidosis or ketosis. In cases of severe infections, trauma, or pre-and post-surgery, this medication should be temporarily discontinued and resumed only after the patient’s condition stabilizes. Caution is also warranted for patients with poor nutritional status, impaired liver function, or excessive alcohol intake. In pregnant women at risk of placental insufficiency or preeclampsia, the use of this medication should be avoided. During therapy, if dietary intake is irregular or insufficient, intense exercise is undertaken, or other medications are used concurrently, the risks of lactic acidosis and hypoglycemia may increase, thus requiring careful monitoring. Gastrointestinal disturbances such as nausea, vomiting, and diarrhea are common at the beginning of treatment but usually improve over time. This medication is excreted through the kidneys; therefore, regular renal function assessments should be conducted, and if abnormalities are found, the medication should be discontinued. Alcohol can increase the risk of side effects, so excessive consumption should be avoided. If blood sugar control becomes difficult or hypoglycemic symptoms occur, immediate consultation with healthcare providers is necessary. Elderly patients are at higher risk of diminished renal function, so dosage adjustments and regular renal function monitoring need to be performed. This medication may be used during pregnancy for blood sugar control, but careful observation of fetal growth is necessary and is not recommended during breastfeeding. In cases of overdose, dialysis may be required, and prompt medical attention is necessary. This medication should be swallowed whole without chewing or crushing, and it is normal for part of the tablet to pass in the stool. There is potential for interactions with other medications, so patients should inform healthcare providers about any other medications they are taking.

Serious side effects

Severe lactic acidosis (including deaths due to lactic acidosis), symptoms associated with lactic acidosis (fatigue, muscle pain, difficulty breathing, weakness, abdominal pain, lowered body temperature, hypotension, bradyarrhythmias), severe allergic reactions (including hives), risk of lactic acidosis due to renal dysfunction, liver abnormalities (risk of lactic acidosis related to liver dysfunction), hypoglycemia (including severe hypoglycemia), severe edema or urination abnormalities (risk in renal impaired patients)

Mild side effects

• Vitamin B12 deficiency
• altered taste
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• erythema
• itching
• hives

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. A recommended storage temperature is between 1 degree and 30 degrees Celsius to maintain its effectiveness over time.

Appearance

White to off-white, oval, biconvex extended-release tablet

Package unit

60 tablets (10 tablets/PTP) × 6