Dapagluem Sustained Release Tablet 10/1000 mg (Dapagliflozin Propanediol Monohydrate, Metformin Hydrochloride)

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment regimen, efficacy, and tolerability, without exceeding the maximum recommended dose of 10 mg of dapagliflozin and 2000 mg of sustained-release metformin. Typically, it is administered once a day with the evening meal. The maximum dose is 10 mg of dapagliflozin/2000 mg of sustained-release metformin once daily, given as two tablets of 5 mg/1000 mg. For patients with no prior experience with diabetes medication treatment, if sufficient blood sugar control is difficult with monotherapy, the recommended starting dosage for initial treatment is one tablet of 5 mg/500 mg or 10 mg/500 mg taken once daily. To reduce gastrointestinal side effects of metformin, the dosage should be titrated gradually. In patients receiving treatment with metformin, the recommended dose of dapagliflozin is 10 mg once daily, and this medication's dosage should provide a dosage of metformin that the patient was previously taking or a dose that is therapeutically appropriate. When changing from immediate-release metformin to sustained-release preparation, blood sugar control should be closely monitored, and adjustments made appropriately. In patients transitioning to this medication from a combination therapy of dapagliflozin and metformin, the dosage may be initiated based on the existing dosing of dapagliflozin and metformin. There should be close monitoring of blood sugar control and appropriate dosage adjustments made when converting from immediate to sustained-release formulations. When this medication is used in conjunction with insulin or insulin secretagogues such as sulfonylureas, lower doses of insulin or secretagogues may be considered to reduce the risk of hypoglycemia. The safety and efficacy of this medication have not been specifically evaluated in patients transitioning from other hypoglycemic agents. Any changes in diabetes treatment in type 2 diabetes patients should be performed under careful monitoring due to potential alterations in blood sugar control. This medication must be swallowed whole and should never be crushed, cut, or chewed. Occasionally, inactive ingredients of this medication may be excreted in the stool, resembling soft hydrated mass similar to the tablet.

This medication helps lower blood sugar. However, it should not be used in patients with poor kidney function or conditions such as dehydration, severe infections, or cardiovascular problems. Women who are pregnant or breastfeeding should also refrain from taking this medication. It can occasionally cause a severe condition called lactic acidosis, so any symptoms must be reported to a doctor immediately. There is a risk of hypoglycemia, so caution is required when used with insulin or other hypoglycemic agents. During treatment, urinary tract infections or genital infections may occur, and any related symptoms should be treated immediately. For patients at risk of decreased blood volume or hypotension, blood pressure and kidney function should be monitored frequently. Vitamin B12 levels may decrease, so blood tests may be necessary during long-term treatment. Excessive alcohol consumption can increase risks, so caution is necessary. This medication should be discontinued for a certain period before and after surgery or radiographic procedures, and it should be restarted only after confirming normal kidney function. Elderly patients commonly experience decreased kidney function, so dosing adjustment and regular kidney function tests may be needed. In case of overdose, immediate medical attention is required. This medication has not been established as safe and effective for children.

Serious side effects

Lactic acidosis, severe hypoglycemia, severe ketoacidosis, urosepsis, pyelonephritis, acute kidney injury, kidney function impairment, severe allergic reactions, Guillain-Barré syndrome, atrial fibrillation, acute cholecystitis, perineal necrosis, severe edema, elevated blood pressure, hives, severe swelling, chest tightness, respiratory difficulty, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, oral/eye mucosal pain, shortness of breath or difficulty breathing

Mild side effects

• Vulvitis
• balanitis and related genital infections
• urinary tract infections
• fungal infections
• hypoglycemia
• dry mouth
• dizziness
• constipation
• lumbar pain
• dysuria

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve its effectiveness.

Appearance

Yellow, double-sided convex oval sustained-release film-coated tablets

Package unit

30 tablets/box [(10 tablets/PTP (Alu-Alu) x 3)]