Jensigamet Sustained Release Tablet 10/500 mg

Adult dose

The dosage of this medication should be individualized based on the patient's current treatment protocols, efficacy, and tolerability, without exceeding the maximum recommended doses of dapagliflozin 10 mg and sustained-release metformin 2000 mg. This medication is typically administered once daily with the evening meal. The maximum dosage is dapagliflozin 10 mg/sustained-release metformin 2000 mg once daily, administered as 2 tablets of 5 mg/1000 mg. If the patient has no previous experience with diabetes medication treatment and finds it difficult to adequately control blood sugar levels with monotherapy: For patients with no prior history of diabetes medication treatment, the recommended starting dosage of this medication when used as initial therapy is once daily 1 tablet of 5 mg/500 mg or 10 mg/500 mg. Dosages should be titrated gradually to reduce gastrointestinal side effects of metformin. In patients transitioning to this medication from combination therapy with dapagliflozin and metformin, the initial dosage can be started based on the existing doses of dapagliflozin and metformin. When converting from immediate-release metformin to the sustained-release form, close monitoring of blood sugar control is necessary with appropriate dose adjustments. The safety and efficacy of this medication have not been specifically evaluated in patients transitioning from other hypoglycemic agents; therefore, any changes in type 2 diabetes treatment should be carefully monitored due to potential changes in blood sugar control. This medication should be swallowed whole and must not be crushed, cut, or chewed. Occasionally, inactive ingredients of this medication may be excreted in the form of soft hydrate resembling tablets through stools. Renal impairment: No dose adjustment is necessary for patients with mild renal impairment. For patients with an estimated glomerular filtration rate (eGFR) of 45 mL/min/1.73 m2 or greater but less than 60 mL/min/1.73 m2, and without symptoms that may increase the risk of lactic acidosis, the starting dosage of the metformin hydrochloride component of this medication is 500 mg once daily and the maximum daily dosage is 1000 mg. The administration of this medication is not recommended for patients with an eGFR less than 45 mL/min/1.73 m2. If the eGFR decreases to less than 45 mL/min/1.73 m2, the medication should be discontinued immediately. Renal function should be evaluated every 3 to 6 months. Elderly patients: As metformin is excreted through the kidneys and renal function tends to decrease with age, caution is advised in the usage of this medication in older patients.

This medication contains metformin hydrochloride and dapagliflozin for the treatment of diabetes. Renal function is crucial when taking this medication, and patients with severely impaired renal function should not take it. Additionally, this medication should be avoided in acute conditions such as dehydration, severe infections, cardiovascular problems, or acute myocardial infarction. It is not safe to use this medication in pregnant or breastfeeding women. Since this medication contains lactose, patients with lactose intolerance should not take it. While taking this medication, there is a rare but serious risk of lactic acidosis; if symptoms such as malaise or difficulty breathing occur, immediate consultation with a physician is necessary. Caution is required when taking this medication with insulin or sulfonylureas due to the risk of hypoglycemia; insulin dosages should be adjusted as needed. This medication may cause reduced fluid volume or low blood pressure; therefore, elderly patients or those on diuretics should exercise particular caution and regularly monitor their blood pressure and renal function. Additionally, this medication may increase the risk of genital and urinary tract infections, necessitating prompt treatment if infection symptoms appear. Before undergoing surgery or radiologic examinations, this medication should be discontinued for a certain period, and it should be restarted only after renal function is confirmed to be normal post-examination. Since vitamin B12 levels may decrease, regular checks for vitamin B12 levels are advisable during prolonged use. Excessive alcohol consumption should be avoided as it increases the risk of side effects from this medication. This medication may lead to blood sugar control failures, so consult a physician for appropriate measures during infections or stressful situations. No safety and efficacy have been established for this medication in children; hence, it should not be used in this population. While taking this medication, dizziness may occur when driving or operating machinery, so caution is warranted. Finally, this medication should be kept out of reach of children and stored in its original container for safety.

Serious side effects

Lactic acidosis, severe hypoglycemia, ketoacidosis, urosepsis and pyelonephritis, acute kidney injury and renal dysfunction, atrial fibrillation, acute cholecystitis, Guillain-Barré syndrome, perineal necrosis, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver problems (jaundice), serious neurological symptoms, severe edema or urination abnormalities

Mild side effects

Vulvovaginitis, balanitis and related genital infections, urinary tract infections, fungal infections, hypoglycemia (when taken with insulin or sulfonylureas), reduced fluid volume, thirst, dizziness, constipation, dry mouth, back pain, dysuria, polyuria, nocturia, vulvar itching, genital itching, increased hematocrit, decreased early treatment renal creatinine clearance, dyslipidemia, increased serum creatinine early in treatment, elevated blood urea, weight

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

Appearance

Pink, double convex, oval-shaped sustained release film-coated tablet

Package unit

30 tablets/box [(6 tablets/PTP) * 5], 30 tablets/bottle