Bilsus Tablets 50mg (Vildagliptin)

Adult dose

This medication can be administered as monotherapy or for patients with no prior experience of diabetes medication treatment, in combination with metformin at a dose of 50mg once daily in the morning, or 100mg divided into two doses of 50mg each in the morning and evening. When used in combination with metformin or thiazolidinediones, the recommended dose is 100mg daily, divided into two doses of 50mg each in the morning and evening. When taken with sulfonylureas, if adequate blood sugar control cannot be achieved, the recommended dose is 50mg once daily in the morning. In these patients, administering 100mg of vildagliptin once daily is not more effective than 50mg once daily. In cases where adequate blood sugar control cannot be achieved with a combination of sulfonylureas and metformin, the recommended dose when co-administered (third-line therapy) is 100mg daily, divided into doses of 50mg each in the morning and evening. If adequate blood sugar control cannot be achieved with insulin (either as monotherapy or in combination with metformin), the recommended dose when co-administered is 100mg daily, divided into two doses of 50mg each in the morning and evening. This medication can be taken without regard to meals, and doses above 100mg are not recommended. When taken with sulfonylureas, the dose of sulfonylureas may need to be reduced to lower the risk of hypoglycemia. If a dose is forgotten, take it as soon as it is remembered and adjust the next dose according to the regular schedule. If it is close to the next dose time, do not take the missed dose. Do not take two doses at once to make up for a missed dose. For patients with liver impairment, this medication is not recommended for those with ALT or AST levels exceeding 2.5 times the normal upper limit before administration. For patients with renal impairment: - Mild renal impairment (creatinine clearance ≥50 mL/min): No dosage adjustment is needed. - Moderate and severe renal impairment or end-stage renal disease (ESRD) patients: A dosage of 50mg once daily is recommended. (Refer to the caution in ‘3. General precautions’ in the usage information)

This medication should not be used in certain patients. Patients with allergies to this drug's active ingredient or other components, patients with type 1 diabetes, and patients with diabetic ketoacidosis should not be administered this drug. Furthermore, patients with lactose intolerance or genetic lactose-related conditions should not take this medication. While taking this medication, it is important to regularly undergo liver function tests, as liver function abnormalities may rarely occur before and during treatment. If there is a significant increase in liver enzymes or symptoms like jaundice appear, the medication should be discontinued immediately. This medication may cause hypoglycemia, particularly when taken with sulfonylureas, raising the risk of hypoglycemia. Immediate action should be taken if hypoglycemic symptoms appear, and dosage adjustments should be discussed with a physician if necessary. This medication is not recommended for pregnant or breastfeeding women. It is safest to avoid taking it during pregnancy or breastfeeding. It can be used in elderly patients without separate dosage adjustments, but its safety and efficacy have not been established in children and adolescents under 18 years of age, hence it is not recommended for use in this population. Dizziness may occur during treatment, so caution should be exercised when driving or operating machinery. Severe joint pain or skin symptoms like blisters or ulcers should be reported to a doctor immediately for treatment. If symptoms of acute pancreatitis are suspected, the use of this medication should be stopped immediately, and patients with a history of pancreatitis should use it cautiously. In the case of overdose, as there is no specific antidote, appropriate treatment and supportive therapy according to symptoms may be necessary. This medication should be kept out of the reach of children and should not be transferred to other containers.

Serious side effects

• Hives
• angioedema
• blistering
• exfoliative skin lesions
• bullous pemphigoid-like reactions
• hepatitis
• liver dysfunction
• jaundice
• acute pancreatitis
• severe swelling

Mild side effects

• Headache
• dizziness
• tremors
• weakness
• fatigue
• nausea
• constipation
• weight gain
• hypoglycemia
• gastroesophageal reflux

This medication should be stored in an airtight container and kept in a cool place below 30 degrees Celsius, protected from moisture. Storing it this way will help maintain the drug's efficacy for a longer period.

Appearance

White to light yellow round tablets

Package unit

28 tablets/box [14 tablets/PTP(x2)]