Newjenta CR Tablets (Linagliptin, Metformin)

Adult dose

One tablet containing 5 mg of Linagliptin and 1000 mg of Metformin Hydrochloride (sustained release) can be administered once daily with a meal. To reduce gastrointestinal side effects caused by Metformin, it is recommended to take this medication with dinner. To maintain the sustained-release properties, the tablet should be swallowed whole and should not be split, crushed, ground, or chewed. The medication may be inadequately dissolved and excreted in the stool. It is unknown whether the active ingredient is present in the stools. If a patient repeatedly reports finding this medication in their stool, healthcare providers should assess if blood sugar is being adequately controlled (refer to prescribing precautions, section 5. General Precautions). Special Groups: Impaired Kidney Function: Dosage adjustments are necessary according to kidney function, hence periodic assessment of kidney function before and after administration is recommended. For patients with mild renal impairment [creatinine clearance (CrCl) ≧ 60 mL/min or estimated glomerular filtration rate (eGFR) ≧ 60 mL/min/1.73 m2], dosage adjustment is not necessary. In cases of moderate renal impairment (CKD stage 3A), where CrCl is between 45 mL/min and 60 mL/min or eGFR is between 45 mL/min/1.73 m2 and 60 mL/min/1.73 m2, Metformin Hydrochloride can be used with adjusted dosages, provided there are no symptoms that significantly increase the risk of lactic acidosis. The starting dosage of sustained release Metformin Hydrochloride is either 500 mg or 750 mg taken once daily, and initiation of therapy should not begin with this medication. The maximum daily dosage of Metformin Hydrochloride is 1000 mg. If CrCl falls below 45 mL/min or eGFR falls below 45 mL/min/1.73 m2, this medication should be discontinued immediately.

This medication can rarely cause severe lactic acidosis or hypoglycemia, so it should be used with caution. In particular, it should not be used in patients with severely impaired kidney function or liver dysfunction, or in cases of acute infection or dehydration. It is also unsafe for pregnant women or those with severe heart diseases such as congestive heart failure or acute myocardial infarction to take this medication. Patients should be vigilant for symptoms of hypoglycemia during treatment, and the risk of hypoglycemia may increase if used in conjunction with sulfonylureas or insulin. If symptoms of lactic acidosis such as muscle cramps, abdominal pain, or weakness occur, notify a doctor immediately, and the use of this medication should be determined based on kidney function. Additionally, if iodinated contrast agents are used during radiological examinations, this medication should be temporarily discontinued and resumed only after kidney function has recovered. Patients scheduled for surgery should stop taking this medication 48 hours prior to surgery and may restart it once kidney function has normalized post-operation. This medication should be swallowed whole without chewing or breaking it. It is normal for the outer coating of the tablet to appear in the stool. If symptoms suggestive of acute pancreatitis or blistering skin conditions arise during treatment, the patient should stop the medication immediately and consult a doctor. Long-term use may reduce vitamin B12 levels, so regular blood tests to monitor this are necessary. This medication may interact with other drugs, so it is essential to inform the doctor or pharmacist about any other medications being taken. Elderly patients are commonly at risk for reduced kidney function, so kidney function should be evaluated before administration and dosage adjustments may be necessary. Women who are pregnant or breastfeeding should avoid using this medication. In cases of overdose, there is a risk of lactic acidosis, and immediate medical attention is required. Keep out of reach of children, store in a moisture-free environment, and keep in the original container.

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, lactic acidosis, pancreatitis, blistering dermatitis, liver function abnormalities (jaundice, hepatitis), angina pectoris, acute myocardial infarction, unstable angina, cardiac arrest, joint pain accompanied by severity and disability, acute kidney injury, end-stage renal disease, angioedema, shock, sepsis, asthma, respiratory distress, acute choledochitis, acute cholecystitis, cholangitis, angioedema, acid respiratory distress related to lactic acidosis, weakness, abdominal pain

Mild side effects

Hypoglycemia, taste disturbance, cough, decreased appetite, diarrhea, constipation, nausea, vomiting, abdominal pain, oral ulcers, itching, erythema, rash, joint pain accompanied by severity and disability, abnormal vitamin B12 absorption test results, liver function abnormalities, hepatitis, increased serum triglycerides, elevated amylase, infections (e.g., rhinitis), hypersensitivity reactions, fatigue, headache, dizziness, drowsiness, insomnia, depression, anxiety, hypertension, lightheadedness, chest pain,

This medication is sensitive to air and moisture, so it must be stored in a tightly sealed container. To maintain the drug's efficacy, it is important to store it at room temperature between 1°C and 30°C.

Appearance

White, double-sided, convex, elongated, sustained-release film-coated tablet

Package unit

60 tablets / box [10 tablets / PTP × 6]