Nin Tebro Tablet 100 Milligrams (Nintedanib Esylate)

Adult dosage

The recommended dose for adults is 150mg twice daily, 12 hours apart. Take immediately after a meal, swallowing the dose whole with water without chewing or crushing it. A dose of 100mg twice daily is recommended only when the regimen of 150mg twice daily is poorly tolerated. Treatment with this drug should be initiated by a physician experienced in diagnosing and treating conditions related to its indications. Liver function and pregnancy tests should be performed when treatment is first initiated. If a dose is missed at the scheduled time, take the recommended dose at the next scheduled administration time. Do not take an additional dose. Do not exceed the recommended daily dose of 300mg. <Dose Adjustment> If management of an adverse reaction (see Precautions for Use) is required along with symptomatic treatment, the dose may be reduced or treatment temporarily interrupted until the adverse reaction has resolved to a level that allows treatment to continue. Treatment with this drug may then be resumed at the recommended dose (150mg twice daily) or the reduced dose (100mg twice daily). If the 100mg twice-daily dose is poorly tolerated, treatment with this drug should be discontinued. If treatment has been temporarily interrupted because aminotransferases (AST or ALT) exceeded 3 times the upper limit of normal (ULN) but were less than 5 times the ULN, treatment may be resumed at the reduced dose (100mg twice daily) once aminotransferase levels have returned to baseline, and the dose may subsequently be increased to the recommended dose (150mg twice daily) (see Precautions for Use). Discontinue treatment with this drug if aminotransferases (AST or ALT) exceed 5 times the ULN, or exceed 3 times the ULN in the presence of signs or symptoms of severe liver injury. <Elderly Patients> No differences in safety or efficacy were observed in patients aged 65 years or older compared with patients younger than 65 years. No dose adjustment is necessary for elderly patients aged 65 years or older. Patients aged 75 years or older may require dose reduction to manage adverse reactions. <Patients with Renal Impairment> Less than 1% of a single dose of this drug was excreted through the kidneys. No adjustment of the starting dose is necessary in patients with mild to moderate renal impairment. The safety, efficacy, and pharmacokinetic properties of this drug have not been studied in patients with severe renal impairment (creatinine clearance less than 30mL/min). <Patients with Hepatic Impairment> This drug is eliminated mainly (>90%) via biliary/fecal excretion. Exposure was increased in patients with hepatic impairment (Child Pugh A, Child Pugh B). In patients with mild hepatic impairment (Child Pugh A), the recommended dose is 100mg twice daily, 12 hours apart; treatment interruption or discontinuation should be considered to manage adverse reactions. Use of this drug is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment.

Children's dosage

Nintedanib is not approved for the treatment of pediatric patients.

This medication should not be used in patients who are allergic to the active ingredient or any components, women who are pregnant or breastfeeding, and patients with severe liver impairment. Patients with gastrointestinal disorders such as diarrhea, nausea, or vomiting, patients with a tendency to bleed or those taking high doses of anticoagulants, patients with thrombosis, and those who have recently undergone abdominal surgery should use this drug with caution. Side effects such as diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, and elevated liver enzymes may commonly occur. Patients should be cautious upon the onset of symptoms. If diarrhea is severe, fluid supplementation and the use of antidiarrheal medication are necessary, and if symptoms are severe, the drug dosage may need to be reduced or temporarily suspended. As this medication can affect liver function, regular liver function tests should be conducted before initiation and for 3 months after starting treatment. If there are signs of liver damage, treatment should be stopped immediately. This medication may also affect kidney function, so patients with kidney disease should be closely monitored, and dosage adjustments may be necessary. There may be an increased risk of bleeding, so patients at high risk for bleeding should use this medication cautiously. Blood pressure may increase, so regular monitoring and management of blood pressure are necessary, particularly in patients with a history of cardiovascular disease. This medication has a risk of gastrointestinal perforation, so patients with a history of abdominal surgery, peptic ulcers, or diverticular disease must consult with healthcare professionals before use. Pregnant women should avoid this medication, as it may harm the fetus, and women of childbearing age should use effective contraception during and for a certain period after treatment. Breastfeeding women should also avoid this medication, as it may affect the baby, and it is recommended to discontinue breastfeeding. This medication can interact with other drugs, so it is important to inform healthcare professionals, especially if taking specific antifungals, antibiotics, or anticonvulsants. Smoking may reduce the effectiveness of this medication, so it is recommended to quit smoking before and during treatment. There is no specific antidote for overdose, and treatment should be temporarily halted and appropriate actions should be taken according to symptoms. This medication should be kept out of the reach of children, not crushed or transferred to other containers, and if contact with the drug occurs, hands should be washed immediately.

Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, increased liver enzymes, pancreatitis, drug-induced liver damage, elevated alanine aminotransferase (ALT), elevated aspartate aminotransferase (AST), elevated alkaline phosphatase (ALKP), elevated gamma-glutamyl transferase (GGT), hyperbilirubinemia, hypertension, bleeding, thrombocytopenia, hair loss, headache, proteinuria, skin ulcer, fatigue, fever, back pain, dizziness, rash, itching, renal failure, aneurysm, arterial dissection, reversible posterior leukoencephalopathy syndrome, weight loss, cough, cystitis, irritable bowel syndrome, stomatitis, dyspepsia, gastrointestinal disorders, asthenia

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 and 30 degrees Celsius. Proper storage will help ensure the safety and effectiveness of the medication.

Appearance

Pale pink oval film-coated tablets

Package unit

Bottle - 60 tablets/bottle, PTP - 60 tablets/PTP [(10 tablets/PTP x 6)]