Opilide Tablet 100mg (Nintedanib Esylate)

Adult dose

Adults: The recommended dose is 150mg twice daily, 12 hours apart. Take immediately after a meal. Swallow the tablet whole with water without chewing. Do not crush the tablet. A dose of 100mg twice daily is recommended only if the 150mg twice-daily regimen is not well tolerated. If a dose is missed, take the recommended dose at the next scheduled dosing time. Do not take an additional dose. Do not exceed the recommended daily dose of 300mg. If management of an adverse reaction (see Precautions for Use) is needed along with symptomatic treatment, the dose may be reduced or treatment temporarily interrupted until the adverse reaction has improved to a level that allows treatment to continue. Treatment with this medicine 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 not well tolerated, treatment with this medicine should be discontinued. If treatment is temporarily interrupted because aminotransferases (AST or ALT) exceed 3 times the upper limit of normal (ULN) but are less than 5 times the ULN, treatment may be resumed at a 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 medicine if aminotransferases (AST or ALT) exceed 5 times the ULN, or if they exceed 3 times the ULN and there are signs or symptoms of severe liver injury. 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. Less than 1% of a single dose of this medicine was excreted through the kidneys. No adjustment of the starting dose is necessary in patients with mild to moderate renal impairment. Safety, efficacy, and pharmacokinetic characteristics have not been studied in patients with severe renal impairment (creatinine clearance less than 30mL/min). This medicine is eliminated mainly (>90%) through 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 of this medicine is 100mg twice daily, 12 hours apart, and treatment interruption or discontinuation should be considered for the management of adverse reactions. Use of this medicine is not recommended in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment.

Child dose

Treatment with nintedanib is not approved for pediatric patients.

This medication should not be used in patients with hypersensitivity to the active ingredient or any of the components. Pregnant or nursing women should not take this medication. Patients with moderate to severe liver impairment should not be given this medication. Patients with gastrointestinal disorders such as diarrhea, nausea, or vomiting should use this medication with caution and strictly adhere to the dosage and administration guidelines. Patients with a tendency to bleed or on anticoagulants need to exercise caution while using this medication. Patients with thrombosis or those who have recently undergone abdominal surgery, as well as patients with gastrointestinal perforation, should be cautious when using this medication. Careful administration is required around the time of surgery, as it may affect wound healing. Patients with hypertension should monitor their blood pressure frequently while taking this medication as blood pressure may rise. Patients with QT interval prolongation, which can affect cardiac electrical activity, should also exercise caution. Diarrhea may frequently occur when taking this medication, and in severe cases, hydration and antidiarrheals may be required, and the dosage should be reduced or temporarily discontinued if necessary. Nausea and vomiting are also common side effects; if symptoms persist, dosage adjustment or discontinuation of treatment may be needed. Liver function abnormalities may occur, so regular blood tests to check liver levels before and after taking this medication is necessary. Renal function impairment has also been reported, so renal status should be closely monitored. As there is a risk of bleeding, patients with a tendency to bleed or on anticoagulants should exercise particular caution. Patients at high risk for cardiovascular disease should consult a doctor before taking this medication, and those with a history of myocardial infarction or stroke should be particularly cautious. There is a risk of gastrointestinal perforation, so patients with a history of abdominal surgery or peptic ulcer disease should use this medication carefully. Women planning to become pregnant should avoid pregnancy during treatment with this medication and should perform pregnancy tests before and during treatment. It is safest for nursing women to discontinue breastfeeding while taking this medication. There are no specific antidotes in case of overdose; thus, if unusual symptoms occur, consult medical personnel immediately. Keep this medication out of reach of children, do not transfer it to another container, and do not crush the tablets. Caution is advised while driving or operating machinery during treatment.

Diarrhea, nausea, vomiting, abdominal pain, decreased appetite, weight loss, increased liver enzymes, pancreatitis, drug-induced liver injury, 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 disturbances, malaise

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This helps to preserve the medication's efficacy and safety.

Appearance

Pink colored round film-coated tablets

Package unit

Bottle - 60 tablets/bottle