Dirolba Tablet (Amlodipine Besilate)

Adult dose

Administer 5 mg orally once daily as amlodipine, and the dose may be increased to a maximum of 10 mg per day depending on the patient's response. Adjust as appropriate based on age and symptoms.

This medication should not be used in certain patients. It is not to be administered to patients who have had allergic reactions to this medication or similar class of drugs, nursing women, patients with severe liver dysfunction, patients with severe aortic stenosis of the heart, and patients in shock. Care should be taken in administering this medication to patients with very low blood pressure, patients with severely impaired kidney function who require dialysis, elderly patients, and women who are pregnant or may become pregnant. This medication primarily lowers blood pressure and acts on the heart, and side effects such as flushing, fatigue, swelling, palpitations, dizziness, headaches, drowsiness, abdominal pain, and nausea may occur during use. More rarely, excessively low blood pressure, various adverse reactions in the nervous system or digestive tract, skin, and allergic reactions may also occur. In patients with heart failure, this medication may worsen symptoms of pulmonary congestion. In patients with liver dysfunction, the drug's half-life may be prolonged, requiring dose adjustments. Since this medication slowly lowers blood pressure, it may not be suitable for acute heart conditions. It is known to have minimal impact on driving or operating machinery. This medication can interact with several other medications, so if taking other drugs, it is essential to consult with a physician or pharmacist. Particularly, taking it with grapefruit juice may lead to excessive blood pressure-lowering effects and is not recommended. The safety of this drug in pregnant women has not been established, so it should generally not be used unless absolutely necessary, and nursing women are advised to discontinue breastfeeding while on this medication. In children, the effectiveness has only been confirmed in those aged 6 years and older, and safety and efficacy in younger ages are not known. In case of overdose, there may be severe decreases in blood pressure and rapid heart rate necessitating immediate emergency treatment, and blood pressure and heart function need to be continuously monitored. This medication has been reported to have a low risk of carcinogenicity and genotoxicity, and its safety has been confirmed even with long-term administration.

Serious side effects

• Urticaria, severe swelling (edema), angioedema, severe allergic reactions
• Toxic epidermal necrolysis, severe skin reactions
• Shortness of breath, difficulty breathing, respiratory problems
• Jaundice, liver abnormalities (jaundice)
• Severe edema
• Myocardial infarction, arrhythmias (including bradycardia, ventricular tachycardia, atrial fibrillation), chest pain
• Severe headaches, seizures, confusion, visual disturbances, paralysis
• Significantly reduced urine output, severe edema accompanied by elevated blood pressure
• In overdose, systemic hypotension

Mild side effects

• Flushing
• fatigue
• swelling
• palpitations
• dizziness
• headache
• drowsiness
• abdominal pain
• nausea
• weakness

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it should be kept at room temperature between 1 to 30 degrees Celsius. Therefore, it is advisable to avoid direct sunlight and not to place it in excessively hot or cold locations.

Appearance

White octagonal tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle