Ramiril Tablet (Ramipril)

Adult dose

1. Hypertension ① Adults not receiving diuretics: The initial dose of ramipril is 2.5㎎ once daily, taken orally with plenty of water during or after a meal. However, depending on the patient's response, the dose may be increased at intervals of 2‐3 weeks, first to a maximum of 5㎎ daily and then to a maximum of 10㎎ daily; a diuretic may be administered concomitantly. ② Adults receiving diuretics: Since an undesirable excessive decrease in blood pressure may occur after the first dose, discontinue the diuretic 2‐3 days before starting treatment, if possible. If this is not possible, administer an initial dose of 1.25㎎ once daily, then adjust as appropriate as needed. ③ Patients with renal impairment 1) Creatinine clearance of 50㎖/min or higher (serum creatinine less than 1.5㎎/㎗): Dose adjustment is not required. 2) Creatinine clearance of 20~50㎖/min (serum creatinine 1.5‐3㎎/㎗): Administer an initial dose of 1.25㎎ once daily; the dose may be increased to a maximum of 5㎎ once daily. 3) Creatinine clearance below 20㎖/min (serum creatinine 3㎎/㎗ or higher): Administer an initial dose of 1.25㎎ every other day; the maintenance dose should not exceed 2.5㎎ once daily. ④ Patients with hepatic impairment: Administer under close medical supervision and do not exceed 2.5㎎ daily. 2. Heart failure after myocardial infarction ① Patients not receiving diuretics: The recommended initial dose is 2.5mg twice daily. For patients who experience symptoms of hypotension with this dose, the dose may be changed to 1.25mg twice daily; however, all patients should have their dose increased gradually to the target dose of 5mg twice daily. Patients should be closely monitored for at least 2 hours after the initial dose of this medicine and for at least an additional 1 hour until blood pressure has stabilized. If hypotension occurs after the initial dose, treat the hypotension appropriately and then carefully adjust the dose of this medicine. ② Patients receiving diuretics: Symptomatic hypotension may occur after the first dose of this medicine in patients who have been taking a diuretic. To reduce the possibility of hypotension, discontinue the diuretic 2~3 days before starting this medicine, if possible. Thereafter, if blood pressure is not controlled with this medicine alone, the diuretic should be restarted. If the diuretic cannot be discontinued, administer an initial dose of 1.25mg of this medicine to avoid excessive hypotension. The dose of any concomitant diuretic should be reduced as much as possible to reduce the possibility of hypotension. ③ Patients with heart failure and renal failure The recommended initial dose is 1.25mg once daily. Depending on clinical response and tolerability, the dose may be increased to 1.25mg twice daily and up to a maximum of 2.5mg twice daily. 3. Reduction in the risk of death due to myocardial infarction, stroke, or cardiovascular disease, or the need for revascularization ① The initial dose is 2.5mg once daily, and the dose is increased gradually according to tolerability. Thus, increase the dose to 5mg daily after one week and to 10mg daily after 3 weeks. The usual maintenance dose is 10mg once daily. Patients stabilized on a lower dose for another indication should be adjusted to 10mg once daily. ② Patients with renal impairment: No dose adjustment is required in patients with creatinine clearance of 30ml/min or higher (plasma creatinine<165 μmol/l). In patients with creatinine clearance below 30ml/min (plasma creatinine>165 μmol/l), the initial dose is 1.25mg once daily and the maximum dose is 5mg once daily. In patients with severe renal impairment (creatinine clearance of 10ml/min or less and plasma creatinine of 400~650 μmol/l), the initial dose is 1.25mg once daily and the dose should not exceed 2.5mg daily. ③ Patients with hepatic impairment: In patients with hepatic impairment, decreased esterase activity in the liver reduces the metabolism of the parent compound ramipril and, consequently, the formation of its biologically active metabolite ramiprilat, ultimately increasing plasma ramipril levels. Therefore, Tritace treatment should be initiated at a dose of 1.25mg under close medical supervision. 4. Nephropathy ① Patients not receiving diuretics The recommended initial dose is 1.25㎎ once daily. Increase the dose according to the patient's tolerability. When increasing the dose, double it at intervals of 2‐3 weeks; the maximum daily dose is 5㎎. ② Patients receiving diuretics Consider whether to discontinue the diuretic or at least reduce the dose of the diuretic being taken 2‐3 days before starting this medicine. In general, the initial dose of this medicine for patients receiving diuretics is 1.25㎎ once daily. ③ Patients with hepatic impairment: Increase or decrease the dose according to the patient's response. Therefore, treatment with this medicine should be initiated carefully according to the doctor's instructions, and the maximum daily dose is 2.5㎎. Adjust the dose appropriately according to age and symptoms.

This medication is used to lower blood pressure and works by dilating blood vessels to control blood pressure. During treatment, angioedema, characterized by sudden swelling of the face, lips, tongue, or throat, may occur. If such symptoms appear, you must inform your doctor immediately. Angioedema can pose life-threatening risks, especially if it occurs in the larynx, making breathing difficult and requiring urgent treatment. This medication can cause serious harm to the fetus, especially in the second and third trimesters of pregnancy, so it should not be used by women who are pregnant or may become pregnant. It is not recommended for patients with severe renal impairment or for children, as its safety and efficacy have not been sufficiently established. Patients with allergic reactions to this drug, a history of angioedema, those with certain heart valve diseases, and certain dialysis patients should not take this drug. Since taking this medication may cause sudden severe drops in blood pressure, it is essential to start at a low dose and carefully monitor blood pressure, especially during initial treatment. Regular blood tests and kidney function tests are required, and blood potassium levels should also be frequently checked. This drug can lead to various side effects such as cough, dizziness, headache, indigestion, skin rash, muscle pain, etc. If symptoms are severe or persistent, consult with your doctor. There may be interactions with other medications, so you should inform your doctor or pharmacist about all medications you are taking, especially potassium-sparing diuretics, lithium, some analgesics, and antihypertensive medications. Caution is advised when driving or operating machinery as dizziness or lightheadedness may occur, particularly at the beginning of treatment or when switching to other medications. In case of overdose, severe hypotension, shock, or electrolyte imbalances may occur, requiring immediate emergency treatment, and gastric lavage or detoxification measures might be necessary. This medication should be kept out of reach of children and should not be transferred to another container.

Angioedema, abdominal pain, nausea, vomiting, angina pectoris, myocardial infarction, myocardial ischemia, tachycardia, arrhythmia, palpitations, peripheral edema, eosinophilia, leukopenia, erythrocytopenia, decreased hemoglobin levels, thrombocytopenia, bone marrow failure, pancytopenia, hemolytic anemia, headache, dizziness, lightheadedness, sensory disturbances, ageusia, dysgeusia, tremors, balance disorders, ischemic stroke, transient ischemic attack, psychomotor impairment, flushing, abnormal olfaction, blurred vision, visual impairment, conjunctivitis, hearing impairment, tinnitus, itchy throat with dry cough, bronchitis, sinusitis, dyspnea, bronchospasm, congestion, inflammatory response in the gastrointestinal tract, dyspepsia, abdominal discomfort, indigestion, diarrhea, nausea, vomiting, pancreatitis, increased pancreatic enzymes, intestinal vascular edema, gastritis, upper abdominal pain, constipation, dry mouth, glossitis, aphthous stomatitis, acute renal failure, renal impairment, increased urine output, worsening of proteinuria, elevated blood urea, increased serum creatinine, rash, angioedema, pruritus, hyperhidrosis, exfoliative dermatitis, urticaria, onycholysis, photosensitivity reaction, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, exacerbation of psoriasis, psoriasiform dermatitis, paraneoplastic pemphigus, lichenoid eruption, alopecia, muscle spasms, muscle cramps, myalgia, arthralgia, inappropriate antidiuretic hormone secretion syndrome, hyperkalemia, anorexia, decreased appetite, hyponatremia, hypotension, orthostatic hypotension, syncope, flushing, vascular stenosis, decreased perfusion, vasculitis, Raynaud's phenomenon, chest pain, fatigue, fever, asthenia, anaphylaxis, anaphylactic reaction, increased antinuclear antibodies, elevated liver enzymes, increased bilirubin polymers, cholestatic jaundice, hepatocellular damage, acute liver failure, cholestasis, cytolytic hepatitis, transient erectile dysfunction, decreased libido, gynecomastia, low mood, anxiety, nervousness, restlessness, sleep disturbances, drowsiness, confusional state, attention deficit, cough

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is advisable to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance

Pale red oblong tablets

Package unit

For domestic use: 30 tablets/bottle, 100 tablets/bottle; for export: 100 tablets (10 tablets/PTP x 10)