Tritas Protect 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. Depending on the patient's response, the dose may be increased at intervals of 2­3 weeks, initially to up to 5㎎ daily and then to a maximum of 10㎎ daily; a diuretic may be used concomitantly. ② Adults receiving diuretics: Since an undesirable excessive decrease in blood pressure may occur after the first dose, discontinue the diuretic 2­3 days before starting treatment, if possible. If this is not possible, administer an initial dose of 1.25㎎ once daily and adjust appropriately as needed. ③ Patients with renal impairment 1) Creatinine clearance of 50㎖/min or more (serum creatinine less than 1.5㎎/㎗): No dose adjustment is necessary. 2) Creatinine clearance of 20~50㎖/min (serum creatinine 1.5­3㎎/㎗): 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 more): Administer an initial dose of 1.25㎎ every other day and do not exceed a maintenance dose of 2.5㎎ once daily. ④ Patients with hepatic impairment: Administer under careful 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 develop symptoms of hypotension at 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 first dose of this medicine and for at least an additional 1 hour until blood pressure has stabilized. If hypotension occurs after the first dose, treat the hypotension appropriately and then adjust the dose of this medicine carefully. ② Patients receiving diuretics: Symptomatic hypotension may occur after the first dose of this medicine in patients taking diuretics. 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, resume diuretic treatment. If the diuretic cannot be discontinued, administer an initial dose of 1.25mg of this medicine to avoid excessive hypotension. To reduce the possibility of hypotension, reduce the dose of the concomitantly administered diuretic as much as possible. ③ Patients with heart failure accompanied by renal failure The recommended initial dose is 1.25mg once daily. Depending on the 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 of the risk of death from myocardial infarction, stroke, or cardiovascular disease, or of the need for revascularization ① The initial dose is 2.5mg once daily, and the dose is increased gradually according to tolerability. Accordingly, 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 impaired renal function: No dose adjustment is necessary in patients with creatinine clearance of 30ml/min (plasma creatinine<165 μmol/l) or more. 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 should not exceed 2.5mg daily. ③ Patients with impaired hepatic function: In patients with impaired hepatic function, 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, treatment with Tritace 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 2­3 weeks; the maximum daily dose is 5㎎. ② Patients receiving diuretics Consider whether the diuretic should be discontinued or at least reduced 2­3 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 as directed by a physician, and the maximum daily dose is 2.5㎎. Adjust the dose appropriately according to age and symptoms.

This drug belongs to the class of ACE inhibitors, used to lower blood pressure and protect the function of the heart and kidneys. During the course of taking this medication, sudden swelling may occur in the face, lips, tongue, throat, or limbs, which can be life-threatening, so if such symptoms appear, you must immediately inform your doctor. Furthermore, this drug can cause severe harm to the fetus during pregnancy, especially in the second and third trimesters, so it should not be used by women who are pregnant or planning to become pregnant. Patients with severely impaired kidney function or patients undergoing dialysis, and children have limited experience with this drug, so caution is needed. Patients who have had allergic reactions to this drug or similar drugs, patients with specific heart valve diseases, and patients with hyperkalemia should not take this drug. Patients with too low blood pressure or issues with renal arteries, and certain diabetic patients need special caution when taking this drug, and blood pressure and kidney function should be monitored frequently at the start of administration. When taking this drug, regular blood tests and electrolyte level checks should be conducted to detect and manage side effects early. In particular, this drug may interact with other medications, so if you are taking any other drugs, you must inform your doctor or pharmacist. Taking potassium supplements or potassium-sparing diuretics together can dangerously raise blood potassium levels. This medication can cause low blood pressure before or during surgery, so if you have surgery planned, inform your healthcare provider in advance. Dizziness or vertigo may occur at the beginning of treatment, so it is advisable to avoid driving or operating dangerous machinery if such symptoms occur. In case of overdose, severe hypotension, bradycardia, electrolyte disturbances, and renal failure may occur, so immediate emergency treatment is required. This drug is not recommended for children, and elderly patients or those with impaired liver function need careful dose adjustment and monitoring. Finally, this drug should be kept out of reach of children, and it is safest not to transfer it to other containers.

Angioedema, facial swelling, limb swelling, lip swelling, tongue swelling, laryngeal swelling, glottic swelling, abdominal pain, nausea, vomiting, angina pectoris, myocardial infarction, myocardial ischemia, tachycardia, arrhythmia, palpitations, peripheral edema, eosinophilia, leukopenia, neutropenia, agranulocytosis, anemia, decreased hemoglobin levels, decreased platelet count, bone marrow failure, pancytopenia, hemolytic anemia, headache, dizziness, lightheadedness, sensory abnormalities, ageusia, dysgeusia, tremors, balance disorders, ischemic stroke, transient ischemic attack, psychomotor impairment, flushing, olfactory disturbance, blurred vision, visual impairment, conjunctivitis, hearing impairment, tinnitus, itchy dry cough, bronchitis, sinusitis, shortness of breath, bronchial spasm, congestion, gastrointestinal inflammatory response, digestive disorders, abdominal discomfort, dyspepsia, diarrhea, nausea, vomiting, pancreatitis, increased pancreatic enzymes, small intestinal vascular edema, gastritis, epigastric pain, constipation, dry mouth, glossitis, aphthous stomatitis, acute renal failure, renal impairment, increased urine output, exacerbation of proteinuria, increased 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, psoriasis-type dermatitis, pseudo-pemphigus, ringworm-like rash, alopecia, muscle spasms, muscle cramps, myalgia, arthralgia, inappropriate secretion of antidiuretic hormone syndrome, increased serum potassium, anorexia, decreased appetite, decreased serum sodium, hypotension, orthostatic hypotension, syncope, flushing, vascular constriction, decreased perfusion, vasculitis, Raynaud's phenomenon, chest pain, fatigue, fever, weakness, anaphylaxis, anaphylactic reaction, increased antinuclear antibodies, elevated liver enzymes, increased bilirubin polymer, cholestatic jaundice, hepatocyte damage, acute hepatic failure, cholestasis, cytolytic hepatitis, temporary erectile dysfunction, decreased libido, gynecomastia, low mood, anxiety, neuroexcitability, restlessness, drowsiness, sleep disorders, altered mental state, attention deficit, cough

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. Also, it is recommended to store it at a cool room temperature, specifically between 1 degree and 30 degrees Celsius.

Appearance

Oval-shaped white tablet

Package unit

30 tablets (10 tablets/PTPX3), 30 tablets/bottle