TriTace 5 mg Tablets (Ramipril)

Adult dose

1. Hypertension ① Patients not receiving diuretics Adults: 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 2‐3 weeks, initially up to 5㎎ daily and then up to a maximum of 10㎎ daily; a diuretic may be administered concomitantly. ② Patients receiving diuretics Adults: Since an undesirable excessive reduction in blood pressure may occur after the initial 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 and adjust appropriately as needed. ③ Patients with renal impairment 1) Creatinine clearance of at least 50㎖/min (serum creatinine less than 1.5㎎/㎗): No dosage adjustment is necessary. 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 at least 3㎎/㎗): 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 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 gradually increased 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, manage the hypotension appropriately and then carefully adjust the dose of this medicine. ② Patients receiving diuretics Patients taking diuretics may develop symptomatic hypotension after the initial dose of this medicine. To reduce the likelihood of hypotension, discontinue the diuretic 2~3 days before starting this medicine, if possible. Thereafter, if blood pressure is not controlled by this medicine alone, resume diuretic treatment. If the diuretic cannot be discontinued, administer an initial dose of this medicine of 1.25mg to avoid excessive hypotension. To reduce the likelihood of hypotension, reduce the dose of the concomitant 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 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 myocardial infarction, stroke, or death due to cardiovascular disease, or the need for revascularization ① The initial dose is 2.5mg once daily, and the dose is gradually increased according to tolerability. Accordingly, increase 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 dosage adjustment is necessary in patients with creatinine clearance of 30ml/min or greater (plasma creatinine<165 μmol/l). For 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. For patients with severe renal impairment (creatinine clearance of 10ml/min or less and plasma creatinine 400~650 μmol/l), the initial dose is 1.25mg once daily and should not exceed 2.5mg daily. ③ Patients with hepatic impairment: In patients with hepatic impairment, reduced esterase activity in the liver decreases 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 2‐3 weeks; the maximum daily dose is 5㎎. ② Patients receiving diuretics Consider whether the diuretic should be discontinued or at least reduced 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 Adjust the dose upward or downward 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 is used to lower blood pressure and protect the functions of the heart and kidneys. While taking this medication, there may be a sudden swelling known as angioedema affecting the face, lips, tongue, or throat, so if these symptoms occur, immediately inform a healthcare provider. Angioedema can be life-threatening and requires emergency treatment; hospitalization is necessary until the symptoms completely resolve. This medication can cause serious harm to the fetus during pregnancy, especially in the second and third trimesters, so women who are pregnant or may become pregnant should not take it. Patients with severely impaired kidney function or children should consult a healthcare provider before using this medication, as safety has not been fully established. Patients with a history of allergies to this drug or angioedema, certain heart valve diseases, pregnant women, and kidney transplant recipients should avoid taking it. Taking this drug together with other antihypertensives, diuretics, or potassium-sparing medications may increase the risk of side effects, so it should be taken only under medical supervision. During treatment, blood pressure, kidney function, blood potassium, and white blood cell counts should be regularly monitored, and any abnormal symptoms should be reported to medical personnel immediately. This drug may cause side effects such as dry cough, dizziness, headaches, digestive disturbances, and skin rashes; if symptoms persist or worsen, a healthcare provider should be consulted. Dizziness or lightheadedness may occur while driving or operating hazardous machinery, so caution is advised. In case of overdose, severe hypotension or kidney impairment may occur, so it is crucial to adhere to the prescribed dosage, and seek medical attention immediately if adverse symptoms develop. Keep this medication out of reach of children and do not transfer it to another container.

Angioedema, facial swelling, limb swelling, lip swelling, tongue swelling, laryngeal swelling, glottal swelling, abdominal pain, nausea, vomiting, angina pectoris, myocardial infarction, myocardial ischemia, tachycardia, arrhythmia, palpitations, peripheral edema, eosinophilia, leukopenia, neutropenia, agranulocytosis, anemia, decreased hemoglobin levels, thrombocytopenia, bone marrow failure, pancytopenia, hemolytic anemia, headache, dizziness, lightheadedness, sensory abnormalities, ageusia, dysgeusia, tremors, balance disturbances, ischemic stroke, transient ischemic attack, psychomotor disturbances, flushing, parosmia, blurred vision, visual impairment, conjunctivitis, hearing impairment, tinnitus, itchy throat, dry cough, bronchitis, sinusitis, shortness of breath, bronchospasm, nasal congestion, gastrointestinal inflammatory response, dyspepsia, abdominal discomfort, indigestion, diarrhea, nausea, vomiting, pancreatitis, increased pancreatic enzymes, small bowel angioedema, gastritis, epigastric pain, constipation, dry mouth, glossitis, aphthous stomatitis, acute renal failure, kidney impairment, increased urine output, worsening proteinuria, elevated blood urea, increased serum creatinine, rash, angioedema, pruritus, hyperhidrosis, exfoliative dermatitis, urticaria, onycholysis, photosensitivity reactions, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, worsening psoriasis, psoriatic dermatitis, similar to pemphigus, plaque-like rash, alopecia, muscle spasms, myalgia, arthralgia, inappropriate secretion of antidiuretic hormone syndrome, increased serum potassium, anorexia, decreased appetite, decreased serum sodium, hypotension, orthostatic hypotension, syncope, flushing, vascular stenosis, decreased perfusion, vasculitis, Raynaud's phenomenon, chest pain, fatigue, fever, weakness, anaphylaxis, anaphylactoid reaction, increased antinuclear antibodies, elevated liver enzymes, elevated bilirubin polymers, cholestatic jaundice, hepatocellular damage, acute liver failure, cholestasis, cytolytic hepatitis, temporary erectile dysfunction, decreased libido, gynecomastia, low mood, anxiety, neuroexcitation, restlessness, drowsiness, sleep disorders, confusion, attention deficit, cough

This medication should be stored in a sealed container to prevent air or moisture from entering, and it is better to keep it at room temperature away from direct sunlight. Room temperature typically refers to a range of 15 to 25 degrees Celsius, and avoiding excessively hot or cold places helps maintain the drug's effectiveness.

Appearance

Light red, oval-shaped tablet with a score line on both sides

Package unit

30 tablets, 100 tablets per bottle