SANOFI TRITACE Ramipril Tablets For Hypertension 5mg*7

[Drug Name]
Generic Name: Ramipril Tablets
Trade Name: Ruitai/Sanofi
English Name: Ramipril Tablets
Chinese Pinyin: Leimipuli Pian

[Ingredients]
The main ingredient of this product is ramipril.

[Appearance]
This product is a white to off-white, irregular-shaped tablet.

[Indications]
Essential hypertension; mild to moderate heart failure (NYHA II and III) occurring 2-9 days after acute myocardial infarction.

[Dosage and Administration]
1. Posology of Single and Daily Doses
Note:
Initial treatment with ramipril tablets may cause an excessive decrease in blood pressure, particularly in patients with salt and/or fluid loss (e.g., vomiting/diarrhea, diuretic therapy), heart failure—particularly post-myocardial infarction—or severe hypertension.
If possible, before starting treatment with ramipril tablets, correct salt and/or fluid loss and reduce or discontinue any current diuretics (in patients with heart failure, this must be weighed against the risk of volume overload). Treatment for these patients should begin with the lowest single dose: 1.25 mg of ramipril taken in the morning.
After the initial dose, and whenever the dose of ramipril tablets and/or diuretics is increased, these patients should be under medical supervision for at least 8 hours to avoid uncontrolled hypotension.
Patients with malignant hypertension or heart failure—particularly after an acute myocardial infarction—should be hospitalized when treated with ramipril tablets.
Unless otherwise directed by a physician, the following dosage recommendations apply to patients with normal renal function:
Essential hypertension
The starting dose is generally 2.5 mg of ramipril tablets taken in the morning. If this dose does not normalize blood pressure, it can be increased to 5 mg daily.
Dose increases should be repeated at intervals of at least 3 weeks. The maintenance dose is generally 2.5-5 mg daily, with a maximum dose not exceeding 10 mg daily.
Treatment of mild to moderate heart failure (NYHA II and III) after an acute myocardial infarction (2-9 days)
Note:
Dose adjustments should only be made in hemodynamically stable patients who are hospitalized. Patients taking other antihypertensive medications must be carefully monitored to prevent hypotension.
The starting daily dose is generally 2.5 mg, divided morning and evening.
If this starting dose is not tolerated (e.g., hypotension occurs), it should be reduced to 1.25 mg, divided morning and evening.
The dose may be increased depending on the patient's condition. The dose may be doubled every 1-2 days, up to a maximum daily dose of 5 mg ramipril, divided morning and evening.
For patients with moderate renal impairment (creatinine clearance 30-60 ml/min or serum creatinine concentration >1.2 and <1.8 mg/dL), elderly patients (over 65 years), or those with diabetes, the starting dose is 1.25 mg taken in the morning (see Starting Dosage Precautions). The maintenance dose is usually 2.5 mg ramipril tablets per day. The maximum daily dose should not exceed 5 mg ramipril tablets.
2. Dosage and Duration
Swallow with plenty of liquid, regardless of mealtime. Depending on the indication and dose, the specified daily dose may be taken in one dose in the morning or divided into two doses (one in the morning and one in the evening).
Additional diuretics may enhance the antihypertensive effect of ramipril tablets.
For patients with heart failure after an acute myocardial infarction, ramipril tablets should not be started earlier than 2 days after the infarction, nor later than 10 days after the infarction. Furthermore, it is recommended that ramipril tablets be administered for at least 15 months.

[Adverse Reactions]
The following adverse reactions have been observed during treatment with ramipril tablets or other ACE inhibitors: Cardiovascular: Occasionally, especially during the initial phase of ramipril treatment and in patients with salt and/or fluid loss (e.g., prior diuretic therapy), heart failure—particularly after an acute myocardial infarction—severe hypertension, and when the dose of Retadine and/or diuretics is increased, an excessive decrease in blood pressure (hypotension, orthostatic hypotension) may occur, accompanied by symptoms such as dizziness, lightheadedness (loss of concentration in some patients), sweating, weakness, visual disturbances, and rarely, loss of consciousness (syncope). In rare cases, the following adverse reactions associated with a significant decrease in blood pressure have occurred with the use of ACE inhibitors: tachycardia, palpitations, angina pectoris, myocardial infarction, transient ischemic attack (TIA), and stroke. Cardiac arrhythmias may occur or worsen; circulatory disturbances caused by vascular constriction may worsen during treatment with ramipril tablets. Kidney: Renal impairment may occasionally occur or worsen, leading to acute renal failure in rare cases. Proteinuria has been observed rarely, sometimes accompanied by worsening renal function. Respiratory: Dry cough without sputum and bronchitis may occur occasionally; shortness of breath, sinusitis, rhinitis, and in rare cases, bronchospasm, glossitis, and dry mouth may occur. In rare cases, angioedema caused by ACE inhibitors may progress and involve the larynx, pharynx, and/or tongue. The following emergency measures are recommended: Immediate subcutaneous injection of 0.3-0.5 mg of epinephrine or slow intravenous injection of 0.1 mg of epinephrine under electrocardiographic and blood pressure monitoring, followed by systemic administration of corticosteroids. Intravenous antihistamines and H2 receptor antagonists are also recommended. In addition to epinephrine, C1 inactivators (complement C1 esterase inhibitors) may be considered in cases of known deficiency. Gastrointestinal/Liver: Gastrointestinal side effects such as stomach pain, nausea, vomiting, upper abdominal discomfort (in some cases, elevated pancreatic enzymes), and digestive disturbances may occur occasionally. Rarely, vomiting, diarrhea, constipation, and loss of appetite may occur. A rare syndrome has been reported during ACE inhibitor treatment, beginning with cholestatic jaundice and progressing to hepatic necrosis (sometimes fatal). The relationship of this adverse reaction to the medication is unclear. If jaundice or significant elevations in liver enzymes occur, treatment with ramipril tablets must be discontinued, and the patient must be placed under medical supervision. Abnormal liver function, hepatitis, pancreatitis, and intestinal obstruction (partial ileus) have occurred in isolated cases during treatment with ACE inhibitors. Skin, Vascular: Occasional allergic skin reactions, such as maculopapular or lichenoid rash or rash, urticaria, and pruritus, may occur. Rarely, severe skin reactions, such as erythema multiforme or angioneurotic edema involving the lips, face, and/or extremities, may occur, requiring discontinuation of ramipril treatment. Milder non-angioneurotic edema, such as around the ankles, may also occur. During treatment with ACE inhibitors, psoriasiform or pemphigoid eruptions, photosensitivity, flushing, conjunctival irritation, alopecia, loose nails, and exacerbation or induction of Raynaud's phenomenon have been reported rarely. These skin reactions may be accompanied by fever, myalgia, arthralgia/arthritis, vasculitis, eosinophilia, and/or increased antinuclear antibody titers in isolated cases. If a severe skin reaction is suspected, contact your doctor immediately and, if necessary, discontinue ramipril treatment. Nervous System: Rare side effects include headache and fatigue. Rare adverse reactions include drowsiness and sleepiness, depression, sleep disturbances, weakness, decreased libido, paresthesias, imbalance, confusion, anxiety, nervousness, fatigue, tremors, hearing impairment (such as tinnitus), blurred vision, and abnormal or transient loss of taste. Changes in blood cell counts and laboratory parameters: Hemoglobin concentration, hematocrit, white blood cell (WBC) or platelet counts may occasionally decrease. Anemia, thrombocytopenia, neutropenia, and eosinophilia may rarely occur, particularly in patients with renal impairment, connective tissue disease, or those taking allopurinol, procainamide, or some immunosuppressive medications. Granulocytopenia or pancytopenia (e.g., as a result of bone marrow suppression) has been reported in isolated cases. Hemolysis/hemolytic anemia associated with G-6-PDH deficiency has been reported in isolated cases; there is no evidence of a causal relationship between this adverse reaction and ACE inhibitors. Rarely, increases in serum urea nitrogen, creatinine, and potassium concentrations (hyperkalemia) may occur, particularly in patients with renal impairment, and a decrease in serum sodium concentration may occur. Increases in serum potassium concentrations have been observed in patients with diabetes. Increased urinary protein excretion may be detected. In rare cases, increases in bilirubin and liver enzyme concentrations may occur. Important: The above laboratory values ​​should be monitored regularly before and during treatment with ramipril tablets. Short-term monitoring of serum electrolytes, creatinine concentrations, and blood counts is recommended, especially at the start of treatment and in patients at risk (those with renal impairment and connective tissue disease) or those receiving immunosuppressants, cytostatics, allopurinol, or procainamide. If fever, lymphadenopathy, and/or sore throat develop during treatment with ramipril tablets, the white blood cell count should be promptly checked. Patient Response Attention: Treatment with this drug requires regular medical monitoring. Due to individual variability, some patients' responses may alter significantly, impairing their ability to drive, operate machinery, or work without a handrail or safety stand. This is particularly true during initial treatment, when increasing the dose or changing the dosage form, or when alcohol is consumed concomitantly.

[Contraindications]
Patients with a history of angioedema, bilateral renal artery stenosis or unilateral renal artery stenosis, decreased left ventricular blood flow or output, hypotension, or unstable circulatory status, and pregnant or lactating women.

[Precautions]
Use with caution in patients with severe or malignant hypertension, severe heart failure, existing or potential fluid or salt depletion, or those taking diuretics.

[Use in Special Populations:
Precautions for use in children:
This product has not been studied in children and is therefore contraindicated in children.

Precautions for Pregnancy and Lactation:
This product is contraindicated in pregnant and lactating women.

Precautions for Elderly Patients:
This product should be used with caution in patients taking diuretics, elderly patients with congestive heart failure, or those with hepatic or renal insufficiency. The dosage should be carefully adjusted based on blood pressure control needs.

[Drug Interactions]
Concomitant use of ramipril tablets or other ACE inhibitors with the following medications may produce the following effects: Potassium salts, potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene): Significant increase in serum potassium concentration (serum potassium concentration must be closely monitored when these medications are used concomitantly). Antihypertensive drugs (especially diuretics) and other drugs with potential hypotensive effects (e.g., nitrates, tricyclic antidepressants): Enhanced antihypertensive effect of ramipril (regular monitoring of serum sodium concentration is recommended during concurrent diuretic therapy). Hypnotics, sedatives, and anesthetics: Significant decrease in blood pressure (the anesthesiologist should be informed of ramipril treatment before surgery). Sympathomimetic vasopressors (e.g., epinephrine): May reduce the antihypertensive effect of ramipril (close blood pressure monitoring is recommended). Allopurinol, procainamide, cytostatics, immunosuppressants, systemically acting corticosteroids, and other drugs that can cause hematologic changes: Increased likelihood of hematologic reactions, particularly decreased white blood cell count and leukopenia. Lithium: Increased serum lithium concentrations may enhance lithium's cardiotoxicity and neurotoxicity (serum lithium concentrations require regular monitoring). Oral hypoglycemic agents (e.g., sulfonylureas, biguanides) and insulin: Due to their potential to reduce insulin resistance, this medication may enhance the effects of hypoglycemic agents and carry the risk of hypoglycemia (blood glucose levels should be carefully monitored, especially during the initial stages of treatment). Nonsteroidal anti-inflammatory drugs and analgesics (e.g., indomethacin, acetylsalicylic acid): May reduce the antihypertensive effect of ramipril and increase the risk of renal impairment and elevated serum potassium concentrations. Heparin: May increase serum potassium concentrations. Sodium chloride: Reduces ramipril's antihypertensive effect and ability to relieve heart failure symptoms. Ethanol: Enhances the blood pressure-lowering and ethanol-induced effects.

[Pharmacological Actions]
Ramipril is a prodrug that, after absorption from the gastrointestinal tract, is hydrolyzed in the liver to form the active angiotensin-converting enzyme (ACE) inhibitor ramiprilat, a potent and long-acting ACE inhibitor. Administration of ramipril results in increased plasma renin activity and decreased plasma concentrations of angiotensin II and aldosterone. ACE inhibitors can lead to peripheral vasodilation and decreased vascular resistance due to a reduction in angiotensin II, resulting in beneficial hemodynamic effects. Evidence suggests that tissue ACE, particularly in the vascular system, rather than circulating ACE, is the primary determinant of hemodynamic effects. Like kininase II, angiotensin-converting enzyme (ACE) can also degrade bradykinin. Evidence suggests that ACE inhibition by ramiprilat may have some effects on the kallikrein-kinin-prostaglandin system. This mechanism has been hypothesized to contribute to the antihypertensive and metabolic effects of ramipril. Ramipril administration to hypertensive patients results in a decrease in supine and standing blood pressure. Significant antihypertensive effects occur within 1-2 hours of dosing; peak effects occur 3-6 hours after dosing; and the antihypertensive effect at therapeutic doses has been shown to persist for at least 24 hours. Reproductive toxicology studies in rats, rabbits, and monkeys have not revealed any teratogenic effects. No impairment of reproductive capacity has been observed in either male or female rats. Daily administration of ramipril at doses of 50 mg/kg or greater to pregnant and lactating female rats can cause irreversible renal damage (dilatation of the renal pelvis) in offspring.

Storage: Store tightly closed, away from light, below 30°C.

Specifications: 7 tablets (5 mg)

Packaging: Box

Expiration Date: 36 months

Approval Number: National Medicine Standard H20060766

Manufacturer: Sanofi-Aventis (Beijing) Pharmaceutical Co., Ltd.