Ramipril Tablets

Ramipril is a prodrug that is absorbed from the gastrointestinal tract and hydrolyzed in the liver into the active angiotensin converting enzyme (ACE) inhibitor ramiprilat to exert its effect. Taking ramipril can lead to an increase in plasma renin activity and a decrease in plasma concentrations of angiotensin II and aldosterone. Because of the reduction of angiotensin II, ACE inhibitors can lead to peripheral vasodilation and a decrease in vascular resistance, thereby producing beneficial hemodynamic effects.

Ramipril. Chemical name: (2s, 3as, 6as)-1-{(s)-2-{[(s)-1-(ethoxycarbonyl)-3-phenylpropyl]amino}propanoyl}-octahydrocyclopenta[b]pyrrole-2-carboxylic acid.

This product is white or off-white tablets.

Essential hypertension; congestive heart failure; mild to moderate heart failure after acute myocardial infarction (2 to 9 days).

Dosage precautions: An excessive decrease in blood pressure may occur during the initial treatment with ramipril, especially in patients with salt and/or fluid loss (e.g., vomiting/diarrhea, diuretic therapy), heart failure (especially after myocardial infarction), or severe hypertension. If possible, salt and/or fluid loss should be corrected and current diuretics should be reduced or stopped for at least 2-3 days before starting treatment with ramipril (in patients with heart failure, the risk of volume overload must be weighed). Treatment of these patients should begin with the lowest single dose, 1.25 mg of ramipril (e.g., half a 2.5 mg ramipril tablet) in the morning. After the initial dose, ramipril and/or

The following adverse reactions may occur during treatment with Ramipril tablets or other ACE inhibitors: Cardiovascular system: Occasionally, especially in the initial stage of treatment with Ramipril and in patients with salt and/or fluid loss (such as those who have been treated with diuretics), patients with heart failure (especially after acute myocardial infarction) and patients with severe hypertension, when the dosage of this product and/or diuretics is increased, excessive decrease in blood pressure (hypotension, orthostatic hypotension), dizziness, lightheadedness (loss of concentration in some patients), sweating, weakness, visual impairment, and rarely loss of consciousness (syncope) may occur. Adverse reactions that may be associated with a significant decrease in blood pressure include tachycardia, palpitations, angina, myocardial infarction, TIA, and ischemic stroke. Arrhythmias may occur or aggravate arrhythmias; circulatory disturbances caused by vascular stenosis may be aggravated. Kidney: Occasionally, renal damage may occur or aggravate renal damage, and acute renal failure may occur in individual cases. Rarely, proteinuria and proteinuria with worsening renal function. Respiratory system: dry cough without sputum, rarely bronchospasm, dyspnea, bronchitis, sinusitis or rhinitis, angioedema causing edema of the larynx, pharynx and/or tongue. Emergency treatment measures should be taken at this time, (1) immediate subcutaneous injection of 0.3-0.5 mg of epinephrine or slow intravenous injection of 0.1 mg of epinephrine while monitoring the electrocardiogram and blood pressure (follow the dilution instructions), followed by systemic administration of glucocorticoids; (2) intravenous administration of antihistamines and H2 receptor antagonists. In addition to epinephrine, C1 inactivators (complement C1 esterase inhibitors) can also be considered when there is a known deficiency of C1 inactivators. Patients should be hospitalized for at least 12-24 hours for monitoring and can be discharged only when the symptoms disappear completely. The incidence of angioedema during ACE inhibitor treatment in blacks is higher than that in non-blacks. Gastrointestinal tract/liver: Stomach pain, nausea, vomiting, upper abdominal discomfort (in some cases, elevated pancreatic enzymes) and digestive system disorders may occur. Rarely, vomiting, diarrhea, constipation, loss of appetite, inflammation of the oral mucosa, tongue or digestive tract, dry mouth, thirst, abnormal liver function (including acute liver failure), hepatitis, pancreatitis and intestinal obstruction (incomplete obstruction) may occur. Rarely, fatal liver necrosis may occur. If jaundice or significant increase in liver function occurs, the drug must be discontinued and monitored. Skin, blood vessels: Skin or mucosal reactions, rash (in some cases, maculopapular or lichenoid rash or mucosal rash), urticaria, pruritus, or angioneurotic edema involving the lips, face and/or limbs, in which case the drug must be discontinued. Milder non-angioneurotic edema, such as edema around bare joints, may also occur. Rarely, erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis. Rarely, pemphigus, exacerbation of psoriasis, psoriatic or pemphigus-like skin or mucosal lesions, skin photosensitivity, flushing, conjunctival irritation, alopecia, onychomycosis, vasculitis and aggravation or induction of Raynaud's phenomenon. Some skin reactions may be accompanied by fever, myalgia, arthralgia/arthritis, vasculitis, eosinophilia and/or increased antinuclear antibody titers. If severe skin reactions occur, the drug should be discontinued immediately. Allergic or allergic-like reactions to insect venom may occur and worsen the condition. Nervous system: Headache and fatigue are rare. Rarely, drowsiness and somnolence, depression, sleep disorders, weakness, decreased libido, paresthesia, imbalance, confusion, anxiety, nervousness, fatigue, tremor, hearing impairment (such as tinnitus), blurred vision and taste disturbance or transient loss. Others: muscle cramps, myalgia, arthralgia or fever.

Patients with a history of angioedema, patients with bilateral renal artery stenosis or single kidney with renal artery stenosis, patients with reduced left ventricular blood input or output, hypotension or unstable circulatory status, and pregnant and lactating women.

Precautions for children: No study has been conducted on the use of this product in children, so this product is contraindicated for use in children. Precautions for pregnancy and lactation: It is contraindicated for pregnant and lactating women. Precautions for the elderly: This product should be used with caution in elderly patients who are using diuretics, have congestive heart failure, or have liver and kidney dysfunction. When using this product, the dosage should be carefully adjusted according to the need for blood pressure control.

The following effects may occur when Ramipril or other ACE inhibitors are used in combination with the following drugs: Potassium salts, potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene): serum potassium concentration increases significantly (serum potassium concentration must be closely monitored when these drugs are used simultaneously). Antihypertensive drugs (especially diuretics) and other drugs with potential hypotensive effects (e.g., nitrates, tricyclic antidepressants): the hypotensive effect of Ramipril is enhanced (during concurrent treatment with diuretics, it is recommended to regularly monitor serum sodium concentration). Hypnotics, sedatives, anesthetics: blood pressure decreases significantly (before surgery, the anesthesiologist should be informed that Ramipril is being used for treatment). Sympathomimetic vasopressors (e.g., epinephrine): the hypotensive effect of Ramipril may be reduced (close monitoring of blood pressure is recommended). Allopurinol, procainamide, cytostatics, immunosuppressants, systemically acting corticosteroids and other drugs that can cause changes in blood counts: increased likelihood of hematological reactions, especially a decrease in the white blood cell count, leukopenia. Lithium: Increased serum lithium concentration, thereby enhancing lithium's cardiac and neurotoxicity (serum lithium concentration needs to be monitored regularly). Oral hypoglycemic drugs (such as sulfonylureas, biguanides), insulin: Due to the potential reduction of insulin resistance, this product can enhance the effect of hypoglycemic drugs and has the risk of hypoglycemia (especially in the early stages of treatment, blood sugar levels should be carefully monitored). Non-steroidal anti-inflammatory drugs, analgesics (such as indomethacin, acetylsalicylic acid): May weaken the antihypertensive effect of ramipril, and may also increase the risk of renal impairment and increased serum potassium concentration. Heparin: May increase serum potassium concentration. Sodium chloride: Reduces the antihypertensive effect of ramipril and its effect in relieving heart failure symptoms. Ethanol: Enhances the effects of blood pressure reduction and ethanol.

Sealed, protected from light, and stored below 30°C.

2.5mg

24 months

Kun Shan Rotam Reddy Pharmaceutical Co., Ltd.

• Founded in:

  1993-12-31

• Address:

  No. 2158 Huangpujiang Middle Road, Kunshan Development Zone, Jiangsu Province

• Tax NO.:

  91320583608278334C

• Registered Funds:

  $25,416,780

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