Pravastatin Sodium Tablets

This product is an angiotensin converting enzyme inhibitor. After oral administration, it is hydrolyzed into Enalaprilat in the body, which strongly inhibits angiotensin converting enzyme, reduces the content of angiotensin II, causes systemic vasodilation, and causes blood pressure reduction. It has a significant antihypertensive effect on rat models of renal hypertension II, renal hypertension I, and spontaneous hypertension.

The main ingredient of this product is: Enalapril Maleate. Its chemical name is: Enalapril Maleate; N-[(S)-1-(ethoxycarbonyl)-3-phenylpropyl]-L-alanyl-L-proline (Z)-2-butenedioate (1:1). Molecular formula: C20H28N2O5C4H4O4.

This product is white tablets.

Essential hypertension of all stages; renovascular hypertension; heart failure of all levels. For patients with symptomatic heart failure, this product is also suitable for improving the survival rate, delaying the progression of symptomatic heart failure, and reducing hospitalizations due to heart failure; preventing symptomatic heart failure. For patients with asymptomatic left ventricular dysfunction, it prevents coronary ischemic events in patients with left ventricular dysfunction. This product is suitable for reducing the incidence of myocardial infarction and reducing hospitalizations caused by unstable angina.

The starting dose for adults is 10 mg to 20 mg, once a day, taken before bedtime, with a maximum daily dose of 40 mg.

Symptoms may include dizziness, headache, drowsiness, dry mouth, fatigue, upper abdominal discomfort, nausea, palpitations, chest tightness, cough, flushing, rash, and proteinuria. Reduce the dosage if necessary. If leukopenia occurs, stop taking the drug.

Patients who are allergic to this product or have bilateral renal artery stenosis should not use this product. Patients with severe renal impairment should use it with caution.

Precautions for children: Although there have been studies abroad evaluating the efficacy and safety of this product at a daily dose of 40 mg in children and adolescents aged 8-18 years, data on people under 18 years old in China have not yet been established. Therefore, it is not recommended for patients under 18 years old at present. Precautions for pregnancy and lactation: It is contraindicated for pregnant and lactating women. Precautions for the elderly: The average AUC of oral pravastatin in the elderly is slightly higher than that in healthy young people (25-50%), but the average Cmax, Tmax and half-life are no different in these two groups. No obvious accumulation effect of pravastatin has been observed in the elderly.

Antihypertensive therapy: When this product is used simultaneously with other antihypertensive drugs, additive effects may occur, especially when diuretics are used simultaneously. This product can enhance the antihypertensive effect when used in combination with beta-blockers, methyldopa or calcium channel blockers. When ganglion blockers or adrenal receptor blockers are used in combination with this product, the patient's condition should be carefully observed. The simultaneous use of this product can reduce the decrease in serum potassium caused by thiazide diuretics. The drug interaction between enalapril maleate and the following compounds is not clinically significant: hydrochlorothiazide, furosemide, digoxin, timolol, methyldopa, warfarin, indomethacin and sulindac. The combination of propranolol and enalapril maleate reduces the serum concentration of enalaprilat, but this is not of any clinical significance. Since there is no interaction between cimetidine and enalapril maleate in animals, no drug interaction is expected to occur in humans. Serum potassium: In clinical trials, serum potassium generally remained within the normal range. After 48 weeks of treatment of hypertensive patients with this drug alone, an average increase in serum potassium of approximately 0.2 mEq/L was observed. In patients treated with this drug plus a thiazide diuretic, the potassium-excreting effect of the diuretic is often attenuated by the effect of enalapril. This drug can be used with a potassium-excreting diuretic to reduce diuretic-induced hypokalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, and concomitant use of potassium-sparing diuretics (such as spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes. The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes (especially in patients with renal insufficiency) can cause a significant increase in serum potassium. If the concomitant use of these agents is considered appropriate, they should be used with caution and serum potassium should be monitored frequently. Serum lithium, as with other sodium-excreting agents, may reduce sodium clearance. Therefore, serum lithium concentrations should be carefully monitored if lithium salts are taken. Nonsteroidal anti-inflammatory drugs For some patients with renal insufficiency, the combined use of angiotensin-converting enzyme inhibitors and nonsteroidal anti-inflammatory drugs may lead to further impairment of renal function, an effect that is usually reversible.

Keep in a dark place and sealed. The validity period is tentatively three years.

10mg

Tentative 24 months

Han Hui Pharmaceuticals Company Limited

• Founded in:

  2012-09-06

• Address:

  No. 2 Haizheng Road, Xukou Town, Fuyang District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100053653670B

• Registered Funds:

  1852.03035908 yuan

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