Fosinopril Sodium Tablets (Mono)

This product is an antihypertensive drug and an angiotensin converting enzyme inhibitor. It is converted into pharmacologically active fosinoprilat in the body, which can inhibit angiotensin converting enzyme, reduce the concentration of angiotensin II and aldosterone, dilate peripheral blood vessels, reduce vascular resistance, and produce a hypotensive effect.

Fosinopril sodium.

This product is white or off-white tablets.

It is suitable for the treatment of hypertension and heart failure. When treating hypertension, it can be used alone as an initial treatment drug, or used in combination with other antihypertensive drugs. When treating heart failure, it can be used in combination with diuretics.

Oral administration, usage and dosage for adults and children over 12 years old are as follows: 1. Hypertensive patients who are not treated with diuretics: The dosage range is 10-40 mg per day, a single dose, regardless of meals. The normal initial dose for patients is 10 mg, once a day. After about four weeks, the dosage is appropriately adjusted according to the blood pressure response. If the dosage exceeds 40 mg per day and does not enhance the antihypertensive effect, a diuretic can be added. 2. Hypertensive patients who are also taking diuretics: Before starting treatment with this product, it is best to stop taking diuretics for a few days to reduce the risk of excessive blood pressure drop. If blood pressure cannot be adequately controlled after an observation period of about 4 weeks, diuretic treatment can be resumed. Another option is that if diuretics cannot be stopped, close observation for several hours should be given when the initial dose of 10 mg of this product is given until blood pressure stabilizes. Hypertensive patients treated with diuretics can maintain average cerebral blood flow between 4 hours and 24 hours, although blood pressure is significantly reduced after taking this product. 3. Heart failure: The recommended initial dose is 10 mg, once a day, and close medical monitoring is required. If the patient can tolerate it well, the dose can be gradually increased to 40 mg, once a day. Even if hypotension occurs after the initial dose, the dose should be increased cautiously and the hypotension should be effectively treated. This product should be used in combination with diuretics. 4. High-risk patients with heart failure: The following patients should start treatment in the hospital: patients with severe heart failure (NYHA IV grade); patients who are particularly at risk of hypotension after the first dose, such as patients receiving multiple or high-dose diuretics (such as furosemide ≥ 80 mg), patients with reduced blood volume, hyponatremia (blood sodium ≤ 130 meq/L), patients with hypotension (systolic blood pressure ≤ 90 mmhg), and patients with unstable heart failure and receiving high-dose vasodilator therapy. 5. Elderly people and patients with impaired liver or kidney function do not need to reduce the dose.

1. The most common side effects of this product are dizziness, cough, upper respiratory tract symptoms, nausea or vomiting, diarrhea and abdominal pain, palpitations or chest pain, rash or itching, skeletal muscle pain or paresthesia, fatigue and taste disorders. 2. In trials for the treatment of heart failure, like other ACE inhibitors, it can cause hypotension, including orthostatic hypotension. 3. There have been occasional reports of pancreatitis in patients treated with ACE inhibitors, which has proven to be fatal in some cases. 4. There is no difference in the incidence and type of side effects between young and elderly patients. 5. Laboratory tests showed mild, temporary decreases in hemoglobin and red blood cell values, and occasional mild increases in blood urea nitrogen.

It is contraindicated for pregnant and lactating women and those who are allergic to ACE inhibitors or other ACE inhibitors.

Precautions for children: This experiment has not been conducted and there is no reliable reference literature, so it is not recommended for children. Precautions for pregnancy and lactation: It is forbidden for pregnant and lactating women. Precautions for the elderly: Elderly patients do not need to reduce the dose.

1. Potassium supplements and potassium-sparing diuretics: This product can reduce the decrease in serum potassium induced by thiazide diuretics. Potassium-sparing diuretics or potassium supplements can increase the risk of hyperkalemia. Therefore, if these drugs are used at the same time, caution should be exercised and the patient's serum potassium needs to be monitored frequently. 2. Antacids: Antacids may affect the absorption of this product. This product and antacids must be taken separately, at least 2 hours apart. 3. Nonsteroidal anti-inflammatory drugs: Nonsteroidal anti-inflammatory drugs may affect the antihypertensive effect, but the simultaneous use of this product and nonsteroidal anti-inflammatory drugs (including aspirin) does not increase clinically significant adverse reactions. 4. Lithium: Simultaneous treatment with lithium may increase serum lithium concentrations. 5. Other antihypertensive drugs: Combination use with other antihypertensive drugs, such as beta-receptor blockers, methyldopa, calcium ion antagonists and diuretics can increase the antihypertensive effect.

Keep away from light, seal tightly, and store in a cool (not exceeding 20℃) and dry place.

10 mg

36 months.

SINO-AMERICAN Shanghai Squibb Pharmaceuticals Ltd.

• Founded in:

  1982-10-14

• Address:

  No. 1315, Jianchuan Road, Minhang District, Shanghai

• Tax NO.:

  91310000607220034F

• Registered Funds:

  $18.44 million

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