Product Overview
[Drug Name]
Generic Name: Fosinopril Sodium Tablets
Trade Name: Monno
English Name: Sodium Fosinopril Tablets
Chinese Pinyin: Fuxinpuliena Pian
[Ingredients]
Fosinopril sodium.
[Appearance]
This product is white or off-white tablets.
[Indications]
It is indicated for the treatment of hypertension and heart failure. For hypertension, it can be used alone as the initial treatment or in combination with other antihypertensive drugs. For heart failure, it can be used in combination with a diuretic.
[Dosage and Administration]
Oral administration. The dosage and administration for adults and children over 12 years of age are as follows:
1. For patients with hypertension not receiving diuretics: The dosage range is 10-40 mg per day, taken as a single dose, regardless of meals. The normal initial dose is 10 mg once daily. After approximately four weeks, the dose can be adjusted appropriately based on blood pressure response. If the dose exceeds 40 mg per day without enhancing the antihypertensive effect, a diuretic may be added. 2. Hypertensive patients taking diuretics: Before starting treatment with this drug, it is best to discontinue diuretics for several days to reduce the risk of an excessive drop in blood pressure. If blood pressure is not adequately controlled after an observation period of approximately 4 weeks, diuretic therapy can be resumed. Alternatively, if discontinuation of diuretics is not possible, the patient should be closely observed for several hours after the initial 10 mg dose of this drug until blood pressure stabilizes. Although blood pressure may be significantly lowered after taking this drug, mean cerebral blood flow in patients taking diuretics can be maintained over a 4-24 hour period.
3. Heart failure: The recommended initial dose is 10 mg once daily under close medical supervision. If tolerated well, the dose can be gradually increased to 40 mg once daily. Even if hypotension occurs after the initial dose, the dose should be increased cautiously and effectively managed. This drug should be used in combination with a diuretic. 4. High-risk patients with heart failure: The following patients should initiate treatment in a hospital setting: patients with severe heart failure (NYHA class IV); patients at particular risk for hypotension after the first dose, such as those receiving multiple or high-dose diuretics (e.g., furosemide >80 mg), those with hypovolemia, hyponatremia (serum sodium <130 meq/L), those with pre-existing hypotension (systolic blood pressure <90 mmHg), and those with unstable heart failure and those receiving high-dose vasodilators.
5. Elderly patients and patients with impaired hepatic or renal function do not require dose reduction.
[Adverse Reactions]
1. The most common side effects of this drug are dizziness, cough, upper respiratory symptoms, nausea or vomiting, diarrhea and abdominal pain, palpitations or chest pain, rash or itching, skeletal muscle pain or paresthesia, fatigue, and dysgeusia. 2. In trials for the treatment of heart failure, as with other ACE inhibitors, it can cause hypotension, including orthostatic hypotension. 3. There have been rare reports of pancreatitis in patients treated with ACE inhibitors, which in some cases have proven fatal. 4. The incidence and type of side effects do not differ between younger and elderly patients. 5. Laboratory tests may reveal mild, transient decreases in hemoglobin and red blood cell counts, and occasionally mild increases in blood urea nitrogen.
[Contraindications]
Precautions: This medication is contraindicated in pregnant or lactating women, especially those allergic to ACE inhibitors or other ACE inhibitors.
[Precautions]
1. Hypotension: As with all ACE inhibitors, hypotension may be observed. 2. Renal Impairment: Patients with pre-existing congestive heart failure, renovascular hypertension (especially renal artery stenosis), or water or salt depletion from any cause are at increased risk of developing signs of renal dysfunction when treated with ACE inhibitors, including elevated blood urea nitrogen, elevated serum creatinine and potassium, proteinuria, changes in urine volume (including oligouria/anuria), and abnormal urinalysis results. In these cases, the dose of diuretics and/or this medication should be reduced or discontinued. 3. Anaphylactoid Reactions: Recent clinical observations have shown a higher incidence of anaphylactoid reactions in patients receiving ACE inhibitors undergoing hemodialysis with high-flow dialysis membranes (e.g., AN69). Therefore, such combined therapy should be avoided. Similar reactions have also been observed with sulfated polysaccharides used to separate LDL. As with other ACE inhibitors, rare cases of anaphylactoid reactions have been documented during desensitization therapy (with hymenoptera toxins). 4. Idiosyncratic Reactions: Angioedema involving the limbs, face, lips, mucous membranes, tongue, glottis, or larynx has been observed in patients treated with ACE inhibitors. If such symptoms occur during treatment, treatment should be discontinued. 5. Hepatic Impairment: Rare cases of potentially fatal bilious jaundice and hepatocellular damage have been reported with ACE inhibitors. ACE inhibitor therapy should be discontinued in patients who develop jaundice or markedly elevated liver enzymes.
[Use in Special Populations]
Precautions for Pediatric Patients:
This drug has not been tested and no reliable literature is available. Therefore, its use in pediatric patients is not currently recommended. Precautions for Pregnancy and Lactation:
This product is contraindicated in pregnant and lactating women.
Precautions for the Elderly:
No dose reduction is required for elderly patients.
[Drug Interactions]
1. Potassium Supplements and Potassium-Sparing Diuretics: This product can reduce the hypokalemia induced by thiazide diuretics. Potassium-sparing diuretics or potassium supplements can increase the risk of hyperkalemia. Therefore, caution should be exercised if these drugs are used concomitantly, and the patient's serum potassium should 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 concomitant use of this product and NSAIDs (including aspirin) does not increase clinically significant adverse reactions. 4. Lithium: Concomitant treatment with lithium may increase serum lithium concentrations. 5. Other Antihypertensive Drugs: Concomitant use with other antihypertensive drugs, such as beta-blockers, methyldopa, calcium antagonists, and diuretics, may enhance the antihypertensive effect.
[Pharmacological Action]
This product is an antihypertensive drug and an angiotensin-converting enzyme inhibitor. It is converted into the pharmacologically active fosinoprilat in the body, which inhibits angiotensin-converting enzyme, reducing the concentrations of angiotensin II and aldosterone, leading to peripheral vasodilation and decreased vascular resistance, resulting in a hypotensive effect.
[Storage] Store in a cool, dry place (not exceeding 20°C), sealed and protected from light.
[Specification] 10mg x 14 tablets
[Packaging Specification] Box
[Expiry Date] 36 months.
[Approval Number] National Medicine Standard H19980197
[Manufacturer] Company Name: Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.
