Fluvastatin Sodium Capsules

This product is a fully synthetic cholesterol-lowering drug, a hydroxymethylglutaryl coenzyme A (HMG-Coa) reductase inhibitor, which can convert HMG-CoA into 3-methyl-3,5-dihydroxyvaleric acid. The site of action of this product is in the liver, which has the effects of inhibiting the synthesis of endogenous cholesterol, reducing the cholesterol content in liver cells, stimulating the synthesis of low-density lipoprotein (LDL) receptors, increasing the uptake of LDL particles, and reducing the total plasma cholesterol concentration. For male and female patients aged 35-75 years with mild-moderate cholesterolemia (baseline LDL-C is 115-190mg/dl, or 3.0-4.9mmol/l) and coronary heart disease (CHD), quantitative coronary angiography is used to study the effect of this product on coronary atherosclerosis.

The main ingredient of this product is fluvastatin, and its chemical name is: [R,S-(E)]-(plusmn;)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1 hydrogen-indol-2-yl]-3,5-dihydroxy-6-heptanoic acid sodium.

This product is a capsule, and the contents are off-white to light yellow powder.

Primary hypercholesterolemia and primary mixed dyslipidemia (Fredrickson lla and llb types) that are not fully controlled by dietary therapy.

Before and during treatment with this product, patients must adhere to a low-cholesterol diet. 1 The recommended dose for regular use is 20 or 40 mg (1 or 2 capsules), once a day, swallowed at dinner or before bedtime. The dose should be adjusted based on the individual's response to medication and dietary therapy and recognized treatment guidelines. For patients with extremely high cholesterol or poor response to medication, the dose can be increased to 40 mg (2 capsules) twice a day. After administration, the maximum effect on LDL cholesterol is achieved within four weeks. Long-term use continues to be effective. 2 Dosage for patients with renal insufficiency Since this product is almost completely cleared by the liver and less than 6% of the drug enters the urine, there is no need to adjust the dosage for patients with mild to moderate renal insufficiency. Patients with severe renal insufficiency cannot be treated with this product.

In placebo-controlled trials, the following adverse reactions occurred at an incidence greater than 1% above placebo: dyspepsia (4.7%), insomnia (1.3%), nausea (1.2%), abdominal pain (1.1%), and headache (1.1%). Dyspepsia was dose-related and was more common in patients taking 80 mg/day. Adverse reactions with an incidence of 0.5-0.9% were sinusitis (0.9%), flatulence (0.8%), hypoesthesia (0.6%), dental disease (0.6%), urinary tract infection (0.6%), and elevated transaminases. Since the introduction of fluvastatin sodium, there have been individual reports of allergic reactions, particularly rash and urticaria, and extremely rare cases of other skin reactions, thrombocytopenia, angioedema, facial edema, vasculitis, and lupus erythematosus.

Patients with known hypersensitivity to fluvastatin or any other component of the drug. Patients with active liver disease or persistent unexplained elevation of transaminases. Pregnant and lactating women and women of childbearing age who are not taking reliable contraceptive measures. Patients with severe renal insufficiency.

Precautions for children: Due to the lack of clinical experience with the use of fluvastatin in age groups under 18 years old, this product is not recommended for patients under 18 years old. Precautions for pregnancy and lactation: Pregnant and lactating women and women of childbearing age who have not taken reliable contraceptive measures. Precautions for the elderly: Clinical studies have shown that this product is effective and tolerable for patients over 65 years old or younger. The efficacy is enhanced in elderly patients (65 years old) and the tolerability is not reduced, so there is no need to adjust the dose.

Food: There is no significant difference in the lipid-lowering effect of fluvastatin when taken at dinner or 4 hours after dinner. Ion exchange resin: Taking this product four hours after taking cholestyramine will produce a clinically significant cumulative effect compared to the two drugs taken alone. In order to avoid interactions that cause fluvastatin to bind to the resin, this product should be given at least 4 hours after taking ion exchange resins (such as cholestyramine). Bezafibrate: The combination of this product with bezafibrate can increase the bioavailability of fluvastatin by about 50%. Immunosuppressants (including cyclosporine), gemfibrozil, niacin and erythromycin: Clinical studies on the combination of this type of drug with this product have found no effect on tolerance, but the risk of myopathy is increased and needs to be closely observed.

Store below 25°C.

20mg

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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