Fluvastatin Sodium Extended Release Tablets

This product is a fully synthetic cholesterol-lowering drug, a hydroxymethylglutaryl coenzyme A 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 receptors, increasing the uptake of LDL particles and reducing the total plasma cholesterol concentration. The effect of this product on coronary atherosclerosis was studied by quantitative coronary angiography in male and female patients aged 35-75 years with mild-moderate hypercholesterolemia (baseline LDL-C is 115-190mg/dl, or 3.0-4.9mmol/l) and coronary heart disease. This is a randomized, double-blind, placebo-controlled clinical study. In addition to standard treatment, 429 patients were given fluvastatin 20 mg twice a day or placebo and angiography was performed at baseline and two and a half years later for evaluation. Fluvastatin sodium significantly slowed the progression of coronary artery disease based on changes in each patient's pre- and post-minimum lumen diameter, percent stenosis diameter, or formation of new lesions.

The main ingredient of this product is fluvastatin sodium.

This product is a yellow round film-coated tablet, which appears light yellow after removing the coating.

It is used for patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson types Ⅱa and Ⅱb) that cannot be fully controlled by diet.

Before and during treatment with this product, patients must adhere to a low-cholesterol diet. The recommended dose is 20 or 40 mg, once a day, swallowed at dinner or before bedtime.

1. In placebo-controlled trials, the incidence of the following adverse reactions was higher than 1% of the placebo group: dyspepsia, insomnia, nausea, abdominal pain, and headache. Dyspepsia is dose-related and is more common in patients taking 80 mg/day. Adverse reactions with an incidence of 0.5-0.9% are sinusitis, flatulence, hypoesthesia, dental disease, urinary tract infection, and elevated transaminases. 2. Since the launch of fluvastatin sodium, there have been individual reports of allergic reactions, especially rash and urticaria. Extremely rare cases include other skin reactions, thrombocytopenia, angioedema, facial edema, vasculitis, and lupus erythematosus-like reactions. 3. Patients with known allergies to fluvastatin or any other component of the drug. 4. Active liver disease or persistent unexplained elevation of transaminases. 5. Pregnant and lactating women and women of childbearing age who have not taken reliable contraceptive measures. 6. Patients with severe renal insufficiency (creatinine greater than 260umol/l, creatinine clearance less than 30m1/min).

Not yet clear.

Precautions for children: Due to the lack of clinical experience with the use of fluvastatin in age groups under 18 years old, it is not recommended for patients under 18 years old. Precautions for pregnancy and lactation: Since HMG-CoA reductase inhibitors reduce the synthesis of cholesterol and may reduce the synthesis of certain biologically active cholesterol derivatives, they may be harmful to the fetus or infant if taken by pregnant or lactating women. Therefore, HMG-CoA reductase inhibitors are contraindicated for pregnant and lactating women, and are also contraindicated for women of childbearing age who do not take reliable contraceptive measures. If you become pregnant during treatment, you must stop taking fluvastatin. There is no data on the excretion of fluvastatin in breast milk, so lactating women should not take this product. Precautions for the elderly: The results of studies in elderly patients did not show reduced tolerance or the need for dose adjustment.

1. Food: There is no significant difference in the lipid-lowering effect of fluvastatin when taken at dinner or 4 hours after dinner. 2. 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 the ion exchange resin. 3. Bezafibrate: The combination of this product with bezafibrate can increase the bioavailability of fluvastatin by about 50%. Immunosuppressants, gemfibrozil, nicotinic acid 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 close observation.

Store below 25°C.

80mg

24 months

Beijing Novartis Pharma Co., Ltd.

• Founded in:

  1987-04-16

• Address:

  No. 31, Yong'an Road, Changping District, Beijing

• Tax NO.:

  9111000060001684X1

• Registered Funds:

  $30 million

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