Niacin extended-release tablets

The main ingredient of this product is nicotinic acid. The auxiliary ingredients of this product are hydroxypropyl methylcellulose, polyvinyl pyrrolidone and stearic acid.

When diet control alone is ineffective, this product can be used as an adjunct to exercise and diet control to reduce elevated levels of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein (ApoB) and triglycerides (TG) in patients with primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (types Iia and Iib), while increasing high-density lipoprotein cholesterol (HDL-C).

This product should be taken after dinner and before bedtime. The tablet should be swallowed whole and should not be broken, crushed or chewed before taking. The simultaneous intake of alcohol or hot drinks increases the incidence of flushing and pruritus, so these two substances should be avoided before and after taking this product. Initial treatment with this product must be used under the guidance of a doctor. Treatment with this product should start with a low dose and then gradually increase the dose. This also applies to patients who have discontinued treatment with this product for a long time or have previously received other niacin products. During treatment, niacin products cannot be used to replace this product. Patients are advised to take this product according to the following dose escalation schedule in the first 7 weeks: Week 1: 1 tablet of 375 mg per day, taken at bedtime; Week 2: 1 tablet of 500 mg per day, taken at bedtime; Week 3: 1 tablet of 750 mg per day, taken at bedtime; Weeks 4-7: 2 tablets of 500 mg per day, taken at bedtime. Please note that the strengths are not interchangeable (e.g., one tablet of 1000 mg cannot be used instead of two tablets of 500 mg). After 7 weeks of maintenance treatment, the doctor will determine the dosage and duration of medication suitable for the individual. Depending on the patient's responsiveness and tolerance to this product, it is recommended that the patient take 1000mg (two 500mg tablets) to 2000mg (two 1000mg tablets) once a day before going to bed. If the patient's response to 1000mg/day is insufficient, the dose can be increased to 2000mg/day. The increase in daily dose within 4 weeks shall not exceed 500mg, and the maximum daily dose is 2000mg.

Flushing In placebo-controlled clinical trials, the most common treatment-related adverse reaction with this product was flushing (such as fever, redness, itching and/or tingling). In the above trials, less than 6% of patients discontinued treatment with this product due to flushing. In the comparative trial of immediate-release niacin and this product, although the number of patients with flushing was similar, the number of flushing episodes reported by patients receiving this product was less. After 4 weeks of maintenance treatment at a daily dose of 1500 mg, the average frequency of flushing episodes in patients within 4 weeks was 1.88 times. Usually, flushing reactions occur at the beginning of treatment and during the dose adjustment phase. The flushing reaction is believed to be caused by the release of prostaglandin D2, and tolerance to flushing will be developed after several weeks of treatment. Rarely, more severe flushing (accompanied by dizziness, rapid heartbeat, palpitations, shortness of breath, sweating, chills and/or edema, and rarely syncope) occurs. Appropriate treatment should be given when necessary. Allergic reactions Allergic reactions are reported extremely rarely. Allergic reactions to this product are manifested as systemic skin reactions, flushing, urticaria, herpes, angioedema, airway stenosis, shortness of breath, hypotension and collapse. Appropriate treatment should be given when necessary. In clinical studies and/or routine treatment of patients, the following adverse reactions were found in patients taking the recommended daily maintenance dose (1000mg, 1500mg and 2000mg). Generally, the incidence of adverse reactions in female patients is higher than that in male patients. Very common (10%): flushing. Common (1%, 0.1%, 0.01%,

The following patients are strictly prohibited from using this product: those who are allergic to niacin or any of the excipients; those with significant liver dysfunction; those in the active stage of gastric ulcer; and those with arterial bleeding.

Precautions for children: This product is not recommended for children and adolescents. Precautions for pregnancy and lactation: This product should not be used by pregnant women unless necessary. It is not clear whether the use of therapeutic doses of niacin to treat lipid abnormalities by pregnant women is harmful to their fetuses or affects their reproductive capacity. Animal studies are not sufficient. This product should not be used by breastfeeding women because niacin can be excreted in breast milk. Precautions for the elderly: No dosage adjustment is required for elderly patients.

Avoid alcohol or hot drinks before or after taking this product. It should be taken separately from bile acid sequestrants. Niacin can enhance the hypotensive effect of ganglion blockers (such as transdermal nicotine or vasoactive drugs such as nitrates, calcium channel blockers and adrenergic inhibitors).

Keep in a light-proof and airtight container.

0.5g

Sanjin Group Hunan Sanjin Pharmaceutical Co., Ltd.

• Founded in:

  2000-01-19

• Address:

  No. 320, Deshan Avenue, Chongde Residential Committee, Deshan Town, Changde Economic and Technological Development Zone

• Tax NO.:

  9143070072794757X4

• Registered Funds:

  160 million yuan

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