Niacin extended-release tablets

Niacin exerts its lipid-lowering effect after being converted to NAD in the nicotinamide adenine dinucleotide (NAD) coenzyme system in the body. Niacin can reduce the levels of total cholesterol (TC), low-density lipoprotein (LDL-C) and triglycerides (TC), and increase the level of high-density lipoprotein (HDL-C). Niacin can also reduce the serum levels of apolipoprotein B-100 (ApoB), most very low-density lipoprotein (VLDL), some LDL and lipoprotein a [Lp(a)]. Lifelong administration of 1% niacin solution to mice has no carcinogenic effect; the Ames test shows that niacin is not teratogenic; the reproductive toxicity of niacin has not been studied, and the carcinogenicity, teratogenicity or reproductive toxicity of niacin sustained-release tablets have not been studied.

The main ingredients and chemical names of this product are: Main ingredient: niacin; Chemical name: pyridine-3-carboxylic acid

It is a special-shaped film-coated tablet, which appears white or off-white after removing the coating.

Used to prevent and treat niacin deficiency diseases such as pellagra.

This product must be swallowed whole and should not be broken or chewed. This product should be taken before bedtime after a small, low-fat meal. For oral administration, the recommended dose for 1-4 weeks is 1 tablet (0.5g) once a day; the dose for 5-8 weeks is 2 tablets (1g) once a day. After 8 weeks, the dose is gradually increased according to the patient's efficacy and tolerance. If necessary, the dose can be increased to 4 tablets (2g) per day. The recommended maintenance dose is 1g-2g (2-4 tablets) per day, taken before bedtime. It is not recommended to exceed 2g (4 tablets) per day. The dose for female patients is lower than that for male patients. If monotherapy with this product is ineffective or the tolerance to higher doses of this product is poor, these patients can use this product in combination with bile acid binding resins or HMG-COA reductase inhibitors. While taking

This product is generally well tolerated, and side effects are mild and short-lived. Common side effects are skin flushing (such as feeling warm, red, itchy or tingling skin), which may be accompanied by dizziness, tachycardia, palpitations, shortness of breath, sweating, chills and/or edema, and in very rare patients may lead to syncope. Other adverse reactions include abdominal pain, diarrhea, indigestion and rash, and occasionally nausea, vomiting and rhinitis. The incidence of adverse reactions in female patients is generally higher than that in male patients. In clinical studies or routine treatment, the following adverse reactions have also been reported with the use of niacin preparations: systemic symptoms: edema, general fatigue, chills; cardiovascular: atrial fibrillation and other arrhythmias, tachycardia, palpitations, orthostatic hypotension; eyes: toxic male amblyopia, cystic plaque edema; gastrointestinal tract: active digestive

Contraindications: Patients with severe or unexplained liver dysfunction, active peptic ulcer or arterial bleeding.

Precautions for children: The safety and effectiveness of niacin in treating pediatric patients (≤16 years old) have not been established. Studies of niacin extended-release tablets have not been conducted in patients under 21 years of age. Therefore, this product is not recommended for patients under 21 years of age. Precautions for pregnancy and lactation: Animal reproduction experiments on niacin or this product have not been studied. If a woman with primary hypercholesterolemia (type I or II) becomes pregnant while taking niacin, she should stop taking this product. There are reports that niacin can be secreted through human milk. Because therapeutic doses of niacin may have serious adverse reactions in infants, decisions to stop breastfeeding or discontinue the drug should be made based on the importance of the drug to the nursing mother. Precautions for the elderly: Not yet clear.

HMG-COA reductase inhibitors: See Precautions and Effects on Skeletal Muscle. Antihypertensives: Niacin may enhance the effects of neuroleptics and vasoactive drugs and cause postural hypotension. Aspirin: Coadministration with aspirin may reduce the metabolic clearance of niacin in vivo. The clinical relevance of this finding is unclear. Bile acid multivalent chelators: An in vitro study observed the binding ability of colestipol and cholestyramine to niacin. About 98% of niacin can be bound to colestipol and 10%-30% can be bound to cholestyramine. The results showed that there should be an interval of 4-6 hours or as long as possible between taking bile acid binding resins and taking this product. Others: Alcohol or hot beverages

Keep in a light-proof and airtight container.

0.5g

24 months

China Resources SAIKE Pharmaceutical Co., Ltd.

• Founded in:

  1981-03-23

• Address:

  Room 2111, 21F, Building 402, Baiziwanxili, Chaoyang District, Beijing

• Tax NO.:

  91110000101208804Q

• Registered Funds:

  168.55 million yuan

• Email:

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