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Colchicine tablets

Category

Anti-gout

Product description

Approval date: April 2, 2011

Modified date: November 30, 2015

Colchicine tablets instructions

Please read the instructions carefully and use them under the guidance of a physician.

【Drug Name】

Common name: colchicine tablets

English name: Colchicine Tablets

Chinese Pinyin: Qiushuixianjian Pian

[Ingredients] The main ingredients of this product are: colchicine. Its chemical name is: N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxo-benzo[a]heptylenetrienheptyltriene -7-yl)acetamide.

Molecular formula: C22H25NO6

Molecular weight: 399.44

【Properties】 This product is a white film.

[Indications] Treatment of acute attacks of gouty arthritis, prevention of acute exacerbation of recurrent gouty arthritis.

[Specification] 0.5mg

[Usage and dosage] Oral.

1. Acute period:

Adults usually take 0.5 to 1 mg (1 to 2 tablets) every 1 to 2 hours until the joint symptoms are relieved, or diarrhea or vomiting occurs. The therapeutic amount is generally 3 to 5 mg (6 to 10 tablets), which is not suitable for 24 hours. More than 6mg (12 tablets). After stopping for 72 hours, the daily dose is 0.5-1.5 mg (1 to 3 tablets), taken in divided doses for 7 to 14 days.

2. Prevention:

Oral administration of 0.5 ~ 1.0mg (1 ~ 2 tablets) under the guidance of a physician, 1 or 2 times a day, according to the doctor's advice. If there is an adverse reaction, stop taking it at any time.

[Adverse reactions] There is a significant correlation with the dose size, and oral administration is safer than intravenous injection.

(1) Gastrointestinal symptoms: abdominal pain, diarrhea, vomiting and loss of appetite are common early adverse reactions, the incidence rate can reach 80%, severe cases can cause dehydration and electrolyte imbalance. Long-term users may have severe hemorrhagic gastroenteritis or malabsorption syndrome.

(2) Muscle and peripheral neuropathy: there is proximal muscle weakness and/or increased serum creatine phosphokinase. Peripheral axonal polyneuropathy can occur at the same time as muscle cell damage, manifested as numbness, tingling and weakness. Muscle neuropathy is rare, often in the prevention of gout and long-term use and mild renal insufficiency.

(3) Myelosuppression: thrombocytopenia, neutrophil decline, and even aplastic anemia. Oral is rare, more common in intravenous medication. Sometimes it is a fatal danger.

(4) Shock: manifested as oliguria, hematuria, convulsions and disturbance of consciousness. High mortality, more common in intravenous medication and the elderly.

(5) phlebitis, cellulitis: more occurs in the site of intravenous injection of this product.

(6) Teratogenicity: It is reported in the literature that the fathers of two infants with Down syndrome have a history of long-term use of colchicine due to familial Mediterranean fever.

(7) Others: hair loss, rash, fever and liver damage.

[Contraindications] For those with low bone marrow hyperplasia, kidney and liver dysfunction are prohibited.

【Precautions】 (1) If vomiting, diarrhea, etc. occur, reduce the dosage. If it is serious, stop the drug immediately.

(2) bone marrow hematopoietic insufficiency, severe heart disease, renal insufficiency and gastrointestinal disease patients with caution.

(3) Blood and liver and kidney functions should be checked regularly during medication.

(4) Female patients should not be pregnant during the medication and within a few weeks after stopping the drug.

[Pregnant women and lactating women] This product can cause teratogenicity, pregnant women and lactating women are prohibited.

[Child medication] This experiment was not performed and there is no reliable reference.

[Geriatric Use] The dose should be reduced for the elderly. Because the amount of poisoning of this product is often related to the accumulation of the body, when the renal excretion function declines, it is easy to cause accumulation of poisoning. This product needs to be detoxified by enterohepatic circulation. When liver function is poor, the detoxification ability is reduced, which is also easy to promote toxicity.

[Drug interactions] (1) This product can cause reversible vitamin B12 malabsorption.

(2) This product can enhance the central nervous system inhibitors and enhance the reactivity of the sympathomimetic drugs.

[Drug overdose] This product is a cell mitotic toxin, which is highly toxic. If there is a lack of rescue measures in excess, special attention should be paid to overdose.

【Pharmacology and Toxicology】 The colchicine passes:

1 neutrophil tubulin subunit binding changes cell membrane function, including inhibition of neutrophil chemotaxis, adhesion and phagocytosis;

2 inhibit phospholipase A2, reduce the release of prostaglandins and leukotrienes by monocytes and neutrophils;

3 inhibit local cells to produce interleukin-6, etc., so as to control the local joint pain, swelling and inflammation. Colchicine does not affect the formation, dissolution and excretion of urate, so there is no effect of lowering blood uric acid. Acute gouty arthritis works 12 to 24 hours after oral administration, and 90% of patients have pain disappeared from 24 hours to 48 hours.

Acute toxicity test results: the LD50 of intravenous injection was 1.6 mg/kg in rats; the LD50 of intravenous injection in mice was 4.13 mg/kg.

[Pharmacokinetics] Rapidly absorbed in the gastrointestinal tract after oral administration, the plasma protein binding rate is low, only 10% to 34%, and the blood concentration reaches a peak 0.5 to 2 hours after taking the drug. Oral 2 mg of blood drug peak was 2.2 ng / ml. The concentration of the drug in the isolated neutrophils is higher than the plasma concentration and can be maintained for 10 days. This product is metabolized in the liver and is excreted from bile and kidneys (10% to 20%). Patients with liver disease have increased excretion from the kidneys. Drug excretion lasted for about 10 days after discontinuation of the drug.

[Storage] Shading, sealed (10 ~ 30 ° C).

[Packaging] Composite film for pharmaceutical packaging, 20 pieces per box; 40 pieces per box.

[Validity period] 24 months.

[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2

[Approval No.] National Drug Standard H20113208

【manufacturer】

Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.

Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province

Postal code: 529331

Phone number: (0750) 2789348 2783621

400-8899-328 (National Service Phone)

Fax number: (0750) 2789348

Website: http://www.pdpharm.com