Yidatong(yi da tong )

Yidatong

The indications of yidatong (allopurinol sustained release tablets) are: ① primary and secondary hyperuricemia, especially hyperuricemia caused by excessive uric acid production; ② recurrent or chronic gout; ③ gout stone; ④ uric acid renal stone and / or uric acid nephropathy; ⑤ hyperuricemia with renal insufficiency.

Ingredients

The main component of this product is allopurinol, whose chemical name is 1h-pyrazolo-pyrimidine-4-ol.
The structure formula is: C5H4N4O < br > molecular weight: 136.11

character

This product is white or almost white.

indication

It is used for ① primary and secondary hyperuricemia, especially hyperuricemia caused by excessive uric acid production; ② recurrent or chronic gout; ③ gout stone; ④ uric acid renal stone and / or uric acid nephropathy; ⑤ hyperuricemia with renal insufficiency.

Specifications

0.25g。

Usage and dosage

Oral, the dose should be determined by the doctor according to the patient's individual condition and biochemical test results (such as blood uric acid and urine acid). Generally, the average dose is one tablet per day, which can be adjusted as appropriate.

Adverse reactions

After stopping the drug, it can generally return to normal.
(1) rash: can present pruritus papule or urticaria. If the rash is extensive and persistent, and is ineffective after symptomatic treatment, and has a tendency to aggravate, the drug must be stopped.
(2) gastrointestinal reactions: including diarrhea, nausea, vomiting and abdominal pain.
(3) leukopenia, or thrombocytopenia, or anemia, or myelosuppression should be considered.
(4) others included alopecia, fever, lymphadenopathy, hepatotoxicity, interstitial nephritis and allergic vasculitis.
(5) several cases of sudden death of unknown cause were reported in foreign countries.

taboo

It is forbidden to use this product in patients with allergy, severe liver and kidney insufficiency and obvious low blood cells.

matters needing attention

(1) This product can not control the acute inflammatory symptoms of gouty arthritis and can not be used as an anti-inflammatory drug. Because this product can induce and aggravate the symptoms of acute arthritis when it promotes the dissolution of uric acid crystal.
(2) this product must be used only after the acute inflammatory symptoms of gouty arthritis disappear (generally about two weeks after the attack).
(3) during the use of this product can occur uric acid transfer gouty arthritis attack, if there is an acute attack should be used in the treatment.
(4) drink more water and make the urine neutral or alkaline to facilitate the excretion of uric acid.
(5) this product is used for the patients with hyperuricemia, gout stone, urinary calculi and not suitable for uric acid excretion.
(6) this product must start from a small dose, gradually increase to the effective dose, maintain the normal blood uric acid and uric acid levels, and then gradually reduce, maintain for a long time with the minimum effective dose.
(7) it can strengthen the curative effect when combined with micturition acid. It is not suitable to take with iron.
(8) it is not used in the acute stage of gouty arthritis, because this product can induce and aggravate the symptoms of acute stage of arthritis when it promotes the dissolution of uric acid crystal.
(9) blood uric acid and 24-hour urine acid levels should be checked regularly before and during medication, which can be used as the basis for adjusting drug dosage.
(10) patients with renal and liver dysfunction and the elderly should be cautious in using drugs, and the daily dosage should be reduced.
(11) blood picture and liver and kidney function should be checked regularly during medication.

Medication for pregnant and lactating women

Disabled.

Medication for children

There is no medication experience of allopurinol sustained-release preparation in children. Because it is difficult to accurately adjust the dosage of this product (sustained-release tablets), it can only be used in children when the risk of the disease itself exceeds that of the drug, and there is no other safer choice. When using, the doctor should adjust the dosage at any time according to the patient's condition and the test results of blood uric acid and urine acid, so as to ensure the minimum dosage of satisfactory uric acid lowering effect.

Medication for the elderly

The elderly should be cautious in drug use, and the daily dosage should be reduced.

Drug interactions

(1) Drinking, chlorthiadone, etanide, furosemide, metolazone, pyrazinamide or thiazide diuretics can increase the serum uric acid content. In order to control gout and hyperuricemia, the dosage should be adjusted. For patients with hypertension or poor renal function, when this product is used together with thiazide diuretics, there are reports of renal failure and allergy.
(2) when the drug is used with ampicillin or amoxicillin, the incidence of skin rash increases, especially in patients with hyperuricemia.
(3) when this product is used with anticoagulants such as dicoumarin and Indanedione derivatives, the effect of anticoagulants can be enhanced. Attention should be paid to prothrombin time and the dosage of anticoagulants should be adjusted to prevent abnormal bleeding.
(4) when this product is used with azathioprine or mercaptopurine, because it can inhibit xanthine oxidase and prolong the half-life of azathioprine or mercaptopurine, the curative effect is increased by 2-4 times and the toxicity is increased, so the dosage of azathioprine or mercaptopurine should be generally reduced to 1 / 4-1 / 3 of the common dosage.
(5) when this product is used with cyclophosphamide, the inhibition of bone marrow is more obvious.
(6) when this product is used together with uric acid drugs, it can increase the possibility of renal stone formation.
(7) when combined with theophylline, it can inhibit the activity of liver enzymes, reduce the clearance of theophylline, increase the concentration of theophylline in blood, and prolong the effect of theophylline.
(8) combination of other anti gout drugs: < br > ① probenecid: the combination of allopurinol and probenecid can enhance the body's ability to eliminate uric acid in vitro, and the combination of two < br > drugs can add up.
(2) butazone: butazone and its metabolite, γ - hydroxybutazone, can excrete uric acid, but its toxicity is too large, and it can also inhibit the secretion of uric acid when applied in small doses, so allopurinol should not be used in combination with butazone.
(3) colchicine: allopurinol can not only block the transformation of xanthine into uric acid in the early stage of treatment, but also cause the rapid redistribution of uric acid in the body and induce acute gout attack; while colchicine acts on the joint cavity and body cavity connecting tissues, which can alleviate the joint pain, inflammation and swelling of acute gout, and reduce the severity and attack frequency of gout. The combination of the two, especially in the early stage of treatment, can effectively inhibit the attack of acute gout.

Drug overdose

When taking large doses of allopurinol, there may be gastrointestinal discomfort (such as nausea, vomiting, diarrhea, etc.). For the symptoms caused by overdose, gastric lavage should be done quickly and supportive therapy should be given appropriately. However, it is necessary to eliminate the unabsorbed drugs as soon as possible and take appropriate symptomatic treatment or hemodialysis.

Pharmacology and Toxicology

This product is a drug that inhibits the synthesis of uric acid. Allopurinol and its metabolite oxypurinol can inhibit xanthine oxidase, prevent hypoxanthine and xanthine from metabolizing to uric acid, thus reducing the production of uric acid. It can reduce the content of uric acid in blood and urine to below the solubility level, prevent the formation of uric acid crystal deposition in joints and other tissues, and also help the uric acid crystal in gout patients to dissolve again. Allopurinol also inhibits the synthesis of new purines in vivo by acting on hypoxanthine guanine phosphonuclease. The serum uric acid concentration began to decrease 24 hours after oral administration, and the most obvious decrease was at 2-4 weeks. Results of acute toxicity test: LD50 of rats was 6000 mg / kg by oral administration and 750 mg / kg by intraperitoneal injection; LD50 of mice was 700 mg / kg by oral administration and 160 mg / kg by intraperitoneal injection.

Pharmacokinetics

It has been reported that allopurinol is absorbed completely in the gastrointestinal tract after oral administration, and its blood concentration can reach the peak within 2-6 hours. It is metabolized into active oxypurinol in the liver, and neither of them can bind to plasma. The half lives of allopurinol and oxypurinol are 1-3 hours and 14-28 hours respectively. Both of them are excreted by the kidney. 10% of them are in the original form, and 70% of them are excreted with urine in the form of metabolites. The excretion of oxypurinol can be promoted by the use of uric acid excretory drugs, but the excretion of oxypurinol is reduced in renal insufficiency.
After a single oral dose of 250mg, the plasma concentration of allopurinol reached the peak in about 2 hours and that of oxypurinol reached the peak in about 6.42 hours. The half-life of allopurinol is about 1 hour and that of oxypurinol is about 24.41.

Storage

Keep in a sealed, dark and dry place.

packing

Each bottle was packed with 16, 30, 40 or 60 pieces of medical polyolefin plastic bottles.

term of validity

24 months.

Executive standard

State Food and Drug Administration Standard (Trial) ybh19022004

Approval number

Guoyao Zhunzi h20041743

manufacturing enterprise

Hainan Puli Pharmaceutical Co., Ltd

Revision date

June 19, 2007

Chinese PinYin : Yi Da Tong