Allopurinol Tablet Package Insert

Allopurinol Tablet Package Insert (Simplified Version)

【Drug Name】 Generic Name: Allopurinol Tablets English Name: Allopurinol Tablets Pinyin: Biepiaochun Pian
【Ingredients】 The active ingredient of this product is allopurinol. Chemical name: 1H-pyrazolo[3,4-d]pyrimidin-4-ol. Molecular formula: C5H4N4O. Molecular weight: 136.11. The excipients in this product are lactose, corn starch, povidone K30, and magnesium stearate.
【Characteristics】 This product is a white or off-white tablet, with a score line on one side.

【Indications】 This product is indicated for
1. Patients with primary or secondary gout (acute attacks, tophi, joint destruction, uric acid stones, and/or renal disease).
2. In patients with leukemia, lymphoma, and malignant tumors receiving treatment, this product may cause elevated serum and urinary uric acid levels. Discontinue use of this product when the risk of excessive uric acid production no longer exists.
3. In the management of patients with recurrent calcium oxalate stones, for male patients with daily uric acid excretion exceeding 800 mg and for female patients with daily uric acid excretion exceeding 750 mg, the therapeutic regimen should first be carefully evaluated and regularly reassessed to ensure that treatment is beneficial in each individual case and that the benefits outweigh the risks. It is not recommended for the treatment of asymptomatic hyperuricemia.

【Specification】0.1g

【Usage and Dosage】 Oral administration:
1. Usual adult dosage: Start with 50 mg (half a tablet) once, 1 to 2 times daily; the dose may be increased by 50 to 100 mg (half to one tablet) each week, up to 200 to 300 mg (2 to 3 tablets) per day, divided into 2 to 3 doses. Monitor serum and urinary uric acid levels every 2 weeks; if these levels have reached the normal range, do not increase the dose further; if they remain elevated, the dose may be increased again. However, the maximum daily dose should not exceed 600 mg (6 tablets).
2. Usual dosage for treating secondary hyperuricemia in children: for those aged 6 years and younger, 50 mg (half a tablet) each time, 1 to 3 times daily; for those aged 6 to 10 years, 100 mg (1 tablet) each time, 1 to 3 times daily. The dosage may be adjusted as appropriate.

【Contraindications】 Contraindicated in patients with hypersensitivity to this product, severe hepatic or renal impairment, or significant cytopenia.

【Precautions】
(1) This product does not control the acute inflammatory symptoms of gouty arthritis and should not be used as an anti-inflammatory agent. This is because, when it promotes the redissolution of urate crystals, it may re-activate and exacerbate the acute-phase symptoms of arthritis.
(2) This product must be initiated only after the acute inflammatory symptoms of gouty arthritis have subsided (typically about two weeks after the onset of an attack).
(3) During medication, patients should drink plenty of water and maintain neutral or alkaline urine to facilitate uric acid excretion.
(4) This product is indicated for patients with hyperuricemia and excessive 24-hour urinary uric acid excretion, or with tophi, or with urinary tract stones, as well as for those who are contraindicated for uricosuric agents.
(5) This product must be initiated at a low dose and gradually titrated up to the effective dose to maintain normal serum uric acid and urinary uric acid levels; thereafter, the dose should be tapered gradually, with the lowest effective dose maintained for an extended period.
(6) Concurrent use with uricosuric agents can enhance therapeutic efficacy and help prevent the renal deposition of urate crystals. It should not be taken concurrently with iron preparations.
(7) Before and during treatment, serum uric acid levels and 24-hour urinary uric acid excretion should be monitored regularly to guide dose adjustments.
(8) Patients with renal or hepatic impairment, as well as elderly patients, should use this medication with caution and reduce the daily dosage.
(9) During medication, blood counts and liver and kidney function should be monitored regularly.
(10) If any cutaneous reactions or other signs of hypersensitivity occur, discontinue the drug immediately and seek prompt dermatological evaluation and treatment; patients with renal or hepatic impairment should have their dosage reduced; and those with renal insufficiency should have their dosage adjusted according to creatinine clearance.
(11) Avoid the formation of xanthine stones under the influence of treatment with this product.
(12) Renal failure associated with the administration of this product has been observed in patients with hyperuricemia secondary to neoplastic diseases. In patients who develop renal impairment following treatment with this product, complications such as multiple myeloma and congestive cardiomyopathy are frequently present. Renal failure is also commonly associated with gouty nephropathy. Patients with chronic renal impairment who are concurrently receiving diuretics—particularly thiazides—may be at increased risk of allergic reactions. Albuminuria has been observed in patients who develop clinical gout following chronic glomerulonephritis or chronic pyelonephritis.
(13) Patients with renal failure require dose reduction and close monitoring at the initiation of treatment. In patients with severe renal impairment or reduced uric acid clearance, the plasma half-life of oxypurinol is markedly prolonged. Therefore, a daily dose of 100 mg or a twice-weekly dose of 300 mg or less is sufficient to maintain adequate xanthine oxidase inhibition and thereby reduce serum urate levels.
(14) Reports indicate that patients receiving this product have experienced bone marrow suppression, with most of these patients also receiving concomitant medications that may precipitate such a reaction. This adverse event has been observed as early as 6 weeks after initiation of treatment with this product and as late as 6 years later. When this product is administered as monotherapy, bone marrow suppression affecting one or more cell lines to varying degrees is rare.
(15) HLA-B*5801 Allele: It has been established that carriage of the HLA-B*5801 allele is associated with an increased risk of severe adverse reactions to allopurinol, such as Stevens–Johnson syndrome or toxic epidermal necrolysis. According to the literature, the prevalence of the HLA-B*5801 allele varies substantially across different ethnic groups: up to 20% in the Han Chinese population, 8–15% in Thai populations, approximately 12% in Korean populations, and 1–2% in Japanese and European populations. In patient populations known to have a high prevalence of the HLA-B*5801 allele, screening for this allele should be performed prior to initiating treatment with this product. For patients who are HLA-B*5801 positive, this product should not be used unless no other reasonable therapeutic options are available and the anticipated benefits outweigh the risks.
(16) Thyroid disorders: In a long-term, open-label extension study, elevated TSH levels (>5.5 μU/mL) were observed in 5.8% of patients receiving long-term allopurinol therapy. Therefore, allopurinol should be used with caution in patients with pre-existing thyroid disorders.

[Use in Pregnant and Lactating Women] Contraindicated.
【Pediatric Use】 Dosage for children should be adjusted as appropriate.
【Medication in the Elderly】 Elderly patients should use medications with caution and reduce the daily dosage.
【Storage】 Protect from light, keep tightly sealed, and store at a temperature not exceeding 25°C.
【Packaging】 Polyvinyl chloride solid medicinal hard blisters and medicinal aluminum foil packaging: 12 tablets per blister, 2 blisters per box. Oral solid medicinal high-density polyethylene bottle packaging: 30 tablets per bottle; 100 tablets per bottle.
【Shelf Life】36 months

[Implementation Standard] Drug Registration Standard of the National Medical Products Administration: YBH10192025
【Approval Number】National Drug Approval No. H44021368
【Marketing Authorization Holder】 Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Registered Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal Code: 529331
Telephone Numbers: 0750-2789348 (Product Inquiries), 2763089 (Quality Inquiries), 400-8899-328 (National Service Hotline)
Fax number: 0750-2789285
Website: http://www.pdpharm.com
【Manufacturing Enterprise】 Enterprise Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Production Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal Code: 529331
Telephone Numbers: 0750-2789348 (Product Inquiries), 2763089 (Quality Inquiries), 400-8899-328 (National Service Hotline)
Fax number: 0750-2789285
Website: http://www.pdpharm.com