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Analgesics & Antipyretics

Allopurinol STADA® 300 mg

 

Pack size:

Box of 3 blisters x 10 tablets.

 

Composition: 

Each tablet contains allopurinol 300 mg.

 

Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place, protect from light. Do not store above 30oC.


 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. gouty arthritis, skin tophi, nephrolithiasis) or is a predictable clinical risk (e.g. treatment of malignancy potentially leading to acute uric acid nephropathy).
  • Management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltransferase.
  • Management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed.
     
  • Allopurinol may be taken orally once a day after a meal. It is well tolerated, especially after food. Should the daily dosage exceed 300 mg and gastrointestinal intolerance be manifested, a divided doses regimen may be appropriate.
  • Adults:
    Allopurinol should be introduced at low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor. The following dosage schedules are suggested:
    100 to 200 mg daily in mild conditions.
    300 to 600 mg daily in moderately severe conditions.
    700 to 900 mg daily in severe conditions.
    If dosage on a mg/kg bodyweight basis is required, 2 to 10 mg/kg bodyweight/day should be used.
  • Children:
    Children under 15 years: 10 to 20 mg/kg bodyweight/day up to a maximum of 400 mg daily.
    Use in children is rarely indicated, except in malignant conditions (especially leukaemia) and certain enzyme disorders such as Lesch-Nyhan syndrome.
  • Elderly:
    In the absence of specific data, the lowest dosage which produces satisfactory urate reduction should be used.
  • Renal impairment:
    Since allopurinol and its metabolites are excreted by the kidney, impaired renal function may lead to retention of the drug and/or its metabolites with consequent prolongation of plasma half-lives. In severe renal insufficiency, it may be advisable to use less than 100 mg per day or to use single doses of 100 mg at longer intervals than one.
    Allopurinol and its metabolites are removed by renal dialysis. If frequent dialysis is required, an alternative schedule of 300 – 400 mg allopurinol after each dialysis.
  • Hepatic impairment:
    Reduced doses should be used in patients with hepatic impairment. Periodic liver function tests are recommended during the early stages of therapy.
  • Treatment of high urate turnover conditions, e.g. neoplasia, Lesch-Nyhan syndrome:
    It is advisable to correct existing hyperuricaemia and/or hyperuricosuria with allopurinol before starting cytotoxic therapy. It is important to ensure adequate hydration to maintain optimum diuresis and to attempt alkalinisation of urine to increase solubility of urinary urate/uric acid. Dosage of allopurinol should be at the lower end of the recommended dosage schedule. If urate nephropathy or other pathology has compromised renal function, the advice given in dosage in renal impairment should be followed.

    Use of suitable dosage forms is recommended when using doses of 100 mg, 200 mg and 700 mg.


Or as prescribed by physicians.

 

  • Hypersensitive to allopurinol or to any ingredient of the drug.
  • Patients with severe liver disease; severe renal disease (azotaemia).
  • Idiopathic haemochromatosis (even if only in the familiar history).
  • Allopurinol administration should not be initiated during an acute gouty attack.
  • The drug is contraindicated in children except those with tumour diseases or enzyme disorder.
     

Most common:

  • Skin rash. Rashes are generally maculopapular or pruritic, sometimes purpuric, but more serious hypersensitivity reactions may occur and include exfoliative rashes, the Stevens-Johnson syndrome, and toxic epidermal necrolysis. It is therefore recommended that allopurinol be withdrawn immediately if a rash occurs.
  • Further symptoms of hypersensitivity include fever and chills, lymphadenopathy, leucopenia or leucocytosis, eosinophilia, arthralgia, and vasculitis leading to renal and hepatic damage and, very rarely, seizures. These hypersensitivity reactions may be servere, even fatal, and patients with hepatic or renal impairment are at special risk. Hepatotoxicity and signs of altered liver function may also be found in patients not exhibiting hypersensitivity.

Others:

  • Haematological effects include thrombocytopenia, aplastic anaemia, agranulocytosis, and haemolytic anaemia.

Rarely:

  • Paraesthesia, peripheral neuropathy, alopecia, gynaecomastia, hypertension, taste disturbances, nausea, vomiting, abdominal pain, diarrhoea, headache, malaise, drowsiness, vertigo, and visual disturbances. Patients with gout may experience an increase in acute attacks on beginning treatment with allopurinol, although attacks usually subside after several months.

     

  • Allopurinol should be withdrawn immediately when a skin rash or other evidence of sensitivity occurs. Reduced doses should be used in patients with hepatic or renal impairment. Patients under treatment for hypertension or cardiac insufficiency, for example with diuretics or ACE inhibitors, may have some concomitant impairment of renal function and allopurinol should be used with care in this group.
  • Asymptomatic hyperuricaemia per se is generally not considered an indication for use of allopurinol. Fluid and dietary modification with management of the underlying cause may correct the condition.
  • Acute gouty attacks: Allopurinol treatment should not be started until an acute attack of gout has completely subsided, as further attacks may be precipitated.
  • In the early stages of treatment with allopurinol, as with uricosuric agents, an acute attack of gouty arthritis may be precipitated. Therefore it is advisable to give prophylaxis with a suitable anti-inflammatory agent or colchicine for at least one month.
  • If acute attacks develop in patients receiving allopurinol, treatment should continue at the same dosage while the acute attack is treated with a suitable anti-inflammatory agent.
  • Xanthine deposition: In conditions where the rate of urate formation is greatly increased (e.g. malignant disease and its treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract. This risk may be minimized by adequate hydration to achieve optimal urine dilution.
  • Impaction of uric acid renal stones: Adequate therapy with allopurinol will lead to dissolution of large uric acid renal pelvic stones, with the remote possibility of impaction in the ureter.
  • Lactose intolerance: Allopurinol tablets contain lactose and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
  • There is inadequate evidence of safety of allopurinol in human pregnancy, although it has been in wide use for many years without apparent ill consequence. Use in pregnancy only when there is no safer alternative and when the disease itself carries risk for the mother or unborn child.
  • Reports indicate that allopurinol and oxipurinol are excreted in human breast milk. However, there are no data concerning the effects of allopurinol or its metabolites on the breast-fed baby.
  • Since adverse reactions such as somnolence, vertigo and ataxia have been reported in patients receiving allopurinol, patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that allopurinol does not adversely affect performance.


     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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