Allopurinol

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Allopurinol 100mg;  

Disponible desde:

Clinect NZ Pty Limited

Designación común internacional (DCI):

Allopurinol 100 mg

Dosis:

100 mg

formulario farmacéutico:

Tablet

Composición:

Active: Allopurinol 100mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate

Unidades en paquete:

Bottle, HDPE, 100 tablets

clase:

Prescription

tipo de receta:

Prescription

Fabricado por:

Srini Pharmaceuticals Pvt Ltd

indicaciones terapéuticas:

· Allopurinol is mainly used in the management of primary gout or secondary hyperuricaemia associated with chronic gout. It is not, however, used to treat an acute attack of gout as it has no analgesic, antiinflammatory or uricosuric activity and may prolong the attack. If changing therapy from a uricosuric agent alone, the dose should be reduced gradually while allopurinol is introduced. In severe cases of chronic gout, allopurinol can be used together with a uricosuric agent unless the latter is contra-indicated.

Resumen del producto:

Package - Contents - Shelf Life: Bottle, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 250 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, HDPE - 1000 tablets - 36 months from date of manufacture stored at or below 25°C

Fecha de autorización:

2001-11-29

Ficha técnica

NEW ZEALAND DATA SHEET
APO-ALLOPURINOL
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 8
1. PRODUCT NAME
APO-ALLOPURINOL 100mg and 300mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Allopurinol 100mg
Allopurinol 300mg
EXCIPIENT(S) WITH KNOWN EFFECT
Nil.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Apo-ALLOPURINOL 100mg tablets are white, round, biconvex tablets,
scored and engraved “ALL”
over”100” on one side and engraved “APO” on the other side.
Each tablet contains 100mg allopurinol
and typically weighs 113mg.
Apo-ALLOPURINOL 300mg tablets are orange, round, biconvex tablets,
scored and engraved “ALL”
over “300” on one side and engraved “APO” on the other side.
Each tablet contains 300mg allopurinol
and typically weighs 340mg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Allopurinol is mainly used in the management of primary gout or
secondary hyperuricaemia associated
with chronic gout. It is not, however, used to treat an acute attack
of gout as it has no analgesic, anti-
inflammatory or uricosuric activity and may prolong the attack. It is
indicated for reducing urate/uric acid
formation in conditions where urate/uric acid deposition may occur
such as: uric acid nephropathy;
recurrent uric acid stone formation; certain enzyme disorders or blood
disorders which lead to
overproduction of urate (e.g. Lesch-Nyhan syndrome; haemolytic
anaemia); hyperuricaemia associated
with malignancy and cytotoxic therapy which result in a high cell
turnover rate
Allopurinol is indicated for the prevention and treatment of calcium
oxalate/phosphate renal stones in
the presence of high uric acid levels of the blood and/or urine.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Allopurinol may increase the frequency of acute attacks during the
first few months of therapy; it is
therefore recommended that
low doses be given
initially
and slowly
increased, and
that anti-
inflammatory agents or colchicine should be given concomit