ALLOPURINOL tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

Allopurinol (UNII: 63CZ7GJN5I) (Allopurinol - UNII:63CZ7GJN5I)

Beschikbaar vanaf:

Dr. Reddy's Laboratories Limited

INN (Algemene Internationale Benaming):

Allopurinol

Samenstelling:

Allopurinol 100 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

THIS IS  NOT AN INNOCUOUS DRUG. IT  IS  NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol reduces serum and urinary uric acid concentrations. Its use should be individualized for each patient and requires an understanding of its mode of action and pharmacokinetics (see CLINICAL PHARMACOLOGY , CONTRAINDICATIONS , WARNINGS and PRECAUTIONS ). Allopurinol is indicated in: - the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis and/or nephropathy). the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis and/or nephropathy). - the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present - th

Product samenvatting:

Allopurinol Tablets, USP; 100 mg, round, flat, off-white, scored tablet, debossed ‘0524’ over ‘0405’. Bottles of 100                 NDC 55111-729-01 Bottles of 1000               NDC 55111-729-10 300 mg; round, convex, off-white tablet, debossed ‘AL3’. Bottles of 100                 NDC 55111-730-01 Bottles of 500                 NDC 55111-730-05 Bottles of 1000               NDC 55111-730-10 Store at 15°-30°C (59°-86°F) and protect from moisture. QUESTIONS OR COMMENTS? Call toll free 1-888-375-3784.You may report side effects to FDA at 1-800-FDA-1088. Rx Only   Manufactured by Dr. Reddy’s Laboratories Louisiana, LLC Shreveport, LA 71106 USA Issued August, 2014                                                         150019989-03

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ALLOPURINOL- ALLOPURINOL TABLET
DR. REDDY'S LABORATORIES LIMITED
----------
ALLOPURINOL TABLETS
DESCRIPTION
DESCRIPTION: Allopurinol has the following structural formula:
Allopurinol is known chemically as 1,5-dihydro-4H-pyrazolo
[3,4-d]pyrimidin-4-one. It is a xanthine
oxidase inhibitor which is administered orally. It is available in 100
mg and 300 mg strengths.
INACTIVE INGREDIENTS: lactose, magnesium stearate, starch, povidone.
Its solubility in water at 37°C is
800 mg/mL and is greater in an alkaline solution.
CLINICAL PHARMACOLOGY
Allopurinol acts on purine catabolism, without disrupting the
biosynthesis of purines. It reduces the
production of uric acid by inhibiting the biochemical reactions
immediately preceding its formation.
Allopurinol is a structural analogue of the natural purine base,
hypoxanthine. It is an inhibitor of
xanthine oxidase, the enzyme responsible for the conversion of
hypoxanthine to xanthine and of xanthine
to uric acid, the end product of purine metabolism in man. Allopurinol
is metabolized to the
corresponding xanthine analogue, oxipurinol (alloxanthine), which also
is an inhibitor of xanthine
oxidase.
It has been shown that reutilization of both hypoxanthine and xanthine
for nucleotide and nucleic acid
synthesis is markedly enhanced when their oxidations are inhibited by
allopurinol and oxipurinol. This
reutilization does not disrupt normal nucleic acid anabolism, however,
because feedback inhibition is an
integral part of purine biosynthesis. As a result of xanthine oxidase
inhibition, the serum concentration
of hypoxanthine plus xanthine in patients receiving allopurinol for
treatment for hyperuricemia is
usually in the range of 0.3 to 0.4 mg/dL compared to normal level of
approximately 0.15 mg/dL. A
maximum of 0.9 mg/dL of these oxypurines has been reported when the
serum urate was lowered to
less than 2 mg/dL by high doses of allopurinol. These values are far
below the saturation levels at
which point their precipitation would be expected to occur (above 7
mg/dL).
The renal c