ALLOPURINOL tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Aphena Pharma Solutions - Tennessee, LLC

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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

Ապրանքի ամփոփագիր:

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

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ALLOPURINOL- ALLOPURINOL TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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ALLOPURINOL TABLETS
DESCRIPTION
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. The 100mg tablets contain the inactive ingredients
lactose, magnesium
stearate, potato starch, and povidone. The 300mg tablets contain the
inactive
ingredients lactose, magnesium stearate, corn starch, and povidone.
Its solubility in
water at 37°C is 80.0 mg/dL and is greater in an alkaline solution.
Allopurinol has the following structural formula:
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
a 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
allopur