ALLOPURINOL tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Quality Care Products, 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 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

Ապրանքի ամփոփագիր:

Allopurinol Tablets, USP; 100 mg, round, flat, off-white, scored tablet, debossed ‘0524’ over ‘0405’. 55700-879-90 300 mg; round, convex, off-white tablet, debossed ‘AL3’. 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
QUALITY CARE PRODUCTS, LLC
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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 clearan