ALLOPURINOL tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ALLOPURINOL (UNII: 63CZ7GJN5I) (ALLOPURINOL - UNII:63CZ7GJN5I)

Διαθέσιμο από:

Northstar RxLLC

INN (Διεθνής Όνομα):

ALLOPURINOL

Σύνθεση:

ALLOPURINOL 100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

THIS IS NOT AN INNOCUOUS DRUG. IT IS NOT RECOMMENDED FOR THE TREATMENT OF ASYMPTOMATIC HYPERURICEMIA. Allopurinol tablets 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 tablets are 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 leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol tablets should be discontinued when the potential for overproduction of uric acid is no longer present. - the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day

Περίληψη προϊόντος:

Allopurinol Tablets USP are supplied as follows: 100 mg: White, flat, circular, uncoated tablets with "N020" debossed on one side and score line on the other side. Bottle of 30 tablets        NDC 16714-041-07 Bottle of 100 tablets     NDC 16714-041-10 Bottle of 1000 tablets   NDC 16714-041-12 300 mg: Orange color, biconvex, circular, uncoated tablets with “N021”debossed on one side and score line on the other side. Bottle of 30 tablets        NDC 16714-042-07 Bottle of 100 tablets     NDC 16714-042-10 Bottle of 500 tablets     NDC 16714-042-11 Store at 20° to 25°C (68 to 77°F). See USP Controlled room temperature. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN. Manufactured for: Northstar Rx LLC                                        Memphis, TN 38141 Manufactured by: Piramal Pharma Limited ,                                       Pithampur, Madhya Pradesh 454775                                       INDIA October 2020

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ALLOPURINOL - ALLOPURINOL TABLET
NORTHSTAR RXLLC
----------
RX ONLY
DESCRIPTION
Allopurinol has the following structural formula below:
Allopurinol is known chemically as 1,5-dihydro-4_H_-pyrazolo [3,4-_d
_]pyrimidin-4-one. It is a xanthine
oxidase inhibitor which is administered orally. Each scored white
tablet contains 100 mg allopurinol
and the inactive ingredients alcohol, corn starch, lactose
monohydrate, magnesium stearate and
povidone. Each scored orange tablet contains 300 mg allopurinol and
the inactive ingredients alcohol,
corn starch, lactose monohydrate, magnesium stearate, pigment blend
PB53652 orange and povidone. It
is very slightly soluble in water and in alcohol; soluble in solutions
of potassium and sodium
hydroxides; practically insoluble in chloroform and in ether.
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 party of purine biosynthesis. As a result of xanthine oxidase
inhibition, the serum concentration
of hypoxanthine plus xanthine in patients receiving allopurinol for
treatment of 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 maximu