PROBENECID tablet

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

PROBENECID (UNII: PO572Z7917) (PROBENECID - UNII:PO572Z7917)

Prieinama:

Rising Pharma Holdings, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Probenecid tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis. As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given. Hypersensitivity to probenecid. Children under 2 years of age. Not recommended in persons with known blood dyscrasias or uric acid kidney stones. Therapy with probenecid should not be started until an acute gouty attack has subsided.

Produkto santrauka:

Probenecid Tablets USP, 500 mg are bisected, capsule-shaped, yellow, film-coated tablets debossed with “C84” on one side and break line on other side. They are supplied in bottles as follows:           100 count:   NDC 16571-831-01           1000 count: NDC 16571-831-10 Dispense in well-closed container with child-resistant closure. Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India. Neutral Code: 3407600/TS/DRUGS/2022 Revised: 11/2023 PIR83110-04

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

PROBENECID - PROBENECID TABLET
RISING PHARMA HOLDINGS, INC.
----------
PROBENECID TABLETS USP, 500 MG
RX ONLY
DESCRIPTION
Probenecid is a uricosuric and renal tubular transport blocking agent.
Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl]
benzoic acid. It has the
following structural formula:
C
H
NO S M.W.
285.36
Probenecid USP is a white or practically white, fine, crystalline
powder. Probenecid is
soluble in dilute alkali, in alcohol, in chloroform, and in acetone;
it is practically insoluble in
water and in dilute acids.
Each tablet for oral administration contains 500 mg of probenecid.
Probenecid Tablets USP 500 mg contain the following inactive
ingredients: colloidal silicon
dioxide, corn starch, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No.
40,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polyvinyl alcohol,
povidone, sodium lauryl sulphate, sodium starch glycolate, talc and
titanium dioxide.
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY
Probenecid is a uricosuric and renal tubular blocking agent. It
inhibits the tubular
reabsorption of urate, thus increasing the urinary excretion of uric
acid and decreasing
serum urate levels. Effective uricosuria reduces the miscible urate
pool, retards urate
deposition, and promotes resorption of urate deposits.
13
19
4
Probenecid inhibits the tubular secretion of penicillin and usually
increases penicillin
plasma levels by any route the antibiotic is given. A 2-fold to 4-fold
elevation has been
demonstrated for various penicillins.
Probenecid has also been reported to inhibit the renal transport of
many other
compounds including aminohippuric acid (PAH), aminosalicylic acid
(PAS), indomethacin,
sodium iodomethamate and related iodinated organic acids,
17-ketosteroids,
pantothenic acid, phenolsulfonphthalein (PSP), sulfonamides, and
sulfonylureas. See also
DRUG INTERACTIONS.
Probenecid decreases both hepatic and renal excretion of
sulfobromophthalein (BSP).
The tubular reabsorption of phosp