PROBENECID tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Marlex Pharmaceuticals Inc

INN (International Name):

PROBENECID

Composition:

PROBENECID 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Probenecid Tablets, USP are available containing 500 mg of Probenecid, USP. The tablets are capsule shaped, film-coated yellow, debossed LCI on one side and 1367 on the other side. They are available as follows: NDC 10135-0541-01 bottles of 100 tablets NDC 10135-0541-10 bottles of 1000 tablets STORE AT 20˚ to 25˚C (68˚-77˚F) [See USP Controlled Room Temperature] PROTECT FROM LIGHT. Dispense in a well closed, light-resistant container using a child-resistant closure as defined in the USP. MANUFACTURED BY LANNETT COMPANY, INC. PHILADELPHIA, PA 19136 DISTRIBUTED BY MARLEX PHARMACEUTICALS, INC. NEW CASTLE, DE 19720 Made in the USA Rev.1 10/14LAN

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROBENECID- PROBENECID TABLET, FILM COATED
MARLEX PHARMACEUTICALS INC
----------
PROBENECID
PROBENECID- PROBENECID TABLET, FILM COATED MARLEX PHARMACEUTICALS INC.
----------
PROBENECID TABLETS, USP
PROBENECID TABLETS, USP 500 MG
RX ONLY
DESCRIPTION:
Probenecid is a uricosuric and renal tubular transport blocking agent.
The chemical name for probenecid is 4-[(dipropylamino) sulfony1]
benzoic acid. It has
the following structural formula:
Probenecid, USP is a white or nearly 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 and
the following
inactive ingredients: Microcrystalline cellulose, corn starch, sodium
starch glycolate,
povidone, colloidal silicon dioxide, magnesium stearate, sodium lauryl
sulfate, polyvinyl
alcohol, titanium dioxide, polyethylene glycol, talc, D&C Yellow #10
Aluminum Lake, FD&C
Yellow #6 Aluminum Lake, and FD&C Blue #2 Aluminum Lake.
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
serum urate levels. Effective uricosuria reduces the miscible urate
pool, retards urate
deposition, and promotes resorption of urate deposits.
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 also has 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 Intera