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:

Aphena Pharma Solutions - Tennessee, LLC

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:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. 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 10135-541-10 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 Revised 07/12, Revision 1 10-243

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROBENECID- PROBENECID TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 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 Interactions.
Probenecid decreases both hepatic and renal excretion of
sulfobromophtalein (BSP). The tubular
reabsorption of phosphorus is inhibited in hypoparathyroid but n