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:

Mylan 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 with MYLAN 156 on one side, 500 on the other side. They are available as follows: NDC 0378-0156-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 REVISED MARCH 2006 PROB:R4AQ

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROBENECID- PROBENECID TABLET, FILM COATED
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Probenecid is a uricosuric and renal tubular transport blocking agent.
The chemical name for probenecid is 4-[(dipropylamino) sulfonyl]
benzoic acid (molecular weight
285.37). It has the following structural formula:
C
H NO S
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: colloidal silicon dioxide, hypromellose, magnesium
stearate, microcrystalline cellulose,
polydextrose, polyethylene glycol, sodium carbonate, sodium lauryl
sulfate, sodium starch glycolate,
cornstarch, titanium dioxide, triacetin, FD&C Yellow #6, D&C Yellow
#10, and FD&C Blue #2.
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
sulfobromophthalein (BSP). The tubular
reabsorption of phosphorus is inhibited in hypoparathyroid but not in
euparathyroid individuals.
Probenecid does not influence pla