Complete SPL Sections#
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
P robenecid Tablets, USP 500 mg Rx only
DESCRIPTION:
DESCRIPTION SECTION
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
CLINICAL PHARMACOLOGY SECTION
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 not in euparathyroid individuals. Probenecid does not influence plasma concentrations of salicylates, nor the excretion of streptomycin, chloramphenicol, chlortetracycline, oxytetracycline, or neomycin.
INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
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.
CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
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.
WARNINGS
WARNINGS SECTION
Exacerbation of gout following therapy with probenecid may occur; in such cases colchicine or other appropriate therapy is advisable. Probenecid increases plasma concentrations of methotrexate in both animals and humans. In animal studies, increased methotrexate toxicity has been reported. If probenecid is given with methotrexate, the dosage of methotrexate should be reduced and serum levels may need to be monitored. In patients on probenecid the use of salicylates in either small or large doses is contraindicated because it antagonizes the uricosuric action of probenecid. The biphasic action of salicylates in the renal tubules accounts for the so-called “paradoxical effect” of uricosuric agents. In patients on probenecid who require a mild analgesic agent the use of acetaminophen rather than small doses of salicylates would be preferred. Rarely, severe allergic reactions and anaphylaxis have been reported with the use of probenecid. Most of these have been reported to occur within several hours after readministration following prior usage of the drug. The appearance of hypersensitivity reactions requires cessation of therapy with probenecid.
PRECAUTIONS
PRECAUTIONS SECTION
ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following adverse reactions have been observed and within each category are listed in order of decreasing severity. Central Nervous System : headache, dizziness. Metabolic : precipitation of acute gouty arthritis Gastrointestinal : hepatic necrosis, vomiting, nausea, anorexia, sore gums. Genitourinary : nephrotic syndrome, uric acid stones with or without hematuria, renal colic, costovertebral pain, urinary frequency. Hypersensitivity : anaphylaxis, fever, urticaria, pruritus Hematologic : aplastic anemia, leukopenia, hemolytic anemia which in some patients could be related to genetic deficiency of glucose -6- phosphate dehydrogenase in red blood cells, anemia. Integumentary : dermatitis, alopecia, flushing.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
HOW SUPPLIED
HOW SUPPLIED SECTION
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
Repackaging Information
SPL UNCLASSIFIED SECTION
Please reference the How Supplied section listed above for a description of individual tablets or capsules. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 500mg 90 43353-839-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20140528SC
PRINCIPAL DISPLAY PANEL - 500mg
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 43353-839 - Probenecid 500mg - Rx Only
