Probenecid

Probenecid is an FDA-registered drug product whose active ingredient is PROBENECID. It is labelled by REMEDYREPACK INC. taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 70518-4649, application ANDA217020, label effective 20260429. It is one of 2 FDA drug label records sharing the active ingredient PROBENECID. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PROBENECID are most often described in connection with: indications usage, probenecid tablets, hyperuricemia associated, gouty arthritis, adjuvant therapy, ampicillin methicillin, oxacillin cloxacillin, prolongation plasma. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS & USAGE 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.

DOSAGE & ADMINISTRATION Gout Therapy with probenecid should not be started until an acute gouty attack has subsided. However, if an acute attack is precipitated during therapy, probenecid may be continued without changing the dosage, and full therapeutic dosage of colchicine or other appropriate therapy should be given to control the acute attack. The recommended adult dosage is 250 mg (1/2 tablet of probenecid) twice a day for one week, followed by 500 mg (1 tablet) twice a day thereafter. Some degree of renal impairment may be present in patients with gout. A daily dosage of 1000 mg may be adequate. However, if necessary, the daily dosage may be increased by 500 mg increments every 4 weeks within tolerance (and usually not above 2000 mg per day) if symptoms of gouty arthritis are not controlled or the 24 hour uric acid excretion is not above 700 mg. As noted, probenecid may not be effective in chronic renal insufficiency, particularly when the glomerular filtration rate is 30 mL/minute or less. Gastric intolerance may be indicative of overdosage, and may be corrected by decreasing the dosage. As uric acid tends to crystallize out of an acid urine, a liberal fluid intake is recommended, as well as sufficient sodium bicarbonate (3 to 7.5 g daily), or potassium citrate (7.5 g daily) to maintain an alkaline urine (see PRECAUTIONS ) . Alkalization of the urine is recommended until the serum urate level returns to normal limits and tophaceous deposits disappear, i.e., during the period when urinary excretion of uric acid is at a high level. Thereafter, alkalization of the urine and the usual restriction of purine-producing foods may be somewhat relaxed. Probenecid should be continued at the dosage that will maintain normal serum urate levels. When acute attacks have been absent for 6 months or more and serum urate levels remain within normal limits, the daily dosage may be decreased by 500 mg every 6 months. The maintenance dosage should not be reduced to the point where serum urate levels tend to rise. Probenecid and Penicillin Therapy (General) Adults The recommended dosage is 2000 mg (4 tablets of probenecid) daily in divided doses. This dosage should be reduced in older patients in whom renal impairment may be present. Children 2 to 14 years of age Initial dose: 25 mg/kg body weight ( or 0.7 g/square meter body surface). Maintenance dose: 40 mg/kg body weight ( or 1.2 g/square meter body surface) per day, divided into 4 doses. For children weighing more than 50 kg (110 lb) the adult dosage is recommended. Probenecid is contraindicated in children under 2 years of age. The PSP excretion test may be used to determine the effectiveness of probenecid in retarding penicillin excretion and maintaining therapeutic levels. The renal clearance of PSP is reduced to about one-fifth the normal rate when dosage of probenecid is adequate. Penicillin Therapy (Gonorrhea)* In uncomplicated gonococcal infections in men and women (urethral, cervical, rectal), 1 g of probenecid should be given orally with 4.8 million units of aqueous procaine penicillin G** (given IM), or 3 g of amoxicillin** (given orally), or 3.5 g of ampicillin** (given orally). For further guidance, see CDC recommendations for definition of regimens of choice, alternative regimens, treatment of hypersensitive patients, and other aspects of therapy. *Recommended by the Centers for Disease Control, U.S. Department of Health and Human Services, Public Health Service (Morbidity and Mortality Weekly Report Supplement, Volume 34, Number 4S, October 18, 1985). **See package circulars of manufacturers for detailed information about CONTRAlNDICATIONS , WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS .

CONTRAINDICATIONS 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 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. Use in Pregnancy Probenecid crosses the placental barrier and appears in cord blood. The use of any drug in women of childbearing potential requires that the anticipated benefit be weighed against possible hazards.

ADVERSE REACTIONS 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. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

FDA lists 2 drug label records with PROBENECID as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Probenecid used for?
INDICATIONS & USAGE 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.

Who makes Probenecid?
REMEDYREPACK INC. is the labeler of record for Probenecid. 2 FDA label records share the active ingredient PROBENECID, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Probenecid come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Probenecid prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PROBENECID?
Yes. 2 FDA drug label records list PROBENECID as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Probenecid been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.