NDC 69367-154 Probenecid

NDC Product Code 69367-154

NDC CODE: 69367-154

Proprietary Name: Probenecid What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent gout and gouty arthritis. It will not treat a sudden/severe attack of gout and may make it worse. Probenecid belongs to a class of drugs known as uricosurics. It lowers high levels of uric acid in your body by helping the kidneys to get rid of uric acid. When uric acid levels get too high, crystals can form in the joints, causing gout. Lowering uric acid levels may also help your kidneys. Probenecid may be prescribed in combination with certain antibiotics (such as penicillins). It increases the levels of antibiotic in the blood, which helps the antibiotic work better. Probenecid should not be used in children younger than 2 years.

Product Characteristics

Color(s):
YELLOW (C48330)
Shape: OVAL (C48345)
Size(s):
18 MM
Imprint(s):
DAN;DAN;5347
Score: 2

NDC Code Structure

  • 69367 - Westminster Pharmaceuticals, Llc

NDC 69367-154-00

Package Description: 8 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Probenecid with NDC 69367-154 is a product labeled by Westminster Pharmaceuticals, Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 198152.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Westminster Pharmaceuticals, Llc
Labeler Code: 69367
Start Marketing Date: 07-28-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2018 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Probenecid

Probenecid is pronounced as (proe ben' e sid)

Why is probenecid medication prescribed?
Probenecid is used to treat chronic gout and gouty arthritis. It is used to prevent attacks related to gout, not treat them once they occur. It acts on the kidneys to hel...
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Probenecid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Probenecid is a uricosuric and renal tubular transport blocking agent.Probenecid is the generic name for 4-[(dipropyl-amino)sulfonyl] benzoic acid. It has the following structural formula:Probenecid 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.Probenecid Tablets USP 500 mg contain the following inactive ingredients: colloidal silicon dioxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Yellow No. 6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate and titanium dioxide.

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 has also 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 plasma concentrations of salicylates, nor the excretion of streptomycin, chloramphenicol, chlortetracycline, oxytetracycline, or neomycin.

Indications And Usage

For 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

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.

General

Hematuria, renal colic, costovertebral pain, and formation of uric acid stones associated with the use of probenecid in gouty patients may be prevented by alkalization of the urine and a liberal fluid intake (see
DOSAGE AND ADMINISTRATION). In these cases when alkali is administered, the acid-base balance of the patient should be watched.
Use with caution in patients with a history of peptic ulcer.Probenecid has been used in patients with some renal impairment but dosage requirements may be increased. Probenecid may not be effective in chronic renal insufficiency particularly when the glomerular filtration rate is 30 mL/minute or less. Because of its mechanism of action, probenecid is not recommended in conjunction with a penicillin in the presence of
known renal impairment.
A reducing substance may appear in the urine of patients receiving probenecid. This disappears with discontinuance of therapy. Suspected glycosuria should be confirmed by using a test specific for glucose.

Drug Interactions

When probenecid is used to elevate plasma concentrations of penicillin or other betalactams, or when such drugs are given to patients taking probenecid therapeutically, high plasma concentrations of the other drug may increase the incidence of adverse reactions associated with that drug. In the case of penicillin or other beta-lactams, psychic disturbances have been reported.The use of salicylates antagonizes the uricosuric action of probenecid (see
WARNINGS). The uricosuric action of probenecid is also antagonized by pyrazinamide.
Probenecid produces an insignificant increase in free sulfonamide plasma concentrations but a significant increase in total sulfonamide plasma levels. Since probenecid decreases the renal excretion of conjugated sulfonamides, plasma concentrations of the latter should be determined from time to time when a sulfonamide and probenecid are coadministered for prolonged periods. Probenecid may prolong or enhance the action of oral sulfonylureas and thereby increase the risk of hypoglycemia.It has been reported that patients receiving probenecid require significantly less thiopental for induction of anesthesia. In addition, ketamine and thiopental anesthesia were significantly prolonged in rats receiving probenecid.The concomitant administration of probenecid increases the mean plasma elimination half-life of a number of drugs which can lead to increased plasma concentrations. These include agents such as indomethacin, acetaminophen, naproxen, ketoprofen, meclofenamate, lorazepam, and rifampin. Although the clinical significance of this observation has not been established, a lower dosage of the drug may be required to produce a therapeutic effect, and increases in dosage of the drug in question should be made cautiously and in small increments when probenecid is being co-administered. Although specific instances of toxicity due to this potential interaction have not been observed to date, physicians should be alert to this possibility.Probenecid given concomitantly with sulindac had only a slight effect on plasma sulfide levels, while plasma levels of sulindac and sulfone were increased. Sulindac was shown to produce a modest reduction in the uricosuric action of probenecid, which probably is not significant under most circumstances.In animals and in humans, probenecid has been reported to increase plasma concentrations of methotrexate (see
WARNINGS).
Falsely high readings for theophylline have been reported in an
in vitro study, using the Schack and Waxler technic, when therapeutic concentrations of theophylline and probenecid were added to human plasma.

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.

Dosage And Administration

GoutTherapy 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)AdultsThe 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 2-14 years of ageInitial 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
CONTRAINDICATIONS,
WARNINGS,
PRECAUTIONS, and
ADVERSE REACTIONS.

How Supplied

Probenecid Tablets USP 500 mg are bisected, capsule-shaped, yellow, film-coated tablets imprinted
DAN DAN and
5347 supplied in bottles of 8.
Dispense in well-closed container with child-resistant closure.Store at 20°-25° (68°-77°F). [See USP controlled room temperature.]
Protect From LightManufactured By:
Watson Pharma Private Ltd.
Verna, Salcette Goa 403 722 INDIA
Distributed By:
Westminster Pharmaceuticals, LLC
154 Downing Street, Unit 1 & 2

Olive Branch, MS 38654
Revised: 08/1615408160609B

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