Probenecid (Page 2 of 2)

DOSAGE AND 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 (½ probenecid tablet), 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: 2-14 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)1

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 2 (given IM), or 3 g of amoxicillin2 (given orally), or 3.5 g of ampicillin 2 (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.


1
Recommended by the Center 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).
2
See package circulars of manufacturers for detailed information about CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

HOW SUPPLIED

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 0527-1367-01 bottles of 100 tablets

NDC 0527-1367-10 bottles of 1000 tablets

STORE AT 20° -25°C (68° -77°F) [See USP Controlled Room Temperature]

PROTECT FROM LIGHT.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

CIB70317B
Rev 04/16

PRINCIPAL DISPLAY PANEL

NDC 0527-1367-10

Lanne tt

PROBENECID TABLETS, USP

500 mg

Rx Only

1000 TABLETS

probenecid-500mg-1000count-container-label
(click image for full-size original)
PROBENECID
probenecid tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1367
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROBENECID (PROBENECID) PROBENECID 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
TALC
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
ALUMINUM OXIDE
Product Characteristics
Color YELLOW (Yellow) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code LCI;1367
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1367-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:0527-1367-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080966 07/29/1976
Labeler — Lannett Company, Inc. (002277481)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 829757603 ANALYSIS (0527-1367)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 006422406 LABEL (0527-1367), MANUFACTURE (0527-1367), PACK (0527-1367), RELABEL (0527-1367), REPACK (0527-1367)

Revised: 04/2016 Lannett Company, Inc.

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