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PROBALAN (PROBENECID) TABLETS: PRESCRIBING INFORMATION (see "References")

DESCRIPTION

Probenecid (Probalan) is a uricosuric and renal tubular transport blocking agent.

The chemical name for probenecid is 4-[(dipropylamino) sulfonyl] benzoic acid.

Probenecid, USP is a white or nearly white, fine, crystalline powder. It is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids.

Each Probalan tablet for oral administration contains 500 mg of probenecid and the following inactive ingredients: sodium lauryl sulfate, microcrystalline cellulose, sodium starch glycolate, povidone, corn starch, colloidal silicon dioxide, polyvinyl alcohol, magnesium stearate, titanium dioxide, talc, polyethylene glycol, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, and FD&C Blue #2 Aluminum Lake.


CLINICAL PHARMACOLOGY

Probalan clinical pharmacology


INDICATIONS AND USAGE

Probalan (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 methicillin, ampicillin, 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.

Probenecid (Probalan) tablets are not recommended in persons with known blood dyscrasias or uric acid kidney stones. Therapy with this medication should not be started until an acute gouty attack has subsided.


WARNINGS

Probalan warnings


PRECAUTIONS

Probalan precautions


DRUG INTERACTIONS

Probalan drug interactions


ADVERSE REACTIONS

Probalan adverse reactions


DOSAGE AND ADMINISTRATION

Probalan dosage and administration


DOSAGE AND ADMINISTRATION FOR PENICILLIN THERAPY

Probalan dosage and administration for penicillin therapy


HOW SUPPLIED

Probalan (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.

Storage

Store Probalan (Probenecid) tablets 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.

Manufactured and distributed by Lannett pharmaceutical company and its divisions.

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