PROBENECID AND COLCHICINE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROBENECID (UNII: PO572Z7917) (PROBENECID - UNII:PO572Z7917), COLCHICINE (UNII: SML2Y3J35T) (COLCHICINE - UNII:SML2Y3J35T)

Available from:

Rising Pharmaceuticals, Inc.

INN (International Name):

PROBENECID

Composition:

PROBENECID 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For the treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout. Hypersensitivity to this product or to probenecid or colchicine. Probenecid and colchicine tablets are contraindicated in children under 2 years of age. Not recommended in persons with known blood dyscrasias or uric acid kidney stones. Therapy with probenecid and colchicine should not be started until an acute gouty attack has subsided. Pregnancy: Probenecid crosses the placental barrier and appears in cord blood. Colchicine can arrest cell division in animals and plants. In certain species of animal under certain conditions, colchicine has produced teratogenic effects. The possibility of such effects in humans also has been reported. Because of the colchicine component, probenecid and colchicine is contraindicated in pregnant patients. The use of any drug in women of child bearing potential requires that the anticipated benefit be weighed against the possible hazards.

Product summary:

Probenecid and Colchicine Tablets, USP 500 mg-0.5 mg are bisected, white, capsule-shaped tablets debossed with CL025 on one side and supplied in bottles of 100. Bottles of 100 (NDC 64980-149-01) Dispense in well-closed light resistant container with child resistant closure. Store at controlled room temperature 20°– 25° C (68°– 77°F). [See USP Controlled Room Temperature]. Protect from light. Distributed by:                                  Manufactured by: Rising Pharmaceuticals, Inc.             Ingenus Pharmaceuticals NJ, LLC. Saddle Brook, NJ 07663                   Fairfield, NJ 07004 Rx only 550101 Rev. 08/18

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROBENECID AND COLCHICINE - PROBENECID AND COLCHICINE TABLET
RISING PHARMACEUTICALS, INC.
----------
PROBENECID AND COLCHICINE TABLETS, USP
RX ONLY
DESCRIPTION
Probenecid and colchicine contains probenecid, which is a uricosuric
agent, and colchicine, which has
anti-gout activity, the mechanism of which is unknown.
Probenecid is the generic name for 4-[(dipropylamino) sulfonyl]
benzoic acid. The structural formula is
represented below:
Probenecid is a white or nearly white, fine crystalline powder.
C H NO S M.W. 285.36
It is soluble in dilute alkali, in alcohol, in chloroform, and in
acetone; it is practically insoluble in water
and in dilute acids.
Colchicine is an alkaloid obtained from various species of Colchicum.
The chemical name for
colchicine is (_S)-N-_(5,6,7,9-
tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[_α_]heptalen-7-yl)
acetamide.
The structural formula is represented below:
C H NO M.W. 399.44
Colchicine consists of pale yellow scales or powder; it darkens on
exposure to light. Colchicine is
soluble in water, freely soluble in alcohol and in chloroform, and
slightly soluble in ether.
Each tablet for oral administration contains 500 mg of probenecid and
0.5 mg of colchicine. Each tablet
13
19
4
22
25
6
also contains the following inactive ingredients: colloidal silicon
dioxide crospovidone, magnesium
stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium
starch glycolate.
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 reabsorption 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 o