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:

Actavis Pharma, 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. Probenecid crosses the placental barrier and appears in cord blood. Colchicine can arrest cell division in animals and plants. In certain species of animals 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 childbearing 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 imprinted DAN DAN and 5325 supplied in bottles of 100. Dispense in a well closed, light-resistant container with child-resistant closure. Store at 20 - 25°C (68 - 77°F). [See USP controlled room temperature.] Protect from light. Manufactured by: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016                                                               

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PROBENECID AND COLCHICINE- PROBENECID AND COLCHICINE TABLET
ACTAVIS PHARMA, INC.
----------
PROBENECID AND
COLCHICINE
TABLETS USP
REVISED: DECEMBER 2016
RX ONLY 190813-1
DESCRIPTION
Probenecid and colchicine contains probenecid, which is a uricosuric
agent, and
colchicine, which has antigout activity, the mechanism of which is
unknown.
Probenecid is the generic name for 4-[(dipropylamino)sulfonyl] benzoic
acid. The
structural formula is represented below:
C
H
NO S          M.W. 285.36
Probenecid 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.
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.
13
19
4
22
25
6
Each tablet for oral administration contains 500 mg of probenecid and
0.5 mg of
colchicine. Each tablet also contains the following inactive
ingredients: colloidal silicon
dioxide, 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 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.
P