PROBENECID AND COLCHICINE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Ingenus Pharmaceuticals, LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 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.

leaflet_short:

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 50742-263-01) 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. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Rx only 554000 Revised: 03/2019 ingenus

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PROBENECID AND COLCHICINE- PROBENECID AND COLCHICINE TABLET
INGENUS PHARMACEUTICALS, LLC
----------
PROBENECID AND COLCHICINE TABLETS, USP
RX ONLY
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:
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
also contains the following inactive ingredients: colloidal silicon
dioxide, crospovidone, magnesium
13
19
4
22
25
6
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.
Probenecid also has been reported to inhibit the renal transport of
man