Probenecid and Colchicine (Page 2 of 2)

ADVERSE REACTIONS

The following adverse reactions have been observed and within each category are listed in order of decreasing severity.

Probenecid

Central Nervous System: headache, dizziness.

Metabolic: precipitation of acute gouty arthritis.

Gastrointestinal: hepatic necrosis, vomiting, nausea, anorexia, sore gums.

Genitourinary: nephrotic syndrome, uric acid stones with or without hematuria, renal colic, costovertebral pain, urinary frequency.

Hypersensitivity: anaphylaxis, fever, urticaria, pruritus.

Hematologic: aplastic anemia, leukopenia, hemolytic anemia which in some patients could be related to genetic deficiency of glucose-6-phosphate dehydrogenase in red blood cells, anemia.

Integumentary: dermatitis, alopecia, flushing.

Colchicine

Side effects due to colchicine appear to be a function of dosage. The possibility of increased colchicine toxicity in the presence of hepatic dysfunction should be considered. The appearance of any of the following symptoms may require reduction of dosage or discontinuance of the drug.

Central Nervous System: peripheral neuritis.

Musculoskeletal: muscular weakness.

Gastrointestinal: nausea, vomiting, abdominal pain, or diarrhea may be particularly troublesome in the presence of peptic ulcer or spastic colon.

Hypersensitivity: urticaria.

Hematologic: aplastic anemia, agranulocytosis.

Integumentary: dermatitis, purpura, alopecia.

At toxic doses, colchicine may cause severe diarrhea, generalized vascular damage, and renal damage with hematuria and oliguria.

DOSAGE AND ADMINISTRATION

Therapy with probenecid and colchicine should not be started until an acute gouty attack has subsided. However, if an acute attack is precipitated during therapy, probenecid and colchicine may be continued without changing the dosage, and additional colchicine or other appropriate therapy should be given to control the acute attack.

The recommended adult dosage is 1 tablet of probenecid and colchicine daily for one week, followed by 1 tablet twice a day thereafter.

Some degree of renal impairment may be present in patients with gout. A daily dosage of 2 tablets may be adequate. However, if necessary, the daily dosage may be increased by 1 tablet every four weeks within tolerance (and usually not above 4 tablets 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 and colchicine (or probenecid) should be continued at the dosage that will maintain normal serum urate levels. When acute attacks have been absent for six months or more and serum urate levels remain within normal limits, the daily dosage of probenecid and colchicine may be decreased by 1 tablet every six months. The maintenance dosage should not be reduced to the point where serum urate levels tend to rise.

HOW SUPPLIED

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

PRINCIPAL DISPLAY PANEL

NDC 0591-5325-01
Probenecid and
Colchicine
Tablets USP
500 mg /
0.5 mg
Actavis
100 Tablets Rx only

1
(click image for full-size original)
PROBENECID AND COLCHICINE
probenecid and colchicine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-5325
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROBENECID (PROBENECID) PROBENECID 500 mg
COLCHICINE (COLCHICINE) COLCHICINE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (Capsule-shaped) Size 18mm
Flavor Imprint Code DAN;DAN;5325
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-5325-01 100 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084279 10/01/1982
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 12/2016 Actavis Pharma, Inc.

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