Colbenemid

The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Colbenemid (Colbenemid) has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.

Treatment of hyperuricemia associated with gout and gouty arthritis; adjunctive therapy with penicillins or cephalosporins to elevate and prolong serum levels.

Probenecid (Colbenemid) and Colbenemid combination is used to treat gout or gouty arthritis.

The Probenecid (Colbenemid) in Probenecid (Colbenemid) and Colbenemid helps to prevent gout attacks by removing extra uric acid from the body. The Colbenemid in Probenecid (Colbenemid) and Colbenemid also helps to prevent gout attacks. Although Colbenemid may also be used to relieve an attack of gout, this requires more Colbenemid than this combination medicine contains. Probenecid (Colbenemid) and Colbenemid combination does not cure gout. Probenecid (Colbenemid) and Colbenemid will help prevent gout attacks only as long as you continue to take it.

Probenecid (Colbenemid) and Colbenemid combination is available only with your doctor's prescription.

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

The recommended adult dosage is 1 tablet of Probenecid (Colbenemid) and Colbenemid 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 (Colbenemid) 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.

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 (Colbenemid) and Colbenemid (or Probenecid (Colbenemid)) 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 (Colbenemid) and Colbenemid 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 (Colbenemid) and Colbenemid 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).

Protect from light.

Watson Laboratories, Inc. Corona, CA 92880 USA. FDA Rev date: 5/6/2002

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What is the most important information I should know about Colbenemid?

Hypersensitivity to this product or to Probenecid (Colbenemid) or Colbenemid.

Colbenemid (Colbenemid) and Colbenemid 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 (Colbenemid) and Colbenemid should not be started until an acute gouty attack has subsided.

Pregnancy

Colbenemid (Colbenemid) crosses the placental barrier and appears in cord blood. Colbenemid can arrest cell division in animals and plants. In certain species of animal under certain conditions, Colbenemid has produced teratogenic effects. The possibility of such effects in humans also has been reported. Because of the Colbenemid component, Probenecid (Colbenemid) and Colbenemid 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.

Use Colbenemid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Colbenemid by mouth with or without food.
• You should not start taking Colbenemid if you are currently having a gout attack. Wait until the gout attack stops to begin taking Colbenemid, unless directed otherwise by your doctor. If you are already taking Colbenemid, you may continue to take it during a gout attack unless your doctor tells you otherwise.
• Drinking extra fluids while you are taking Colbenemid is recommended. Check with your doctor for instructions.
• Talk with your doctor before eating grapefruit or drinking grapefruit juice while taking Colbenemid.
• If you miss a dose of Colbenemid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Colbenemid.

Use: Labeled Indications

Treatment of chronic gouty arthritis when complicated by frequent, recurrent acute attacks of gout

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What other drugs will affect Colbenemid?

When Probenecid (Colbenemid) is used to elevate plasma concentrations of penicillin, or other beta-lactams, or when such drugs are given to patients taking Probenecid (Colbenemid) therapeutically, high plasma concentrations of the other drug may increase the incidence of adverse reactions associated with that drug. In the case of penicillin, or other beta-lactams, psychic disturbances have been reported.

The use of salicylates antagonizes the uricosuric action of Probenecid (Colbenemid). The uricosuric action of Probenecid (Colbenemid) is also antagonized by pyrazinamide.

Colbenemid produces an insignificant increase in free sulfonamide plasma concentrations but a significant increase in total sulfonamide plasma levels. Since Probenecid (Colbenemid) decreases the renal excretion of conjugated sulfonamides, plasma concentrations of the latter should be determined from time to time when a sulfonamide and Probenecid (Colbenemid) and Colbenemid are co-administered for prolonged periods. Colbenemid may prolong or enhance the action of oral sulfonylureas and thereby increase the risk of hypoglycemia.

It has been reported that patients receiving Probenecid (Colbenemid) require significantly less thiopental for induction of anesthesia. In addition, ketamine and thiopental anesthesia were significantly prolonged in rats receiving Probenecid (Colbenemid).

The concomitant administration of Probenecid (Colbenemid) increases the mean plasma elimination half-life of a number of drugs which can lead to increased plasma concentrations. These include agents such as indomethacin, acetaminophen, naproxen, ketoprofen, meclofenamate, lorazepam, and rifampin. Although the clinical significance of this observation has not been established, a lower dosage of the drug may be required to produce a therapeutic effect, and increases in dosage of the drug in question should be made cautiously and in small increments when Probenecid (Colbenemid) is being co-administrated. Although specific instances of toxicity due to this potential interaction have not been observed to date, physicians should be alert to this possibility.

Colbenemid given concomitantly with sulindac had only a slight effect on plasma sulfide levels, while plasma levels of sulindac and sulfone were increased. Sulindac was shown to produce a modest reduction in the uricosuric action of Probenecid (Colbenemid), which probably is not significant under most circumstances.

In animals and in humans, Probenecid (Colbenemid) has been reported to increase plasma concentrations of methotrexate.

Falsely high readings for theophylline have been reported in an in vitro study, using the Schack and Waxler technique, when therapeutic concentrations of theophylline and Probenecid (Colbenemid) were added to human plasma.

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What are the possible side effects of Colbenemid?

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

Probenecid (Colbenemid)

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.

Colbenemid

Side effects due to colchicines appear to be a function of dosage. The possibility of increased Colbenemid 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, Colbenemid may cause severe diarrhea, generalized vascular damage, and renal damage with hematuria and oliguria.