Anturane

Anturane, sulfinpyrazone USP, is auricosuric agent available as 100-mg tablets and 200-mg capsules for oral administration. Its chemical name is 1,2-diphenyl-4-[2-(phenylsulfinyl)ethyl]-3,5-pyrazolidinedione.

Sulfinpyrazone USP is a white to off-white powder practically insoluble in water and in solvent hexane, soluble in alcohol and in acetone, and sparingly soluble in dilute alkali. Its molecular weight is 404.48.

Inactive Ingredients

Anturane (sulfinpyrazone) tablets: Colloidal silicon dioxide, gelatin, lactose, magnesium stearate, cornstarch, stearic acid, and talc.

Anturane (sulfinpyrazone) capsules: D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, lactose, magnesium stearate, methylparaben, propylparaben, silicon dioxide, sodium lauryl sulfate, cornstarch, stearic acid, talc, and titanium dioxide.

Anturane (sulfinpyrazone) is indicated for the treatment of:

1. Chronic gouty arthritis

2. Intermittent gouty arthritis

Tablets 100 mg round, white, scored (imprinted CIBA 41)

Bottles of 100                     NDC 0083-0041-30

Capsules 200 mg green (imprinted Anturane (sulfinpyrazone) 200 CIBA 168)

Bottles of 100                     NDC 0083-0168-30

Do not store above 86° F (30° C).

Dispense in tight container (USP).

Its pharmacologic activity is the potentiation of the urinary excretion of uric acid. It is useful for reducing the blood urate levels in patients with chronic tophaceous gout and acute intermittent gout, and for promoting the resorption of tophi.

Its pharmacologic activity is the potentiation of the urinary excretion of uric acid. It is useful for reducing the blood urate levels in patients with chronic tophaceous gout and acute intermittent gout, and for promoting the resorption of tophi.

Patients with an active peptic ulcer or symptoms of gastrointestinal inflammation or ulceration should not receive the drug.

      The drug is contraindicated in patients with a history or the presence of:

1. Hypersensitivity to phenylbutazone or other pyrazoles
   
2. Blood dyscrasias

The most frequently reported adverse reactions with Anturane have been upper gastrointestinal disturbances. In these patients it is advisable to administer the drug with food, milk, or antacids. Despite this precaution, Anturane may aggravate or reactivate peptic ulcer.

      Rash has been reported. In most instances, this reaction did not necessitate discontinuance of therapy. In general, Anturane has not been observed to affect electrolyte balance.

      Blood dyscrasias (anemia, leukopenia, agranulocytosis, thrombocytopenia, and aplastic anemia) have rarely been reported. There has also been a published report associating Anturane, administered concomitantly with other drugs including colchicine, with leukemia following long-term treatment of patients with gout. However, the circumstances involved in the two cases reported are such that a cause-and-effect relationship to Anturane has not been clearly established.

Tablets 100 mg – round, white, scored (imprinted CIBA 41)

      Bottles of 100 ....................................... NDC 0083-0041-30

Capsules 200 mg – green (imprinted Anturane 200 CIBA 168)

      Bottles of 100 ....................................... NDC 0083-0168-30

Do not store above 86°F (30°C).

Dispense in tight container (USP).

                                         C96-18 (Rev. 4/96)

C I B A

Ciba-Geigy Corporation

Pharmaceuticals Division

Summit, New Jersey 07901

There are no data on the excretion of sulfinpyrazone into human milk.