Sulfin, sulfinpyrazone, is a uricosuric agent available as 100-mg tablets 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 diluted alkali. Its molecular weight is 404.48.
Excipients/Inactive Ingredients: Colloidal silicon dioxide, gelatin, lactose, magnesium stearate, cornstarch, stearic acid, and talc.
Pharmacology: 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.
Chronic gouty arthritis.
Intermittent gouty arthritis.
Initial: 200-400 mg daily in two divided doses, with meals or milk, gradually increasing when necessary to full maintenance dosage in one week.
Maintenance: 400 mg daily, given in two divided doses, as previously mentioned. This dosage may be increased to 800 mg daily. If necessary and it may sometimes be reduce to as low as 200 mg daily after the blood urate level has been controlled. Treatment should be continued without interruption even in the presence of acute exacerbations, which can be concomitantly treated with phenylbutazone or colchicine. Patients previously controlled with other uricosuric therapy may be transferred to Sulfin at full maintenance dosage.
Symptoms: Nausea, vomiting, diarrhea, epigastric pain, ataxia, labored respiration, convulsions, coma. Possible symptoms, seen after overdosage with other pyrazolone derivatives: anemia, jaundice, ulceration.
Treatment: No specific antidote. Induce emesis; gastric lavage; supportive treatment (intravenous glucose infusion, analeptics).
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: Hypersensitivity to phenylbutazone or other pyrazoles; Blood dyscrasias.
Studies on the teratogenicity of pyrazole compounds in animals have yielded inconclusive results. Up to the present time, however, there have been no reported cases of human congenital malformation proved to be due to the use of the drug.
It is suggested that Sulfin should not be used in pregnant women and nursing mother.
As with all pyrazole compounds, patients receiving Sulfin should be kept under close medical supervision and periodic blood counts are recommended. It may be administered with care to patients with a history of healed peptic ulcer.
Recent reports have indicated that Sulfin potentiates the action of certain sulfonamides, such as sulfadiazine and sulfisoxazole. In addition, other pyrazole compounds (phenylbutazone) have been observed to potentiate the hypoglycemic sulfonylurea agents, as well as insulin. In view of these observations, it is suggested that Sulfin be used with caution in conjunction with sulfa drugs, the sulfonylurea hypoglycemic agents and insulin.
Because Sulfin is a potent uricosuric agent, it may precipitate urolithiasis and renal colic, especially in the initial stages of therapy. For this reason, an adequate fluid intake and alkalinization of the urine are recommended. In cases with significant renal impairment, periodic assessment of renal function is indicated. Occasional cases of renal failure have been reported; but a cause-and-effect relationship has not always been clearly established.
Salicyclates antagonize the uricosuric action of Sulfin and for this reason their concomitant use is contraindicated in gouty arthritis.
Sulfin may accentuate the action of coumarin-type anticoagulants and further depress prothrombin activity when these medications are employed simultaneously.
NOTE: Sulfin has minimal anti-inflammatory effect and is not intended for the relief of an acute attack of gout. In the initial stages of therapy, because of the marketed ability of Sulfin to
mobilize urate, acute attacks of gouty arthritis may be precipitated.
It is suggested that Sulfin should not be used in pregnant women and nursing mother.
The most frequently reported adverse reactions with Sulfin have been upper gastrointestinal disturbances. In these patients, it is advisable to administer the drug with food, milk, or antacids. Despite this precaution, Sulfin may aggravate or reactivate peptic ulcer.
Rash has been reported. In most instances, this reaction did not necessitate discontinuance of therapy. In general, Sulfin has not been observed to affect electrolyte balance.
Blood dyscrasias (anemia, leucopenia, agranulocytosis, thrombocytopenia, and aplastic anemia) have rarely been reported. There was also been a published report associating Sulfin, 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 cause-and-effect relationship to Sulfin has not been clearly established.
Do not store above 86°F (30°C).
Avoid exposure to direct sunlight.
M04AB02 - sulfinpyrazone ; Belongs to the class of preparations increasing uric acid excretion. Used in the treatment of gout.
Sulfin tab 100 mg
10 × 10's
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