Dimethyl Sulfoxide

FDA Drug Profile — RIMSO-50

Drug Details

Generic Name
Dimethyl Sulfoxide
Brand Names
RIMSO-50
Application Number
NDA017788
Sponsor
Mylan Institutional LLC
NDC Codes
1
Dosage Forms
IRRIGANT
Routes
INTRAVESICAL
Active Ingredients
DIMETHYL SULFOXIDE

Indications and Usage

INDICATIONS AND USAGE RIMSO-50 ® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50 ® has not been approved as being safe and effective for any other indication. There is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract.

Warnings

WARNINGS Dimethyl sulfoxide can initiate the liberation of histamine and there has been occasional hypersensitivity reaction with topical administration of dimethyl sulfoxide. This hypersensitivity has been reported in one patients receiving intravesical RIMSO-50 ® . The physician should be cognizant of this possibility in prescribing RIMSO-50 ® . If anaphylactoid symptoms develop, appropriate therapy should be instituted.