국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
Dimethyl Sulfoxide (UNII: YOW8V9698H) (Dimethyl Sulfoxide - UNII:YOW8V9698H)
Mylan Institutional LLC
Dimethyl Sulfoxide
Dimethyl Sulfoxide 0.54 g in 1 mL
INTRAVESICAL
PRESCRIPTION DRUG
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. None known. None known.
Vials contain 50 mL of sterile and non-pyrogenic RIMSO-50® (50% w/w dimethyl sulfoxide aqueous solution). Dimethyl sulfoxide is clear and colorless. NDC 67457-177-50 carton containing a 50 mL vial Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from strong light. For additional information concerning RIMSO-50®, contact Mylan Institutional LLC, Morgantown, WV 26505. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland
New Drug Application
RIMSO-50- DIMETHYL SULFOXIDE IRRIGANT MYLAN INSTITUTIONAL LLC ---------- RIMSO-50 BRAND OF DIMETHYL SULFOXIDE IRRIGATION, USP PRESCRIBING INFORMATION RX ONLY DESCRIPTION RIMSO-50 (DIMETHYL SULFOXIDE) (DMSO) 50% W/W AQUEOUS SOLUTION FOR INTRAVESICAL INSTILLATION. EACH ML CONTAINS 0.54 GM DIMETHYL SULFOXIDE STERILE AND NON-PYROGENIC. INTRAVESICAL INSTILLATION FOR THE TREATMENT OF INTERSTITIAL CYSTITIS. NOT FOR INTRAMUSCULAR OR INTRAVENOUS INJECTION. The active component of RIMSO-50 is dimethyl sulfoxide which has the empirical formula C H OS, and is structurally represented as: Dimethyl sulfoxide is a clear, colorless and essentially odorless liquid which is miscible with water and most organic solvents. Other physical characteristics include: molecular weight 78.13, melting point 18.3° C, and a specific gravity of 1.096. CLINICAL PHARMACOLOGY Dimethyl sulfoxide is metabolised in man by oxidation to dimethyl sulfone or by reduction to dimethyl sulfide. Dimethyl sulfoxide and dimethyl sulfone are excreted in the urine and feces. Dimethyl sulfide is eliminated through the breath and skin and is responsible for the characteristic odor from patients on dimethyl sulfoxide medication. Dimethyl sulfone can persist in serum for longer than two weeks after a single intravesical instillation. No residual accumulation of dimethyl sulfoxide has occurred in man or lower animals who have received treatment for protracted periods of time. Following topical application, dimethyl sulfoxide is absorbed and generally distributed in the tissues and body fluids. INDICATIONS AND USAGE ® ® ® 2 6 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. CONTRAINDICATIONS None known. WARNINGS Dimethyl sulfoxide can initiate the liberation of histamine and there has been o 전체 문서 읽기