Riik: Kanada
keel: inglise
Allikas: Health Canada
DIMETHYL SULFOXIDE
MYLAN PHARMACEUTICALS ULC
G04BX13
DIMETHYL SULFOXIDE
500MG
SOLUTION
DIMETHYL SULFOXIDE 500MG
INTRAVESICAL
50ML
Prescription
MISCELLANEOUS THERAPEUTIC AGENTS
Active ingredient group (AIG) number: 0103075002; AHFS:
APPROVED
2000-04-04
_ _ _ Page 1 of 6_ PRODUCT MONOGRAPH Pr RIMSO-50 (Dimethyl Sulfoxide 500 mg/g) Intravesical Instillation for the TREATMENT OF INTERSTITIAL CYSTITIS Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Date of Preparation: March 11, 2014 Submission Control No: 171866 _ _ _ Page 2 of 6_ Pr RIMSO-50 (Dimethyl Sulfoxide 50%) NOT FOR I.M or I.V Injection THERAPEUTIC CLASSIFICATION Intravesical instillation for the treatment of interstitial cystitis. STRUCTURAL FORMULA AND CHEMISTRY The active component of RIMSO-50 is dimethyl sulfoxide which has the empirical formula C 2 H 6 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 18.4°C, boiling point 189°C, and a specific gravity of 1.100. ACTION The mode of action of RIMSO-50 (DMSO) as a treatment for interstitial cystitis is speculative at this time. Hypotheses center around the following: a) Anti-inflammation b) Analgesic c) Improvement of blood supply d) Softening of collagen due to action on cross-linking METABOLISM Dimethyl sulfoxide is metabolised 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. _ _ _ Page 3 of 6_ INDICATIONS AND CLINICAL USES RIMSO-50 (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis Lugege kogu dokumenti