RIMSO-50 SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DIMETHYL SULFOXIDE

Boleh didapati daripada:

MYLAN PHARMACEUTICALS ULC

Kod ATC:

G04BX13

INN (Nama Antarabangsa):

DIMETHYL SULFOXIDE

Dos:

500MG

Borang farmaseutikal:

SOLUTION

Komposisi:

DIMETHYL SULFOXIDE 500MG

Laluan pentadbiran:

INTRAVESICAL

Unit dalam pakej:

50ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS THERAPEUTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0103075002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2000-04-04

Ciri produk

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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
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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.
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INDICATIONS AND CLINICAL USES
RIMSO-50 (dimethyl sulfoxide) is indicated for the symptomatic relief
of patients with
interstitial cystitis