RIMSO-50- dimethyl sulfoxide irrigant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dimethyl Sulfoxide (UNII: YOW8V9698H) (Dimethyl Sulfoxide - UNII:YOW8V9698H)

Available from:

Mylan Institutional LLC

INN (International Name):

Dimethyl Sulfoxide

Composition:

Dimethyl Sulfoxide 0.54 g in 1 mL

Administration route:

INTRAVESICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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

Authorization status:

New Drug Application

Summary of Product characteristics

RIMSO-50- DIMETHYL SULFOXIDE IRRIGANT
MYLAN INSTITUTIONAL LLC
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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