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Rimso-50 (Dimethyl Sulfoxide) - Indications and Dosage

 
 



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.

DOSAGE AND ADMINISTRATION

Instillation of 50 mL of RIMSO-50® (dimethyl sulfoxide) directly into the bladder may be accomplished by catheter or asepto syringe and allow to remain for 15 minutes. Application of an analgesic lubricant gel such as lidocaine jelly to the urethra is suggested prior to insertion of the catheter to avoid spasm. The medication is expelled by spontaneous voiding. It is recommended that the treatment be repeated every two weeks until maximum symptomatic relief is obtained. Thereafter, time intervals between therapy may be increased appropriately.

Administration of oral analgesic medication or suppositories containing belladonna and opium prior to the instillation of RIMSO-50® can reduce bladder spasm.

In patients with severe interstitial cystitis with very sensitive bladders, the initial treatment, and possibly the second and third (depending on patient response) should be done under anesthesia. (Saddle block has been suggested).

HOW SUPPLIED

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,
Rockford, IL 61103.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

INFORMATION FOR PATIENTS (Physician Copy)

RIMSO-50® is a sterile solution of 50% dimethyl sulfoxide (DMSO) and 50% water that has been approved by the U.S. Food and Drug Administration for use in the symptomatic relief of patients with interstitial cystitis.

RIMSO-50® will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician.

Some data indicate that dimethyl sulfoxide could change the effectiveness of medication(s) that you may be presently receiving. Be sure to mention the name and dosage of all medicines you are taking to your physician before a RIMSO-50® instillation.

A garlic-like taste may be noted by the patient within a few minutes after instillation of RIMSO-50® (dimethyl sulfoxide). This taste may last several hours. An odor on the breath and skin may be present and remain for up to 72 hours.

Some patients may experience discomfort on administration of the drug. Usually this becomes less prominent with repeated administration.

If you are pregnant or nursing, ask your physician about the advisability of using RIMSO-50®.

Some eye changes have been observed in animals treated with DMSO in large doses for prolonged periods. Therefore your doctor may want you to have eye evaluations, including slit lamp examinations prior to and periodically during treatment.

RIMSO-50®
(dimethyl sulfoxide) irrigation, USP                                                                                 0582L103

Mylan Institutional LLC                                                                                 REVISED JULY 2012
Rockford, IL 61103 U.S.A.                                                                                      MI:RIMSIG:R2

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