Dimethyl Sulfoxide
FDA Drug Information • Also known as: Rimso-50
- Brand Names
- Rimso-50
- Dosage Form
- LIQUID
- Product Type
- BULK INGREDIENT
Description
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 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 18.3° C, and a specific gravity of 1.096. Chemical Structure
What Is Dimethyl Sulfoxide Used For?
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
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).
Side Effects (Adverse Reactions)
ADVERSE REACTIONS 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 and because of the presence of metabolites, an odor on the breath and skin may remain for 72 hours. Transient chemical cystitis has been noted following instillation of dimethyl sulfoxide. The patient may experience moderately severe discomfort on administration. Usually this becomes less prominent with repeated administration.
Warnings and Precautions
WARNINGS Dimethyl sulfoxide can initiate the liberation of histamine and there has been occasional hypersensitivity reaction with topical administration of dimethyl sulfoxide. This hypersensitivity has been reported in one patients receiving intravesical RIMSO-50 ® . The physician should be cognizant of this possibility in prescribing RIMSO-50 ® . If anaphylactoid symptoms develop, appropriate therapy should be instituted.
Contraindications
CONTRAINDICATIONS None known.
Overdosage
OVERDOSAGE The oral LD 50 of dimethyl sulfoxide in the dog is greater than 10 gm/kg. It is improbable that this dosage level could be obtained with intravesical instillation of RIMSO-50 ® in the patient. In case of accidental oral ingestion, specific measures should be taken to induce emesis. Additional measures which may be considered are gastric lavage, activated charcoal and force diuresis.
How Supplied
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, Morgantown, WV 26505. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.