Dimethyl sulfoxide

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# Overview
Dimethyl sulfoxide is an anti inflammatory that is FDA approved for the treatment of symptomatic relief of patients with interstitial cystitis.   Common adverse reactions include garlic breath, garlic taste, chemical cystitis.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Dimethyl sulfoxide is indicated for the symptomatic relief of patients with interstitial cystitis. Dimethyl sulfoxide 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.
- Instillation of 50 mL of dimethyl sulfoxide directly into the bladder may be accomplished by catheter or aseptic 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 dimethyl sulfoxide 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).
- Instillation of 50 mL of 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of dimethyl sulfoxide in adult patients.

### NonGuideline-Supported Use
- Injection site extravasation

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Dimethyl sulfoxide in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Dimethyl sulfoxide in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Dimethyl sulfoxide in pediatric patients.

# Contraindications
- None known.

# 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 dimethyl sulfoxide. The physician should be cognizant of this possibility in prescribing . If anaphylactoid symptoms develop, appropriate therapy should be instituted.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Dimethyl sulfoxide in the drug label.

## Postmarketing Experience
- 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 dimethyl sulfoxide. If anaphylactoid symptoms develop, appropriate therapy should be instituted.

# Drug Interactions
There is limited information regarding Dimethyl sulfoxide Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dimethyl sulfoxide in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Dimethyl sulfoxide during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Dimethyl sulfoxide with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Dimethyl sulfoxide with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Dimethyl sulfoxide with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Dimethyl sulfoxide with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Dimethyl sulfoxide with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Dimethyl sulfoxide in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Dimethyl sulfoxide in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Dimethyl sulfoxide in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Dimethyl sulfoxide in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Intravesical instillation

### Monitoring
There is limited information regarding Monitoring of Dimethyl sulfoxide in the drug label.
- Description

# IV Compatibility
There is limited information regarding IV Compatibility of Dimethyl sulfoxide in the drug label.

# Overdosage
- The oral LD50 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 dimethyl sulfoxide 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.

# Pharmacology

## Mechanism of Action
There is limited information regarding Dimethyl sulfoxide Mechanism of Action in the drug label.

## Structure
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 the compound is dimethyl sulfoxide which has the empirical formula C2H6OS, 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.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Dimethyl sulfoxide in the drug label.

## Pharmacokinetics
- 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.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Dimethyl sulfoxide in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Dimethyl sulfoxide in the drug label.

# How Supplied
- Vials contain 50 mL of sterile and non-pyrogenic dimethyl sulfoxide (50% w/w dimethyl sulfoxide aqueous solution).
- Dimethyl sulfoxide is clear and colorless.
- NDC 67457-177-50
- Carton containing a 50 mL vial

## Storage
- Store at 20 to 25C (68 to 77F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
- Dimethyl sulfoxide 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.
- Dimethyl sulfoxide 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 dimethyl sulfoxide instillation.
- A garlic-like taste may be noted by the patient within a few minutes after instillation of 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.

# Precautions with Alcohol
- Alcohol-Dimethyl sulfoxide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- RIMSO-50

# Look-Alike Drug Names
There is limited information regarding Dimethyl sulfoxide Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price