Dimethyl sulfoxide (DMSO) has local antiinflammatory and analgesic effects and free-radical scavenging properties. Intravesical DMSO is used for the symptomatic relief of patients with interstitial cystitis but has not been shown to be effective for bacterial infections of the urinary tract. DMSO has been used as a solvent in biological studies and as a vehicle for drug therapy.. Additionally, DMSO has been used for the prevention of soft-tissue damage after the extravasation of cytotoxic drugs. DMSO 50% aqueous irrigation solution (RIMSO-50) received FDA approval in November 2002 for the symptomatic relief of patients with interstitial cystitis.
General Administration Information
-For storage information, see the specific product information within the How Supplied section.
-Dimethyl sulfoxide (DMSO) 50% aqueous irrigation solution (RIMSO-50) is not for IM or IV use.
Route-Specific Administration
Topical Administration
Other Topical Formulations
Topical Solution Administration
NOTE: Dimethyl sulfoxide (DMSO) is not approved by the FDA for topical administration.
-Apply a 99% DMSO solution topically over an area twice the size of that affected.
-Leave the affected area to dry without dressing following topical DMSO administration.
-Use in conjunction with local cooling (via cold pack for 60 minutes) for the first 3 days of topical DMSO therapy.
Other Administration Route(s)
Intravesical Administration
-Instill dimethyl sulfoxide DMSO 50% aqueous irrigation solution (RIMSO-50) directly into the bladder using a catheter or syringe.
-Allow the solution to remain for 15 minutes before spontaneous voiding.
-Application of an analgesic lubricant gel (eg, lidocaine jelly) prior to catheter insertion and/or the administration of an oral analgesic medication suppository containing belladonna and opium prior to solution administration may reduce bladder spasm.
-Initial treatment (and possibly the second and third treatments depending on patient response) should be done under anesthesia (saddle block has been suggested) in patients with severe interstitial cystitis and very sensitive bladders.
Mild induration of perivascular tissues without functional impairment (9.7%) and hyperpigmentation of the skin (4.9%) were reported following topical administration of a 99% dimethyl sulfoxide (DMSO) solution in patients with suspected extravasation in an open-label study.
Hypersensitivity reactions caused by histamine release may occur with dimethyl sulfoxide (DMSO). Hypersensitivity has been reported in 1 patient following intravesical administration of DMSO 50% aqueous irrigation solution (RIMSO-50). Initiate appropriate therapy if anaphylactoid reactions occur.
Dysgeusia has been reported with dimethyl sulfoxide (DMSO) 50% aqueous irrigation solution (RIMSO-50). A garlic-like taste may develop within a few minutes of intravesical DMSO administration and may last several hours; breath and skin odor may persist for 72 hours.
Transient chemical cystitis has been reported with intravesical administration of dimethyl sulfoxide (DMSO) 50% irrigation solution. Moderate to severe bladder discomfort during intravesical administration may occur but usually lessens with repeat instillations. Bladder spasm may occur with intravesical administration of dimethyl sulfoxide (DMSO) 50% irrigation solution. Premedication with oral analgesic suppositories containing belladonna and opium may reduce this event.
Uncomplicated urinary tract infection was reported in 2 of 33 patients following the intravesical administration of dimethyl sulfoxide (DMSO) in a randomized, placebo-controlled, crossover trial. Both patients responded to a short course of antibiotics.
Due to the potential for dimethyl sulfoxide (DMSO)-induced vasodilation, intravesical DMSO 50% aqueous irrigation solution (RIMSO-50) may cause harm in patients with bladder cancer, specifically urinary tract malignancy.
Use dimethyl sulfoxide (DMSO) cautiously in patients with cataracts. High, chronic doses of DMSO caused changes in the refractive index and lens opacities in monkeys, dogs, and rabbits. Full eye evaluations (eg, slit lamp examinations) are recommended prior to and periodically during DMSO treatment.
The safety and effectiveness of dimethyl sulfoxide 50% aqueous irrigation solution (RIMSO-50) have not been established in neonates, infants, and children.
Dimethyl sulfoxide (DMSO) 50% aqueous irrigation solution (RIMSO-50) for intravesical use is classified as FDA pregnancy category C. There are no adequate and well controlled studies of DMSO in pregnant females. Although oral or topical doses of DMSO resulted in no reproductive problems in rates, mice, or hamsters, teratogenic responses were observed following high doses of interperitoneal (2.5-12 grams/kg) and topical (5 grams/kg x2 days, then 2.5 grams/kg x10 days) DMSO. DMSO should only be used during pregnancy if the benefit justifies the potential risk to the fetus.
According to the manufacturer, it is not known if dimethyl sulfoxide (DMSO) 50% aqueous irrigation solution (RIMSO-50) is excreted in human milk. Caution is advised when administering DMSO to a nursing woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
For the symptomatic relief of interstitial cystitis:
Intravesical dosage:
Adults: Instill 50 mL of dimethyl sulfoxide (DMSO) 50% aqueous irrigation solution directly into the bladder using a catheter or syringe and allow the solution to remain for 15 minutes before spontaneous voiding. Repeat therapy every 2 weeks until maximum symptomatic relief occurs, then increase the interval between therapies as appropriate. The application of an analgesic lubricant gel (eg, lidocaine jelly) prior to catheter insertion and/or the administration of an oral analgesic medication or suppository containing belladonna and opium prior to solution administration may reduce bladder spasm. In patients with severe disease with very sensitive bladders, the initial treatment (and possibly the second and third) should be performed under anesthesia (saddle block has been suggested). In a randomized, placebo-controlled, crossover trial in 33 patients with interstitial cystitis, objective improvement was reported in 93% of patients who received 50 ml of DMSO 50% solution administered intravesically every 2 weeks for 4 doses compared with 35% of patients who received placebo instillations. Following a 4-week rest period, 86% of patients who had originally received DMSO experienced an objective improvement following 4 placebo treatments.
For the prevention of soft tissue injury from extravasation* of IV chemotherapy agents:
Topical dosage*:
Adults: Four drops per 10 cm2 of skin surface of a 99% dimethyl sulfoxide (DMSO) solution over an area twice the size of that affected was applied topically following suspected extravasation from doxorubicin, epirubicin, mitomycin, mitoxantrone, cisplatin, carboplatin, ifosfamide, or fluorouracil in 144 adult patients with suspected extravasation in an open-label study. Following topical DMSO application, the affected area was left to dry without dressing and the dose was repeated every 8 hours for 1 week. Treatment continued past the 1-week evaluation if necessary. For the first 3 days, all patients received local cooling for 60 minutes (via cold pack) repeated every 8 hours. Resolution of symptoms occurred in about 70 to 90% after 1 week of treatment depending on the chemotherapy agent, with an additional 8 to 29% responding with additional DMSO treatment. Of the 58 evaluable patients who had extravasation following doxorubicin, epirubicin, or mitomycin, 68.9% of patients had a complete resolution of symptoms after 1 week of topical DMSO therapy, and an additional 29.3% of patients had local pain and/or erythema disappear after continuing topical DMSO therapy beyond 1 week (for up to 6 weeks). One patient who had extravasation following epirubicin that resolved within 1 week of topical DMSO therapy experienced a recall reaction at the extravasation site 1 month later after receiving another epirubicin course administered in a vein located on the other arm. Of the 69 evaluable patients who had extravasation following mitoxantrone, cisplatin, carboplatin, ifosfamide, or fluorouracil, 91.3% of patients had a complete resolution of symptoms after 1 week of topical DMSO therapy, and an additional 8.5% of patients achieved a remission of symptoms after 2 to 4 weeks of topical DMSO therapy. Adverse effects associated with topical DMSO therapy included mild induration of perivascular tissues without functional impairment (9.7%) and hyperpigmentation of the skin (4.9%).
Maximum Dosage Limits:
-Adults
50 ml intravesically once every 2 weeks.
-Geriatric
50 ml intravesically once every 2 weeks.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available.
*non-FDA-approved indication
Sulindac: (Major) Do not use dimethyl sulfoxide (DMSO) with sulindac. Concomitant administration has been reported to reduce plasma concentrations of the active sulfide metabolite of sulindac and potentially reduce efficacy. Peripheral neuropathy has been observed with concurrent use.
Verteporfin: (Moderate) Use caution if coadministration of verteporfin with dimethyl sulfoxide is necessary due to the risk of decreased verteporfin efficacy. Verteporfin is a light-activated drug used in photodynamic therapy. Once activated, highly reactive, short-lived singlet oxygen and reactive oxygen radicals are generated. Concomitant use of drugs that quench active oxygen species or scavenge radicals, such as dimethyl sulfoxide, would be expected to decrease verteporfin activity.
The exact mechanism of action of dimethyl sulfoxide (DMSO) is unknown. DMSO has antiinflammatory and analgesic effects and intravesical administration of DMSO 50% aqueous irrigation solution (RIMSO-50) may provide relief of interstitial cystitis symptoms, although the therapeutic effects do not appear to be due to histamine release from mast cells. When used with local cooling, 99% DMSO applied topically (off-label use) has prevented soft-tissue damage associated with extravasation from IV chemotherapy agents (doxorubicin, epirubicin, mitomycin, mitoxantrone, cisplatin, carboplatin, ifosfamide, or fluorouracil) possibly due to antiinflammatory and free-radical scavenging properties.
Dimethyl sulfoxide (DMSO) is administered as an intravesical instillation or off-label as a topical solution. DMSO is metabolized by oxidation to dimethyl sulfone or by reduction to dimethyl sulfide. Both DMSO and dimethyl sulfone are excreted in the urine and feces. DMSO is eliminated in from the skin and breath. When given over a prolonged period, DMSO does not appear to accumulate.
-Route-Specific Pharmacokinetics
Topical Route
Dimethyl sulfoxide (DMSO) is absorbed and distributed in tissues and body fluids following topical application.
Other Route(s)
Intravesical Route
Dimethyl sulfone, a metabolite of dimethyl sulfoxide (DMSO), may be found in the serum for longer than 2 weeks following a single DMSO intravesical instillation.