RIMSO-50® brand of dimethyl sulfoxide (DMSO) 50% w/w Aqueous Solution for intravesical instillation. Each mL contains 0.54 gm dimethyl sulfoxide. Intravesical instillation for the treatment of interstitial cystitis. NOT FOR I.M. OR I.V. INJECTION. Rx ONLY.

The active component of RIMSO-50® solution is dimethyl sulfoxide which has the empirical formula C₂H₆OS. 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 specifc gravity of 1.096.

Last updated on RxList: 4/9/2009

RIMSO-50® brand of dimethyl sulfoxide is indicated for the symptomatic relief of patients with interstitial cystitis. RIMSO-50® solution 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 RIMSO-50® brand of dimethyl sulfoxide directly into the bladder may be accomplished by catheter or 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 suppositories containing belladonna and opium prior to the instillation of RIMSO-50® solution 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.)

Bottles contain 50 mL of sterile and non-pyrogenic RIMSO-50® (50% w/w dimethyl sulfoxide aqueous solution).

Dimethyl sulfoxide is clear and colorless.

Protect from strong light. Store at room temperatures 59° to 86° F (15° to 30°C).

NDC #67457-177-50

REFERENCES

1. Photographs courtesy of Interstitial Cystitis Association and C. Lowell Parsons, M.D.

2. Erickson DR. Interstitial Cystitis: Update on Etiologies and Therapeutic Options. J Women's Health & Gender-Based Med 1999; 6:745.

3. Parkin J, et al. Intravesical Dimethyl Sulfoxide (DMSO) for Interstitial Cystitis -A Practical Approach. Urology, 1997; 49(5A, Suppl):106.

4. Sant GR, et al. Intravesical 50% Dimethyl Sulfoxide (RIMSO-50® solution) in Treatment of Interstitial Cystitis. Urology 1987; 29(4, Suppl):19.

Manufactured for: Bioniche Pharma USA LLC, Lake Forest, IL 60045. Manufactured by: Bioniche Teo., Inverin, Co. Galway, Ireland.

Last updated on RxList: 4/9/2009

A garlic-like taste may be noted by the patient within a few minutes after instillation of RIMSO-50® brand of 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.

Drug Abuse and Dependence: None known.

No information provided.

Last updated on RxList: 4/9/2009

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 patient receiving intravesical RIMSO-50® solution. The physician should be cognizant of this possibility in prescribing RIMSO-50® solution. If anaphylactoid symptoms develop, appropriate therapy should be instituted.

Changes in the refractive index and lens opacities have been seen in monkeys, dogs, and rabbits given high doses of dimethyl sulfoxide chronically. Since lens changes were noted in animals, full eye evaluations, including slit lamp examinations, are recommended prior to and periodically during treatment.

Approximately every six months patients receiving dimethyl sulfoxide should have a biochemical screening, particularly liver and renal function tests, and complete blood count.

Intravesical instillation of RIMSO-50® solution may be harmful to patients with urinary tract malignancy because of dimethyl sulfoxide-induced vasodilation.

Some data indicate that dimethyl sulfoxide potentiates other concomitantly administered medications.

Pregnancy Category C. Dimethyl sulfoxide caused teratogenic responses in hamsters, rats and mice when administered interperitoneally at high doses (2.5 to 12 g/kg). Oral or topical doses of dimethyl sulfoxide did not cause problems of reproduction in rats, mice and hamsters. Topical doses (5 g/kg frst two days, then 2.5 g/kg last eight days) produced terata in rabbits, but in another study, topical doses of 1.1 g/kg days 3 through 16 of gestation failed to produce any abnormalities. There are no adequate and well controlled studies in pregnant women. Dimethyl sulfoxide should be used during pregnancy only if the potential beneft justifes the potential risk to the fetus.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dimethyl sulfoxide is administered to a nursing woman.

Safety and effectiveness in children have not been established.

Last updated on RxList: 4/9/2009

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 RIMSO-50® solution in the patient.

In case of accidental oral ingestion, specifc measures should be taken to induce emesis. Additional measures which may be considered are gastric lavage, activated charcoal and force diuresis.

None known

Last updated on RxList: 4/9/2009

Dimethyl sulfoxide is metabolized in man by oxidation to dimethyl sulfone or by reduction to dimethyl sulfde. Dimethyl sulfoxide and dimethyl sulfone are excreted in the urine and feces. Dimethyl sulfoxide is eliminated through the breath and skin and is responsible for 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 fuids.

Last updated on RxList: 4/9/2009

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last updated on RxList: 4/9/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

DIMETHYL SULFOXIDE SOLUTION - IRRIGATION

(DI-meth-ill SULF-ox-ide)

COMMON BRAND NAME(S): Rimso-50

USES: This medication is used to treat a certain bladder condition (interstitial cystitis). Dimethyl sulfoxide is also known as DMSO. It is believed to reduce swelling and pain due to interstitial cystitis and may improve blood supply to the treated area.

HOW TO USE: This medication is placed into the bladder, usually through a tube (catheter device). The medication is kept in the bladder for at least 15 minutes or as directed by your doctor. After this time, urinate to remove the drug from the bladder.

This treatment is usually repeated every two weeks until relief of symptoms occurs. Follow your doctor's instructions carefully.

This medication is not meant to be given in any other way such as injection into a vein, muscle, or joint. Also, DMSO should not be placed into the bladder at the same time as any other medications.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Bladder pain and discomfort may occur. A garlic-like taste in the mouth may be noticed within minutes of placing this medication in the bladder. This taste may last several hours, and an odor on the breath or from the skin may be noticed for up to 3 days following use of this medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using dimethyl sulfoxide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer of the urinary tract.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver function, kidney function, complete blood counts, eye exams) should be performed from time to time to check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.