Rimso-50

Metabolism: oxidized to dimethylsulfone & reduced to dimethylsulfide

Excretion: feces, urine, breath, sweat

Mechanism of Action

Analgesic & antiinflammatory; may inhibit free radical formation

Has anti-inflammatory, analgesic, mast cell inhibition, and muscle relaxing effects

Pharmacokinetics

Absorption: Well absorbed

Metabolism: Oxidation to dimethyl

Excretion: Urine, feces, skin, lungs

Distribution: Rapidly penetrates tissues

Metabolism: Oxidized to dimethylsulfone & reduced to dimethylsulfide

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers if you feel severe discomfort or irritation when the medicine is inserted, or while you are holding it in your bladder. This discomfort may become less noticeable over time with repeat treatments.

You may notice a garlic- or onion-like taste in your mouth while you are receiving dimethyl sulfoxide. This effect may last for several hours after you receive the medicine, and you may also sense these odors on your breath or skin. This is a normal side effect of dimethyl sulfoxide and is not cause for concern.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For bladder irrigation dosage form:
  • For interstitial cystitis of bladder:
    • Adults—50 mL (milliliters) of a 50% solution is instilled into the bladder and left there for fifteen minutes. The treatment is repeated every two weeks until relief is obtained; then the treatment is repeated less often.
    • Children—Use and dose must be determined by your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Nasal congestion
• shortness of breath or troubled breathing
• skin rash, hives, or itching
• swelling of face

Some patients may have some discomfort during the time this medicine is being put into the bladder. However, the discomfort usually becomes less each time the medicine is used.

Dimethyl sulfoxide may cause you to have a garlic-like taste within a few minutes after the medicine is put into the bladder. This effect may last for several hours. It may also cause your breath and skin to have a garlic-like odor, which may last up to 72 hours.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

PRESCRIBING INFORMATION

Rx only

None known.

Applies to dimethyl sulfoxide: intravesical solution

Along with its needed effects, dimethyl sulfoxide (the active ingredient contained in Rimso-50) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dimethyl sulfoxide:

• Nasal congestion
• shortness of breath or troubled breathing
• skin rash, hives, or itching
• swelling of face

Some patients may have some discomfort during the time this medicine is being put into the bladder. However, the discomfort usually becomes less each time the medicine is used.

Dimethyl sulfoxide may cause you to have a garlic-like taste within a few minutes after the medicine is put into the bladder. This effect may last for several hours. It may also cause your breath and skin to have a garlic-like odor, which may last up to 72 hours.