* Administration of oral analgesic medication or suppositories containing belladonna and opium prior to the instillation of RIMSO-50® can reduce bladder spasm.
* 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).
* 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).
|offLabelAdultGuideSupport=* Interstitial cystitis, chronic: instill 50 mL (50% solution) into bladder, allow to remain for 15 min; repeat at 14-day intervals until symptomatic relief attained
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.
|offLabelAdultNoGuideSupport=* Injection site extravasation
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
|offLabelAdultNoGuideSupport=* Injection site extravasation
|fdaLIADPed=
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
|offLabelPedGuideSupport=
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|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 RIMSO-50®. The physician should be cognizant of this possibility in prescribing RIMSO-50®. If anaphylactoid symptoms develop, appropriate therapy should be instituted.
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
|postmarketing=* Dimethyl sulfoxide can initiate the liberation of histamine and there has been occasional hypersensitivity reaction with topical administration of dimethyl sulfoxide.
=====Digestive=====
* 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.
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=* Drug
:* Description
:* Description
<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
|FDAPregCat=C
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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<!--Overdosage-->
<!--Overdosage-->
|overdose====Acute Overdose===
|overdose=* 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® 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.
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox={{Chembox2
|drugBox={{Chembox2
| Name = Dimethyl sulfoxide
| Name = Dimethyl sulfoxide
Line 301:
Line 137:
<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=* 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-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
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<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*
|howSupplied=*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
|storage=* Store at 20° to 25°C (68° to 77°F)
|packLabel=<!--Patient Counseling Information-->
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=* RIMSO-50® 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.
* RIMSO-50® will be instilled in the bladder on an inpatient or out-patient basis, which will be determined by your physician.
<!--Precautions with Alcohol-->
* 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 RIMSO-50® instillation.
* 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. 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.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* RIMSO-50®<ref>{{Cite web | title = | url = }}</ref>
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Overview
Dimethyl sulfoxide is a 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)
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.
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).
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.
Off-Label Use and Dosage (Adult)
Non–Guideline-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.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-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 RIMSO-50®. The physician should be cognizant of this possibility in prescribing RIMSO-50®. 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 RIMSO-50®. If anaphylactoid symptoms develop, appropriate therapy should be instituted.
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
Oral
Intravenous
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 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.
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 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
Storage
Store at 20° to 25°C (68° to 77°F)
Images
Drug Images
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RIMSO-50® 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.
RIMSO-50® 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 RIMSO-50® instillation.
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. 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.
