Rimso-50
Dimethyl Sulfoxide
Mylan Institutional Llc
Human Prescription Drug
NDC 67457-177Rimso-50 also known as Dimethyl Sulfoxide is a human prescription drug labeled by 'Mylan Institutional Llc'. National Drug Code (NDC) number for Rimso-50 is 67457-177. This drug is available in dosage form of Irrigant. The names of the active, medicinal ingredients in Rimso-50 drug includes Dimethyl Sulfoxide - .54 g/mL . The currest status of Rimso-50 drug is Active.
Drug Information:
| Drug NDC: | 67457-177 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Rimso-50 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Dimethyl Sulfoxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mylan Institutional Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Irrigant |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | DIMETHYL SULFOXIDE - .54 g/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVESICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 04 Apr, 1978 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 29 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA017788 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Mylan Institutional LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 208361 562359
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | YOW8V9698H
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 67457-177-50 | 1 VIAL, GLASS in 1 CARTON (67457-177-50) / 50 mL in 1 VIAL, GLASS | 04 Apr, 1978 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Rimso-50 dimethyl sulfoxide dimethyl sulfoxide dimethyl sulfoxide water
Indications and Usage:
Indications and usage 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.
Warnings:
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.
Dosage and Administration:
Dosage and administration 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).
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions 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 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.
Overdosage:
Overdosage the oral ld 50 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.
Description:
Description 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 rimso-50 ® is dimethyl sulfoxide which has the empirical formula c 2 h 6 os, 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. chemical structure
Clinical Pharmacology:
Clinical pharmacology 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.
How Supplied:
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 store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] protect from strong light. for additional information concerning rimso-50®, contact mylan institutional llc, morgantown, wv 26505. manufactured for: mylan institutional llc morgantown, wv 26505 u.s.a. manufactured by: mylan institutional galway, ireland
Information for Patients:
Information for patients (physician copy) 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 rep
Read more...eated 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. rimso-50® (dimethyl sulfoxide) irrigation, usp 1013l102 mylan institutional llc morgantown, wv 26505 u.s.a. revised: 3/2021 mi:rimsig:r5 rimso-50 is a registered trademark of mylan teoranta, a viatris company.
Information for patients (patient copy) 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 repea
Read more...ted 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.
Package Label Principal Display Panel:
Principal display panel - 50 ml vial ndc 67457-177-50 50 ml rimso-50 ® (dimethyl sulfoxide) irrigation, usp 50 ml (54 gm) 50% w/w aqueous solution for irrigation only not for injection rx only vial sterile. non-pyrogenic. contains: 50% w/w dimethyl sulfoxide in water for injection. usual dosage: see accompanying prescribing information. store at 20° to 25°c (68° to 77°f). [see usp controlled room temperature.] protect from strong light. manufactured for: mylan institutional llc morgantown, wv 26505 u.s.a. manufactured by: mylan institutional galway, ireland rimso-50 is a registered trademark of mylan teoranta, a viatris company. mi:177:1c:r5 mylan.com rimso-50 (dimethyl sulfoxide) irrigation usp, 50 ml carton label