RIMSO-50 Aqueous solution for instillation (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Mylan Institutional LLC

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1. 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 ...

2. 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 ...

3. 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 ...

4. Contraindications

None known.

5. 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 ...

6. Precautions

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, ...

7. 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 ...

8. Drug Abuse and Dependence

None known.

9. Overdosage

The oral LD<sub>50</sub> 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. ...

10. 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 ...

11. 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 Manufactured ...

12. Storage and Handling

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, Rockford, IL 61103. ...