Rimso-50

What is Rimso-50 used for?

Rimso-50 is a prescription medicine that is used to ease pain, swelling, and irritation of the bladder. This medicine may be used on your skin for some problems caused by other drugs. Rimso-50 may be given to you for other reasons.

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 C2H6OS, 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.

Before taking Rimso-50, tell your doctor:

• If you are allergic to Rimso-50; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Rimso-50 with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Rimso-50?

• Tell all of your health care providers that you take Rimso-50. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have an eye exam as you have been told by your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Rimso-50 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Rimso-50 best taken?

Use Rimso-50 as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Bladder irrigation:

• Do not take Rimso-50 by mouth. It is for use as a bladder rinse only.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

Skin:

• Do not take Rimso-50 by mouth. Use on your skin only.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Rimso-50 that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

For all uses of Rimso-50:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad irritation where Rimso-50 is used.

Bladder irrigation:

• Change in eyesight, eye pain, or very bad eye irritation.

What are some other side effects of Rimso-50?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

For all uses of Rimso-50:

• Irritation where Rimso-50 is used.

Bladder irrigation:

• Skin odor and breath odor like a garlic-like taste has happened with Rimso-50. This may last for up to 72 hours after you get Rimso-50.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Rimso-50?

• If you need to store Rimso-50 at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

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, IrelandRIMSO-50 is a registered trademark of Mylan Teoranta, a Viatris Company.
• MI:177:1C:R5
• Mylan.com

SRC: NLM .