Regonol

What is Regonol used for?

Regonol is a prescription medicine that is used to get back function in muscles after surgery. Regonol may be given to you for other reasons.

Description

REGONOL® (pyridostigmine bromide injection, USP) is an active cholinesterase inhibitor chemically designated as 3-hydroxy-1-methylpyridinium bromide dimethyl-carbamate.

Its structural formula is:

REGONOL® is supplied as a sterile, isotonic, nonpyrogenic solution for injection. Each mL contains 5 mg of pyridostigmine bromide USP as active, 10 mg BENZYL ALCOHOL NF as preservative WHICH IS NOT INTENDED FOR USE IN NEWBORNS, 0.23 mg sodium citrate dihydrate USP and 0.1 mg anhydrous citric acid USP as buffering agent, pH adjusted with sodium hydroxide NF and anhydrous citric acid USP if necessary and water for injection USP.

Before taking Regonol, tell your doctor:

• If you are allergic to Regonol; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have bowel block or trouble passing urine.
• If the patient is a newborn or infant. This medicine has benzyl alcohol in it. Benzyl alcohol may cause severe and sometimes deadly side effects in newborns or infants. Do not give Regonol to a newborn or infant.

This is not a list of all drugs or health problems that interact with this medicine.

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 Regonol 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 Regonol?

• Tell all of your health care providers that you take Regonol. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Unsafe effects, including death, may happen.
• This medicine is not approved for use in children. However, the doctor may decide the benefits of taking Regonol outweigh the risks. If your child has been given Regonol, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving Regonol to your child.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Regonol best taken?

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

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Regonol 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:

• 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.
• Muscle weakness that is new or worse.
• Trouble breathing that is new or worse.
• Upset stomach or throwing up.
• Stomach cramps.
• Diarrhea.
• More saliva.
• Small pupils.
• Sweating a lot.
• Muscle cramps.
• Twitching.
• Slow heartbeat.

What are some other side effects of Regonol?

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 you have any side effects that bother you or do not go away.

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 Regonol?

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

Label

CARTON

• NDC 0781-3040-95
• Regonol® Contains Benzyl Alcohol. Not for use in neonates.
• (Pyridostigmine Bromide Injection, USP)
• 10 mg/2 mL (5 mg/mL)
• FOR INTRAVENOUS USE ONLY
• Rx only
• Sterile
• 10 x 2 mL Single-Dose Ampules
• SANDOZ – A Novartis Division

SRC: NLM .