Reversol (Injection)

Edrophonium injection is used to help diagnose myasthenia gravis (severe muscle weakness) and may be used to help choose the right treatment for the disease. It is also used to reverse the effects of some muscle relaxants (for example, gallamine, tubocurarine) during surgery or after an overdose of the muscle relaxant. Edrophonium is an anticholinesterase agent.

This medicine must be given only by or under the direct supervision of a doctor.

Your doctor will closely monitor the progress of you or your child while receiving this medicine. This will help your doctor determine if the medicine is effective and if you should continue to receive it.

The stopper of the vial contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Inform your doctor if you or your child have a latex allergy before starting this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Notify your doctor or nurse right away if you experience itching, hoarseness, difficulty breathing, difficulty swallowing, or any swelling of your hands, face, mouth, or throat while receiving this medicine.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed so far have not shown any specific problems in children that would limit the usefulness of edrophonium injection.

Geriatric

No information is available on how age affects the effects of edrophonium injection in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

While some medicines should not be used together at all, in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around mealtimes or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Allergy to sulfites, history of—May cause severe allergic reactions.

• Asthma or other breathing problems, history of or
• Bradycardia (slow heart rate) or
• Heart rhythm problems—Use with caution. May worsen these conditions.

• Bladder blockage (unable to urinate) or
• Bowel blockage (unable to have a stool) or
• Kidney blockage (unable to urinate)—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Chest pain or discomfort
• dizziness
• fainting
• fast, slow, or irregular heartbeat
• increased frequency of urination
• increased sweating
• lightheadedness, dizziness, or fainting
• loss of bladder control
• muscle twitches that are visible under the skin
• seizures
• slurred speech
• trouble breathing
• trouble speaking
• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Abdominal or stomach cramps
• constricted pupils (black part of the eye)
• diarrhea
• double vision
• hoarseness
• increased salivation
• muscle weakness
• nausea
• redness of the white part of the eyes or inside of the eyelids
• sore throat
• vomiting
• watering of the eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Enlon
• Reversol

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Myasthenia Gravis

Pharmacologic Class: Cholinesterase Inhibitor

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given as a shot into a muscle or into a vein.