Prostigmin Bromide (Oral)

Neostigmine is used to treat a muscle disease known as myasthenia gravis.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

If your symptoms do not improve or if they become worse, check with your doctor.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been conducted on how neostigmine affects children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how neostigmine affects older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might occur. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this medicine, it is very important that your healthcare professional knows if you are also taking any of the medicines listed below. The following interactions are selected based on their potential significance and may not include all possible interactions.

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

• Amifampridine
• Bupropion
• Donepezil

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment option for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Succinylcholine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, particularly:

• Intestine blockage (blocked gut or abdomen) or
• Kidney blockage (blocked urine flow) or
• Peritonitis (inflammation of the abdominal lining)—This medicine should not be used in patients with these conditions.

• Asthma or
• Bradycardia (slow heartbeat) or
• Recent heart attack or
• Heart rhythm problems or
• Overactive thyroid or
• Seizures or
• Stomach ulcer—Use with caution. This medicine may worsen these conditions.

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

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

More common

• Twitches of the muscle visible under the skin

Incidence not known

• Blurred or loss of vision
• Changes in patterns and rhythms of speech
• Chest pain or discomfort
• Confusion
• Cough
• Difficult or labored breathing
• Difficulty in moving
• Difficulty swallowing
• Disturbed color perception
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Double vision
• Fast, pounding, or irregular heartbeat or pulse
• Halos around lights
• Hives
• Irregular, fast or slow, or shallow breathing
• Itching
• Lightheadedness, dizziness, or fainting
• Loss of consciousness
• Muscle cramps and spasms
• Muscle pain or stiffness
• Night blindness
• No blood pressure or pulse
• Noisy breathing
• Overbright appearance of lights
• Pain in joints
• Pale or blue lips, fingernails, or skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Seizures
• Shortness of breath
• Skin rash
• Slow or irregular heartbeat
• Slurred speech
• Stopping of heart
• Sweating
• Tightness in chest
• Trouble speaking
• Tunnel vision
• Unconsciousness
• Unusual tiredness or weakness
• Wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of Overdose

• Constipation
• Decreased sexual ability
• Difficult urination
• Dry mouth
• Enlarged pupils
• Muscle weakness

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 also 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:

More common

• Increased watering of mouth

Incidence not known

• Bloated
• Constricted, pinpoint, or small pupils (black part of eye)
• Diarrhea
• Drowsiness
• Excess air or gas in stomach or intestines
• Feeling of warmth
• Full feeling
• Headache
• Increase in mucus from lungs
• Increased need to urinate
• Increased sweating
• Nausea
• Passing gas
• Passing urine more often
• Redness of skin
• Redness of the face, neck, arms, and occasionally, upper chest
• Skin rash
• Stomach cramps
• Vomiting

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

• Prostigmin Bromide

Pharmacologic Class: Cholinesterase Inhibitor

It is important to keep a daily record of when you take each dose and how long it lasts. This will help your doctor decide if your dose needs to be adjusted.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For myasthenia gravis: Adults—The usual dose is 15 to 375 milligrams (mg) each day, given in divided doses. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.