Pronunciation:

nee-oh-STIG-meen

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Cholinesterase Inhibitor

Uses of This Medicine:

Neostigmine injection is used to treat a muscle disease called myasthenia gravis.

Neostigmine injection is also used to prevent or treat certain kidney or intestinal problems. This medicine is also given after surgery to help reverse the effects of certain types of medicines that have been used to relax the muscles.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. 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 tell your health care 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of neostigmine injection in children. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Bloxiverz™ in children. However, infants and small children may be more sensitive to the effects of this medicine.

Older adults—

No information is available on the relationship of age to the effects of neostigmine injection in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Bloxiverz™ in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution for patients receiving Bloxiverz™.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment 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

Other interactions—

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

Other medical problems—

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

• Asthma or
• Bradycardia (slow heartbeat) or
• Coronary artery disease (heart disease) or
• Heart attack, recent or
• Heart rhythm problems or
• Hypotension (low blood pressure) or
• Overactive thyroid or
• Seizures or
• Stomach ulcer—Use with caution. May make these conditions worse.

• Intestinal (bowel) blockage or
• Peritonitis (swelling of the lining of the abdomen or stomach) or
• Urinary tract blockage—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins, under your skin, or into your muscle.

Precautions While Using This Medicine:

Your doctor will only give you a few doses of this medicine until your condition improves, and then you will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Side Effects of This Medicine:

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

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

More common

Blurred or loss of vision

chest pain, discomfort, or tightness

confusion

difficult or labored breathing

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fast, slow, pounding, or irregular heartbeat or pulse

lightheadedness, dizziness, or fainting

sweating

twitches of the muscle visible under the skin

unusual tiredness or weakness

Incidence not known

Changes in patterns and rhythms of speech

cough

difficulty in moving

difficulty swallowing

disturbed color perception

double vision

halos around lights

hives

irregular, fast or slow, or shallow breathing

itching

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 the joints

pale or blue lips, fingernails, or skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

skin rash

slurred speech

stopping of the heart

trouble in speaking

tunnel vision

unconsciousness

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. Also, 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 or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at site

drowsiness

headache

increased watering of the mouth

nausea

sleeplessness

sore throat

trouble sleeping

unable to sleep

vomiting

Incidence not known

Bloated

constricted, pinpoint, or small pupils (black part of eye)

diarrhea

dry mouth

excess air or gas in the stomach or intestines

feeling of warmth

full feeling

increase in mucous from the lungs

increased need to urinate

increased sweating

passing gas

passing urine more often

redness of the face, neck, arms and occasionally, upper chest

redness of the skin

skin rash

stomach cramps

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.