Brand Name

    US Brand Name

    Prostigmin Bromide


    Description

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

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


    Before Using

    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.

    Pediatric

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

    Geriatric

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

    Breastfeeding

    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.

    Drug Interactions

    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 taking 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:

    • Intestine blockage (blocked gut or abdomen) or
    • Kidney blockage (blocked urine flow) or
    • Peritonitis (lining of the abdomen is inflamed)—Should not be used in patients with these conditions.
    • Asthma or
    • Bradycardia (slow heartbeat) or
    • Heart attack, recent or
    • Heart rhythm problems or
    • Overactive thyroid or
    • Seizures or
    • Stomach ulcer—Use with caution. May make these conditions worse.

    Proper Use

    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.


    Precautions

    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 .


    Side Effects

    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 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 from a lying or sitting position suddenly
    • 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 in 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. 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

    • 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 mucous 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 healthcare professional.

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






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