FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
Prostigmin should be used with caution in patients with epilepsy, bronchial asthma, bradycardia, recent coronary occlusion, vagotonia, hyperthyroidism, cardiac arrhythmias or peptic ulcer. As a rule, 15 mg of neostigmine bromide orally is equivalent to 0.5 mg of neostigmine methylsulfate parenterally, due to poor absorption of the tablet from the intestinal tract. Large doses should be avoided in situations where there might be an increased absorption rate from the intestinal tract. It should be used with caution when co-administered with anticholinergic drugs, in order to avoid reduction in intestinal mobility.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Prostigmin is indicated for the symptomatic treatment of myasthenia gravis. Its greatest usefulness is in prolonged therapy where no difficulty in swallowing is present. In acture myasthenic crisis where difficulty in breathing and swallowing is present, the parenteral form (neostigmine methylsulfate) should be used. The patient can be transferred to the oral form as soon as it can be tolerated.
History
There is currently no drug history available for this drug.
Other Information
Prostigmin (neostigmine bromide), an anticholinesterase agent, is available for oral administration in 15-mg tablets. Each tablet also contains gelatin, lactose, corn starch, stearic acid, sugar and talc.
Chemically, neostigmine bromide is (m-hydroxy-phenyl)trimethylammonium bromide dimethylcarbamate. It is a white, crystalline, bitter powder, soluble 1:1 in water, with a molecular weight of 303.20 and the following structural formula:
Sources
Prostigmin Manufacturers
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Valeant Pharmaceuticals North America Llc
Prostigmin | Valeant Pharmaceuticals North America Llc
The onset of action of Prostigmin given orally is slower than when given parenterally, but the duration of action is longer and the intensity of action more uniform. Dosage requirements for optimal results vary from 15 mg to 375 mg per day. In some instances it may be necessary to exceed these dosages, but the possibility of cholinergic crisis must be recognized. The average dose is 10 tablets (150 mg) administered over a 24-hour period. The interval between doses is of paramount importance. The dosage schedule should be adjusted for each patient and changed as the need arises. Frequently, therapy is required day and night. Larger portions of the total daily dose may be given at times when the patient is more prone to fatigue (afternoon, mealtimes, etc.). The patient should be encouraged to keep a daily record of his or her condition to assist the physician in determining an optimal therapeutic regimen.
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