WARNINGS
Neostigmine Methylsulfate Injection should be used with
caution in patients with epilepsy, bronchial asthma, bradycardia,
recent coronary occlusion, vagotonia, hyperthyroidism,
cardiac arrhythmias or peptic ulcer. When large doses
of Neostigmine Methylsulfate Injection are administered,
the prior or simultaneous injection of atropine sulfate
may be advisable. Separate syringes should be used for
the neostigmine methylsulfate and atropine. Because of
the possibility of hypersensitivity in an occasional patient,
atropine and antishock medication should always be readily
available.
PRECAUTIONS
General
It is important to differentiate between myasthenic crisis
and cholinergic crisis caused by ovendosage of Neostigmine
Methylsulfate Injection. Both conditions result in extreme
muscle weakness but require radically different treatment.
(See OVERDOSAGE)
Drug Interactions
See DRUG INTERACTIONS section.
Carcinogenesis, Mutagenesis and Impairment of
Fertility
There have been no studies with neostigmine methylsulfate
which would permit an evaluation of its carcinogenic or
mutagenic potential. Studies on the effect of neostigmine
methylsulfate on fertility and reproduction have not been
performed.
Pregnancy
Teratogenic Effects: Pregnancy Category C
— There are no adequate or well-controlled studies
of neostigmine methylsulfate in either laboratory animals
or in pregnant women. It is not known whether neostigmine
methylsulfate can cause fetal harm when administered to
a pregnant woman or can affect reproductive capacity. Neostigmine
methylsulfate should be given to a pregnant woman only if
clearly needed.
Nonteratogenic Effects: Anticholi nesterase
drugs may cause uterine irritability and induce premature
labor when given IV to pregnant women near term.
Nursing Mothers
It is not known whether neostigmine methylsulfate is
excreted in human milk. Because many drugs are excreted
in human milk and because of the potential for serious
adverse reactions from neostigmine methylsulfate in nursing
infants, a decision should be made whether to discontinue
nursing onto discontinue the drug, taking into account
the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in children have not been established.
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