" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
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Prostigmin (neostigmine) 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 of intestinal motility.
It is important to differentiate between myasthenic crisis and cholinergic crisis caused by overdosage of Prostigmin (neostigmine) . Both conditions result in extreme muscle weakness but require radically different treatment. (See OVERDOSAGE section.)
Carcinogenesis, Mutagenesis and Impairment of Fertility
There have been no studies with Prostigmin (neostigmine) which would permit an evaluation of its carcinogenic or mutagenic potential. Studies on the effect of Prostigmin (neostigmine) on fertility and reproduction have not been performed.
Teratogenic Effects: Pregnancy Category C. There are no adequate or well-controlled studies of Prostigmin (neostigmine) in either laboratory animals or in pregnant women. It is not known whether Prostigmin (neostigmine) can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Prostigmin (neostigmine) should be given to a pregnant woman only if clearly needed.
Anticholinesterase drugs may cause uterine irritability and induce premature labor when given intravenously to pregnant women near term.
It is not known whether Prostigmin (neostigmine) is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from Prostigmin (neostigmine) in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in children have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/26/2009
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