In patients receiving cholinesterase inhibitors such as HUMORSOL (demecarium) , succinylcholine should be administered with extreme caution before and during general anesthesia.
Because of possible adverse additive effects, HUMORSOL (demecarium) should be administered only with extreme caution to patients with myasthenia gravis who are receiving systemic anticholinesterase therapy; conversely, extreme caution should be exercised in the use of an anticholinesterase drug for the treatment of myasthenia gravis patients who are already undergoing topical therapy with cholinesterase inhibitors.
Gonioscopy is recommended prior to medication with HUMORSOL (demecarium) .
HUMORSOL (demecarium) should be used with caution in patients with chronic angle-closure (narrow-angle) glaucoma or in patients with narrow angles, because of the possibility of producing pupillary block and increasing angle blockage.
When an intraocular inflammatory process is present, the intensity and persistence of miosis and ciliary muscle contraction that result from anticholinesterase therapy require abstention from, or cautious use of, HUMORSOL (demecarium) .
Systemic effects are infrequent when HUMORSOL (demecarium) is instilled carefully. Compression of the lacrimal duct for several seconds immediately following instillation minimizes drainage into the nasal chamber with its extensive absorption surface. Wash the hands immediately after instillation.
Discontinue HUMORSOL (demecarium) if salivation, urinary incontinence, diarrhea, profuse sweating, muscle weakness, respiratory difficulties, shock, or cardiac irregularities occur.
Persons receiving cholinesterase inhibitors who are exposed to organophosphate-type insecticides and pesticides (gardeners, organophosphate plant or warehouse workers, farmers, residents of communities which are undergoing insecticide spraying or dusting, etc.) should be warned of the added systemic effects possible from absorption through the respiratory tract or skin. Wearing of respiratory masks, frequent washing, and clothing changes may be advisable.
Anticholinesterase drugs should be used with extreme caution, if at all, in patients with marked vagotonia, bronchial asthma, spastic gastrointesinal disturbances, peptic ulcer, pronounced bradycardia and hypotension, recent myocardial infarction, epilepsy, parkinsonism, and other disorders that may respond adversely to vagotonic effects.
After long-term use of HUMORSOL (demecarium) , dilation of blood vessels and resulting greater permeability increase the possibility of hyphema during ophthalmic surgery. Therefore, this drug should be discontinued before surgery.
Despite observance of all precautions and the use of only the recommended dose, there is some evidence that repeated administration may cause depression of the concentration of cholinesterase in the serum and erythrocytes, with resultant systemic effects.
There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. (See
PRECAUTIONS, Information for Patients . )
Information for Patients
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.
Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. (See
PRECAUTIONS , General . )
Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma, ocular surgery or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
The preservative in HUMORSOL (demecarium) , benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling HUMORSOL (demecarium) before they insert their lenses.
WARNINGS regarding possible drug interactions of HUMORSOL (demecarium) with succinylcholine or with other anticholinesterase agents.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate the effects of HUMORSOL (demecarium) on fertility or carcinogenic potential.
Pregnancy Category X: See CONTRAINDICATIONS.
It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from HUMORSOL (demecarium) , 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.
The occurrence of iris cysts is more frequent in pediatric patients. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION.)
Extreme caution should be exercised in pediatric patients receiving HUMORSOL (demecarium) who may require general anesthesia (see
Since HUMORSOL (demecarium) is a potent cholinesterase inhibitor it should be kept out of the reach of children.