"The U.S. Food and Drug Administration today approved the Argus II Retinal Prosthesis System, the first implanted device to treat adult patients with advanced retinitis pigmentosa (RP). The device, which includes a small video camera, transmitter "...
(Generic versions may still be available.)
Humorsol Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Humorsol in Detail - Patient Information: Side Effects
Contact your doctor immediately if you notice any decrease in vision or an increase in "floaters" in your visual field. Rarely, demecarium bromide ophthalmic may cause retinal detachment. Retinal detachment can lead to blind spots, floaters in the visual field, and even blindness. Your doctor will want to check your retina before you use this medication to determine if you have an increased risk of retinal detachment.
If you experience any of the following serious side effects, stop using demecarium bromide ophthalmic and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives);
- abdominal cramps or diarrhea;
- watering mouth;
- excessive sweating;
- urinary incontinence;
- muscle weakness;
- difficulty breathing; or
- an irregular heart beat.
Other, less serious side effects may be more likely to occur. Continue to use demecarium bromide ophthalmic and talk to your doctor if you experience
- burning, stinging, red, or tearing eyes;
- eyelid muscle twitches;
- headache or brow ache; or
- decreased vision in poor light.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Humorsol (Demecarium) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Humorsol FDA Prescribing Information: Side Effects
Iris cysts may form, enlarge, and obscure vision. Occurrence is more frequent in children. The iris cyst usually shrinks upon discontinuance of the miotic. Rarely, the cyst may rupture or break free into the aqueous. Frequent examination for this occurrence is advised.
Lens opacities have been reported in patients on miotic therapy. Routine slit-lamp examinations, including the lens, should accompany prolonged use.
Prolonged use may cause conjunctival thickening and obstruction of nasolacrimal canals.
Systemic effects, which occur rarely, are suggestive of increased cholinergic activity. Such effects may include nausea, vomiting, abdominal cramps, diarrhea, urinary incontinence, salivation, sweating, difficulty in breathing, bradycardia, or cardiac irregularities. Medical management of systemic effects may be indicated (see TREATMENT OF ADVERSE EFFECTS ).
TREATMENT OF ADVERSE EFFECTS
If HUMORSOL (demecarium) is taken systemically by accident, or if systemic effects occur after topical application in the eye or from accidental skin contact, administer atropine sulfate parenterally (intravenously if necessary) in a dose (for adults) of 0.4 to 0.6 mg or more. The recommended dosage of atropine in infants and children up to 12 years of age is 0.01 mg/kg repeated every two hours as needed until the desired effect is obtained, or adverse effects of atropine preclude further usage. The maximum single dose should not exceed 0.4 mg.
The use of much larger doses of atropine in treating anticholinesterase intoxication in adults has been reported in the literature. Initially 2 to 6 mg may be given followed by 2 mg every hour or more often, as long as muscarinic effects continue. The greater possibility of atropinization with large doses, particularly in sensitive individuals, should be borne in mind.
Pralidoxime** chloride has been reported to be useful in treating systemic effects due to cholinesterase inhibitors. However, its use is recommended in addition to and not as substitute for atropine.
A short-acting barbiturate is indicated if convulsions occur that are not entirely relieved by atropine. Barbiturate dosage should be carefully adjusted to avoid central respiratory depression. Marked weakness or paralysis of muscles of respiration should be treated promptly by artificial respiration and maintenance of a clear airway.
The oral LD 50 of HUMORSOL (demecarium) is 2.96 mg/kg in the mouse.
**PROTOPAM® Chloride (Pralidoxime Chloride). Ayerst Laboratories
Read the entire FDA prescribing information for Humorsol (Demecarium) »
Additional Humorsol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.