MYDRIACYL Tropicamide 5mg / mL (0.5%) Sterile Ophthalmic Solution 5mL
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Features
- Tropicamide
Description
Indications/Uses
Dosage/Direction for Use
Overdosage
Systemic toxicity may occur following topical use, particularly in children. It is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distention in infants, convulsions and hallucinations and the loss of neuromuscular coordination.
Treatment is symptomatic and supportive. In infants and small children the body surface must be kept moist.
Contraindications
Warnings
Reproductive studies have not been performed in animals. There is no adequate information on whether this drug may affect fertility in human males or females or have a teratogenic potential or other adverse effect on the fetus. This preparation may cause CNS disturbances which may be dangerous in infants and children. Possibility of occurrence of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be borne in mind.
Patient Warning: Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation.
Special Precautions
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to avoid excessive systemic absorption.
Tropicamide-induced psychotic reactions and behavioral disturbances may occur in patients with increased susceptibility to anticholinergic drugs.
TROPICAMIDE (MYDRIACYL) Sterile Ophthalmic Solution contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to the application of TROPICAMIDE (MYDRIACYL) Sterile Ophthalmic Solution and wait at least 15 minutes before reinsertion.
Effects on Ability to Drive and Use Machines: Tropicamide may cause drowsiness, blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear.
Use in Children: Do not use in concentration greater than 0.5% in small infants. Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children.
Excessive use in children may produce systemic toxic symptoms. Use with extreme caution in infants, small or premature children, or children with Down syndrome, spastic paralysis or brain damage.
Parents should be warned of the oral toxicity of this preparation for children and advised to wash their own hands and the child’s hands following administration.
Use In Pregnancy & Lactation
Use in Lactation: It is unknown whether tropicamide/metabolites are excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from TROPICAMIDE (MYDRIACYL) Sterile Ophthalmic Solution therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Adverse Reactions
The following adverse reactions have been reported following use of tropicamide topical ophthalmic preparations. Frequencies cannot be estimated from the available data. Within each System Organ Class, adverse reactions are presented in order of decreasing seriousness. (See table.)
Other toxic manifestations of anticholinergic drugs include flushing of the skin, dryness of mucous membranes, tachycardia, decrease secretion in sweat glands and dryness of the mouth, diminished gastrointestinal motility and constipation, urinary retention and decreased nasal, bronchial and lachrymal secretions.