MYDRIACYL Tropicamide 5mg / mL (0.5%) Sterile Ophthalmic Solution 5mL
RXDRUG-DR-XY13767
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
For mydriasis and cycloplegia for diagnostic procedures.
Dosage/Direction for Use
For examination of fundus, one or two drops 15 or 20 minutes prior to examination. Individuals with heavily pigmented irides may require larger doses.
Overdosage
An ocular overdose of TROPICAMIDE (MYDRIACYL) Sterile Ophthalmic Solution can be flushed from the eye(s) with lukewarm water.
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.
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
Contraindicated in patients with known or suspected angle-closure glaucoma. Hypersensitivity to the active substance or to any of the excipients.
Warnings
FOR EXTERNAL USE ONLY-NOT FOR INJECTION.
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.
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
Tropicamide may cause increased intraocular pressure. The possibility of undiagnosed glaucoma should be considered in some patients, such as elderly patients. Determine the intraocular pressure and an estimation of the depth of the angle of the anterior chamber prior to initiation of therapy.
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.
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 Pregnancy: There are no or limited amount of data from the use of Tropicamide in pregnant women. TROPICAMIDE (MYDRIACYL) Sterile Ophthalmic Solution is not recommended during pregnancy.
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.
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
Increased intraocular pressure: Psychotic reactions, behavioral disturbances, and cardiorespiratory collapse in children with this class of drugs have been reported. Transient stinging, dryness of the mouth, blurred vision, photophobia with or without corneal staining, tachycardia, headache, parasympathetic stimulation, or allergic reaction may occur.
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.)
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.)
Cycloplegic drugs may increase intraocular pressure and can precipitate angle-closure glaucoma in predisposed patients. Psychotic reactions and behavioral disturbances have been reported with this class of drug, especially in children.
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.
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.
Drug Interactions
The effects of tropicamide may be enhanced by concomitant use of other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics, and tricyclic antidepressants.
Storage
Store at a temperature not exceeding 25°C. Protect from light. Keep container tightly closed.
Action
Clinical particulars: This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). This preparation acts rapidly and the duration of activity is relatively short. May be useful in producing mydriasis with only slight cycloplegia
MedsGo Class
Mydriatic Drugs
Features
Brand
Mydriacyl
Full Details
Dosage Strength
5 mg / mL (0.5%)
Drug Ingredients
- Tropicamide
Drug Packaging
Sterile Ophthalmic Solution 5ml
Generic Name
Tropicamide
Dosage Form
Sterile Ophthalmic Solution
Registration Number
DR-XY13767
Drug Classification
Prescription Drug (RX)
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