Tropicamide is pharmacologically related to the parasympatholytic (anticholinergic) group

Used for mydriasis and cycloplegia for diagnostic purposes. For cycloplegic effect in refractions, the 1.0 % solution is necessary

Posology
Adults, Elderly, and Children

Fundoscopy:
1 or 2 drops of 0.5% Tropicamide Eye drops MYDRIACYL* sterile ophthalmic solution, solution instilled into the eye(s) 15 to 20 minutes prior to examination.

Cycloplegic Refraction:
1 or 2 drops of 1% MYDRIACYL* sterile ophthalmic solution repeated after 5 minutes. If the patient is not seen within 20 to 30 minutes an additional drop may be instilled to prolong the effect.

Pediatric Population
Do not use in concentrations greater than 0.5% in small infants (See section 4.4, Section 4.8 and Section 4.9)

Use in Patients with Hepatic or Renal Impairment
The safety and efficacy of MYDRIACYL* sterile ophthalmic solution , in patients with hepatic and renal impairment have not been established.

Method of Administration
For ocular use

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended.

This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

If more than one topical ophthalmic product is being used, the products must be administered at least 5 minutes apart. Eye ointments should be administered last.

-  MYDRIACYL* sterile ophthalmic solution 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 the therapy.
- MYDRIACYL* sterile ophthalmic solutioninduced psychotic reactions and behavioral disturbances may occur in patients with increased susceptibility to anticholinergic drugs (See Section 4.8 Undesirable effects).
-  MYDRIACYL* sterile ophthalmic solution contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of MYDRIACYL* sterile ophthalmic solution and wait at least 15 minutes before reinsertion.

Paediatric Population
- 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 (See section 4.2).
- 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 effects of MYDRIACYL* sterile ophthalmic solution may be enhanced by concomitant use of other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics, and tricyclic antidepressants.

Pregnancy
There are limited data from the use of MYDRIACYL* sterile ophthalmic solution in pregnant women. MYDRIACYL* sterile ophthalmic solution ,is not recommended during pregnancy.

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 breast- feeding or to discontinue/abstain from MYDRIACYL* sterile ophthalmic solution , therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

MYDRIACYL* sterile ophthalmic solution 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.

The following adverse reactions have been reported following use of MYDRIACYL* sterile ophthalmic solution. Frequency cannot be estimated from the available data. Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.

Cycloplegic drugs may increase intraocular pressure and can precipitate angle-closure glaucoma in predisposed patients (See Section 4.3 Contraindications and Section 4.4 Special warnings and precautions for use).

Psychotic reactions and behavioral disturbances have been reported with this class of drug, especially in children (See Section 4.4 Special warnings and precautions for use).

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.

To report any side effect(s):
       Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
O Fax: +966-11-205-7662
O Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
O Toll free phone: 8002490000
O E-mail: npc.drug@sfda.gov.sa
O Website: www.sfda.gov.sa/npc
     Other GCC States:
- Please contact the relevant competent authority

An ocular overdose of 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 distension 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.

Pharmacotherapeutic group: Mydriatics and cycloplegics – Anticholinergics ATC Code: S01F A06

Mechanism of Action
Tropicamide is an anticholinergic preparation that blocks the response of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, dilating the pupil (mydriasis). The stronger preparation (1%) also paralyzes accommodation.

Pharmacodynamic Effects
Tropicamide acts within 15-30 minutes and the duration of activity is approximately 3-8 hours.

Clinical Studies
Tropicamide is an established medication.

Pediatric population
Two prospective randomized studies evaluated the effectiveness of tropicamide 1% compared to cyclopentolate 1% during routine ophthalmic examination. Both agents demonstrated comparable effectiveness in measuring refractive error, however tropicamide was found to inhibit accommodation to a lesser degree than cyclopentolate.

Absorption
MYDRIACYL* sterile ophthalmic solution is rapidly absorbed into the systemic circulation following instillation into the eye. Maximal systemic concentrations of tropicamide are generally detected 5 to 30 minutes after instillation and thereafter, systemic tropicamide concentrations decline rapidly.

Distribution:
Following intravenous administration, diffusion of tropicamide from blood to the iris is rapid while there is a lack of mydriatic response in the contralateral or undosed eye after topical administration.
These data may suggest that tropicamide distributes rapidly across the cornea to the site of action, the iris. Loss of mydriatic effect suggests that there is a subsequent rapid distribution of tropicamide from the iris into the systemic circulation may account for its rapid disappearance from the eye.
The duration and amplitude of the mydriatic response from tropicamide is also influenced by iris coloration.

Biotransformation
There are no data on the metabolism of tropicamide.

Elimination
MYDRIACYL* sterile ophthalmic solution is rapidly eliminated from plasma
after ocular administration.

Linearity non-linearity
The duration and maximum intensity of mydriasis exhibit a consistent increase with dose as determined by the tropicamide concentration.

Pharmacokinetic pharmacodynamics relationship(s)
The relationship between tropicamide tissue response and concentration has been evaluated and a dose-response relationship obtained. The onset of mydriasis occurs within 15 to 30 minutes after administration and generally persists for 3 to 8 hours, but the duration may be up to 24 hours in some subjects.

PK in renal or hepatic impaired patients
There are no data on the pharmacokinetics of tropicamide in patients with renal and/or hepatic impairment.

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Inactive (Preservative):Benzalkonium chloride
Excipients: Disodium edetate, Sodium chloride, Sodium hydroxide, hydrochloric acid & Purified water

Not applicable

Store below 30°C. Do not refrigerate or store at high temperature.
Discard 4 weeks after first opening.
Do not use this medicine after the expiry date which is stated on the packaging.
Keep this medicine out of the sight and reach of children.

15 mL DROP TAINER, White LDPE bottles with LDPE dispensing plug and PP closure.

No special requirements.