Product Monograph - Odan-Cyclopentolate
INDICATIONS AND CLINICAL USE
Odan-Cyclopentolate (cyclopentolate hydrochloride ophthalmic solution, USP) is used to produce mydriasis and cycloplegia.
Geriatrics (> 65 years of age):
Evidence from clinical studies and experience suggests that use in the geriatric population may be associated with differences in safety or effectiveness (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
Pediatrics (< 6 years of age):
Odan-Cyclopentolate should not be used in pediatric patients < 6 years of age due to the risk of serious side effects.
Pediatrics (≥ 6 years of age):
Evidence from clinical studies and experience suggests that use in certain subgroups of the pediatric population is associated with differences in safety or effectiveness (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics (≥ 6 years of age) and DOSAGE AND ADMINISTRATION).
CONTRAINDICATIONS
Odan-Cyclopentolate is contraindicated in:
- Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Prescribing Information.
- Patients with known or suspected angle-closure glaucoma.
- Pediatric patients < 6 years of age.
WARNINGS AND PRECAUTIONS
General
Odan-Cyclopentolate is for topical use only and is not for injection.
Odan-Cyclopentolate should be used with caution in patients, especially children, who have previously had a severe systemic reaction to atropine.
Because of the risk of provoking hyperthermia, Odan-Cyclopentolate should be used with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.
Ophthalmologic
Odan-Cyclopentolate may cause increased intraocular pressure (IOP). In the elderly and others where increased IOP may be encountered, mydriatics and cycloplegics should be used cautiously. To avoid inducing angle closure glaucoma, IOP and an estimation of the depth of the angle of the anterior chamber should be made prior to initiation of therapy.
Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation.
Cyclopentolate may cause drowsiness, blurred vision and sensitivity to light. Patients should be advised not to drive or engage in other hazardous activities unless vision is clear.
Odan-Cyclopentolate contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses (see DOSAGE AND ADMINISTRATION).
Psychiatric
Cyclopentolate-induced psychotic reactions and behavioural disturbances and other central nervous system (CNS) disturbances may occur in patients with increased susceptibility to anticholinergic drugs (see WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics (≥ 6 years of age) and Geriatrics (> 65 years of age)).
Sexual Function/Reproduction
Studies have not been performed to evaluate the effects of topical ocular administration of cyclopentolate on fertility.
Special Populations
Pregnant Women: There is little or no data from the use of cyclopentolate in pregnant women. Odan-Cyclopentolate should only be used during pregnancy if the potential benefit to the mother justifies the potential risk to the fetus.
Nursing Women: It is not known whether cyclopentolate or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, precaution should be exercised.
Pediatrics (< 6 years of age): Odan-Cyclopentolate should not be used in pediatric patients <6 years of age (see CONTRAINDICATIONS).
Serious adverse reactions may occur with the use of this product in young children (see ADVERSE REACTIONS). Odan-Cyclopentolate is contraindicated in children less than 6 years of age (see CONTRAINDICATIONS).
Pediatrics (≥ 6 years of age): Odan-Cyclopentolate should be used with extreme caution, if at all, in children with Down syndrome, spastic paralysis or brain damage.
Young patients and children with Down syndrome, spastic paralysis or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary and gastrointestinal toxicity from systemic absorption of cyclopentolate.
Seizures and acute psychosis induced by cyclopentolate are especially prominent in children. Odan-Cyclopentolate should be used with caution in children, with known epilepsy.
Fair-skinned children with blue eyes may exhibit an increased response and/or increased susceptibility to adverse reactions.
Parents should be warned not to get this preparation in their child’s mouth and to wash their own hands and the child’s hands following administration.
Geriatrics (> 65 years of age): Elderly patients may be at a higher risk of having undiagnosed glaucoma and developing cyclopentolate-induced psychotic reactions and behavioural disturbances and other CNS disturbances.
ADVERSE REACTIONS
Odan-Cyclopentolate produces reactions similar to those of other anticholinergic drugs. Central nervous system manifestations, such as ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people, are possible. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distension, feeding intolerance and necrotizing enterocolitis in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchii and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis, death, and hypotension with rapid progressive respiratory depression (see OVERDOSAGE).
Use of cyclopentolate has been associated with psychotic reactions and behavioural disturbances in children. Central nervous system reactions manifest similar to those listed above. Seizures and acute psychosis induced by cyclopentolate are especially prominent in children.
A local or generalized allergic-type response to cyclopentolate consisting of an urticarial rash has been described in children.
Additional adverse reactions observed following the use of Odan-Cyclopentolate include the following:
Eye disorders: drug effect prolonged (mydriasis), hyperemia, eye irritation, eye pain, increased intraocular pressure, conjunctivitis, punctate keratitis, photophobia, vision blurred; Gastrointestinal disorders: dry mouth, nausea, vomiting;
General disorders and administration site conditions: fatigue, gait disturbance, pyrexia;
Immune system disorders: hypersensitivity;
Nervous system disorders: dizziness, headache, incoherent retrograde amnesia, somnolence; Psychiatric disorders: agitation, confusional state, disorientation, hallucination, restlessness; Skin and subcutaneous tissue disorders: erythema.
DRUG INTERACTIONS
The effects of Odan-Cyclopentolate may be enhanced by concomitant use of other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics and tricyclic antidepressants.
DOSAGE AND ADMINISTRATION
Patients must be instructed to remove contact lenses prior to application of Odan-Cyclopentolate and wait at least 15 minutes before re-insertion. Odan-Cyclopentolate contains the preservative benzalkonium chloride, which may cause eye irritation and is known to discolour soft contact lenses.
Dosing Considerations
Individuals with heavily pigmented irides may require larger doses.
Recommended Dose
Adults: One drop in the eye(s), followed by a second drop in 5 minutes, if necessary. Complete recovery usually occurs in 24 hours.
Pediatrics (≥6 years of age): One drop in the eye(s), followed by a second drop 5 minutes later, if necessary. Pretreatment with Odan-Cyclopentolate on the day prior to examination is usually not necessary.
Pediatrics (<6 years of age): Odan-Cyclopentolate should not be used in pediatric patients <6 years of age (see CONTRAINDICATIONS).
Administration
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 decreased in systemic adverse reactions.
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 distension in infants, convulsions and hallucinations and the loss of neuromuscular coordination. Severe intoxication is characterized by CNS depression, coma, circulatory and respiratory failure and death.
The onset of cyclopentolate toxicity occurs within 20 to 30 minutes of drug instillation, and although usually transient (subsiding in 4 to 6 hours), the symptoms can last up to 12 to 24 hours.
Patients exhibiting signs of overdosage should receive supportive care and monitoring.
In case of accidental use/overdose in infants and small children, the body surface must be kept moist.
ACTION AND CLINICAL PHARMACOLOGY
Odan-Cyclopentolate blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia). Cyclopentolate acts rapidly, but has a shorter duration of action than atropine.
STORAGE AND STABILITY
Store at 15oC – 30oC. Keep container tightly closed. Keep out of the reach and sight of children.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
DOSAGE FORMS, COMPOSITION AND PACKAGING
Odan-Cyclopentolate is an anticholinergic prepared as a sterile borate buffered topical ophthalmic solution.
Each mL contains:
Active: Cyclopentolate Hydrochloride 0.5% w/v or 1% w/v.
Preservative: Benzalkonium Chloride 0.01% w/v.
Inactives: Purified Water, Boric Acid, Potassium Chloride, Edetate Disodium, Sodium Carbonate Sodium Chloride, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH).
Odan-Cyclopentolate is available in 10 mL multiple-dose plastic dropper bottles.
Tamper evidence is provided by a closure with an extended skirt that locks to the bottle finish on application and breaks away from the closure on opening. After cap is removed: if tamper evident snap collar is loose, remove before using product.
REFERENCES
Precribing Information - CYCLOGYL™ (Cyclopentolate Hydrochloride Ophthalmic Solution, USP) 1% w/v, Alcon Canada Inc. Submission No. 242648; Date of Revision: September 11, 2020.