Minims Cyclopentolate Hydrochloride Product Monograph

SUMMARY PRODUCT INFORMATION

INDICATIONS AND CLINICAL USE

MINIMS CYCLOPENTOLATE HYDROCHLORIDE (cyclopentolate hydrochloride solution) 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)

MINIMS CYCLOPENTOLATE HYDROCHLORIDE should not be used in pediatric patients < 6 years of age due to the increased risk of systemic toxicity.

CONTRAINDICATIONS

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 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 Product Monograph.
• Patients with known or suspected angle-closure glaucoma.
• Use in children with organic brain syndromes, including congenital or neuro-developmental abnormalities, particularly those predisposing to epileptic seizure.
• Pediatric patients < 6 years of age.

WARNINGS AND PRECAUTIONS

General

MINIMS CYCLOPENTOLATE HYDROCHLORIDE is for topical use only and is not for injection.

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 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, MINIMS CYCLOPENTOLATE HYDROCHLORIDE should be used with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.

Use with extreme caution in individuals susceptible to belladonna alkaloids because of increased risk of systemic toxicity. Atropine-like effects have been reported as side effects.

Use with caution in patients with Down syndrome.

Caution is advised in hyperemia as increased systemic resorption may occur.

Use with caution in patient with epilepsy, cardiovascular disease, prostate disorders, ataxia, rhinitis sicca, tachycardias, heart failure, mechanical stenosis of the gastrointestinal tract, toxic megacolon, myasthenia gravis and obstructive urinary tract disorders and in case of senile dementia.

Ophthalmologic

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 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.

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. MINIMS CYCLOPENTOLATE HYDROCHLORIDE should only be used during pregnancy if the potential benefit to the mother outweighs 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. Cyclopentolate should not be used during breastfeeding unless considered essential to the mother.

Pediatrics (< 6 years of age)

MINIMS CYCLOPENTOLATE HYDROCHLORIDE should not be used in pediatric patients <6 years of age (see CONTRAINDICATIONS)

Use with extreme caution in those who are particularly susceptible to severe central nervous system disorders as there is an increased risk of toxicity in the central nervous system, cardiopulmonary, and gastrointestinal due to systemic uptake of cyclopentolate.

Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 30 minutes.

Serious adverse reactions may occur with the use of this product in young children (see ADVERSE REACTIONS). MINIMS CYCLOPENTOLATE HYDROCHLORIDE is contraindicated in children less than 6 years of age (see CONTRAINDICATIONS).

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 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. MINIMS CYCLOPENTOLATE HYDROCHLORIDE 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

MINIMS CYCLOPENTOLATE HYDROCHLORIDE produces reactions similar to those of other anticholinergic drugs. Central nervous system manifestations, cerebellar dysfunction, such as ataxia, dysarthria, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, balance disorders, disorientation as to time and place, and failure to recognize people, are possible.

Other toxic manifestations of anticholinergic drugs are dry skin, skin rash, abdominal distension, feeding intolerance and necrotizing enterocolitis in infants, unusual drowsiness, bradycardia, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi, nasal passages, erythema, flushing, pyrexia, constipation, dry mouth, nausea, vomiting, arrhythmia, cardiopulmonary failure, palpitations, hyperpyrexia, urinary retention, diminished gastrointestinal motility and mucosal dryness.

Use of cyclopentolate has been associated with psychotic reactions, and behavioural disturbances, especially in infants, young children and in children with brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, seizure, somnolence and failure to recognise people.

A local or generalized allergic-type response to cyclopentolate consisting of an urticarial rash has been described in children.

Severe manifestations of toxicity include coma, medullary paralysis, death, and hypotension with rapid progressive respiratory depression (see OVERDOSAGE).

Necrotising colitis, hypersensitivity, anaphylactic reaction and anaphylactic shock have also been observed.

Ocular

Increased intraocular pressure, conjunctivitis, accommodation disorder, blurred vision, visual impairment, angle closure glaucoma, irritation, pain, hyperemia.

DRUG INTERACTIONS

The anticholinergic effects of other pharmaceuticals (e.g. antihistamines, phenothiazines, tricyclic and tetracyclic antidepressants, amantadine, quinidine, disopyramide, metoclopramide)

could be increased since systemic cyclopentolate effects cannot be excluded even with topical application.

MINIMS CYCLOPENTOLATE may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

The mydriatic effect of cyclopentolate hydrochloride is ended by the use of parasympathomimetic drugs such as physostigmine or pilocarpine.

DOSAGE AND ADMINISTRATION

Recommended Dose

MINIMS CYCLOPENTOLATE HYDROCHLORIDE is for topical ophthalmic use only.

Patients must be instructed to remove contact lenses prior to application of MINIMS

CYCLOPENTOLATE HYDROCHLORIDE and wait at least 15 minutes before re-insertion.

Adult Dosage

One or two drops to be instilled into the conjunctival sac. Frequency and duration of the therapy will vary according to the therapeutic response.

Children Dosage

At the discretion of the physician.

Pediatrics (< 6 years of age)

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 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 decrease 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.

In isolated cases, ocular topical application of eye drops containing cyclopentolate can lead to central nervous system disorders and general systemic manifestations, especially in children with central nervous system disorders. Treatment is supportive and symptomatic.

Physostigmine or pilocarpine can be administered as an antidote.

ACTION AND CLINICAL PHARMACOLOGY

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 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 between 8-25ºC in the original container. Do not freeze. Do not expose to strong light.

Discard after use.

Keep out of the reach and sight of children.

DOSAGE FORMS, COMPOSITION AND PACKAGING

MINIMS CYCLOPENTOLATE HYDROCHLORIDE is available in 20 units of 0.5 mL.

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 0.5 % w/w: Each unit of 0.5 mL contains cyclopentolate hydrochloride 2.5 mg (0.5% w/v).

MINIMS CYCLOPENTOLATE HYDROCHLORIDE 1 % w/w: Each unit of 0.5 mL contains cyclopentolate hydrochloride 5 mg (0.1% w/v)

Single Dose Eye Drops.

Preservative Free.

Non-medicinal ingredients: Purified Water and Hydrochloric Acid (to adjust pH).