Schedule H

Ophthalmic (Topical)

• Eye drops: 0.5% w/v solution

• Eye drops: 1% w/v solution

• Eye drops (Combination): Cyclopentolate 1% + Phenylephrine 2.5%

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Cycloplegic Refraction (Diagnostic Use) — Adults

Parameter Recommendation

Starting dose 1% solution: 1 drop in each eye

Titration Repeat 1 drop after 5–10 minutes if required

Usual maintenance dose Not applicable (single diagnostic use)

Maximum dose 2–3 drops per eye per session

Onset: 30–60 minutes

Duration of effect: Up to 24 hours

Clinical Notes:

• Apply nasolacrimal occlusion for 1–2 minutes after instillation to reduce systemic absorption

• Refraction should be performed 30–60 minutes after last drop

• Counsel patient regarding temporary blurred near vision and photophobia

1. Pre-operative Mydriasis — Adults

Parameter Recommendation

Starting dose 1% solution: 1 drop in operative eye

Titration May repeat once after 5–10 minutes if inadequate mydriasis

Usual maintenance dose Not applicable (single pre-operative use)

Maximum dose 2 drops per eye

Timing: Administer 30–60 minutes before procedure

Clinical Notes:

• Combination product (cyclopentolate 1% + phenylephrine 2.5%) provides enhanced mydriasis for surgical procedures

• Phenylephrine combination to be avoided in patients with uncontrolled hypertension

1. Anterior Uveitis (Ciliary Spasm Relief and Synechiae Prevention) — Adults

Parameter Recommendation

Starting dose 1% solution: 1 drop in affected eye

Titration Adjust frequency based on severity and response

Usual maintenance dose 1 drop every 8–12 hours

Maximum dose 1 drop every 6 hours in severe cases

Duration: Continue as part of multi-drug regimen until inflammation controlled

Clinical Notes:

• Used adjunctively with topical corticosteroids

• For posterior synechiae prevention, maintain adequate mydriasis

• Monitor intraocular pressure during prolonged use

Secondary Indications — Adults (Off-label)

Not applicable — No significant off-label ophthalmic or systemic indications documented in Indian practice.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Cycloplegic Refraction

Age-Based Dosing:

3 months to <1 year 0.5% solution 1 drop per eye Once after 5–10 min if needed Mandatory nasolacrimal occlusion

1 year to <6 years 0.5% solution 1 drop per eye Once after 5–10 min if needed Monitor for CNS effects

≥6 years 1% solution 1 drop per eye Once after 5–10 min if needed Adult protocol applicable

Onset: 30–60 minutes

Duration: Up to 24 hours

Maximum effect (cycloplegia): 45–60 minutes

Clinical Notes:

• 0.5% strength preferred in children <6 years to minimize systemic absorption and CNS toxicity risk

• Apply nasolacrimal occlusion for 2–3 minutes in all paediatric patients

• Observe child for 30 minutes post-instillation for behavioural changes

1. Anterior Uveitis — Paediatric

Parameter Recommendation

Starting dose 0.5–1% solution: 1 drop in affected eye

Titration Based on severity

Usual maintenance dose 1 drop every 8–12 hours

Maximum dose 1 drop every 6 hours

Clinical Notes:

• Paediatric ophthalmologist supervision recommended

• Use lowest effective concentration

• Monitor intraocular pressure

Safety Monitoring:

• Observe for systemic anticholinergic effects: flushing, fever, tachycardia, behavioural changes, hallucinations

• Increased CNS sensitivity in children with Down syndrome — use with extreme caution

Secondary Indications — Paediatric (Off-label)

Not applicable — No documented off-label paediatric uses.

Age Restrictions:

• Not recommended in infants <3 months except under specialist paediatric ophthalmology supervision for essential indications

• In premature infants: avoid due to high risk of systemic toxicity

No dose adjustment required — topical ophthalmic administration results in negligible systemic absorption when nasolacrimal occlusion is applied.

Note: Minimal systemic exposure with proper topical ophthalmic administration technique.

• Known hypersensitivity to cyclopentolate or any component of formulation

• Narrow-angle (angle-closure) glaucoma — diagnosed or suspected

• Anatomically narrow anterior chamber angles at risk of closure

• Infants <3 months of age (except under specialist supervision)

• Untreated primary angle-closure glaucoma

• Elderly patients with shallow anterior chambers or narrow iridocorneal angles — perform gonioscopy before use if uncertain

• Children with Down syndrome — increased CNS sensitivity to anticholinergic effects

• History of seizures or epilepsy — rare CNS excitatory effects reported

• Dark iris pigmentation — may require additional drops for adequate effect

• Contact lens wearers — remove lenses before instillation; wait 15 minutes before reinsertion

• Patients with spastic paralysis or brain damage in children — increased susceptibility to systemic effects

• Repeated or prolonged use — monitor intraocular pressure

• Combination with phenylephrine — use caution in patients with cardiovascular disease, hypertension, hyperthyroidism

Parameter Information

Risk Category Not formally classified; limited human data

Overall Safety Avoid unless clearly necessary; topical use results in minimal systemic exposure

Preferred Alternatives Tropicamide (shorter duration, less systemic absorption)

When May Be Used Single diagnostic dose with nasolacrimal occlusion if refraction essential during pregnancy

Monitoring Signs of systemic anticholinergic absorption in mother; fetal heart rate monitoring not typically required for single topical dose

Parameter Information

Compatibility Likely compatible for single diagnostic use

Expected Milk Levels Negligible with proper topical administration technique

Preferred Alternatives Tropicamide (shorter duration)

Decision Single dose for diagnostic refraction — no need to interrupt breastfeeding

Infant Monitoring If repeated use: monitor for anticholinergic effects (dry mouth, irritability, feeding difficulties)

Parameter Recommendation

Starting dose Standard adult dosing (1% solution: 1 drop)

Titration Not applicable

Special considerations Higher risk of precipitating angle-closure glaucoma

Extra monitoring Assess anterior chamber depth before use; monitor IOP if repeated doses

Risk factors Slower recovery of accommodation; prolonged mydriasis; increased photosensitivity; confusion risk if significant systemic absorption

Interacting Drug Effect & Mechanism Management

Systemic anticholinergics (antihistamines, TCAs, antipsychotics, antiparkinson drugs) Additive anticholinergic effects if systemic absorption occurs Use nasolacrimal occlusion; monitor for systemic anticholinergic toxicity

MAO inhibitors (with phenylephrine combination) Severe hypertensive crisis (phenylephrine component) Avoid phenylephrine combination in patients on MAOIs

Carbachol, pilocarpine (miotics) Antagonistic effects — reduced miotic action Avoid concurrent use; separate timing if both indicated

Interacting Drug Effect Management

Topical beta-blockers (timolol, betaxolol) May partially antagonize mydriatic effect Allow adequate interval between drops; may need repeated cyclopentolate

Topical alpha-agonists (brimonidine) Complex interaction on pupil size Monitor clinical effect

Topical prostaglandin analogues (latanoprost) May have opposing effects on accommodation No significant clinical issue with single diagnostic use

Phenylephrine (in combination products) in hypertensive patients Risk of blood pressure elevation Monitor blood pressure; avoid in uncontrolled hypertension

• Transient stinging or burning on instillation

• Blurred vision (may persist up to 24 hours)

• Photophobia

• Ocular discomfort and irritation

• Conjunctival hyperaemia

• Dry mouth (mild, especially in children)

• Transient elevation of intraocular pressure

Adverse Effect Clinical Action

CNS toxicity in children (ataxia, disorientation, hallucinations, hyperactivity, seizures) Immediate discontinuation; supportive care; may require physostigmine in severe cases

Acute angle-closure glaucoma Immediate ophthalmology referral; IOP-lowering therapy; possible laser iridotomy

Severe hypersensitivity (lid oedema, conjunctival chemosis, periorbital dermatitis) Discontinue immediately; topical/systemic antihistamines; ophthalmology review

Tachycardia and cardiovascular effects (especially with phenylephrine combination) Discontinue; cardiac monitoring; supportive management

During/After instillation Monitor children for 30 minutes for behavioural changes and systemic anticholinergic effects

With repeated use (uveitis) Periodic IOP measurement; corneal assessment for epithelial toxicity

Long-term Not typically required — drug used for acute/short-term indications

Single Agent:

• Cyclogyl (Alcon)

• Cyclomid (Sun Pharma)

• Cyclopen (Cipla)

• Cylopent (FDC)

• Cyclopentolate Eye Drops IP (multiple generic manufacturers)

Combination Products:

• Tropicacyl Plus (Sunways) — Combination formulations

Note: Not specifically included in NLEM 2022; generic formulations available at lower cost in government supply.

• Use 0.5% strength in children <6 years — 1% solution significantly increases risk of CNS toxicity in young children

• Nasolacrimal occlusion is essential in paediatric patients — apply firm pressure on inner canthus for 2–3 minutes after instillation to prevent systemic absorption

• Cyclopentolate provides more complete cycloplegia than tropicamide — preferred for accurate refraction in hyperopia assessment and accommodative esotropia evaluation

• Duration of action is significantly longer than tropicamide (up to 24 hours vs 4–6 hours) — counsel patients regarding prolonged photophobia and inability to read

• Assess angle status before use in patients >40 years or those with hypermetropia, family history of glaucoma, or previous angle-closure episodes

• Combination with phenylephrine provides synergistic mydriasis — useful for fundoscopy and surgery but avoid in hypertensive and cardiovascular patients

Cyclopentolate; mydriatic; cycloplegic; anticholinergic; ophthalmic; cycloplegic refraction; paediatric ophthalmology; uveitis; CNS toxicity risk; angle-closure glaucoma caution

RxIndia v1.0 — 05 Jan 2025

• CDSCO Approved Drug Formulations Database

• Indian Pharmacopoeia 2022

• National Formulary of India 2021

• AIIMS Department of Ophthalmology Clinical Protocols

• IAP Guidelines for Paediatric Refraction

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• AIOS (All India Ophthalmological Society) Practice Guidelines

• Harrison's Principles of Internal Medicine, 21st Edition (Anticholinergic toxicity)