Cycloptic (Drops) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

S01FA04 (Cyclopentolate)

Active Substance

Cyclopentolate (Rec.INN registered by WHO)

Dosage Form

Cycloptic

Eye drops 1%: bottle 5 ml with dropper cap

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless or slightly yellowish-brown solution.

Excipients: boric acid – 7.2 mg, potassium chloride – 4.3 mg, disodium edetate dihydrate – 1 mg, benzalkonium chloride – 0.1 mg, 0.2 M sodium carbonate solution or 0.1 M hydrochloric acid solution – to adjust pH to 4.7-5.0, purified water – up to 1 ml.

5 ml – polyethylene bottles (1) with dropper cap – cardboard packs.

Clinical-Pharmacological Group

M-Cholinoreceptor blocker for topical use in ophthalmology (mydriatic)

Pharmacotherapeutic Group

M-cholinoblocker

Pharmacological Action

m-Cholinoreceptor blocker for topical use in ophthalmology. It causes pupil dilation and paralysis of accommodation. Accommodation recovery occurs within 24 hours.

Pharmacokinetics

It is well absorbed through the conjunctiva. A significant concentration in the CNS is reached within 0.5-1 hour. Plasma protein binding is moderate. T_1/2 is 2 hours. It penetrates the blood-brain barrier.

Indications

For diagnostic purposes: during ophthalmoscopy; during refraction determination.

In preoperative preparation: for pupil dilation during cataract extraction.

For inflammatory diseases of the anterior segment of the eye – episcleritis, scleritis, keratitis, iridocyclitis, uveitis – as part of complex therapy.

ICD codes

Dosage Regimen

Administer topically as eye drops. The dosage regimen is determined by the indication and patient age.

For diagnostic procedures in adults, instill 1-2 drops into the conjunctival sac of each eye. Repeat after 5-10 minutes if necessary to achieve full mydriasis.

For preoperative mydriasis, instill 1-2 drops into the eye to be operated on, 30-60 minutes before surgery.

For inflammatory conditions, use as part of complex therapy as directed by a physician.

For pediatric patients aged 3 years and older, use a reduced dosage. Instill 1 drop into each eye. A second drop may be administered after 5-10 minutes if necessary.

To minimize systemic absorption, apply gentle pressure to the lacrimal sac at the inner canthus for 1-2 minutes immediately after instillation.

Avoid allowing the dropper tip to contact any surface to prevent contamination.

Monitor intraocular pressure during therapy, especially in patients at risk for glaucoma.

Adverse Reactions

Local reactions: burning, hyperemia, conjunctival and eyeball edema, photophobia, increased intraocular pressure, decreased visual acuity, blepharoconjunctivitis, punctate keratitis.

Systemic reactions: weakness, nausea, dry mouth, dizziness, headache, drowsiness, tachycardia, intestinal atony, bladder atony, acute urinary retention. Systemic reactions are more often observed in children.

Contraindications

Hypersensitivity to cyclopentolate; angle-closure glaucoma, suspected glaucoma, post-traumatic paresis of the pupil sphincter; children under 3 years of age; pregnancy, breastfeeding period.

With caution

Elderly age, intestinal obstruction, prostatic hyperplasia.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 3 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Intraocular pressure monitoring is necessary when using cyclopentolate.

To reduce the risk of systemic side effects, it is recommended to apply gentle finger pressure to the area of the lacrimal sacs at the inner corner of the eye for 1-2 minutes after instillation.

Effect on the ability to drive vehicles and mechanisms

When using cyclopentolate, patients should avoid driving vehicles and engaging in other activities that require high concentration and speed of psychomotor reactions.

Drug Interactions

When used concomitantly, Cyclopentolate weakens the effect of m-cholinomimetics and cholinesterase inhibitors.

When used concomitantly, adrenomimetics enhance the effect of cyclopentolate.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.