ODAN-CYCLOPENTOLATE 1 %

What is ODAN-CYCLOPENTOLATE?

ODAN-CYCLOPENTOLATE 1 % contains CYCLOPENTOLATE HYDROCHLORIDE : 1 %. It is listed in the Health Canada Drug Product Database under DIN 00626627, held by ODAN LABORATORIES LTD, supplied as SOLUTION for OPHTHALMIC administration. Health Canada currently lists it as marketed, status dated 11-May-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is ODAN-CYCLOPENTOLATE used for?

Odan-Cyclopentolate (cyclopentolate hydrochloride ophthalmic solution, USP) is used to produce mydriasis and cycloplegia.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

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.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at 15°C - 30°C. Keep container tightly closed. Keep out of the reach and sight of children.

How is it supplied?

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.

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)).

What can be used instead?

Other Canadian products sharing ATC code S01FA04 CYCLOPENTOLATE. 3 of 9 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies CYCLOPENTOLATE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. CYCLOPENTOLATE appears in 24 registered pack listings across 7 markets, published on 6 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.