MINIMS

What it is

Minims Cyclopentolate Eye Drops are sterile preservative-free solutions containing cyclopentolate hydrochloride 0.5% (5 mg/mL) or 1% w/v (10 mg/mL) as the active ingredient. The product is supplied as an eye drops solution in clear colourless form, reasonably free from visible particulate matter.

Approved indications

— Production of mydriasis and cycloplegia.

Dosing overview

For refraction and examination of the back of the eye, one drop of solution may be repeated after five minutes, and is usually sufficient. For anterior and posterior uveitis (if associated with signs of anterior uveitis) and for the breakdown of posterior synechiae, one drop is instilled every 6 to 8 hours. Maximum effect is induced 30 to 60 minutes after instillation. In children aged 3 months to 12 years, one drop of the 0.5% solution is instilled to each eye. Children should be observed for 45 minutes after installation. Systemic absorption of cyclopentolate may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops, which blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa.

Key safety warnings

Cyclopentolate may cause central nervous system disturbances when administered topically to the eye, especially in younger age groups and other patients at special risk such as debilitated or aged patients, but may occur at any age. Use of cyclopentolate has been associated with psychotic reactions and behavioural disturbances in paediatric patients. Cyclopentolate should be used with caution in children as convulsions including grand mal have been reported. Increased intraocular pressure may occur in predisposed patients. Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the anterior chamber should be made before use, particularly if therapy is likely to be intense or protracted. Eyes may become sensitive to light while using Minims Cyclopentolate Eye Drops, and patients should be advised to protect their eyes by wearing sunglasses. Complete recovery of accommodation usually occurs within 24 hours, however in some individuals complete recovery may require several days. Feeding intolerance may follow ophthalmic use of this product in infants, and it is recommended that feeding be withheld for four hours after examination. Particular caution should be used when used in children because cases of necrotic colitis have been reported following administration of cyclopentolate eye drops in premature babies.

Contraindications

Minims Cyclopentolate Eye Drops are contraindicated in patients with hypersensitivity to any of the components of the preparation. Do not use in patients with narrow-angle glaucoma or in those with a shallow anterior chamber. Do not use in at risk patients, especially premature babies, small infants, adults over 65 years old and patients with Down's syndrome, as well as in children with brain damage. Do not use in children with organic brain syndromes, including congenital or neuro-developmental abnormalities, particularly those predisposing to epileptic seizures. Do not use in patients with cardiovascular disorders.

Regulatory history

Minims Cyclopentolate Hydrochloride 0.5% (ARTG 32265) and 1% (ARTG 32267) eye drops were first listed on the ARTG on 30 October 1991.