Cyclopentolate Hydrochloride

Registered South African indications:

• Mydriasis
• Cycloplegia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients 
• Neonates except where, on expert evaluation, the need is considered to be compelling
• Confirmed or suspected narrow angle glaucoma

Cautions

• Pregnancy
• Breastfeeding
• Elderly 
• Debilitated patients
• Hyperaemia
• Paediatrics

Forms avail. in SA and covered in this monograph: opd

Mydriasis
Cycloplegia

• Ophthalmic (opd): 1 drop into eye(s) 40min before diagnostic procedure; Can repeat once after 5-10min

Anterior uveitis

• Ophthalmic (opd): 1 drop into affected eye(s), 8hrly

Paed. forms avail. in SA and covered in this monograph: opd

Mydriasis
Cycloplegia

Younger than 3 months

• Not established for use

Between 3 months - 12 years

• Ophthalmic (opd): 1 drop into eye(s) 40min before diagnostic procedure

Older than 12 years

• See adult dosage

Pregnancy

• Caution
• There is insufficient evidence as to drug safety in pregnancy. Cyclopentolate should not be used during pregnancy unless it is considered essential

Breastfeeding 

• Caution
• Cyclopentolate secretion into breast milk is unknown. There is insufficient evidence as to drug safety in breastfeeding women

Renal Impairment 

• No dose adjustment recommended

Hepatic Impairment 

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended 

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Cerebellar dysfunction
• Visual 
• Tactile hallucinations

Immune, Blood and Lymphatic System Disorders

• Allergic reactions

Sensory Disorders 

• Eye irritation
• Increased intraocular pressure  
• Photophobia

• Anticholinergics

None routine

Pharmacokinetics

• Onset of action - Cycloplegia: 25-75mins
• Onset of action - Mydriasis: 15-60mins
• Duration of action - Cycloplegia: 6-24hrs
• Duration of action - Mydriasis: ≤24hrs
• Recovery time: up to 24hrs

Cyclopentolate hydrochloride is a synthetic tertiary amine, an antimuscarinic compound which paralyses the sphincter muscle of the iris, causing pupillary dilation. It also paralyses the ciliary muscle, thus causing paralysis of accommodation. It acts rapidly, but has a shorter duration of action then atropine.

Eye drops (per 0.5ml) 5mg

• Cyclogyl 1% (Alcon) originator
• Minims Cyclopentolate HCl 1% (Soflens) originator
• Minims Cyclopentolate HCL 1% (Inova Pharmaceuticals)