Kenyan Health Patient Information Leaflet
Therapeutic agent (verify pharmacological class)
INDICATIONS AND USAGE: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia. Clinical selection for Cyclopentolate should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC. Class context: Therapeutic agent (verify pharmacological class). Confirm site-specific dose, duration and monitoring before prescribing.
DOSAGE AND ADMINISTRATION: Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.
ADVERSE REACTIONS: Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe manifestations of toxicity include coma, medullary paralysis and death.
HOW SUPPLIED: In multiple-dose plastic DROP-TAINER® dispensers: 0.5% CYCLOGYL 1% CYCLOGYL 2% CYCLOGYL 15 mL NDC 0065-0395-15 2 mL NDC 0065-0396-02 2 mL NDC 0065-0397-02 5 mL NDC 0065-0396-05 5 mL NDC 0065-0397-05 15 mL NDC 0065-0396-15 15 mL NDC 0065-0397-15 Storage: Store at 8°C to 25°C (46°F to 77°F). After opening, Cyclogyl can be used until the expiration date on the bottle.