Cyclopentolate and phenylephrine are used together in an ophthalmic preparation for producing mydriasis for ophthalmologic examination. Cyclopentolate is a cycloplegic mydriatic agent that causes loss of accommodation and mydriasis. Phenylephrine is a sympathomimetic agent that causes vasoconstriction and mydriasis. The amount of mydriasis produced by this combination is greater than that produced by either agent alone. Cyclomydril was approved by the FDA in September 1975.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-Wash hands before and after use.
-To prevent contamination or spread of infection, do not touch dropper tip to any surface. Do not use dropper for more than 1 person.
-Tilt the patient's head back slightly and pull the lower eyelid down with the index finger to form a pouch.
-Squeeze the prescribed number of drops into the pouch.
-To avoid excessive systemic absorption, apply finger pressure on the lacrimal sac for 2-3 minutes following topical application to the eye.
-In children, take care not to get into the mouth of the child or infant. Wash the hands of the child after administration.
-Observe infants closely for at least 30 minutes after administration. Feeding intolerance may follow ophthalmic use of this product in infants. Withhold feeding for four (4) hours after examination.
-The patient's eyes will be sensitive to light and vision will be blurry for a time of 30-60 minutes following dilation with this product.
-Patients should not drive of perform hazardous activities while eyes are dilated.
Adverse ocular effects associated with cyclopentolate; phenylephrine include increased intraocular pressure, burning and ocular irritation upon instillation, and superficial punctate keratitis. Photophobia has been reported with use; protection for the eyes (such as sunglasses) may be helpful. Blurred vision is also an adverse effect and patients should be advised not to drive cars or perform hazardous activities while their pupils are dilated.
The cyclopentolate component of cyclopentolate; phenylephrine has been associated with psychotic reactions (psychosis) and behavioral disturbances in children. Increased susceptibility has been reported in infants, young children, and in children with spastic paralysis or brain damage. Reported effects include ataxia, incoherent speech (e.g., dysarthria), restlessness, hallucinations, hyperactivity or excitability, seizures, and impaired cognition such as disorientation as to time and place and failure to recognize people. Feeding intolerance may also occur following ophthalmic use in infants. If used in infants, closely observe them for 30 minutes after administration and withhold feedings for 4 hours.
Hypertension and sinus tachycardia have been reported in patients receiving adrenergic and anticholinergic topical ophthalmic drugs, such as cyclopentolate; phenylephrine.
Hyperpyrexia (i.e., fever) and peripheral vasodilation have been reported in patients receiving adrenergic and anticholinergic topical ophthalmic drugs, such as cyclopentolate; phenylephrine.
Urinary retention and decreased GI motility have been reported in patients receiving adrenergic and anticholinergic topical ophthalmic drugs, such as cyclopentolate; phenylephrine.
Decreased secretions in the salivary and sweat glands (anhidrosis), pharynx, bronchi and nasal passages (nasal dryness) have been reported in patients receiving adrenergic and anticholinergic topical ophthalmic drugs, such as cyclopentolate; phenylephrine.
Cyclopentolate; phenylephrine is contraindicated in patients who are allergic to or have a known or suspected hypersensitivity to cyclopentolate, phenylephrine or any ingredient or excipient in this product.
The effect of long-term use of this preparation has not been established, therefore, it should be restricted to short-term use.
Cyclopentolate; phenylephrine is contraindicated for use in patients with untreated narrow angle glaucoma (closed-angle glaucoma). Mydriatic agents may cause a transient rise in intraocular pressure. Use cautiously in those predisposed to increased intraocular pressure, such as geriatric patients. No specific differences in safety and efficacy of cyclopentolate; phenylephrine have been observed in the elderly versus younger adults.
Cyclopentolate; phenylephrine is for topical ophthalmic use only. It is not for parenteral administration.
It is recommended not to use cyclopentolate; phenylephrine with a monoamine oxidase inhibitor (MAOI therapy) or within 10 days of stopping such treatment.
Due to the pharmacologic actions of cyclopentolate; phenylephrine the product should be used cautiously by patients with cardiac disease, hypertension, or hyperthyroidism.
Cyclopentolate; phenylephrine contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should not be worn during administration.
Children and infants are more susceptible to the central nervous system and cardiovascular effects of cyclopentolate; phenylephrine. Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in children. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Some patients are particularly susceptible to these reactions, including those children with Down syndrome, spastic paralysis (e.g., cerebral palsy), and those with brain-damage (e.g., head trauma). Observe infants and children closely for at least 30 minutes following ophthalmic instillation; because feeding intolerance may occur, infant feedings should be held for 4 hours following administration. Safety and efficacy have not been established in neonates. Neonates, especially premature neonates, are at higher risk of systemic adverse effects. The use of cyclopentolate-containing products should be approached with caution in children with a history of a seizure disorder.
No adequate human studies have examined the effects of cyclopentolate; phenylephrine on the fetus. When use is necessary during pregnancy, proper lacrimal occlusion after dosage will help limit the risk of maternal systemic absorption. In making the decision to administer this drug during pregnancy, the potential risks to the fetus must be weighed against the potential benefits to the mother.
It is not known whether cyclopentolate; phenylephrine is excreted in human milk with ophthalmic use; use with caution during breast-feeding. Proper lacrimal occlusion after a dose will help limit the risk of maternal systemic absorption. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Patients should be advised not to drive or engage in driving or operating machinery or other hazardous activities while pupils are dilated. Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation, including sunlight (UV) exposure.
For mydriasis induction for ophthalmic diagnostic procedures:
Ophthalmic dosage:
Adults: Instill 1 drop in each eye to be examined, which may be repeated 5 to 10 minutes later if necessary. To minimize systemic absorption, apply pressure over the nasolacrimal sac for 2 to 3 minutes following instillation. Heavily pigmented irides may require larger dosages. Maximum application is 3 drops per eye.
Infants and Children: Instill 1 drop in each eye to be examined, which may be repeated 5 to 10 minutes later by a second application if necessary. To minimize systemic absorption, apply pressure over the nasolacrimal sac for 2 to 3 minutes following instillation. Observe infants closely for 30 minutes after administration.
Neonates: Safety and efficacy have not been established.
Maximum Dosage Limits:
-Adults
3 drops/day per eye receiving dilation.
-Geriatric
3 drops/day per eye receiving dilation.
-Adolescents
3 drops/day per eye receiving dilation.
-Children
Usual maximum is 2 drops/day per eye receiving dilation.
-Infants
Usual maximum is 2 drops/day per eye receiving dilation.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
No dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Cyclopentolate; Phenylephrine products.
Cyclopentolate; phenylephrine is used in combination as an ophthalmic solution to produce mydriasis. The amount of mydriasis produced by this combination is greater than that produced by either agent alone.
-Cyclopentolate: Cyclopentolate blocks the action of acetylcholine to produce relaxation of the sphincter muscle of the iris resulting in dilation of the pupil (mydriasis). This agent has an anticholinergic effect similar to atropine. Paralysis of accommodation (cycloplegia) is produced by blocking cholinergic stimulation of the ciliary muscle of the lens.
-Phenylephrine: Phenylephrine is a sympathomimetic agent that causes vasoconstriction and mydriasis.
Cyclopentolate; phenylephrine is administered topically as an ophthalmic solution. Cyclopentolate; phenylephrine is absorbed rapidly (maximum mydriatic and cycloplegic effect within 15-60 minutes), works locally, and has minimal systemic absorption when precautions for lacrimal occlusion are followed to limit systemic effect. Systemic absorption via ocular administration is possible, however, and may result in adverse effects. Cyclopentolate may be absorbed systemically either by transcorneal absorption, direct topical absorption through the skin, or by absorption from the nasal or nasolacrimal system. Infants are particularly susceptible to systemic side effects. The duration of mydriatic and cycloplegic effect is normally 20-24 hours. However, mydriasis may persist for several days in selected patients.