Cyclomydril

Mydriatics and Cycloplegics

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.

keratitis / Delayed / Incidence not known
seizures / Delayed / Incidence not known

photophobia / Early / Incidence not known
blurred vision / Early / Incidence not known
excitability / Early / Incidence not known
psychosis / Early / Incidence not known
impaired cognition / Early / Incidence not known
ataxia / Delayed / Incidence not known
hallucinations / Early / Incidence not known
dysarthria / Delayed / Incidence not known
sinus tachycardia / Rapid / Incidence not known
hypertension / Early / Incidence not known
peripheral vasodilation / Rapid / Incidence not known
urinary retention / Early / Incidence not known
anhidrosis / Delayed / Incidence not known

ocular irritation / Rapid / Incidence not known
restlessness / Early / Incidence not known
fever / Early / Incidence not known
nasal dryness / Early / Incidence not known

Cyclomydril

Rx

Cyclopentolate is an anticholinergic agent that causes loss of accommodation and mydriasis; Phenylephrine is a sympathomimetic agent that causes vasoconstriction and mydriasis.
Used to produce mydriasis for ophthalmologic examination.
Patients should not drive or participate in hazardous activities while pupils are dilated.

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.

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.

No dosage adjustments are needed.

No dosage adjustments are needed.

There are no drug interactions associated with Cyclopentolate; Phenylephrine products.

Cyclomydril Ophthalmic Sol: 0.2-1%

3 drops/day per eye receiving dilation.

3 drops/day per eye receiving dilation.

3 drops/day per eye receiving dilation.

Usual maximum is 2 drops/day per eye receiving dilation.

Usual maximum is 2 drops/day per eye receiving dilation.

Safety and efficacy have not been established.

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.

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.[44218]