Cyclomydril

2 mL and 5 mL in plastic DROP-TAINER® dispensers.

2 mL NDC 0065-0359-02
5 mL NDC 0065-0359-05

Storage

Store at 8° - 25°C (46° - 77°F).

ALCON LABORATORIES, INC., 6201 South Freeway, Fort Worth, Texas 76134-2099, a Novartis company. Revised: Jul 2013

For the production of mydriasis.

Instill one drop in each eye every five to ten minutes. To minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. Observe infants closely for at least 30 minutes.

Do not use in patients with untreated narrow-angle glaucoma or with untreated anatomically narrow angles or where there is hypersensitivity to any component of this preparation.

WARNINGS

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. The use of this combination may have an adverse effect on individuals suffering from cardiovascular disease, hypertension, and hyperthyroidism, and it may cause CNS disturbances. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. Observe infants closely for at least 30 minutes.

Mydriatics may produce a transient elevation of intraocular pressure.

PRECAUTIONS

General

The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation to reduce excessive systemic absorption. Caution should be observed when considering use of this medication in the presence of Down's syndrome and in those predisposed to angle-closure glaucoma. The effect of long-term use of this preparation has not been established, therefore, it should be restricted to short-term use.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

There have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL® Ophthalmic Solution should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CYCLOMYDRIL Ophthalmic Solution is administered to a nursing woman.

Pediatric Use

Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients. Increased susceptibility to cyclopentolate has been reported in infants, young children, and in children with spastic paralysis or brain damage. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. Feeding intolerance may follow ophthalmic use of this product in infants. It is recommended that feeding be withheld for four (4) hours after examination. Observe infants closely for at least 30 minutes (See WARNINGS).

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

SIDE EFFECTS

Ocular

The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL: increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis.

Non-Ocular

Use of cyclopentolate hydrochloride 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. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. Other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, 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.

DRUG INTERACTIONS

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Pregnancy Category C

Animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. It is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CYCLOMYDRIL® Ophthalmic Solution should be given to a pregnant woman only if clearly needed.

Ocular

The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL: increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis.

Non-Ocular

Use of cyclopentolate hydrochloride 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. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. Other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, 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.

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.