Cyclopentolate HCl Ophthalmic Solution 1% 2mL - Sandoz

NDC: 61314-396-01

Cyclopentolate Hydrochloride Ophthalmic Solution, USP 1%, 2 mL — Sandoz

Active ingredient	Cyclopentolate hydrochloride 1% (10 mg/mL)
Dosage form	Ophthalmic solution, sterile, borate buffered (preserved with benzalkonium chloride 0.01%)
Route	Ophthalmic (topical)
Size	2 mL multi-dose plastic DROP-TAINER dispenser
Manufacturer	Manufactured by Alcon Laboratories, Inc. for Sandoz Inc.
NDC	61314-396-01

Indications and Usage

Cyclopentolate hydrochloride is used to produce mydriasis (pupillary dilation) and cycloplegia (paralysis of accommodation), typically prior to eye exams such as refraction testing.

Dosage and Administration

Adults and children: Instill one or two drops in the eye, which may be repeated in five to ten minutes if necessary. Complete recovery of accommodation usually occurs within 24 hours; recovery from mydriasis may take several days in some individuals.

Warnings and Precautions

• For topical ophthalmic use only, not for injection; may cause CNS disturbances, particularly in infants and young children — observe infants closely for at least 30 minutes following instillation, and withhold feeding for 4 hours after examination due to reports of feeding intolerance and necrotizing enterocolitis (NEC) in preterm infants
• Use has been associated with psychotic reactions and behavioral disturbances in pediatric patients, including ataxia, hallucinations, seizures, and disorientation
• May produce transient elevation of intraocular pressure; patients with untreated narrow-angle glaucoma or anatomically narrow angles may be susceptible to angle closure
• Use with caution in patients with Down syndrome
• Patients should not drive or engage in hazardous activities while pupils are dilated, and should protect eyes from bright light; avoid contaminating the dropper tip and keep the preparation away from a child's mouth
• May interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors

Contraindications

Should not be used if the patient is hypersensitive to any component of this preparation.

Adverse Reactions

Ocular: increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, and punctate keratitis. Non-ocular: psychotic reactions and behavioral disturbances (usually in children), skin rash, drowsiness, tachycardia, and urinary retention. Severe toxicity may include coma, medullary paralysis, and death.

Storage and Handling

Store at 8°C to 25°C (46°F to 77°F). After opening, may be used until the expiration date on the bottle.

How Supplied

Supplied as a 2 mL fill in a multiple-dose plastic DROP-TAINER dispenser.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.