Cyclogyl 5 mg/mL
cyclopentolate hydrochloride · SOLUTION/ DROPS · Alcon Laboratories, Inc.
Cyclogyl is a solution/ drops containing cyclopentolate hydrochloride at 5 mg/mL, taken ophthalmic. Manufactured by Alcon Laboratories, Inc..
Key Facts
- Brand Name
- Cyclogyl
- Generic Name
- cyclopentolate hydrochloride
- NDC Code (Product)
0065-0395- Manufacturer
- Alcon Laboratories, Inc.
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA084109
- Marketing Start
- 10/15/1975
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Dosage & Administration
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.
Warnings
WARNINGS: FOR TOPICAL OPHTHALMIC USE ONLY . NOT FOR INJECTION. This preparation may cause Central Nervous System (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of 0.5% CYCLOGYL solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation. Mydriatics may produce a transient elevation of intraocular pressure. Therefore, patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration.
Contraindications
CONTRAINDICATIONS: Should not be used if the patient is hypersensitive to any component of this preparation.
Drug Interactions
Drug Interactions: Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Adverse Reactions
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.
Frequently Asked Questions
What is Cyclogyl used for?
Cyclogyl contains cyclopentolate hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Cyclogyl a controlled substance?
Cyclogyl is not classified as a controlled substance by the DEA.
What is the generic name for Cyclogyl?
The generic name for Cyclogyl is cyclopentolate hydrochloride. There are 3 other brand versions of cyclopentolate hydrochloride.
What is the NDC code for Cyclogyl 5 mg/mL?
The NDC (National Drug Code) for Cyclogyl 5 mg/mL is 0065-0395, listed by Alcon Laboratories, Inc..