Uses
Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Source: US FDA prescribing information
- Presentations
- 5
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Cyclopentolate is a prescription medicine. It is available as eye drops and ophthalmic solution. MedsAcross supplies Cyclopentolate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- ATC classification
- S01FA04 Cyclopentolate · Eye medicines, subgroup S01F, subgroup S01FA
- US FDA first approval
- Approved
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Ophthalmic
- Dosage forms
- Eye drops, Ophthalmic solution
- Identifiers
- UNII I76F4SHP7JRxCUI 3001CAS 512-15-2DrugBank DB00979Q867332
Clinical information
From the regulator-approved product information. Each section names its source.
Dosing overview
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.
Source: US FDA prescribing information
Contraindications
Should not be used if the patient is hypersensitive to any component of this preparation.
Source: US FDA prescribing information
Warnings and precautions
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.
Source: US FDA prescribing information
Side effects
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.
Source: US FDA prescribing information
Interactions
Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Source: US FDA prescribing information
Storage
Store at 8°C to 25°C (46°F to 77°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
5 presentations of Cyclopentolate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Cyclogyl 20 mg/mL eye dropsOphthalmic | Alcon Laboratories | US FDA | Available on request |
| Cyclopentolate 10 mg/mL ophthalmic solutionOphthalmicGeneric name | — | US FDA | Available on request |
| Cyclogyl 10 mg/mL eye dropsOphthalmic | Alcon Laboratories | US FDA | Available on request |
| Cyclopentolate 10 mg/mL eye dropsOphthalmicGeneric name | — | US FDA | Available on request |
| Cyclogyl 5 mg/mL eye dropsOphthalmic | Alcon Laboratories | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | Approved | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Cyclopentolate available for export from India?
Yes, on request. MedsAcross lists 5 presentations of Cyclopentolate and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Cyclopentolate have?
The catalogue lists 1 brand names for Cyclopentolate, including Cyclogyl.
Does Cyclopentolate need cold chain shipping?
No listed presentation of Cyclopentolate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Cyclopentolate in?
Cyclopentolate is classified under ATC code S01FA04 (Cyclopentolate).
References
- Cyclogyl prescribing information (Alcon Laboratories). U.S. National Library of Medicine, DailyMed. Retrieved 25 June 2024
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