Cyclopentolate Hydrochloride
10 mg/mL · Solution
- Prescription only
- Active substance
- Cyclopentolate Hydrochloride
- Made by
- Sandoz Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2022-06-21
- Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Should not be used if the patient is hypersensitive to any component of this preparation.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
From the official label · 2022-06-21 · DailyMed
How it works
From this product’s own US prescribing label.
This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).
It acts rapidly, but has a shorter duration than atropine.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2022-06-21
Do not take it if
Should not be used if the patient is hypersensitive to any component of this preparation.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- 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% Cyclopentolate Hydrochloride Ophthalmic Solution 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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- For topical ophthalmic use.
- 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% cyclopentolate hydrochloride ophthalmic solution, USP 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.
- Patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration.
- Mydriatics may produce a transient elevation of intraocular pressure.
- 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.
- Information for Patients Do not touch dropper tip to any surface, as this may contaminate the solution.
- Drug Interactions Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
- Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of Cyclopentolate Hydrochloride Ophthalmic Solution USP.
- Pregnancy Pregnancy:
- Nursing Mothers It is not known whether this drug is excreted in human milk.
- Pediatric Use Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances in pediatric patients.
- Geriatric Use No overall differences in safety or effectiveness between elderly and younger patients.
- 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate.
- It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Cyclopentolate should be administered to a pregnant woman only if clearly needed.
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cyclopentolate hydrochloride is administered to a nursing woman.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- 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.
Quoted from the official label, section “Overdosage”.
Use in children
- 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 and necrotizing enterocolitis (NEC) in preterm infants may follow ophthalmic use of this product.
- Cases of NEC have been reported in preterm infants following administration; however, causality has not been established.
- It is recommended that feeding be withheld for four (4) hours after examination in infants.
- Observe infants closely for at least 30 minutes (See WARNINGS ).
Quoted from the official label, section “Pediatric Use”.
Use in older people
No overall differences in safety or effectiveness between elderly and younger patients.
Quoted from the official label, section “Geriatric Use”.
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.
- 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.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Do not touch dropper tip to any surface, as this may contaminate the solution.
- A transient burning sensation may occur upon instillation.
- Patients should be advised not to drive or engage in other hazardous activities while pupils are dilated.
- Patients may experience sensitivity to light and should protect eyes in bright illumination during dilation.
- Parents should be warned not to get this preparation in their child's mouth and to wash their own hands and the child's hands following administration.
- Feeding intolerance may follow ophthalmic use of this product in infants.
- It is recommended that feeding be withheld for four (4) hours after examination in infants.
Quoted from the official label, section “Patient Counseling Information”.
What it looks like and how it is packed
- In multiple-dose plastic DROP-TAINER* dispensers:
- Cyclopentolate Hydrochloride Ophthalmic Solution USP 0.5% 1% 2% 15 mL NDC 61314-395-01 2 mL NDC 61314-396-01 2 mL NDC 61314-397-01 5 mL NDC 61314-396-02 5 mL NDC 61314-397-02 15 mL NDC 61314-396-03 15 mL NDC 61314-397-03 Storage:
- Store at 8° to 25°C (46° to 77°F).
- After opening, cyclopentolate hydrochloride can be used until the expiration date on the bottle.
- To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- Rx Only
Quoted from the official label, section “How Supplied”.
What is in it
- Cyclopentolate Hydrochloride Ophthalmic Solution USP is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use.
- It is supplied in three strengths.
- The active ingredient is represented by the structural formula:
- Established name:
- Cyclopentolate Hydrochloride Chemical name:
- 2-(Dimethylamino)ethyl 1-hydroxy-a-phenylcyclopentaneacetate hydrochloride Each mL of cyclopentolate hydrochloride ophthalmic solution, USP contains:
- Active:
- cyclopentolate hydrochloride 0.5%, 1% or 2%.
- Preservative: benzalkonium chloride 0.01%.
- Inactives:
- boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid (to adjust pH), purified water.
- The pH range is between 3.0 and 5.5. chemical
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (3)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 3 of 3
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Sandoz Inc. |
|---|---|
| Active substance | Cyclopentolate Hydrochloride |
| Strength | 10 mg/mL |
| Form | Solution |
| Route | Ophthalmic |
| Packs | 2 mL in 1 BOTTLE · 5 mL in 1 BOTTLE |
| NDC | 61314-396 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Solution1 products
- 10 mg/mL
- Solution/ Drops1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.