Cyclopentolate Hydrochloride 10 mg/mL Solution, 2 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Anticholinergics class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Cyclopentolate ophthalmic is used to cause mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscle of the eye) before an eye examination. Cyclopentolate is in a class of medications called mydriatics. Cyclopentolate works by blocking certain receptors found in the eye to temporarily relax or provide short-term paralysis of the eye muscles.
Read the full MedlinePlus article ↗- Cyclopentolate does two important things: it widens your pupil so the provider can see the back of your eye clearly, and it stops your eye from automatically adjusting its focus. T...
- Why is my eye care provider using these drops before my eye exam?
- That's very normal and expected — it's actually the whole point of the drops. Your ability to focus should return within 6 to 24 hours for most people. Your pupil may stay wider th...
- How long will my vision be blurry and my eyes sensitive to light?
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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UNII 45P3261C7T
Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $2.567 | $5.13 / 2 ml |
| Medicaid paysCMS SDUD · 12 mo | $5.47 | $10.93 / 2 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cyclopentolate Hydrochloride 10 mg/mL 24208-0735-01 | Bausch | 1 bottle | $2.567 | AT | Availability likely | — |
| Cyclopentolate Hydrochloride 10 mg/mLthis 61314-0396-01 | Sandoz | 2 ml | $2.567 | AT | Availability likely | — |
| Cyclogyl 10 mg/mL 00065-0396-02 | Alcon | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 61314-0396-01 You're viewing this | 2 mL in 1 BOTTLE (61314-396-01) | $2.57 / mL | $5.13 | 2002-08-22 | Active |
| 61314-0396-02 | 5 mL in 1 BOTTLE (61314-396-02) | — | — | 2002-08-22 | Active |
| 61314-0396-03 | 15 mL in 1 BOTTLE (61314-396-03) | $0.9314 / mL | $13.97 | 2002-08-22 | Active |
You're viewing the smallest of 3 pack sizes for this product.
Per mL, this pack runs about 176% above the cheapest pack (15 mL, $0.9314 vs $2.57 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 90% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 61314-0396-01?
What is the difference between NDC 61314-0396-01 and NDC 61314-0396-02?
What NDC number is used to bill for this package of Cyclopentolate Hydrochloride 10 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
⏱️ Dosage and 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% 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Should not be used if the patient is hypersensitive to any component of this preparation.
⚠️ Warnings ▾
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.
🤒 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.
🔄 Drug Interactions ▾
Drug Interactions Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
🤰 Pregnancy ▾
Pregnancy 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.
🧒 Pediatric Use ▾
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 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 ).
🧓 Geriatric Use ▾
Geriatric Use No overall differences in safety or effectiveness between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY 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. Maximal cycloplegia occurs within 25 to 75 minutes after instillation.
Complete recovery of accommodation usually takes 6 to 24 hours. Complete recovery from mydriasis in some individuals may require several days. Heavily pigmented irides may require more doses than lightly pigmented irides.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED 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
📋 Description ▾
DESCRIPTION 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
💬 Information for Patients ▾
Information for Patients 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.