Cyclopentolate Hydrochloride

Akorn
Human Prescription Drug
NDC 17478-097

Cyclopentolate Hydrochloride is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Cyclopentolate Hydrochloride is 17478-097. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Cyclopentolate Hydrochloride drug includes Cyclopentolate Hydrochloride - 20 mg/mL . The currest status of Cyclopentolate Hydrochloride drug is Active.

Drug Information:

Drug NDC:	17478-097
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Cyclopentolate Hydrochloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Cyclopentolate Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Akorn
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution/ Drops
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	CYCLOPENTOLATE HYDROCHLORIDE - 20 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	OPHTHALMIC
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	13 Jan, 1997
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA040165
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Akorn
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1298066 1298070
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0317478097105 0317478100027
UPC stands for Universal Product Code.
UNII:	736I6971TE
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
17478-097-02	1 BOTTLE, DROPPER in 1 CARTON (17478-097-02) / 2 mL in 1 BOTTLE, DROPPER	13 Jan, 1997	N/A	No
17478-097-10	1 BOTTLE, DROPPER in 1 CARTON (17478-097-10) / 5 mL in 1 BOTTLE, DROPPER	13 Jan, 1997	N/A	No
17478-097-12	1 BOTTLE, DROPPER in 1 CARTON (17478-097-12) / 15 mL in 1 BOTTLE, DROPPER	13 Jan, 1997	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Cyclogyl

Cyclopentolate Hydrochloride

Solution/ Drops
Alcon Laboratories, Inc.
NDC: 0065-0397

Cyclopentolate

Cyclogyl

Cyclopentolate Hydrochloride

Solution/ Drops
Alcon Laboratories, Inc.
NDC: 0065-0395

Cyclopentolate Hydrochloride

Solution/ Drops
Bausch & Lomb Incorporated
NDC: 24208-735

Cyclopentolate Hydrochloride

Solution/ Drops
Akorn
NDC: 17478-100

Cyclogyl

Cyclopentolate Hydrochloride

Solution/ Drops
Alcon Laboratories, Inc.
NDC: 0065-0396

Product Elements:

Cyclopentolate hydrochloride cyclopentolate hydrochloride cyclopentolate hydrochloride cyclopentolate benzalkonium chloride boric acid edetate disodium potassium chloride sodium carbonate hydrochloric acid water cyclopentolate hydrochloride cyclopentolate hydrochloride cyclopentolate hydrochloride cyclopentolate benzalkonium chloride boric acid edetate disodium sodium carbonate hydrochloric acid water

Drug Interactions:

Drug interactions: cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Indications and Usage:

Indications and usage: cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.

Warnings:

Warnings: for topical ophthalmic use only. not for injection. this preparation may cause 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 per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. observe infants closely for at least 30 minutes. mydriatics may produce a transient elevation of intraocular pressure.

General Precautions:

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 and in those predisposed to angle-closure glaucoma.

Dosage and Administration:

Dosage and administration: adults: instill one or two drops of 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 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 1% solution if necessary.

Contraindications:

Contraindications: cyclopentolate hydrochloride ophthalmic solution should not be used when untreated narrow-angle glaucoma, or untreated anatomically narrow angles are present, or if the patient is hypersensitive to any component of this preparation.

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 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 Read more...

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.

Use in Pregnancy:

Pregnancy: pregnancy category c. 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 may follow ophthalmic use of this product in infants. it is recommended that feeding be withheld for four (4) hours after examination. observe infants closely for at least 30 minutes (see warnings ).

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.

Description:

Description: cyclopentolate hydrochloride ophthalmic solution is an anticholinergic prepared as a sterile, borate buffered solution for topical ocular use. it is supplied in two strengths. chemical name: 2-(dimethylamino)ethyl 1-hydroxy-Î±-phenylcyclopentaneacetate hydrochloride mw=327.85 c 17 h 25 no 3 â hcl the active ingredient is represented by the structural formula: cyclopentolate hydrochloride ophthalmic solution usp, 1% & 2% each ml contains: active: cyclopentolate hydrochloride 10 mg (1%) or 20 mg (2%). inactives: boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid may be added to adjust ph (3.0 to 5.5) and water for injection. preservative: benzalkonium chloride 0.1 mg (0.01%). structural formula

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.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, and impairment of fertility: studies in animals or humans have not been conducted to evaluate the carcinogenic potential of cyclopentolate.

How Supplied:

How supplied: cyclopentolate hydrochloride ophthalmic solution, usp is a sterile ophthalmic solution supplied in white opaque plastic dropper bottles as follows: cyclopentolate hydrochloride ophthalmic solution usp, 1% 2 ml ndc 17478-100-02 5 ml ndc 17478-100-10 15 ml ndc 17478-100-12 cyclopentolate hydrochloride ophthalmic solution usp, 2% 2 ml ndc 17478-097-02 5 ml ndc 17478-097-10 15 ml ndc 17478-097-12 do not use if imprinted seal is broken or missing. storage: store at 20Â° to 25Â°c (68Â° to 77Â°f) [see usp controlled room temperature]. keep tightly closed. keep out of the reach of children. akorn distributed by: akorn operating company llc gurnee, il 60031 cc00n rev. 01/22

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.

Package Label Principal Display Panel:

Principal display panel text for container label: ndc 17478-100-02 cyclopentolate hydrochloride ophthalmic solution, usp 1% for topical ophthalmic use only rx only 2 ml principal display panel text for container label

Principal display panel text for carton label: ndc 17478-100-02 cyclopentolate hydrochloride ophthalmic solution, usp 1% for topical ophthalmic use only 2 ml rx only akorn logo principal display panel text for carton label

Principal display panel text for container label: ndc 17478-097-10 cyclopentolate hydrochloride ophthalmic solution, usp 2% 5 ml rx only sterile principal display panel text for container label

Principal display panel text for carton label: ndc 17478-097-10 cyclopentolate hydrochloride ophthalmic solution, usp 2% 5 ml sterile rx only akorn logo principal display panel text for carton label

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