Cyclopentolate
Cyclopentolate Hydrochloride
Akorn
Human Prescription Drug
NDC 17478-096Cyclopentolate also known as Cyclopentolate Hydrochloride is a human prescription drug labeled by 'Akorn'. National Drug Code (NDC) number for Cyclopentolate is 17478-096. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Cyclopentolate drug includes Cyclopentolate Hydrochloride - 5 mg/mL . The currest status of Cyclopentolate drug is Active.
Drug Information:
| Drug NDC: | 17478-096 |
| 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 |
| 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 - 5 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: | 10 Dec, 2015 |
| 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: | ANDA205937 |
| 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: | 1298072
|
| 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: | 0317478096153
|
| 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 |
|---|
| 17478-096-15 | 1 BOTTLE, DROPPER in 1 CARTON (17478-096-15) / 15 mL in 1 BOTTLE, DROPPER | 10 Dec, 2015 | 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. |
Product Elements:
Cyclopentolate cyclopentolate hydrochloride cyclopentolate hydrochloride cyclopentolate boric acid edetate disodium potassium chloride sodium carbonate hydrochloric acid water benzalkonium chloride
Indications and Usage:
Indications & usage cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
Warnings:
Warnings for topical application in the eye . 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 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.
Dosage and Administration:
Dosage & administration adults: instill one or two drops of 0.5% 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% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% 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.
Contraindications:
Contraindications 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 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 n
Read more...asal passages. severe manifestations of toxicity include coma, medullary paralysis and death.
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, usp is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use. the active ingredient is represented by the structural formula: molecular weight=327.85 molecular formula: c 17 h 25 no 3 â¢hcl established name: cyclopentolate hydrochloride chemical name: 2-(dimethylamino)ethyl 1-hydroxy-α-phenylcyclopentaneacetate hydrochloride each ml contains: active: cyclopentolate hydrochloride 0.5%. inactives: boric acid, edetate disodium, potassium chloride, sodium carbonate and/or hydrochloric acid (to adjust ph), water for injection. the ph range is between 3.0 and 5.5. preservative: benzalkonium chloride 0.01%. structure formula image
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 papillary 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:
How supplied cyclopentolate hydrochloride ophthalmic solution, usp 0.5% is supplied in multipleâdose plastic boston round natural ldpe bottle with a 15 mm lldpe dropper-tip and 15 mm polypropylene red cap. ndc 17478-096-15 15 ml fill/15 ml bottle storage: store at 20°c to 25°c (68°f to 77°f) [see usp controlled room temperature]. rx only akorn logo manufactured by: akorn, inc. lake forest, il 60045 cpa0n rev. 06/16
Package Label Principal Display Panel:
Principal display panel text for container label: ndc 17478-096-15 cyclopentolate hydrochloride ophthalmic solution, usp 0.5% for topical application in the eye eye logo rx only 15 ml principal display panel text for carton label: ndc 17478-096-15 cyclopentolate hydrochloride ophthalmic solution, usp 0.5% for topical application in the eye eye logo 15 ml rx only akorn logo container carton