Cyclomydril

Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride

Alcon Laboratories, Inc.
Human Prescription Drug
NDC 0065-0359

Cyclomydril also known as Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride is a human prescription drug labeled by 'Alcon Laboratories, Inc.'. National Drug Code (NDC) number for Cyclomydril is 0065-0359. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Cyclomydril drug includes Cyclopentolate Hydrochloride - 2 mg/mL Phenylephrine Hydrochloride - 10 mg/mL . The currest status of Cyclomydril drug is Active.

Drug Information:

Drug NDC:	0065-0359
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:	Cyclomydril
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 And Phenylephrine Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Alcon Laboratories, Inc.
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 - 2 mg/mL PHENYLEPHRINE HYDROCHLORIDE - 10 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:	30 Jun, 1958
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Jan, 2026
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:	ANDA084300
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:	Alcon Laboratories, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1298068 1298360
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:	0300650359054
UPC stands for Universal Product Code.
UNII:	736I6971TE 04JA59TNSJ
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.
Pharmacologic Class:	Adrenergic alpha1-Agonists [MoA] alpha-1 Adrenergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0065-0359-02	2 mL in 1 BOTTLE, PLASTIC (0065-0359-02)	30 Jun, 1958	N/A	No
0065-0359-05	5 mL in 1 BOTTLE, PLASTIC (0065-0359-05)	30 Jun, 1958	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

Cyclomydril

Cyclopentolate Hydrochloride And Phenylephrine Hydrochloride

Solution/ Drops
Alcon Laboratories, Inc.
NDC: 0065-0359

Product Elements:

Cyclomydril cyclopentolate hydrochloride and phenylephrine hydrochloride cyclopentolate hydrochloride cyclopentolate phenylephrine hydrochloride phenylephrine benzalkonium chloride edetate disodium boric acid hydrochloric acid sodium carbonate water carton label carton label label

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 for the production of mydriasis.

Warnings:

Warnings for topical ophthalmic use only. not for injection. the use of this combination may have an adverse effect on individuals suffering from cardiovascular disease, hypertension, and hyperthyroidism, and it may cause cns disturbances. infants are especially prone to cns and cardiopulmonary side effects from cyclopentolate. 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. the effect of long-term use of this preparation has not been established, therefore, it should be restricted to short-term use.

Dosage and Administration:

Dosage and administration instill one drop in each eye every five to ten minutes. to minimize systemic absorption, apply pressure over the nasolacrimal sac for two to three minutes following instillation. observe infants closely for at least 30 minutes.

Contraindications:

Contraindications do not use in patients with untreated narrow-angle glaucoma or with untreated anatomically narrow angles or where there is hypersensitivity to any component of this preparation.

Adverse Reactions:

Adverse reactions ocular the following ocular adverse experiences have been associated with the use of cyclomydril Â® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution): increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis. nonocular use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. 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 adrenergic and anticholinergic drugs; however, the central nervous system manifestations as noted above are most common. other manifestations of adrenergic and anticholinergic topical ophthalmic drugs include tachycardia, hyperpyrexia, hypertension, vasodilation, urinary retention, diminished ga Read more...

strointestinal 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.

Use in Pregnancy:

Pregnancy animal reproduction studies have not been conducted with cyclopentolate hydrochloride and/or phenylephrine hydrochloride. it is also not known whether cyclopentolate hydrochloride and/or phenylephrine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. cyclomydril Â® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) should be given 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 4 hours after examination. observe infants closely for at least 30 minutes (see precautions ).

Geriatric Use:

Geriatric use no overall differences in safety or effectiveness have been observed 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.

Description:

Description cyclomydrilÂ® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is a mydriatic prepared as a sterile topical ophthalmic solution. the active ingredients are represented by the chemical structures: established name: cyclopentolate hydrochloride chemical name: 2-(dimethylamino)ethyl 1 - hydroxy-Î±-phenylcyclopentaneacetate hydrochloride) molecular formula: molecular weight: established name: phenylephrine hydrochloride chemical name: 3-hydroxy-Î±[(methylamino)-methyl]-, benzenemethanol, hydrochloride (r)-. molecular formula: molecular weight: each ml of cyclomydril Â® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) contains: active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. preservative: benzalkonium chloride 0.01%. inactives: edetate disodium, boric acid, hydrochloric acid and /or sodium carbonate (to adjust ph), purified water. cyclopentolate hydrochloride phenylephrine hydrochloride

Clinical Pharmacology:

Clinical pharmacology cyclopentolate hydrochloride is an anticholinergic drug and phenylephrine hydrochloride is an adrenergic drug. this combination induces mydriasis that is greater than that of either drug alone at its respective concentration. the concentrations of cyclopentolate hydrochloride and phenylephrine hydrochloride have been selected to induce mydriasis with little accompanying cycloplegia. heavily pigmented irides may require more doses than lightly pigmented irides.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility there have been no long-term studies done using cyclopentolate hydrochloride and/or phenylephrine hydrochloride in animals to evaluate carcinogenic potential.

How Supplied:

How supplied cyclomydril Â® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution) is supplied as a sterile solution in 2 ml and 5 ml, in plastic drop-tainer Â® dispensers. 2 ml ndc 0065-0359-02 5 ml ndc 0065-0359-05 storage: store at 8Â°c to 25Â°c (46Â°f - 77Â°f)

Information for Patients:

Information for patients do not touch dropper tip to any surface, as this may contaminate the solution. patient should be advised not to drive or engage in hazardous activities while pupils are dilated. patient 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 ndc 0065-0359-05 alcon cyclomydril Â® (cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution) 5 ml sterile rx only sterile ophthalmic solution usual dosage: instill one drop in each eye every five to ten minutes. read enclosed insert. for topical ophthalmic use only warning: do not touch dropper tip to any surface as this may contaminate the solution. ingredients: each ml contains: active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. preservative: benzalkonium chloride 0.01%. inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust ph), purified water. storage: store at 8Â°-25Â° c (46Â° to 77Â° f). alcon alcon laboratories, inc. fort worth, texas 76134 usa printed in usa sn: lot: exp.: gtin: 00300650359054 300048632-0821 ndc 0065-0359-05 alcon cyclomydril Â® (cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution) 5 ml sterile rx only sterile ophthalmic solution usual dosage: instill one drop in each eye every five to ten minutes. read enclosed insert. for topical ophthalmic use only warning: do not touch dropper tip to any surface as this may contaminate the solution. ingredients: each ml contains: active: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. preservative: benzalkonium chloride 0.01%. inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust ph), purified water. storage: store at 8Â°-25Â° c (46Â° to 77Â° f). Â©2004, 2010, 2013 novartis 9014758 us alcon Â® a novartis company alcon laboratories, inc. fort worth, texas 76134 usa printed in usa lot: exp.: ndc 0065-0359-05 alcon cyclomydril Â® (cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution) sterile 5 ml rx only ingredients: each ml contains: actives: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. preservative: benzalkonium chloride 0.01%. inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust ph), purified water. warning: do not touch dropper tip to any surface as this may contaminate the solution. usual dosage: instill one drop in each eye every five to ten minutes. read enclosed insert. storage: store at 8Â°-25Â° c (46Â° to 77Â° f). printed in usa alcon laboratories, inc. fort worth, texas 76134 usa lot: exp.: 300048631-0821 ndc 0065-0359-05 alcon cyclomydril Â® (cyclopentolate hydrochloride, phenylephrine hydrochloride ophthalmic solution) sterile 5 ml rx only ingredients: each ml contains: actives: cyclopentolate hydrochloride 0.2%, phenylephrine hydrochloride 1%. preservative: benzalkonium chloride 0.01%. inactives: edetate disodium, boric acid, hydrochloric acid and/or sodium carbonate (to adjust ph), purified water. warning: do not touch dropper tip to any surface, as this may contaminate the solution. usual dosage: instill one drop in each eye every five to ten minutes. read enclosed insert. storage: store at 8Â°-25Â°c (46Â°-77Â°f). printed in usa Â©2004, 2013 novartis alcon laboratories, inc. fort worth, texas 76134 usa lot: exp.: h14882 us

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