Cylate

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Cylate uses


DESCRIPTION

Cylate Ophthalmic Solution, USP 1% 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: C17H25NO3 - HCl

Established name: Cylate

Chemical name: 2-(Dimethylamino)ethyl 1-hydroxy-α-phenylcyclopentaneacetate hydrochloride.

Each mL contains:

Active: Cylate, 10 mg (1%)

Inactives: Boric Acid, Edetate Disodium, Potassium Chloride, Purified Water. Sodium Carbonate and/or Hydrochloric Acid (to adjust pH). The pH range is between 3.0 and 5.5.

Preservative added: benzalkonium chloride 0.01%.

chemical structure

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.

INDICATIONS AND USAGE

Cylate Ophthalmic Solution is used to produce mydriasis and cycloplegia.

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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.

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 Cylate solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of a 1% cyclopentolate 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.

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.

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 hours after examination.

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 Cylate Ophthalmic Solution, USP.

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.

Nursing Mothers:

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 Cylate is administered to a nursing woman.

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 hours after examination. Observe infants closely for at least 30 minutes (see WARNINGS ).

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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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.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

DOSAGE AND ADMINISTRATION

Adults: Instill one or two drops of 1% 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% solution in the eye, which may be repeated five to ten minutes later by a second application of 1% solution if necessary.

Individuals with heavily pigmented irides may require higher strengths.

HOW SUPPLIED

Cylate Ophthalmic Solution, USP 1% is available in multidose plastic squeeze bottles with a controlled drop tip and red cap in the following sizes:

2 mL bottle - NDC 24208-735-01

15 mL bottle - NDC 24208-735-06

Storage:

Store between 15°-25°C (59°-77°F).

Rx only

FOR TOPICAL APPLICATION IN THE EYE

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of

Valeant Pharmaceuticals North America LLC

Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9114605 (Folded)

9114705 (Flat)

NDC 24208-735-06

Cyclopentolate

Hydrochloride

Ophthalmic

Solution, USP

1% (Sterile)

FOR TOPICAL APPLICATION

IN THE EYE

Rx only

15 mL

BAUSCH + LOMB

cyclocarton.jpg

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Cylate pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Cylate available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Cylate destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Cylate Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Cylate pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "cyclopentolate". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  3. "cyclopentolate". http://www.drugbank.ca/drugs/DB0097... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Cylate?

Depending on the reaction of the Cylate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cylate not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Cylate addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Cylate, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Cylate consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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