DRUGS & SUPPLEMENTS
Pentolair 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: Pentolair
Chemical name: 2-(Dimethylamino)ethyl 1-hydroxy-α-phenylcyclopentaneacetate hydrochloride.
Each mL contains:
Active: Pentolair, 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%.
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
Pentolair Ophthalmic Solution is used to produce mydriasis and cycloplegia.
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.
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 Pentolair 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.
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.
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 Pentolair 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.
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 Pentolair is administered to a nursing woman.
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 ).
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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.
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.
Pentolair 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
Store between 15°-25°C (59°-77°F).
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
FOR TOPICAL APPLICATION
IN THE EYE
BAUSCH + LOMB
Pentolair pharmaceutical active ingredients containing related brand and generic drugs:
Pentolair available forms, composition, doses:
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.
Pentolair destination | category:
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.
Pentolair Anatomical Therapeutic Chemical codes:
Pentolair pharmaceutical companies:
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.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Pentolair?
Depending on the reaction of the Pentolair after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pentolair 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 Pentolair addictive or habit forming?
Reviewsdrugs.com conducted a study on Pentolair, 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 Pentolair 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.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
Visitor reported price estimatesNo survey data has been collected yet
Visitor reported frequency of useNo survey data has been collected yet
Visitor reported dosesNo survey data has been collected yet
Visitor reported time for resultsNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology