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AK-PENTOLATE

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Overview

What is AK-PENTOLATE?

AK-PENTOLATE™ (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:

MW=327.85            CHNO • HCl

The active ingredient is represented by the structural formula:

AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution) USP, 1% & 2%

Each mL contains: Active:

Preservative:

Inactives:



What does AK-PENTOLATE look like?



What are the available doses of AK-PENTOLATE?

Sorry No records found.

What should I talk to my health care provider before I take AK-PENTOLATE?

Sorry No records found

How should I use AK-PENTOLATE?

Cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.

Adults:

Children:


What interacts with AK-PENTOLATE?

AK-PENTOLATE™ (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.



What are the warnings of AK-PENTOLATE?

To provide information regarding the effects of exposure to carbamazepine, physicians are advised to recommend that pregnant patients taking carbamazepine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

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.


What are the precautions of AK-PENTOLATE?

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 (4) hours after examination.

Drug Interactions

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of cyclopentolate.

Pregnancy

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 cyclopentolate hydrochloride 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 (4) hours after examination. Observe infants closely for at least 30 minutes (see ).


What are the side effects of AK-PENTOLATE?

Ocular:

Non-ocular:


What should I look out for while using AK-PENTOLATE?

AK-PENTOLATE™ (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.

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.


What might happen if I take too much AK-PENTOLATE?

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.


How should I store and handle AK-PENTOLATE?

Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution, USP) is a sterile ophthalmic solution supplied in white opaque plastic dropper bottles as follows:AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%) 15 mL NDC 21695-883-15DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING.AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution, USP) is a sterile ophthalmic solution supplied in white opaque plastic dropper bottles as follows:AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%) 15 mL NDC 21695-883-15DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING.AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution, USP) is a sterile ophthalmic solution supplied in white opaque plastic dropper bottles as follows:AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%) 15 mL NDC 21695-883-15DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING.


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Clinical Information

Chemical Structure

No Image found
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.

Non-Clinical Toxicology
AK-PENTOLATE™ (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.

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.

Cyclopentolate may interfere with the ocular anti-hypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

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.

Ocular:

Non-ocular:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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