Rx Item-Cyclopentolate Ak-Pentolate 1% Drops 15ml By Akorn Pharma

AK-PENTOLATE- cyclopentolate hydrochloride solution/ drops
Rebel Distributors Corp.
DESCRIPTION
AK-PENTOLATE? (Cyclopentolate Hydrochloride Ophthalmic Solution) is an anticholinergic prepared as sterile, borate buffered solution for topical ocular use. It is supplied in two strengths.
Chemical name:
2-(Dimethylamino)ethyl 1-hydroxy-?-phenylcyclopentaneacetate hydrochloride
Each mL contains: Active: Cyclopentolate Hydrochloride 10 mg (1%) or 20 mg (2%).
Preservative: Benzalkonium Chloride 0.1 mg (0.01%).
Inactives: Boric Acid, Edetate Disodium, Potassium Chloride (except 2% strength), Sodium Carbonate and/or Hydrochloric Acid may be added to adjust pH (3.0 to 5.5) and Purified Water USP.
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 shorter duration than atropine. Maximal cycloplegia occurs within 25 to 75 minutes after instillation. Complete recovery of accommodation usually takes 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
Cyclopentolate hydrochloride ophthalmic solution is used to produce mydriasis and cycloplegia.
CONTRAINDICATIONS
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.
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 solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 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 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.
info. for Patients
Do not touch dropper tip to any surface, as this may contaminate the solution. 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, and Impairment of Fertility
Studies in animals or humans have not been conducted to evaluate the carcinogenic potential of cyclopentolate.
Pregnancy
Pregnancy Category C
DOSAGE AND ADMINISTRATION
Adults: Instill one or two drops of 1% or 2% 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% or 2% solution in the eye which may be repeated five to ten minutes later by second application of 1% solution if necessary.
HOW SUPPLIED
AK-PENTOLATE? (Cyclopentolate Hydrochloride Ophthalmic Solution, USP) is sterile ophthalmic solution supplied in white opaque plastic dropper bottles as follows:

Rx Item-Ak-Pentolate 1% Drops 15ml By Ak
NDC No.17478-0100-12 UPC/GTIN No.3-17478-10012-6 MPN No. 10012 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

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Akorn Inc

CYCLOPENTOLATE HCL OPHTHA
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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