CYCLOPENTOLATE- cyclopentolate hydrochloride solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J)

Available from:

Akorn

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cyclopentolate hydrochloride 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.

Product summary:

Cyclopentolate Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in multiple–dose plastic Boston Round Natural LDPE bottle with a 15 mm LLDPE dropper-tip and 15 mm polypropylene red cap. NDC 17478-096-15                                                                      15 mL fill/15 mL bottle Storage: Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Rx Only Akorn Logo Manufactured by: Akorn, Inc. Lake Forest, IL 60045 CPA0N    Rev. 06/16

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Akorn
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SPL MEDGUIDE
Revised: 1/2022
Document Id: 55516550-81ea-4aab-aea4-0e1351c478bc
34391-3
Set id: 84a02489-2753-4543-9712-0345074e5972
Version: 5
Effective Time: 20220125
Akorn

Summary of Product characteristics

CYCLOPENTOLATE - CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/ DROPS
AKORN
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CYCLOPENTOLATE HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 0.5%
DESCRIPTION
Cyclopentolate Hydrochloride Ophthalmic Solution, USP 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: C
H
NO •HCl
Established name: Cyclopentolate Hydrochloride
Chemical name: 2-(Dimethylamino)ethyl
1-hydroxy-α-phenylcyclopentaneacetate
hydrochloride
EACH ML CONTAINS: ACTIVE: cyclopentolate hydrochloride 0.5%.
INACTIVES: boric acid,
edetate disodium, potassium chloride, sodium carbonate and/or
hydrochloric acid (to
adjust pH), water for injection. The pH range is between 3.0 and 5.5.
PRESERVATIVE:
benzalkonium chloride 0.01%.
CLINICAL PHARMACOLOGY
17
25
3
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
papillary 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 & USAGE
Cyclopentolate hydrochloride is used to produce mydriasis and
cycloplegia.
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 APPLICATION IN THE EYE. 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
cardiopulmonar