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 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
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 a second application of 1% solution if necessary.
HOW SUPPLIED
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%)
2 mL NDC 17478-100-20
5 mL NDC 17478-100-10
15 mL NDC 17478-100-12
AK-PENTOLATE™ (Cyclopentolate Hydrochloride Ophthalmic Solution USP, 2%)
2 mL NDC 17478-097-20
5 mL NDC 17478-097-10
15 mL NDC 17478-097-12
CLINICAL PHARMACOLOGY This anticholinergic preparation blocks the responses of the
sphincter muscle of the iris and the ciliary muscle to cholinergic
stimulation, dilating the pupil (mydriasis). The stronger preparation
(1%) also paralyzes accommodation. This preparation acts in 15-30
minutes and the duration of activity is approximately 3-8 hours.
Complete recovery from mydriasis in some individuals may require 24
hours. The weaker strength may be useful in producing mydriasis with
only slight cycloplegia. Heavily pigmented irides may require more doses
than lightly pigmented irides.
INDICATIONS AND USAGE For mydriasis and cycloplegia for diagnostic procedures.
CONTRAINDICATIONS Contraindicated in persons showing hypersensitivity to any
component of this preparation.
DOSAGE AND ADMINISTRATION For refraction, instill one or two drops of 1% solution in the
eye(s), repeated in five minutes. If patient is not seen within 20 to 30
minutes, an additional drop may be instilled to prolong mydriatic
effect. For examination of fundus, instill one or two drops of 0.5%
solution 15 to 20 minutes prior to examination. Individuals with heavily
pigmented irides may require higher strength or more doses. Mydriasis
will reverse spontaneously with time, typically in 4 to 8 hours.
However, in some cases, complete recovery may take up to 24 hours.
HOW SUPPLIED TROPICACYL® Tropicamide Ophthalmic Solution USP, 0.5% and 1%
are supplied as sterile solutions in plastic dropper bottles.
STORAGE
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room
Temperature]. Do not refrigerate or store at high temperatures. Keep
container tightly closed
Disclaimer
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