CYCLOPENTOLATE HYDROCHLORIDE solution/ drops

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Physicians Total Care, Inc.

INN (আন্তর্জাতিক নাম):

CYCLOPENTOLATE HYDROCHLORIDE

রচনা:

CYCLOPENTOLATE HYDROCHLORIDE 10 mg in 1 mL

প্রশাসন রুট:

OPHTHALMIC

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Cyclopentolate Hydrochloride Ophthalmic Solution is used to produce mydriasis and cycloplegia in diagnostic procedures. Should not be used when narrow-angle glaucoma or anatomical narrow angles are present, or where there is hypersensitivity to any component of this preparation.

পণ্য সারাংশ:

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1% is available in multidose plastic squeeze bottles with a controlled drop tip and red cap in the following sizes: 15 mL bottle - Prod. No. 04911     NDC 54868-4697-1 Store between 15°-30°C (59°-86°F). FOR OPHTHALMIC USE ONLY DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. KEEP OUT OF REACH OF CHILDREN.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

CYCLOPENTOLATE HYDROCHLORIDE - CYCLOPENTOLATE HYDROCHLORIDE SOLUTION/
DROPS
PHYSICIANS TOTAL CARE, INC.
----------
CYCLOPENTOLATE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP, 1%
(STERILE)
RX ONLY
DESCRIPTION:
Cyclopentolate Hydrochloride 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 following
structural formula:
C
H NO • HCl
Mol. Wt. 327.85
Chemical name: 2-(Dimethylamino) ethyl
1-hydroxy-α-phenylcyclopentaneacetate hydrochloride.
EACH ML CONTAINS:
ACTIVE: Cyclopentolate Hydrochloride, 10 mg (1%)
INACTIVES: Boric Acid, Potassium Chloride, Edetate Disodium, Purified
Water. Sodium Carbonate
and/or Hydrochloric Acid may be added to adjust pH (3.0-5.5).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.
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.
INDICATIONS AND USAGE:
Cyclopentolate Hydrochloride Ophthalmic Solution is used to produce
mydriasis and cycloplegia in
17
25
3
diagnostic procedures.
CONTRAINDICATIONS:
Should not be used when narrow-angle glaucoma or anatomical narrow
angles are present, or where
there is hypersensitivity to any component of this preparation.
WARNINGS:
For Topical 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
cyclopentolate hydrochloride solution. Premature and small infants are
especially prone to CNS and
cardiopulmonary side effects from systemic ab