ODAN-PHENYLEPHRINE SOLUTION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PHENYLEPHRINE HYDROCHLORIDE

Доступно од:

ODAN LABORATORIES LTD

АТЦ код:

S01FB01

INN (Међународно име):

PHENYLEPHRINE

Дозирање:

2.5%

Фармацеутски облик:

SOLUTION

Састав:

PHENYLEPHRINE HYDROCHLORIDE 2.5%

Пут администрације:

OPHTHALMIC

Јединице у пакету:

15ML

Тип рецептора:

OTC

Терапеутска област:

MYDRIATICS

Резиме производа:

Active ingredient group (AIG) number: 0100662002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2015-10-14

Карактеристике производа

PRESCRIBING INFORMATION
ODAN-PHENYLEPHRINE
PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP
2.5%
MYDRIATIC / VASOCONSTRICTOR
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe-Claire, Québec H9R 2Y6
Control No: 188055
Date of Preparation:
October 14, 2015
www.odanlab.com
2
PRESCRIBING INFORMATION
ODAN-PHENYLEPHRINE
PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP
2.5%
DESCRIPTION
ODAN-PHENYLEPHRINE is a sterile ophthalmic solution containing a
sympathomimetic agent
which produces both vasoconstricting and mydriatic effects.
Phenylephrine hydrochloride is a
synthetic sympathomimetic compound structurally similar to epinephrine
and ephedrine. A
prompt, short acting mydriatic, it causes little or no cycloplegia or
irritation.
ACTIONS
Phenylephrine hydrochloride is presumed to have a direct effect upon
the alpha-adrenergic
receptor stimulator producing pupil dilation and vasocontriction.
INDICATIONS
As an ophthalmic decongestant and vasoconstrictor for pupil dilation
in uveitis (posterior
synechiae),
wide
angle
glaucoma,
surgery,
refraction,
ophthalrnoscopic
examination
and
diagnostic procedures.
CONTRAINDICATIONS
Narrow-angle glaucoma, hypertension, and in persons with a known
hypersensitivity to any
component.
WARNINGS
For topical ophthalmic use only. As with all other adrenergic drugs,
when administered
simultaneously with, or up to 21 days after, administration of
monoamine 1oxidase (MAO)
inhibitors, careful supervision and adjustment of dosages are required
since exaggerated
adrenergic effects may result. The pressor response of adrenergic
agents may also be potentiated
by tricyclic antidepressants .
3
PRECAUTIONS
ODAN-PHENYLEPHRINE
should
be
used
with
caution
in
patients
with
advanced
arteriosclerotic conditions or severe hypertension. Phenylephrine may
be used in patients with
glaucoma when temporary dilation of the pupil may free adhesions or
when vasocontriction of
intrinsic vessels may lower intraocular tension: these advantages may
temporarily outweigh the
danger from coincident dilation of the pupil