Isopto Homatropine

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Homatropine hydrobromide 5%;  

Tilgjengelig fra:

Alcon Laboratories Australia Pty Ltd (NZ)

INN (International Name):

Homatropine hydrobromide 5%

Dosering :

5 %

Legemiddelform:

Eye drops, solution

Sammensetning:

Active: Homatropine hydrobromide 5%   Excipient: Benzethonium chloride Hypromellose Purified water Sodium chloride Sodium hydroxide

Enheter i pakken:

Bottle, dropper, 1x15ml, 15 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Boehringer Ingelheim Pharma GmbH & Co KG

Produkt oppsummering:

Package - Contents - Shelf Life: Bottle, dropper, 1x15ml - 15 mL - 36 months from date of manufacture stored at or below 25°C

Autorisasjon dato:

1969-12-31

Preparatomtale

1
ISOPTO
®
HOMATROPINE
HOMATROPINE HYDROBROMIDE EYE DROPS 2.0%
PRESENTATION
ISOPTO Homatropine (homatropine hydrobromide) is an anticholinergic
prepared as a sterile
topical ophthalmic solution.
Each mL contains: Active: Homatropine Hydrobromide 2.0%. Preservative:
Benzalkonium Chloride
0.01%. Vehicle: Hydroxypropyl Methylcellulose 0.5%. Inactive: Sodium
Chloride, Polysorbate 80,
Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH), Purified
Water.
USES
ACTIONS
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).
PHARMACOKINETICS
Unknown.
INDICATIONS
A moderately, long-acting mydriatic and cycloplegic for refraction and
in the treatment of inflammatory
conditions of the uveal tract. For pre- and post-operative states when
mydriasis is required. Use as an
optical aid in some case of axial lens opacities.
DOSAGE AND ADMINISTRATION
For refraction, instill one or two drops topically in the eye(s). May
be repeated in five to ten minutes if
necessary. For uveitis, instill one or two drops topically up to every
three to four hours. Individuals with
heavily pigmented irides may require larger doses. Only the 2%
strength should be used in pediatric
patients.
CONTRAINDICATIONS
Contraindicated in persons with primary glaucoma or a tendency towards
glaucoma, e.g., narrow
anterior chamber angle, and in those persons showing hypersensitivity
to any component of this
preparation.
Children
less
than
12
years
are
also
contraindicated
(see
WARNINGS
and
PRECAUTIONS).
WARNINGS AND PRECAUTIONS
For topical use only - not for injection.
Use with caution in patients, especially children, who have previously
had a severe systemic reaction
to atropine. Risk-benefit should be considered when the following
medical problems exist: keratoconus
(homatropine may produce fixed dilated pupil); Down's syndrome,
children with brain damage and the