Atropt

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Atropine sulfate monohydrate 0.5%{relative}

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Atropine sulfate monohydrate 0.5% w/v

Dosage:

0.5 %

Pharmaceutical form:

Eye drops, solution

Composition:

Active: Atropine sulfate monohydrate 0.5%{relative} Excipient: Benzalkonium chloride Boric acid Disodium edetate dihydrate Hypromellose Water

Units in package:

Bottle, dropper, 1x15ml, 15 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Boehringer Ingelheim Pharma GmbH & Co KG

Product summary:

Package - Contents - Shelf Life: Bottle, dropper, 1x15ml - 15 mL - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1.
ATROPT EYE DROPS (ATROPINE SULFATE 1%)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 mL contains 10 mg atropine Sulfate (1 %).
Atropine Sulfate exists as odourless, colourless crystals or white
crystalline powder.
It effloresces in dry air.
Atropine Sulfate is soluble in water (1 in 0.5), in boiling water (1
in 2.5), in alcohol (1
in 5), in glycerol (1 in 2.5), practically insoluble in chloroform and
ether. A 2%
solution in water has a pH of 4.5 to 6.2. Solutions may be sterilised
by autoclave.
Atropine Sulfate is both a mydriatic and cycloplegic and has the
following molecular
formula: (C
17
H
23
NO
3
)
2
, H
2
SO
4
,H
2
O. Relative molecular mass is 694.8.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
ATROPT EYE DROPS contains atropine Sulfate (1%) in a sterile aqueous
base. A
clear, or almost clear, slightly viscous, colourless liquid which
foams on shaking.
Odourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATROPT EYE DROPS are indicated where it is necessary to dilate the
pupil and
paralyse accommodation.
4.2
DOSE AND METHOD OF ADMINISTRATION
Instil one drop into the eye as required for treatment. To minimise
the risk of
systemic absorption, gentle pressure should be applied to the tear
duct for one
minute after application.
4.3
CONTRAINDICATIONS
ATROPT EYE DROPS are contraindicated in the presence of angle closure
glaucoma
or where angle closure glaucoma is suspected. If used in glaucoma
susceptible
patients, an estimation of the depth of the angle of the anterior
chamber should be
performed prior to the initiation of therapy.
Hypersensitivity to any ingredient in ATROPT EYE DROPS.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients treated prior to ophthalmic examination should be escorted to
and from
the surgery.
_ _
_USE IN CHILDREN _
ATROPT EYE DROPS should be used with extreme caution, if at all, in
infants
and small children and in children with spastic paralysis or brain
damage,
due to their increased susceptibility to the systemic e