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http://www.medsafe.govt.nz/Profs/Datasheet/a/Atropteyedrop.htm

ATROPT EYE DROPS
Atropine sulphate
Presentation
ATROPT EYE DROPS contains atropine sulphate (0.5% or 1%) in a sterile
aqueous base. A clear, or almost clear, slightly viscous, colourless
liquid which foams on shaking. Odourless. Each ml contains 5mg
atropine sulphate (0.5%).

Uses
Actions
Atropine is a belladonna alkaloid. Atropine sulphate acts in the eye
to block the action of acetylcholine, relaxing the cholinergically
innervated sphincter muscle of the iris. This results in dilation of
the pupil (mydriasis). The cholinergic stimulation of the
accommodative ciliary muscle of the lens is also blocked. This results
in paralysis of accommodation (cycloplegia). Effects on accommodation
may last 6 days; mydriasis may persist for 12 days.

Pharmacokinetics
Atropine is readily absorbed from the gastrointestinal tract; it is
also readily absorbed from mucous membranes, the eye, and to some
extent through intact skin. It is rapidly cleared from the blood and
is distributed throughout the body. It crosses the blood-brain
barrier. It is incompletely metabolised in the liver and is excreted
in the urine as unchanged medicine and metabolites. A half-life of 4
hours has been reported.

Atropine sulphate has a slower onset and more prolonged effects than
most other anticholinergics. Maximum mydriatic effect occurs in around
30-40 minutes. Maximum cycloplegia takes several hours. Mydriasis
usually lasts 7 to 12 days and cycloplegia persists for 14 days or
longer. Onset of effects and duration may be prolonged in heavily
pigmented eyes.

Indications
ATROPT EYE DROPS are indicated where it is necessary to dilate the
pupil and paralyse accommodation.

Dosage and 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.

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.

Warnings and Precautions
Patients treated prior to ophthalmic examination should be escorted to
and from the surgery.

Use in Pregnancy
Atropine sulphate may be systemically absorbed after ocular
administration; however, significant effects on the foetus have not
been reported.

Use in Lactation
Systemically absorbed atropine sulphate is distributed into breast
milk in very small amounts. It may cause adverse effects, such as
rapid pulse, fever, or dry skin, in nursing infants of mothers using
ophthalmic atropine.

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
effects of the medicine.

Atropine sulphate should not be used in children who have previously
had severe systemic reaction to atropine. An increased susceptibility
to atropine has been reported in infants and young children and in
children with blonde hair, blue eyes, Down's Syndrome, spastic
paralysis, or brain damage; therefore, atropine should be used with
great caution in these patients.

Use in the Elderly
Geriatric patients are more susceptible to the effects of atropine,
thus increasing the potential for systemic side effects.

Carcinogenicity, Mutagenicity, Impairment of Fertility
Studies have not been performed in either animals or humans to
evaluate the potential carcinogenic, mutagenic or fertility impairing
effects of atropine. No significant effects have been reported.

Adverse Effects
The following adverse reactions have been reported:

Ophthalmic
Incidence common: Blurred vision.
Incidence less frequent to rare: Conjuctival irritation, follicular
conjunctivitis, increased intraocular pressure (especially in patients
with closed-angle glaucoma), increased sensitivity to light, swelling
of eyelids.
Systemic toxicity may occur in susceptible patients, particularly
children. Such effects include:

Gastrointestinal
Incidence less frequent to rare: Dryness of the mouth with difficulty
in swallowing or talking, thirst, abdominal distention in infants.
Respiratory
Incidence less frequent to rare: Reduced bronchial secretions,
respiratory depression.
Dermatological
Incidence less frequent to rare: Flushing and dryness of the skin,
rash, dermatitis.
Cardiovascular
Incidence less frequent to rare: Rapid and irregular pulse,
hyperaemia, cardiac arrhythmias, hypotension.
Neurological
Incidence less frequent to rare: Fever, clumsiness or unsteadiness,
confusion or unusual behaviour, dizziness, hallucinations, slurred
speech, unusual drowsiness, tiredness or weakness.
Musculoskeletal
Incidence less frequent to rare: Loss of neuromuscular co-ordination,
oedema.
Interactions
Anticholinergics

If significant systemic absorption of ophthalmic atropine occurs,
concurrent use of other anticholinergics or medications with
anticholinergic activity may result in potentiated anticholinergic
effects.

Antiglaucoma agents (cholinergic, long-acting, ophthalmic)

Concurrent use with atropine may antagonize the antiglaucoma and
miotic actions of ophthalmic long-acting cholinergic anti-glaucoma
agents, such as demecarium, ecothiophate, and isoflurophate;
concurrent use with atropine may also antagonize the antiaccommodative
convergence effects of these medications when they are used for the
treatment of strabismus.

Antimyasthenics, potassium citrate, potassium supplements

If significant systemic absorption of ophthalmic atropine occurs,
concurrent use may increase the chance of toxicity and/or side effects
of these systemic medications because of the anti-cholinergic-induced
slowing of gastrointestinal motility.

Carbachol, physostigmine or pilocarpine

Concurrent use with atropine may interfere with the antiglaucoma
action of carbachol, physostigmine or pilocarpine. Also, concurrent
use may counteract the mydriatic effect of atropine; this
counteraction may be used to therapeutic advantage.

CNS depression-producing medications

If significant absorption of systemic atropine occurs, concurrent use
of medications having CNS effects, such as antiemetic agents,
phenothiazines, or barbiturates, may result in opisthotonos,
convulsions, coma, and extrapyramidal symptoms.

Overdosage
Signs of overdosage are similar to those described as systemic effects
(see Adverse Effects ). Treatment is symptomatic and supportive.

For accidental ingestion, emesis or gastric lavage with 4% tannic acid
solution is recommended.

For systemic effects, 0.2 to 1mg (0.2mg in children) physostigmine
should be administered intravenously, as a dilution containing 1mg in
5ml of normal saline. The solution should be injected over a period of
not less than 2 minutes. Dosage may be repeated every 5 minutes up to
a total dose of 2mg in children and 6mg in adults in each 30 minute
period. Physostigmine is contraindicated in hypertensive reactions.
ECG monitoring is recommended during physostigmine administration.

Excitement may be controlled by diazepam or a short acting
barbiturate.

It is recommended that 1mg of atropine be available for immediate
injection if the physostigmine causes bradycardia, convulsion, or
bronchoconstriction.

Supportive therapy may require oxygen and assisted respiration; cool
water baths for fever, especially in children; and catherterization
for urinary retention. In infants and small children, the body surface
should be kept moist.

Pharmaceutical Precautions
Store below 25°C. Protect from light.

Medicine Classification
Prescription Medicine.

Package Quantities
ATROPT EYE DROPS 0.5% and 1%: 15ml plastic dropper bottles with tamper
seals.

Further Information
Atropine sulphate exists as odourless, colourless crystals or white
crystalline powder. It effloresces in dry air.

Atropine sulphate 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. Store in
airtight containers. Protect from light.

ATROPT EYE DROPS contain the following excipients:
disodium edetate,
benzalkonium chloride,
hypromellose,
boric acid,
water - purified.

Atropine sulphate is both a mydriatic and cycloplegic and has the
following molecular formula: (C17H23NO3)2,H2SO4,H2O. Relative
molecular mass is 694.8.

Name and Address
Exclusive New Zealand distributor:

Pharmaco (N.Z.) Ltd
P.O. Box 4079
Auckland

Telephone: (09) 377-3336

Date of Preparation
21 July 1999

If you're spelling it right, it's atropine 1% or 0.5%. Outside the US it's
sold by many names - Atropisol, Liotropina, Ocu-Tropine, Sal-Tropine.

It has several uses. What are you using it for?

-MT