INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ATROPINE EYE DROPS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

ATROPINE EYE DROPS

COMPOSITION:
Contains per mL:
  Atropine sulphate                10 mg
Preservative:
  Benzalkonium chloride         0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A. 15.4 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION:
Atropine eye drops
has parasympatholytic effects which include paralysis of ocular accommodation and dilatation of the pupil.

INDICATIONS:
As a cycloplegic or mydriatic for refraction or for desired dilatation of the iris or uveal tract during acute inflammatory conditions.

CONTRA-INDICATIONS:
Not to be used in glaucoma or tendency towards glaucoma, and in persons hypersensitive to belladonna alkaloids.
Should not be used by children under the age of six.

WARNINGS:
As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR USE:
For uveitis:        One drop three times daily
For refraction: One drop in the eyes twice daily for one or two days before examination, and one hour before examination.
Pressure should be maintained over lacrimal sac, occluding lacrimal duct for one minute after instillation.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Flushing and dryness of the skin. Blurring of vision, rapid pulse and dizziness may occur. It may cause conjunctival irritation. In these cases discontinue its use.
Dryness of the mouth may occur. In this case decrease the dosage. If eye pain occurs discontinue, and see your doctor immediately, as this may indicate undiagnosed glaucoma. May only be used on prescription.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic doses cause tachycardia, rapid or stertorous respiration, hyperplexia, restlessness, confusion and excitement and hallucination passing into delirium. In severe intoxication depression of the central nervous system may occur with respiratory depression. Empty the stomach by aspiration and lavage. A saline purge should be given to promote peristalsis.
Short acting barbiturates may be used for the state of excitement. Peripheral symptoms can be relieved by subcutaneous injection of neostigmine methyl sulphate 5 mg repeated at intervals.

IDENTIFICATION:
Clear solution.

PRESENTATION:
5 mL in a white dropper bottle with red screw-on cap.

STORAGE INSTRUCTIONS:
Store below 25°C and keep tightly closed.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
J/15.4/312

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext. 77
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 December 1977

        100159 06/2003
        Blesston

Updated on this site: December 2005
Source: Hospital Pharmacy

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