MINIMS* ATROPINE SULPHATE 1% Eye Drops
SCHEDULING STATUS:
Schedule 3
PROPRIETARY NAME
(and dosage form):
MINIMS* ATROPINE SULPHATE 1% Eye Drops
COMPOSITION:
(per dispensing unit of 0,5mL)
Atropine sulphate 5mg
PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations: Other.
PHARMACOLOGICAL ACTION:
Atropine sulphate is a parasympatholytic drug which paralyses the sphincter muscle of the iris thus causing dilation; and also paralyses the ciliary muscle, thus causing paralysis of accommodation.
INDICATIONS:
Atropine sulphate's prolonged mydriatic action is used in the treatment of iritis to immobilise the ciliary muscle and to prevent or break down adhesions. It is also used for refractive work in young children by virtue of its powerful cycloplegic action.
CONTRA-INDICATIONS:
Atropine and other anti-cholinergic drugs should not be administered to patients with narrow-angle glaucoma, or to those with a narrow angle between the iris and the cornea, since their use may cause intra-ocular pressure to increase.
DOSAGE AND DIRECTIONS FOR USE:
To be used as directed by the ophthalmologist. Dilation of the pupil occurs 30minutes following its local application and lasts for a week or more and accommodation is paralysed within two hours, with recovery in 2 or 3days.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
May cause conjunctival irritation in sensitive persons. Dryness of the mouth and photophobia. Systemic effects arise from its parasympatholytic action, namely constipation, vomiting and giddiness, increased heart rate, depressant and stimulant action on the C.N.S. These are not normally seen on ocular administration.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Not applicable.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
IDENTIFICATION:
Clear, colourless solution.
PRESENTATION:
Sterile, single-dose disposable eye drops in cartons of 10 units, each containing approximately 0,5mL.
STORAGE INSTRUCTIONS:
Store in the refrigerator protected from strong light. DO NOT FREEZE.
Keep out of reach of children.
REGISTRATION NUMBER:
C/15.4/39
NAME AND BUSINESS ADDRESS OF APPLICANT:
S & N Pharmaceuticals (Pty) Ltd.
30 Gillitts Road
Pinetown
3610
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 26,1970
* Trademark 9/67A SNP 29/2 |
