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

Logo MINIMS* AMETHOCAINE HYDROCHLORIDE 0,5%
MINIMS* AMETHOCAINE HYDROCHLORIDE l,0%

SCHEDULING STATUS:
Schedule 4

PROPRIETARY NAME:
(and dosage form)

MINIMS* AMETHOCAINE HYDROCHLORIDE 0,5%
Eye Drops
MINIMS* AMETHOCAINE HYDROCHLORIDE l,0%
Eye Drops

COMPOSITION:
(per dispensing unit of 0,5 mL)
Amethocaine hydrochloride 2,5 mg (0,5% m/v)
Amethocaine hydrochloride 5,0 mg (1,0 % m/v)

PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations: Other.

PHARMACOLOGICAL ACTION:
Amethocaine hydrochloride is a local surface anaesthetic which acts by blocking sensory nerve endings near the site of application.

INDICATIONS:
In ophthalmology amethocaine hydrochloride is used to anaesthetise the cornea during ophthalmological procedures. Amethocaine hydrochloride is used for minor conjunctival and corneal surgery and is especially useful for the removal of foreign bodies. It is also used for gonioscopy in cases of suspected glaucoma since it does not cause dilation of the pupil.

CONTRA-INDICATIONS:
Patients with a known sensitivity to amethocaine. Amethocaine hydrochloride is hydrolysed in the body to p-aminobenzoic acid which inhibits the action of sulphonamides; amethocaine should not therefore be used in patients being treated with sulphonamides.

DOSAGE AND DIRECTIONS FOR USE:
To be used as directed by the ophthalmologist. Onset of action is 9-26 seconds, and the duration of effect is 10-20 minutes.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Instillation of amethocaine hydrochloride causes conjunctival irritation, and punctate corneal damage may occur due to the accumulation of lactic acid. The use of amethocaine hydrochloride may give rise to dermatitis in sensitive patients. Cardiovascular collapse may occur due to idiosyncrasy and occasionally, convulsions and hyperexcitability.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side effects. Treatment is supportive and symptomatic.

IDENTIFICATION:
Clear, colourless solution.

PRESENTATION:
Sterile, single-dose, disposable eye drops in cartons of 10 units, each containing approximately 0,5 mL.

STORAGE INSTRUCTIONS
Store in the refrigerator, protected from strong light. DO NOT FREEZE.
Keep out of reach of children.

REGISTRATION NUMBERS:
C/15.4/46 Minims Amethocaine Hydrochloride 0,5% Eye Drops
C/15.4/47 Minims Amethocaine Hydrochloride 1% Eye Drops

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
9/67P        SNP 28/2

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