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

Logo MINIMS* HOMATROPINE HYDROBROMIDE 2%

SCHEDULING STATUS:
Schedule 3

PROPRIETARY NAME:
(and dosage form)

MINIMS* HOMATROPINE HYDROBROMIDE 2%
Eye Drops

COMPOSITION:
(per dispensing unit of 0,5 mL)
Homatropine hydrobromide 10 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 15.4 Ophthalmic preparations: other

PHARMACOLOGICAL ACTION:
Homatropine hydrobromide has parasympatholytic properties similar to those of atropine, but is much weaker. Mydriasis occurs within 15-30 minutes and passes off in 6-24 hours. Mydriasis is readily controlled by physostigmine. In children homatropine does not usually produce complete cycloplegia.

INDICATIONS:
Homatropine hydrobromide is used in ophthalmology as a mydriatic, and as a cycloplegic.

CONTRA-INDICATIONS:
Homatropine hydrobromide should not be administered to patients with closed-angle glaucoma or to patients with a narrow angle between the iris and the cornea, since its use may cause intra-ocular pressure to rise.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children: To be used as directed by the ophthalmologist. For simple dilation of the pupil a 1% solution is usually adequate but for full paralysis of accommodation 3-4 drops of a 2% solution may have to be instilled every 15 minutes for 1-2 hours.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Homatropine hydrobromide should be used with caution in patients with prostatic enlargement and in patients suffering from paralytic ileus or pyloric stenosis. Systemic reactions may follow the absorption of homatropine hydrobromide from eye drops. Dryness of the mouth with difficulty in swallowing, thirst, dilation of the pupils with loss of accommodation and photophobia, increased intra-ocular pressure, flushing and dryness of the skin, bradycardia followed by tachycardia, with palpitations and arrhythmias, a desire to urinate with the inability to do so, as well as reduction in the tone and motility of the gastro-intestinal tract leading to constipation. Vomiting, giddiness and staggering may occur. Retrosternal pain may occur due to increased gastric reflux. Hypersensitivity may occur as conjunctivitis or a skin rash.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Toxic doses cause tachycardia, rapid or stertorous respiration, hyperpyrexia, restlessness, confusion and excitement, and hallucinations passing into delirium. A rash may appear on the face and upper trunk. In severe intoxication, depression of the central nervous system may occur with hypertension or with circulatory failure and respiratory depression.

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 0,5 mL.

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

REGISTRATION NUMBER:
C/15.4/51

NAME AND BUSINESS ADDRESS OF APPLICANT:
S & N Pharmaceuticals (Pty) Ltd
30 Gillitts Road
Pinetown 3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 21, 1970.
9/67H
* Trademark                SNP 26/2

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