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

SCHEDULING STATUS:
S4                777075STSA/2M

PROPRIETARY NAME
(and dosage form):

BETNESOL^®
Eye, Ear and Nose Drops

COMPOSITION:
Each 100 mL contains betamethasone sodium phosphate 0,1 g in a sterile stabilised solution.
Contains benzalkonium chloride 0,02% m/v as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A.15.2 Ophthalmic preparations with corticosteroids.

PHARMACOLOGICAL ACTION:
BETNESOL Eye, Ear and Nose Drops contain the water-soluble corticosteroid betamethasone sodium phosphate, and have the advantage of containing no steroid particles to cause irritation. This is of particular value in ophthalmic work.

INDICATIONS:
Eye conditions: Non-infected inflammatory conditions such as non-specific keratitis, conjunctival allergies and acute or chronic uveitis.
Ear conditions: Inflammatory conditions of the ear such as otitis externa.
Nose conditions: Hayfever, vasomotor and non-seasonal allergic rhinitis.

CONTRA-INDICATIONS:
Viral, bacterial, fungal, tuberculous and purulent infections.
Possibility of herpetic keratitis.
Glaucoma. Hypersensitivity to any component of the preparation.
BETNESOL Eye, Ear and Nose Drops contain benzalkonium chloride as a preservative and therefore should not be used to treat patients who wear soft contact lenses.
Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore, BETNESOL Eye, Ear and Nose Drops should not be used during pregnancy.

DOSAGE AND DIRECTIONS FOR USE:

EYE:	One or two drops to be instilled into the eye every one or two hours until control is achieved, when the frequency may be reduced.
EAR:	Two to three drops to be instilled into the ear every two or three hours until control is achieved, when the frequency may be reduced.
NOSE:	Two or three drops to be instilled into each nostril two or three times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Do not administer to 'red eyes' until a definitive diagnosis is made. Treatment with corticosteroid preparations should not be prolonged without regular review.
Eye preparations containing corticosteroids can cause a serious rise in intra-ocular pressure in a small percentage of the population. A milder rise in ocular tension may be experienced by a larger proportion of subjects if treatment is continued for no longer than a few weeks.
Because of the possibility of inducing corneal abscess, fungal keratopathy or glaucoma, the patient should be referred to an ophthalmologist if the eye has not responded within 48 hours. In diseases causing thinning of the cornea, perforation has occurred with use of ophthalmic corticosteroids. Cataract is reported to have occurred after unduly prolonged treatment of eye conditions with ophthalmic corticosteroids.
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.
In infants, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur even without occlusion. The least potent corticosteroid which will control the disease should be selected.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The quantity of betamethasone sodium phosphate present is such that systemic absorption is unlikely to occur to any significant extent. In these circumstances, overdosage is unlikely, although appropriate care should be taken as noted under "Side-effects and special precautions".

IDENTIFICATION:
Clear, colourless solution.

PRESENTATION:
5 mL dropper vial.

STORAGE INSTRUCTIONS:
Protect from light and store below 20°C. Avoid freezing.
Eye drops should be discarded within four weeks of first opening the container.
Keep out of reach of children.

REFERENCE NUMBER:
H1257 (Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
Port Elizabeth
6020
South Atrica

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
10 July 1975

        20005595

Updated on this site: March 2006
Source: Community Pharmacy
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