Source: Pharmaceutical Benefits Scheme (AU) Revision Year: 2021 Publisher: Allergan Australia Pty Ltd, 810 Pacific Highway, Gordon NSW 2072, ABN: 85 000 612 831
Hypersensitivity to any component of these medications; narrow angle glaucoma or anatomically narrow angle.
This preparation should not be used in patients who have glaucoma or other serious eye conditions.
A severe hypertensive crisis may ensue in patients under MAOI medication from use of a sympathomimetic drug.
Use only with caution in patients with hypertension, cardiac diseases, hyperglycaemia (diabetes), hyperthyroidism, and in individual under treatment with antidepressants or when other medications are being used.
ALBALON eye drops should be given with care to patients with prostatic enlargement as it may increase difficulty in micturition.
If the condition requiring treatment does not respond promptly (i.e. within 48 hours) or if symptoms recur following treatment, medical opinion should be sought.
This preparation should not be used for prolonged periods (i.e. more than 14 days) except on medical advice.
ALBALON eye drops should be used with caution on the inflamed eye, as significant hyperemia greatly increases the rate of systemic absorption through the conjunctiva and prolonged or frequent use, especially in inflamed eye, may result in increased absorption and possible systemic effects.
ALBALON eye drops contain the preservative benzalkonium chloride, which may be absorbed by and cause discolouration of soft contact lenses. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses prior to administration and wait at least 15 minutes following administration before reinserting soft contact lenses.
To prevent eye injury or contamination, care should be taken to avoid touching the dispensing container to the eye or to any other surface. The use of the bottle by more than one person may spread infection.
If symptoms persist or worsen after a short period of treatment (approximately 2-3 days), consult a doctor.
No data available.
Safety and effectiveness in children have not been established [see Section 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)]. Use in children, especially infants, may result in CNS depression leading to coma and marked reduction in body temperature.
No data available.
Concurrent use of methyldopa, maprotiline or tricyclic antidepressants and naphazoline may potentiate the pressor effect of naphazoline. Patients under therapy with MAOI medication may experience a severe hypertensive crisis if given a sympathomimetic drug [see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE].
No data available.
Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline should be given to a pregnant woman only if clearly needed.
It is not known whether naphazoline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when naphazoline is administered to a nursing woman.
As with other ocular medication, if transient blurred vision occurs at instillation, the patient should wait until their vision clears before driving or using machinery.
Pupillary dilation with increased intraocular pressure, systemic effects due to absorption (hypertension, cardiac irregularities, hyperglycaemia). Drowsiness may be experienced in some patients.
The following adverse reactions have been identified during postmarketing use of ALBALON eye drops. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
Eye disorders: Eye oedema, eye irritation, eye pain, mydriasis, ocular hyperemia, vision blurred.
Immune system disorders: Hypersensitivity (including allergic dermatitis).
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
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