Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Allergan
ALBALON-A™ Liquifilm® sterile eye drops SCHEDULING STATUS S2 PROPRIETARY NAME (and dosage form) ALBALON-A™ Liquifilm ® sterile eye drops COMPOSITION Each mL contains: naphazoline hydrochloride 0,5 mg, antazoline phosphate 5,0 mg, Liquifilm (polyvinyl alcohol) 14,0 mg, benzalkonium chloride (preservative) 0,004%. PHARMACOLOGICAL CLASSIFICATION A/15.4/Ophthalmic preparations: Other. PHARMACOLOGICAL ACTION Albalon-A combines the effects of the anti-histamine, antazoline and the decongestant, naphazoline. INDICATIONS For relief of ocular irritation and/or congestion in allergic, inflammatory, or infectious ocular conditions. CONTRA-INDICATIONS Hypersensitivity to one or more of the components of this preparation. Should not be used in presence of narrow-angle glaucoma. Not for use in children, unless under medical advice. WARNINGS A severe hypertensive crisis may ensue in patients under MAO inhibitor medication from use of a sympathomimetic product. DOSAGE AND DIRECTIONS FOR USE One or two drops instilled in each eye every three or four hours or less frequently, as required to relieve symptoms. SIDE-EFFECTS AND SPECIAL PRECAUTIONS This preparation should be used only with caution in the presence of hypertension, cardiac irregularities, hyperglycemia (diabetes mellitus) or hyperthyroidism. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding area with the dropper tip of the bottle. It is not known whether naphazoline and/or antazoline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Naphazoline and/or antazoline should be given to a pregnant woman only if clearly needed. Nursing mothers: It is not known whether these drugs are excreted in human milk. Because many drugs are ex Read the complete document