LEVOCABASTINE HYDROCHLORIDE Eye drops, Nasal spray Ref.[9896] Active ingredients: Levocabastine

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2020  Publisher: Johnson & Johnson Pacific, AUSTRALIA NEW ZEALAND, 45 Jones Street, Ultimo NSW 2007, Registered Trademark Consumer Care Centre Australia: 1800 029 979, New Zealand: 0800 446 147, Overseas Customers: +61 ...

4.1. Therapeutic indications

Eye Drops: Symptomatic treatment of seasonal allergic conjunctivitis.

Nasal Spray: Symptomatic treatment of seasonal or perennial allergic rhinitis.

4.2. Posology and method of administration

As ZYRTEC eye drops and nasal spray are available as a microsuspension, the bottle should be shaken before each application.

Eye Drops

As with all ophthalmic preparations containing benzalkonium chloride, patients are advised not to wear soft (hydrophilic) contact lenses while under treatment with ZYRTEC eye drops.

Adults and children 6 years of age and over: the usual dose is one drop of ZYRTEC eye drops per eye, twice daily. If necessary, the dose may be increased to one drop 3 to 4 times daily. The bottle should be well shaken before use. The duration of treatment should be limited to 8 weeks.

Systemic absorption of levocabastine is very low. However, the systemic absorption of drugs from ophthalmic solutions can be minimised by pressure on the tear duct immediately after application.

ZYRTEC eye drops should be used within one month of first opening of the bottle. Patients should be instructed to take appropriate measures to avoid contamination of the container.

Nasal Spray

Adults and children 6 years of age and over: the usual dose is two sprays of ZYRTEC nasal spray per nostril, twice daily. If necessary, the dose may be increased to two sprays 3 to 4 times daily. The duration of treatment should be limited to 8 weeks.

Patients should be instructed to clear the nasal passages prior to administering the spray and to inhale through the nose during spraying. Before using the pump delivery system for the first time, the pump reservoir should be filled by priming until a fine spray is delivered.

4.9. Overdose

There has been no experience with overdose of ZYRTEC eye drops or nasal spray to date. After accidental intake of the contents of the bottle, sedation may occur. In case of overdose, the patient should be advised to drink plenty of water in order to accelerate the renal elimination of levocabastine.For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

ZYRTEC eye drops: 4 mL in 5 mL bottle.

ZYRTEC nasal spray: 10 mL in 15 mL bottle.

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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