LOMIDE Eye drops, solution Ref.[50540] Active ingredients: Lodoxamide

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2020  Publisher: Novartis New Zealand Limited, PO Box 99102, Newmarket, Auckland 1149, New Zealand

4.1. Therapeutic indications

Lomide Eye Drops 0.1% are indicated in the treatment of non-infectious allergic conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis and seasonal allergic conjunctivitis). The aetiologic factors are unknown, but common airborne allergens and contact lenses have been implicated. Lodoxamide trometamol may be effective against other ocular diseases where Type-I, IgE-mediated hypersensitivity (or mast cells) play a major role in the inflammatory process.

Prophylactic use of Lomide Eye Drops will assist in minimising the allergic symptoms associated with seasonal allergic conjunctivitis.

4.2. Posology and method of administration

Adults and children of 4 years and older

One drop in each eye four times a day at regular intervals.

Patients should be advised that the effect of therapy with Lomide Eye Drops is dependent upon its administration at regular intervals, as directed.

Improvements in signs and symptoms in response to therapy with Lomide Eye Drops (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, conjunctival redness, limbal reaction, epithelial disease, ptosis) are usually evident within a few days, however, longer treatment for up to four weeks is sometimes required. Further, continued treatment may result in ongoing improvement in signs and symptoms for at least 3 months. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

Patients should be advised to wait 10 minutes after instilling Lomide Eye Drops before instilling any other eye drops.

Use in the elderly

There are no special precautions required for prescribing Lomide Eye Drops for the elderly.

Concomitant Therapy

Corticosteroids may be used concomitantly with Lomide Eye Drops.

4.9. Overdose

Due to the characteristics of this preparation, toxic effects are unlikely following an ocular overdose of this product. In the event of an ocular overdose, flush from the eye with lukewarm water.

In case of accidental ingestion of doses of 0.1 mg to 10.0 mg of lodoxamide the following adverse effects may occur: feeling of warmth, flushing, nausea, vomiting, diaphoresis and abdominal cramping. Transient elevations of systolic and diastolic blood pressure have been noted with doses of 3.0 and 10.0 mg of oral lodoxamide, but they resolve spontaneously after a short time.

If accidentally ingested, efforts to decrease further absorption may be appropriate.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764 766).

6.3. Shelf life

24 months.

6.4. Special precautions for storage

Store below 25°C. Do not freeze.

Discard container 4 weeks after opening.

6.5. Nature and contents of container

10 mL or 5 mL DROP-TAINER bottle dispenser.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

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