Anti-allergics.

Lodoxamide

Alomide contains 0.1% w/v Lodoxamide (as lodoxamide trometamol).

Eye Drops, Solution

ALOMIDE Ophthalmic Solution is indicated in the treatment of non-infectious allergic conjunctivitis (vernal conjunctivitis, giant papillary conjunctivitis, and allergic-atopic conjunctivitis).

The etiologic 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 immediate hypersensitivity (or mast cells) play a major role in the inflammatory process.

Adults and children: One or two drops in each eye four times a day at regular intervals.

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

Improvements in signs and symptoms in response to ALOMIDE therapy (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, but longer treatment for up to four weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

Patients should also be advised that instillation of eye drops in allergic conjunctivitis may cause discomfort initially and that this will decline with improvement of the disease.

Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.

Children less than 4 years: The safety and effectiveness of ALOMIDE in children below the age of four years have not been established.

Elderly: There are no special precautions to be followed in prescribing ALOMIDE for the elderly.

If required, corticosteroids may be used concomitantly with ALOMIDE.

Children less than 4 years: The safety and effectiveness of ALOMIDE in children below the age of four years have not been established.

There are no special precautions to be followed in prescribing ALOMIDE for the elderly.

ALOMIDE is contraindicated in those persons who have a known hypersensitivity to lodoxamide or any component of the medicament.

• ALOMIDE is not for injection.

• The recommended frequency of administration should not be exceeded.

• Patients should be advised that instillation of eye drops may initially cause discomfort or transient burning or stinging (see section 4.8). Should these symptoms persist, the patient should be advised to contact the prescribing physician.

• ALOMIDE contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of ALOMIDE and wait at least 15 minutes before reinsertion.

No interaction studies have been performed.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

a. Summary of the safety profile

In clinical trials, the most common adverse reaction was ocular discomfort.

b. Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention: very common ( 1/10), common ( 1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions have been observed during clinical trials and post-marketing experience for lodoxamide eye drops. 

Alcon Laboratories (U.K) Limited

(POM)

15 November 2010