ALOMIDE 0.1% w/v

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 (see 4.8 Undesirable Effects).

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.

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. As with all preparations containing benzalkonium chloride, users of soft (hydrophilic) contact lenses should refrain from wearing lenses while under treatment with ALOMIDE. Lenses may be worn within a few hours of discontinuation of treatment.

None known.

Reproduction studies with lodoxamide trometamol administered orally to rats and rabbits in doses of 100 mg/kg/day (more than 5000 times the proposed human dose) produced no evidence of developmental toxicity. However, there are no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, ALOMIDE should be used during pregnancy only if clearly needed.

It is not known whether lodoxamide is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALOMIDE is administered to nursing mothers.

ALOMIDE is unlikely to affect a patient's ability to drive or to use machinery.

During clinical studies of ALOMIDE, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in 13% of patients. Other ocular events occurring in 1 to 5% of the patients included ocular pruritus, blurred vision, lid margin crusting, dry eye, tearing and hyperemia. Events that occurred in less than 1% of the patients included foreign body sensation, ocular pain, discharge, ocular edema, ocular fatigue, ocular warming sensation, lid edema, chemosis, anterior chamber cells, epitheliopathy, keratopathy/keratitis, blepharitis, sticky sensation, corneal erosion, dim vision, corneal abrasion and allergy. Non-ocular events are rare and reported at incidences below 1%; these included warm sensation, headache, nausea, stomach discomfort, dizziness, somnolence, dry nose, sneezing and rash.

In the event of a topical overdose, flush from the eye with running water. Accidental overdose of an oral preparation of 120 to 180 mg of lodoxamide resulted in temporary sensation of warmth, profuse sweating, diarrhoea, light-headedness and a feeling of stomach distension; no permanent adverse effects were observed.

Consideration may be given by the physician to emesis in the event of accidental ingestion.

Pharmacotherapeutic Group - Ophthalmologicals: Antiallergics

ATC Code S01G X05

Lodoxamide, a mast cell stabiliser inhibits the in vivo Type I immediate hypersensitivity reaction in animals and man.

In vitro studies have demonstrated the ability of lodoxamide to stabilise mast cells and prevent the antigen specific induced release of histamine. In addition, lodoxamide prevents the release of other mast cell inflammatory mediators (i.e. SRS-A, slow reacting substances of anaphylaxis also known as the peptido-leukotrienes). Lodoxamide inhibits histamine release in vitro by preventing the movement of calcium into the mast cell after stimulation.

The oral bioavailability of ¹⁴C-lodoxamide in man is 71%, approximately 87% of the absorbed drug undergoes bio transformation. The metabolic transformation of lodoxamide results from stepwise hydrolysis of the oxylamide groups to form the monoxamate and the diamine. The diamine undergoes further hydroxylation followed by conjugation to either the O-glucuronide or O-sulphate. The O-glucuronide and O-sulphate metabolites account for 79% of the biotransformed lodoxamide, with the monoxamate and diamine accounting for 5% and 3% of the excreted metabolites. Only 2.7% of the absorbed dose is recovered as unchanged drug in the urine

There are no preclinical data of relevance to the prescriber which were additional to that already included in other sections of the SPC.

Inactive excipients: Mannitol 4.7 % w/v, Hypromellose 0.38% w/v, sodium citrate

0.0415% w/v, citric acid 0.0175% w/v, disodium edetate 0.01% w/v,

tyloxapol 0.025% w/v, sodium hydroxide QS pH 5.0 and/or hydrochloric acid QS

pH 5.0., purified water QS 100%,.

None known.

24 months.

The contents and bottle should be discarded one month after opening the container for the first time.

Do not store above 25°C. Store upright.

ALOMIDE is supplied in 5 mL,10 mL and 15 mL natural, low-density polyethylene bottles with natural, low density polyethylene dispensing plugs and tamper evident polypropylene screw caps.

Only 5 mL and 10 mL are currently marketed.

The dispensing tip should not be touched with the fingers or by the conjunctiva when drops are instilled. The container should be kept tightly closed.

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

Herts., HP2 7UD.

PL No. 0649/0117

24 March 2002

November 2001