32, Sabo Arobiodu Street, G.R.A., Ikeja, P.O.Box 2680,Yaba, Lagos., 27A, Isaac John St., Ikeja Lagos
Tel: 234-1-4936667, 4967579
Alcon-Couvrer, B-2870, Puurs, Belgium.
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Eye Drop (NRN: 04-1569): Each mL contains Active: Lodoxamide Tromethamine 1.78 mg (equivalent to 1 mg Lodoxamide). Preservative: Benzalkonium Chloride 0.07 mg.
Pack Size: Alomide Ophthalmic Solution is supplied in natural, low density polyethylene bottles with 10 mL fills.
Alomide (Lodoxamide 0.1%) Ophthalmic Solution is a sterile, isotonic, buffered and preserved solution for multiple-dose topical ocular administration.
Lodoxamide is a mast cell stabilizer that inhibits the in vivo type 1 immediate hypersensitivity reaction in animals and man. Allergen-induced bronchospasm and reduced pulmonary function in monkeys are prevented with lodoxamide treatment. A cutaneous vascular permeability increase associated with reagin or 1gE and antigen-mediated reactions in rats, monkeys and humans are inhibited with lodoxamide therapy.
A similar vascular reaction in the palpebral conjunctiva of rats has been inhibited with topical ocular administration of lodoxamide. Therefore, it is anticipated that lodoxamide will be useful in the treatment of ocular diseases where type 1 immediate hypersensitivity plays a major role in the pathogenesis.
In vitro studies have demonstrated the ability of lodoxamide to stabilize 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) and inhibits eosinophil chemotaxis. Lodoxamide inhibits histamine release in vitro by preventin the movement of calcium into the mast cell after stimulation.
In double-masked studies, Alomide Ophthalmic Solution was more effective than 2% and 4% sodium cromoglycate in the treatment of conjunctivitis of an allergic nature (vernal, giant papillary, atopic/allergic types). Ocular signs and symptoms were generally controlled in fourteen to twenty-one days of therapy (q.i.d. dosing), and improvement continued with further therapy.
Based upon physician and patient judgements, a therapeutic effect was observed within seven days of the initiation of treatment. Lodoxamide has no intrinsic vasoconstrictor, antihistamine, cyclooxygenase inhibition or other anti-inflammatory activity.
Alomide Ophthalmic Solution is indicated in the treatment of the ocular signs and symptoms associated with certain allergic ocular disorders referred to by the terms vernal kerato-conjunctivitis, vernal conjunctivitis, giant papillary conjunctivitis, vernal keratitis, and allergic or atopic kerato-conjunctivitis.
The aetiologic factors are unknown, but common airborne allergens and contact lenses have been implicated. Lodoxamide may be effective against other ocular diseases where type 1 immediate hypersensitivity (or mast cells) play a major role in the inflammatory response.
Hypersensitivity to lodoxamide or any component of the preparation.
For topical use only - not for injection. Do not touch dropper tip to any surface as this may contaminate the solution.
As with all preparations containing benzalkonium chloride, users of soft (hydrophilic) contact lenses should refrain from wearing lenses while under treatment with Alomide Ophthalmic Solution.
Lenses may be worn within a few hours of discontinuation of treatment. The recommended frequency of administration should not be exceeded. Alomide Ophthalmic Solution is unlikely to affect a patient’s ability to drive or to use machinery.
Usage During Pregnancy and Lactation:
Reproduction studies with lodoxamide tromethamine administered orally to rats and rabbits have not shown any effect of the product on fertility or reproductive performance or any evidence of embryotoxicity or pre and postnatal 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 Ophthalmic Solution should be used during pregnancy only if clearly needed.
It is not known whether lodoxamide is excreted in human milk. Caution should be exercised when Alomide Ophthalmic Solution is given to a nursing mother.
Alomide Ophthalmic Solution has been generally well tolerated. In controlled clinical studies, the most common side effect reported was mild and transient discomfort upon instillation (8.7% of patients) expressed as burning, stinging, itching or tearing.
Dosage & Administration
The dose for adults and children two years of age or older is one or two rops in each eye four times a day at regular intervals.
Patients should be advised that the effect of therapy with Alomide Ophthalmic Solution is dependent upon its administration at regular intervals, as directed.
Improvements in signs and symptoms in response to Alomide Ophthalmic Solution therapy (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, bulbar conjunctivae, limbus, 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. The safety and effectiveness of Alomide Ophthalmic Solution in children younger than 2 years of age have not been established. If required, corticosteroids may be used concomitantly with Alomide Ophthalmic Solution.
There have been no reports of Alomide Ophthalmic Solution overdose following topical ocular application. In the event of a topical overdose, flush from the eye with running water. Symptomatology in the case of accidental ingestion is unknown. Consideration may be given by the physician to emesis.
Store upright at room temperature (15oC - 27oC). Do not use after the expiration date.
The contents and bottle should be discarded one month after opening the container for the first time