Alomide - Product Information
|Condition:||Conjunctivitis, Keratitis, Keratoconjunctivitis|
|Class:||Ophthalmic antihistamines and decongestants|
|Form:||Liquid solution, Eye drops (ophthalmic)|
|Ingredients:||lodoxamide, benzalkonium chloride 0.007% w/v as preservative, as well as mannitol, hydroxypropyl methylcellulose, sodium citrate, tyloxapol,citric acid, edetate disodium, purified water|
Lodoxamide, a mast cell stabilizer, inhibits the in vivo type I immediate hypersensitivity reaction in animals and man.
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 appears to inhibit eosinophil chemotaxis. Lodoxamide inhibits histamine release in vitro by preventing the movement of calcium into the mast cell after stimulation.
ALOMIDE (lodoxamide ophthalmic solution) is indicated for the treatment of the ocular signs and symptoms associated with:
- Vernal keratoconjunctivitis.
- Giant papillary conjunctivitis.
- Allergic/atopic conjunctivitis.
Pediatrics (< 4 years of age)
The safety and effectiveness of ALOMIDE in pediatric patients < 4 years of age have not been established.
ALOMIDE is contraindicated in:
- Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
Warnings and precautions
Instillation of eye drops may initially cause discomfort or transient burning or stinging (see ADVERSE REACTIONS). Should any of these symptoms persist, the patient should be advised to contact the prescribing physician.
ALOMIDE contains the preservative benzalkonium chloride, which may cause eye irritation. Benzalkonium is known to discolour soft contact lenses. As with all ophthalmic medications containing benzalkonium chloride, patients should be advised to remove their contact lenses before instilling ALOMIDE as benzalkonium accumulates in contact lenses and its subsequent release may possibly irritate the cornea. Patients should be advised to wait at least 15 minutes before reinserting the lenses.
Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
There is no data available on the effect of lodoxamide on fertility in humans.
Use in Pregnancy
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 should be used during pregnancy only if clearly needed.
It is not known whether lodoxamide is excreted in human milk. There is insufficient information on the excretion of lodoxamide in animal milk. A risk to the suckling child cannot be excluded. Caution should be exercised when ALOMIDE is given to a nursing mother.
Pediatrics (<4 years of age)
The safety and effectiveness of ALOMIDE in pediatric patients <4 years of age have not been established.
ALOMIDE 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.
Post-Market Adverse Drug Reactions
Adverse reactions identified in subsequent clinical trials are listed below.
Eye disorders: anterior chamber cell, asthenopia, blepharitis, corneal abrasion, corneal deposits, corneal epithelium defect, corneal erosion, corneal scar, dry eye, eye discharge, eye edema, eye pain, eye pruritis, keratitis, ocular hyperemia, vision blurred, visual impairment;
Gastrointestinal disorders: abdominal discomfort, nausea;
General disorders and administration site conditions: feeling hot;
Immune system disorders: drug hypersensitivity;
Nervous system disorders: dizziness, dysgeusia, headache, somnolence;
Respiratory, thoracic and mediastinal disorders: nasal dryness, sneezing;
Skin and subcutaneous tissue disorders: eyelid exfoliation, rash.
Adverse reactions identified via spontaneous reporting are listed below. Frequencies cannot be estimated from the data.
Cardiac disorders: palpitations.
Symptoms and treatment of overdosage
Overdosage in the use of topical ophthalmic preparations is a remote possibility. Discontinue medication when heavy or protracted use is suspected.
In case of accidental ingestion of doses of 1.0 mg to 10.0 mg of lodoxamide, the following side 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 mg and 10.0 mg of oral lodoxamide, but they resolve spontaneously after a short time. Other possible adverse effects after an oral overdose are headache, dizziness, fatigue and loose stools.
If accidentally ingested, efforts to decrease further absorption may be appropriate.
For management of a suspected drug overdose, contact your regional Poison Control Centre.
Dosage and administration
The dose for adults and children ≥4 years of age is one or two drops in each eye four times a day at regular intervals.
Patient should be instructed to avoid contamination of the dropper tip.
Patients should be advised that the effect of therapy with ALOMIDE is dependent upon its administration at regular intervals, as directed.
Improvements in signs and symptoms in response to therapy with ALOMIDE (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.