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ALOMIDE is a brand name for Lodoxamide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Ophthalmologic 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.
Sexual Function/Reproduction There is no data available on the effect of lodoxamide on fertility in humans.
Special Populations Pregnancy:
Reproduction studies with lodoxamide tromethamine administered orally to rats and rabbits have not shown any effects of the product on fertility or reproductive performance, or any evidence of embryotoxicity or pre- and post-natal toxicity.
However, there are no adequate and well controlled studies in pregnant women. Since animal reproductive studies are not always predictive of human response, ALOMIDE* should be used during pregnancy only if clearly needed.
Nursing Women:
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. ADVERSE REACTIONS Adverse Drug Reaction Overview ALOMIDE* has been generally well tolerated. 7% of patients) expressed as burning, stinging, itching or tearing.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
ALOMIDE* Product Monograph Page 5 of 13 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 pruritus, 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. DOSAGE AND ADMINISTRATION Recommended Dose The dose for adults and children ≥ 4 years of age is 1 or 2 drops in each eye 4 times a day at regular intervals.
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 4 weeks is sometimes required.
Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement. Missed Dose If a dose is missed, a single drop should be applied as soon as possible before reverting to the regular routine.
Do not use a double dose to make up for the one missed. Administration Patients should be instructed to avoid contamination of the dropper tip. After the cap is removed, if the tamper evident snap collar is loose, instruct patients to remove it before using the product.
ALOMIDE* Product Monograph Page 6 of 13 OVERDOSAGE Overdosage in the use of topical ophthalmic preparations is a remote possibility. Discontinue medication when heavy or protracted use is suspected. 0 mg of lodoxamide, the following side effects may occur: feeling of warmth, flushing, nausea, vomiting, diaphoresis and abdominal cramping.
0 mg of oral lodoxamide, but they resolve spontaneously after a short time. Other possible adverse events 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. ACTION AND CLINICAL PHARMACOLOGY Pharmacodynamics Lodoxamide, a mast cell stabilizer, inhibits the in vivo type I 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 IgE and antigen mediated reactions in rats, monkeys and humans is 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 I immediate hypersensitivity plays a major […]