Lodoxamide
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara Ece Dagsali, M.D.[2]
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Overview
Lodoxamide is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of ALOMIDE® (lodoxamide tromethamine ophthalmic solution) 0.1% is indicated in the treatment of the ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.. Common adverse reactions include During clinical studies of ALOMIDE® (lodoxamide tromethamine ophthalmic solution) 0.1%, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in approximately 15% of the subjects. Other ocular events occurring in 1% to 5% of the subjects included ocular itching/pruritus, blurred vision, dry eye, tearing/discharge, hyperemia, crystalline deposits, and foreign body sensation. Events that occurred in less than 1% of the subjects included corneal erosion/ulcer, scales on lid/lash, eye pain, ocular edema/swelling, ocular warming sensation, ocular fatigue, chemosis, corneal abrasion, anterior chamber cells, keratopathy/keratitis, blepharitis, allergy, sticky sensation, and epitheliopathy.
Nonocular events reported were headache (1.5%) and (at less than 1%) heat sensation, dizziness, somnolence, nausea, stomach discomfort, sneezing, dry nose, and rash..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The dose for adults and children greater than 2 years of age is one to two drops in each affected eye four times daily for up to 3 months.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The dose for adults and children greater than 2 years of age is one to two drops in each affected eye four times daily for up to 3 months.
Off-Label Use and Dosage (Pediatric)
Contraindications
Hypersensitivity to any component of this product.
Warnings
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. As with all ophthalmic preparations containing benzalkonium chloride, patients should be instructed not to wear soft contact lenses during treatment with ALOMIDE® (lodoxamide tromethamine ophthalmic solution) 0.1%. Do not touch the dropper tip to any surface, as this may contaminate the solution.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Lodoxamide Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Lodoxamide Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Lodoxamide Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Reproduction studies with lodoxamide tromethamine administered orally to rats and
rabbits in doses of 100 mg/kg/day (more than 5000 times the proposed human clinical
dose) produced no evidence of developmental toxicity. There are, however, no adequate
and well-controlled studies in pregnant women. Because animal reproduction studies are
not always predictive of human response, ALOMIDE (lodoxamide tromethamine
ophthalmic solution) 0.1% should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lodoxamide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lodoxamide during labor and delivery.
Nursing Mothers
It is not known whether lodoxamide tromethamine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1% is administered to nursing women.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established
Geriatic Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Gender
There is no FDA guidance on the use of Lodoxamide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lodoxamide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lodoxamide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lodoxamide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lodoxamide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lodoxamide in patients who are immunocompromised.
Administration and Monitoring
Administration
The dose for adults and children greater than 2 years of age is one to two drops in each affected eye four times daily for up to 3 months.
Monitoring
There is limited information regarding Lodoxamide Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lodoxamide and IV administrations.
Overdosage
There have been no reports of ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1% overdose following topical ocular application. Accidental overdose of an oral preparation of 120 mg to 180 mg of lodoxamide resulted in a temporary sensation of warmth, profuse sweating, diarrhea, light-headedness, and a feeling of stomach distension; no permanent adverse effects were observed. Side effects reported following systemic oral administration of 0.1 mg to 10 mg of lodoxamide include a feeling of warmth or flushing, headache, dizziness, fatigue, sweating, nausea, loose stools, and urinary frequency/urgency. The physician may consider emesis in the event of accidental ingestion.
Pharmacology
There is limited information regarding Lodoxamide Pharmacology in the drug label.
Mechanism of Action
Lodoxamide tromethamine is a mast cell stabilizer that inhibits the in vivo Type I immediate hypersensitivity reaction. Lodoxamide therapy inhibits the increases in ® ® 19 28 12 5 ® cutaneous vascular permeability that are associated with reagin or IgE and antigenmediated reactions. In vitro studies have demonstrated the ability of lodoxamide to stabilize rodent mast cells and prevent antigen-stimulated release of histamine. In addition, lodoxamide prevents the release of other mast cell inflammatory mediators (i.e., SRS-A, slowreacting substances of anaphylaxis, also known as the peptido-leukotrienes) and inhibits eosinophil chemotaxis. Although lodoxamide's precise mechanism of action is unknown, the drug has been reported to prevent calcium influx into mast cells upon antigen stimulation. Lodoxamide has no intrinsic vasoconstrictor, antihistaminic, cyclooxygenase inhibition, or other anti-inflammatory activity. The disposition of C-lodoxamide was studied in six healthy adult volunteers receiving a 3 mg (50 μCi) oral dose of lodoxamide. Urinary excretion was the major route of elimination. The elimination half-life of C-lodoxamide was 8.5 hours in urine. In a study conducted in twelve healthy adult volunteers, topical administration of ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1%, one drop in each eye four times per day for ten days, did not result in any measurable lodoxamide plasma levels at a detection limit of 2.5 ng/mL.
Structure
There is limited information regarding Lodoxamide Structure in the drug label.
Pharmacodynamics
There is limited information regarding Lodoxamide Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Lodoxamide Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Lodoxamide Nonclinical Toxicology in the drug label.
Clinical Studies
During clinical studies of ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1%, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in approximately 15% of the subjects. Other ocular events occurring in 1% to 5% of the subjects included ocular itching/pruritus, blurred vision, dry eye, tearing/discharge, hyperemia, crystalline deposits, and foreign body sensation. Events that occurred in less than 1% of the subjects included corneal erosion/ulcer, scales on lid/lash, eye pain, ocular edema/swelling, ocular warming sensation, ocular fatigue, chemosis, corneal abrasion, anterior chamber cells, keratopathy/keratitis, blepharitis, allergy, sticky sensation, and epitheliopathy.
How Supplied
ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1% is supplied in a plastic ophthalmic dispenser as follows: 10 mL NDC 0078-0736-10
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Lodoxamide Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Lodoxamide interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lodoxamide Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lodoxamide Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.