Lodoxamide tromethamine

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# Overview
Lodoxamide tromethamine is a mast cell stabilizer that is FDA approved for the treatment of ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.   Common adverse reactions include headache, blurred vision, burning sensation in eye, dry eye, itching of eye.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- 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.
- The dose for adults and children greater than two 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)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lodoxamide tromethamine in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Lodoxamide tromethamine in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lodoxamide tromethamine FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lodoxamide tromethamine in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Lodoxamide tromethamine in pediatric patients.

# 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 lodoxamide tromethamine. 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 tromethamine Clinical Trials Experience in the drug label.

## Postmarketing Experience
- During clinical studies of 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.

# Drug Interactions
There is limited information regarding Lodoxamide tromethamine Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
- 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, 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 tromethamine in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Lodoxamide tromethamine 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 lodoxamide tromethamine 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 tromethamine with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Lodoxamide tromethamine with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Lodoxamide tromethamine in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Lodoxamide tromethamine in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lodoxamide tromethamine in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Lodoxamide tromethamine in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Topical

### Monitoring
There is limited information regarding Lodoxamide tromethamine Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Lodoxamide tromethamine and IV administrations.

# Overdosage
- There have been no reports of lodoxamide tromethamine ophthalmic solution 0.1% overdose following topical ocular application. Accidental overdose of an oral preparation of 120 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 10.0 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 tromethamine Pharmacology in the drug label.

## Mechanism of Action
There is limited information regarding Lodoxamide tromethamine Mechanism of Action in the drug label.

## Structure
- Lodoxamide tromethamine ophthalmic solution 0.1% is a sterile ophthalmic solution containing the mast cell stabilizer lodoxamide tromethamine for topical administration to the eyes. Lodoxamide tromethamine is a white, crystalline, water-soluble powder with a molecular weight of 553.91. The chemical structure is presented below:
- N,N'-(2-chloro-5-cyano-m-phenylene)dioxamic acid tromethamine salt
- Molecular Formula: C19H28O12N5Cl
- Each mL of lodoxamide tromethamine ophthalmic solution 0.1% contains: Active: 1.78 mg lodoxamide tromethamine equivalent to 1 mg lodoxamide. Preservative: benzalkonium chloride 0.007%. Inactive: mannitol, hypromellose 2910, sodium citrate, citric acid, edetate disodium, tyloxapol, hydrochloric acid and/or sodium hydroxide (adjust pH), and purified water.

## Pharmacodynamics
There is limited information regarding Lodoxamide tromethamine Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Lodoxamide tromethamine Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Lodoxamide tromethamine Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Lodoxamide tromethamine Clinical Studies in the drug label.

# How Supplied
- Lodoxamide tromethamine ophthalmic solution 0.1% is supplied in plastic ophthalmic DROP-TAINER dispenser as follows:
- 10 mL: NDC 0065-0345-10

## Storage
- Store at 15C - 27C (59F - 80F).

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Lodoxamide tromethamine Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Lodoxamide tromethamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- ALOMIDE

# Look-Alike Drug Names
There is limited information regarding Lodoxamide tromethamine Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price