Lodoxamide tromethamine: Difference between revisions

Lodoxamide tromethamine
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Latest revision as of 15:47, 2 April 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

Disclaimer

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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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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:

This image is provided by the National Library of Medicine.

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 15°C - 27°C (59°F - 80°F).

Images

Drug Images

{{#ask: Page Name::Lodoxamide tromethamine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Lodoxamide tromethamine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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®^[1]

Look-Alike Drug Names

There is limited information regarding Lodoxamide tromethamine 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.

↑ "ALOMIDE- lodoxamide tromethamine solution/ drops".

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[1] "ALOMIDE- lodoxamide tromethamine solution/ drops".

[1]

@@ Line 2: / Line 2: @@
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-|fdaLIADAdult=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.
+|fdaLIADAdult=* 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.
+* 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.
 |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Lodoxamide tromethamine in adult patients.
 |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Lodoxamide tromethamine in adult patients.
@@ Line 15: / Line 16: @@
 |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> 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 ALOMIDE® Ophthalmic Solution. Do not touch the dropper tip to any surface, as this may contaminate the solution.
+|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.
-|postmarketing=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.
+|postmarketing=* 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]].
-Nonocular events reported were headache (1.5%) and (at less than 1%) heat sensation, dizziness, somnolence, nausea, stomach discomfort, sneezing, dry nose, and rash.
 |FDAPregCat=B
-|useInPregnancyFDA=eproduction 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.
+|useInPregnancyFDA=* 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.
-|useInNursing=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® Ophthalmic Solution 0.1% is administered to nursing women.
+|useInNursing=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.
 |useInPed=Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
 |useInGeri=No overall differences in safety or effectiveness have been observed between elderly and younger patients.
 |administration=* [[Topical]]
-|overdose=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 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.
+|overdose=* 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.
-|structure=ALOMIDE® (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:
+|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:
-: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
+: [[File:Structure of Lor 01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
-N,N'-(2-chloro-5-cyano-m-phenylene)dioxamic acid tromethamine salt
+* N,N'-(2-chloro-5-cyano-m-phenylene)dioxamic acid tromethamine salt
+* Molecular Formula: C19H28O12N5Cl
-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.
+|howSupplied=* Lodoxamide tromethamine ophthalmic solution 0.1% is supplied in plastic ophthalmic DROP-TAINER® dispenser as follows:
-Each mL of ALOMIDE® (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.
+* 10 mL: NDC 0065-0345-10
-|howSupplied=ALOMIDE® (lodoxamide tromethamine ophthalmic solution) 0.1% is supplied in plastic ophthalmic DROP-TAINER® dispenser as follows:
+|storage=* Store at 15°C - 27°C (59°F - 80°F).
-mL: NDC 0065-0345-10
-|storage=Store at 15°C - 27°C (59°F - 80°F).
 |alcohol=Alcohol-Lodoxamide tromethamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 |brandNames=* ALOMIDE®<ref>{{Cite web | title = ALOMIDE- lodoxamide tromethamine solution/ drops  | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1b97597f-f2e7-4574-81a8-f35b769c957a }}</ref>
 <!--Look-Alike Drug Names-->
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+{{LabelImage
+|fileName=Lor.jpg
+}}
+{{LabelImage
+|fileName=Lor 03.jpg
+}}
+{{LabelImage
+|fileName=DailyMed - ALOMIDE- lodoxamide tromethamine solution drops .png
+}}
+[[Category:Nitriles]]
+[[Category:Organochlorides]]
+[[Category:Amides]]

Lodoxamide tromethamine: Difference between revisions

Latest revision as of 15:47, 2 April 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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