Accession Number
394014
Source
AHFS Drug Information
Title
Lodoxamide Tromethamine (EENT)
Generic Drug Name
Lodoxamide Tromethamine
Trade Name Manufacturer
Alomide[REGISTERED SIGN](Alcon)
CAS Registry Number
63610-09-3
Drug Information
CHEMICAL NAME: N, N'-2-(chloro-5-cyano-m-phenylene)dioxamic acid compound with 2-amino-
2-(hydroxymethyl)-1,3-propanediol (1:2)
MOLECULAR FORMULA: C11H6ClN3O6[BULLET]2C4H11NO3
INVESTIGATIONAL DRUG NO: U 42585E
Therapeutic Classification
Antiallergic Agents (52-02)
Section Heading
SECTION HEADING/SUBHEADINGS (PRIMARY TEXT):
Uses
Administration
Dosage and Administration
Dosage
Allergic Ocular Disorders
Description
Additional Information
Primary Text
SECTION HEADING: Introduction
Lodoxamide tromethamine has been described as a mast-cell stabilizer.(1,2,4,6,7)
SECTION HEADING: Uses
SUBHEADING: Allergic Ocular Disorders
Lodoxamide tromethamine ophthalmic solution is used for the symptomatic treatment of certain allergic
ocular disorders including vernal keratoconjunctivitis, vernal conjunctivitis, and vernal
keratitis(1,2,6,7)and is designated an orphan drug by the US Food and Drug Administration (FDA) for such
use.(3)Like that with other mast-cell stabilizers, therapy with lodoxamide is prophylactic in nature and,
once mediators are released and manifestations have developed, the drug is ineffective except in
preventing reactions associated with continued or subsequent exposure; occasionally, intermittent
therapy with other agents may be necessary for acute exacerbations.(6,7)
SECTION HEADING: Dosage and Administration
SUBHEADING: Administration
Lodoxamide tromethamine is applied topically to the eye as an ophthalmic solution.(1)The manufacturer
warns that commercially available lodoxamide tromethamine ophthalmic solution is not for injection
and should not be injected subconjunctivally or directly into the anterior chamber of the eye.(1,5)
SUBHEADING: Dosage
Safety and efficacy of lodoxamide tromethamine ophthalmic solution in children younger than 2 years of
age have not been established.(1)Dosage of lodoxamide tromethamine is expressed in terms of
lodoxamide.(1)
SUBHEADING: Allergic Ocular Disorders
For the symptomatic treatment of vernal keratoconjunctivitis, vernal conjunctivitis, or vernal keratitis,
the dosage of lodoxamide recommended by the manufacturer for adults and children 2 years of age and
older is 1 or 2 drops of a 0.1% solution in the affected eye(s) 4 times daily(1,2,6,7)for up to 3 months.
(1,6,7)
SECTION HEADING: Description
Lodoxamide tromethamine has been described as a mast-cell stabilizer.(1,2,4,6,7)Lodoxamide prevents
the activation and release of inflammatory mediators (e.g., histamine, leukotrienes [e.g., slow reacting
substance of anaphylaxis]) from cells involved in hypersensitivity reactions, including mast cells.
(1,2,4,6,7)While lodoxamide shares many of the pharmacologic effects of cromolyn sodium and
nedocromil sodium, lodoxamide is more potent on a weight basis at inhibiting mediator release from
conjunctival tissue.(4,7)Lodoxamide exhibits no direct vasoconstrictor, antihistaminic, or
anti-inflammatory activity.(1,4,6)
SECTION HEADING: Additional Information
SumMon[REGISTERED SIGN](see Users Guide). For additional information on this drug until a more detailed
monograph is developed and published, the manufacturer's labeling should be consulted. It is essential
that the labeling be consulted for detailed information on the usual cautions, precautions, and
contraindications.
Table Headings
Lodoxamide Tromethamine
Table Data
Table Heading: Lodoxamide Tromethamine
--------------------------------------------------
Routes: Ophthalmic
Dosage Forms: Solution
Strengths: 0.1% (of lodoxamide)
Brand Names: Alomide[REGISTERED SIGN] (with benzalkonium chloride)
Manufacturer: Alcon
--------------------------------------------------
References
(1 of 7) 1. Alcon. Alomide[REGISTERED SIGN] (lodoxamide ophthalmic solution) 0.1% prescribing information.
Fort Worth, TX; 1993 Nov.
(2 of 7) 2. Caldwell DR, Verin P, Hartwich-Young R et al. Efficacy and safety of lodoxamide 0.1% vs cromolyn
sodium 4% in patients with vernal keratoconjunctivitis. Am J Ophthalmol. 1992; 113:632-7. [IDIS 297902]
[PubMed 1598953] http://www.ncbi.nlm.nih.gov/pubm...
(3 of 7) 3. Food and Drug Administration. Orphan designations pursuant to section 526 of the Federal Food
and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 30, 1993. Rockville, MD; 1993 Jul.
(4 of 7) 4. Yanni JM, Weimer LK, Glaser RL et al. Effect of lodoxamide on in vitro and in vivo conjunctival
immediate hypersensitivity responses in rats. Int Arch Allergy Immunol. 1993; 101:102-6. [PubMed 7684628]
http://www.ncbi.nlm.nih.gov/pubm...
(5 of 7) 5. Alcon, Fort Worth, TX: Personal communication.
(6 of 7) 6. Anon. Lodoxamide for vernal keratoconjunctivitis. Med Lett Drugs Ther. 1994; 36:26. [PubMed
8121328] http://www.ncbi.nlm.nih.gov/pubm...
(7 of 7) 7. Santos CI, Huang AJ, Abelson MB et al. Efficacy of lodoxamide 0.1% ophthalmic solution in resolving
corneal epitheliopathy associated with vernal keratoconjunctivitis. Am J Ophthalmol. 1994;117:488-97.[IDIS
328164] [PubMed 8154531] http://www.ncbi.nlm.nih.gov/pubm...
Entry Date
20020101
Update Code
20160208
Copyright
AHFS[REGISTERED SIGN] Drug Information. c Copyright, 1959-2016, Selected Revisions January 1, 2002.
American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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Accession Number
597034
Source
HANDBOOK ON INJECTABLE DRUGS
Title
Lenograstim
Therapeutic Classification
Hematopoietic Agents (20-16)
Section Heading
SECTION HEADING/SUBHEADINGS (PRIMARY TEXT):
Products
Units
pH
Trade Name(s)
Administration
Stability
Primary Text
SECTION HEADING: Products
Lenograstim (rHuG-CSF) is available as a lyophilized powder in single-use vials containing 13.4
million I.U. (Granocyte-13) or 33.6 million I.U. (Granocyte-34). In addition to lenograstim, each vial of the
product contains mannitol 2.5%, arginine 1%, phenylalanine 1%, methionine 0.1%, polysorbate 20 0.01%,
and hydrochloric acid to adjust pH.(38)
Lenograstim vials of either strength should be reconstituted with 1.05 mL of the accompanying water
for injection diluent. Gently mix to effect dissolution, usually about 5 seconds. Do not shake the vials
vigorously. Both the lenograstim vials and the diluent are overfilled by 5% to permit withdrawal of a full 1
mL of the reconstituted product containing 13.4 or 33.6 million I.U.(38)
SUB HEADING: Units
Each 13.4-million I.U. vial contains 105 mcg of lenograstim. Each 33.6-million I.U. vial contains 263 mcg
of lenograstim.(38)
SUB HEADING: pH
The reconstituted solution has a pH buffered to 6.5.(38)
SECTION HEADING: Administration
Lenograstim is administered by subcutaneous injection and intravenous infusion after dilution in sodium
chloride 0.9% in glass or PVC containers or dextrose 5% in glass containers. Granocyte 13 should not be
diluted to a concentration lower than 0.26 million I.U. per milliliter (2 mcg/mL); Granocyte-34 should not be
diluted to a concentration lower than 0.32 million I.U. per milliliter (2.5 mcg/mL). The dilution volume should not
exceed 50 mL for each vial of Granocyte-13 and 100 mL for each vial of Granocyte-34.(38)
SECTION HEADING: Stability
Intact vials of lenograstim should be stored at 30 [degrees]C or below and protected from freezing. When
reconstituted as directed, lenograstim is stable for 24 hours under refrigeration. Diluted for administration to
concentrations not less than 0.26 million I.U. (Granocyte-13) or 0.32 million I.U. (Granocyte-34) per milliliter,
lenograstim is stable for up to 24 hours at 5 or 25 [degrees]C.(38)
At concentrations not less than 0.26 million I.U. (Granocyte-13) or 0.32 million I.U. (Granocyte-34) per milliliter,
lenograstim is stable for up to 24 hours at 5 or 25[degrees]C in sodium chloride 0.9% in both PVC and glass
containers and in dextrose 5% in glass containers.(38)
SUB HEADING: Ambulatory Pumps
The stability of lenograstim (Rhone-Poulenc Rorer) 33.6 million I.U. (263 mcg) and 67.2 million I.U. (526 mcg)
each in 100 mL of sodium chloride 0.9% filled into Intermate elastomeric infusion devices (Baxter) was
evaluated stored at 4 [degrees]C for 14 days. No loss of lenograstim was found.(2048)
SUB HEADING: Sorption
Lenograstim prepared in sodium chloride 0.9% is compatible with PVC containers and common administration
sets.(38)
References
For a list of references cited in the text of this monograph, search the monograph titled HID references.
Entry Date:
20121001
Update Code:
20161103
Copyright:
Handbook on Injectable Drugs. Selected Revisions October 1, 2012. c Copyright, 2016. American Society of
Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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