our kids Alomide Generic Name: lodoxamide tromethamine Dosage Form: ophthalmic solution Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons DESCRIPTION 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: Structural Formula: Chemical Name: N,N'-(2-chloro-5-cyano-m-phenylene)dioxamic acid tromethamine salt Molecular Formula: C 19 H 28 O 12 N 5 Cl 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. Slideshow Insomnia and Sleep Deprivation: The Case For A Good Night's Sleep CLINICAL PHARMACOLOGY Lodoxamide tromethamine is a mast cell stabilizer that inhibits the in vivo Type I immediate hypersensitivity reaction. Lodoxamide therapy inhibits the increases in cutaneous vascular permeability that are associated with reagin or IgE and antigen-mediated 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, slow-reacting substances of anaphylaxis, also known as the peptidoleukotrienes) 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 14 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 14 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. INDICATIONS AND USAGE 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. 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. PRECAUTIONS General Patients may experience a transient burning or stinging upon instillation of Alomide Ophthalmic Solution. Should these symptoms persist, the patient should be advised to contact the prescribing physician. Carcinogenesis, Mutagenesis, Impairment of Fertility A long-term study with lodoxamide tromethamine in rats (two-year oral administration) showed no neoplastic or tumorigenic effects at doses 100 mg/kg/day (more than 5000 times the proposed human clinical dose). No evidence of mutagenicity or genetic damage was seen in the Ames Salmonella Assay, Chromosomal Aberration in CHO Cells Assay, or Mouse Forward Lymphoma Assay. In the BALB/c-3T3 Cells Transformation Assay, some increase in the number of transformed foci was seen at high concentrations (greater than 4000 μg/mL). No evidence of impairment of reproductive function was shown in laboratory animal studies. Pregnancy: Pregnancy Category 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, Alomide (lodoxamide tromethamine ophthalmic solution) 0.1% should be used during pregnancy only if clearly needed. 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 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. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. ADVERSE REACTIONS 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. 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 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. DOSAGE AND ADMINISTRATION 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. HOW SUPPLIED Alomide (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 - 25 C (59 F - 77 F). Rx Only 2002, 2003, 2015 Novartis a Novartis company ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 9012548-1115 PRINCIPAL DISPLAY PANEL NDC 0065-0345-10 Alcon Alomide 0.1% (lodoxamide tromethamine ophthalmic solution) 10 mL Sterile EACH mL CONTAINS: lodoxamide tromethamine 1.78 mg, equivalent to 1 mg lodoxamide with benzalkonium chloride 0.007 %, mannitol, hypromellose 2910, sodium citrate, tyloxapol, citric acid, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH), and purified water. Rx Only DROP-TAINER Dispenser STORAGE: Store at 15 -25 C (59 -77 F). FOR TOPICAL OPHTHALMIC USE ONLY. USUAL DOSAGE: Instill one to two drops in affected eye(s) four times daily. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. Alcon a Novartis Company ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 2001, 2003, 2013, 2015 Novartis 9012549-1115 LOT: EXP.: NDC 0065-0345-10 Alcon Alomide 0.1% (lodoxamide tromethamine ophthalmic solution) Sterile 10 mL Rx Only EACH mL CONTAINS: lodoxamide tromethamine 1.78 mg, equivalent to 1 mg lodoxamide STORAGE: Store at 15 -25 C (59 -77 F). FOR TOPICAL OPHTHALMIC USE ONLY. PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution. USUAL DOSAGE: Instill one to two drops in affected eye(s) four times daily. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA 2001, 2004, 2015 Novartis LOT: EXP.: H14106-1115 Alomide lodoxamide tromethamine solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0345 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LODOXAMIDE TROMETHAMINE (LODOXAMIDE) LODOXAMIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE MANNITOL HYPROMELLOSE 2910 (4000 MPA.S) SODIUM CITRATE CITRIC ACID MONOHYDRATE EDETATE DISODIUM TYLOXAPOL HYDROCHLORIC ACID SODIUM HYDROXIDE WATER Packaging # Item Code Package Description 1 NDC:0065-0345-10 1 BOTTLE, PLASTIC in 1 CARTON 1 10 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020191 09/30/1993 Labeler - Alcon Laboratories, Inc. (008018525) Registrant - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Operations Alcon Research Ltd 007672236 MANUFACTURE(0065-0345) Revised: 11/2016 Alcon Laboratories, Inc. Next Pregnancy Warnings Print this page Add to My Med List More about Alomide (lodoxamide ophthalmic) Side Effects During Pregnancy or Breastfeeding Dosage Information Compare Alternatives Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: ophthalmic antihistamines and decongestants Consumer resources Alomide Alomide (Advanced Reading) Professional resources Alomide (AHFS Monograph) Related treatment guides Conjunctivitis Keratitis Keratoconjunctivitis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug 10 + years Approval History FDA approved 1993 Manufacturer Novartis Pharmaceuticals Corporation Drug Class Ophthalmic antihistamines and decongestants Related Drugs ophthalmic antihistamines and decongestants azelastine ophthalmic , Pataday , Patanol , phenylephrine ophthalmic , olopatadine ophthalmic , Zaditor Conjunctivitis triamcinolone , diclofenac ophthalmic , dexamethasone ophthalmic , ceftriaxone , Rocephin , Lotemax , cortisone , gatifloxacin ophthalmic , More... Keratitis prednisone , triamcinolone , prednisolone ophthalmic , dexamethasone , Decadron , Lotemax , Deltasone , More... Keratoconjunctivitis diclofenac ophthalmic , Maxitrol , cromolyn ophthalmic , Blephamide , Pred-G , Voltaren Ophthalmic , More... Alomide Rating No Reviews - Be the first! 2.0 /10 No Reviews - Be the first! 2.0 Rate it!} } land up
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