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ALREX is a brand name for Loteprednol Etabonate, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE................................................................ 3 CONTRAINDICATIONS ..................................................................................... 3 WARNINGS AND PRECAUTIONS.................................................................... 4 ADVERSE…
Verbatim from this product's HC label. Tap a section to expand.
General For ophthalmic use only. Alrex® is indicated as a short-term treatment only (up to 14 days). The initial prescription and renewal of Alrex® should be made by a physician only after appropriate ophthalmologic examination is performed.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated. If Alrex® is used for 10 days or longer, intraocular pressure should be closely monitored. See WARNINGS and PRECAUTIONS – Ophthalmologic. Prolonged use of corticosteroids may result in cataract and/or glaucoma formation.
Alrex® should not be used in the presence of glaucoma or elevated intraocular pressure, unless absolutely necessary and close ophthalmologic monitoring is undertaken. Extreme caution should be exercised, and duration of treatment should be kept as short as possible.
See WARNINGS and PRECAUTIONS – Ophthalmologic. Alrex® should not be used in cases of existing (suspected or confirmed) ocular viral, fungal, or mycobacterial infections. Alrex® may suppress the host response and thus increase the hazard of secondary ocular infections.
The use of Alrex® in patients with a history of herpes simplex requires great caution and close monitoring. See WARNINGS and PRECAUTIONS – Ophthalmologic. Alrex® contains benzalkonium chloride. See DOSAGE and ADMINISTRATION section. Alrex® has not been studied in pregnant or nursing women, but has been found to be teratogenic in animals.
Alrex® should not be used in pregnant or nursing women unless the benefits to the mother clearly outweigh the risk to the fetus or the nursing child. See WARNINGS AND PRECAUTIONS – Special Populations. Carcinogenesis and Mutagenesis Long-term animal studies have not been conducted to evaluate the carcinogenic potential of loteprednol etabonate.
Loteprednol etabonate was not genotoxic in vitro in the Ames test, the mouse lymphoma tk assay, or in a chromosome aberration test in human lymphocytes, or in vivo in the single dose mouse micronucleus assay. See TOXICOLOGY. Ophthalmologic Alrex® should be used as a brief temporary treatment.
If Alrex® is used for 10 days or longer, intraocular pressure should be closely monitored. The initial prescription and renewal of Alrex® should be made by a physician only after appropriate ophthalmologic examination is performed with the aid of magnification, such as slit lamp biomicroscopy Alrex® Product Monograph; 17December08 Page 5 of 29 and, where appropriate, fluorescein staining.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Loteprednol Etabonate in Canada.
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If signs and symptoms fail to improve after two days, the patient should be re-evaluated. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.
Alrex® should not be used in the presence of glaucoma or elevated intraocular pressure, unless absolutely necessary and careful and close appropriate ophthalmologic monitoring (including intraocular pressure and lens clarity) is undertaken.
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.
Fungal cultures should be taken when appropriate. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Formulations with benzalkonium chloride should be used with caution in soft contact lens wearer. See DOSAGE AND ADMINISTRATION – Administration.
Sexual Function/Reproduction The effects of Alrex® on sexual function and reproduction have not been studied in humans. , ability of females to become pregnant). However, these doses were highly toxic and had significant toxic effects on the pregnancies, and the survival and development of the offspring.
Maternal toxicity, possible occurrence of abnormalities and growth retardation started at 10 times the Alrex® clinical dose. See WARNINGS and PRECAUTIONS- Special Populations- Pregnant Women. Neurologic Disturbances and suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis can occur with systemic exposure to corticosteroids.
However, given the very low systemic exposure to loteprednol etabonate when using Alrex®as directed, these possible effects are not likely. See ACTION and CLINICAL PHARMACOLOGY. Alrex® Product Monograph; 17December08 Page 6 of 29 Endocrine and Metabolism Glucocorticoids, mostly when systemic exposure occurs, decrease the hypoglycemic activity of insulin and oral hypoglycemics, so that a change in dose of the antidiabetic drugs may be necessitated.
In high doses, glucocorticoids also decrease the response to somatotropin. The usual doses of mineralocorticoids and large doses of some glucocorticoids cause hypokalemia and may exaggerate the hypokalemic effects of thiazides and high-ceiling diuretics.
In combination with amphotericin-B, they also may cause hypokalemia. Glucocorticoids appear to enhance the ulcerogenic effects of non-steroidal anti- inflammatory drugs. They decrease the plasma levels of salicylates, and salicylism may occur on discontinuing steroids.
Glucocorticoids may increase or decrease the effects of […]