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LOTEMAX is a brand name for Loteprednol Etabonate, supplied as a ointment. 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…
Verbatim from this product's HC label. Tap a section to expand.
General For ophthalmic use only. Lotemax® Ointment is indicated as a short-term treatment only (up to 14 days). The initial prescription and renewal of Lotemax® Ointment should be made by a doctor only after appropriate ophthalmologic examination is performed.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated. If Lotemax® Ointment 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. Lotemax® Ointment 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. Lotemax® Ointment should not be used in cases of existing (suspected or confirmed) ocular viral, fungal, or mycobacterial infections.
Lotemax® Ointment may suppress the host response and thus increase the hazard of secondary ocular infections. The use of Lotemax® Ointment in patients with a history of herpes simplex requires great caution and close monitoring. See WARNINGS and PRECAUTIONS – Ophthalmologic.
Lotemax® Ointment has not been studied in pregnant or nursing women, but has been found to be teratogenic in animals. Lotemax® Ointment should not be used in pregnant or nursing women unless the benefits to the mother clearly outweigh the risk to the embryo or 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. Endocrine and Metabolism Glucocorticoids, mostly when systemic exposure occurs, decrease the hypoglycemic activity of insulin and oral hypoglycemic, so that a change in dose of the antidiabetic drugs many be necessitated.
In high doses, glucocorticoids also decrease the response to somatotropin. The usual doses of mineralocorticoids and large doses of some glucocorticoids cause lypokalemia and may exaggerate the hypokaliemic effects of thiazides and high-ceiling diuretics.
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 prothrombopenic anticoagulants. 5% Product Monograph Page 5 of 32 Estrogens, phenobarbital, phenytoin and rifampin increase the metabolic clearance of adrenal steroids and hence necessitate dose adjustments.
However, given the very low systemic exposure to loteprednol etabonate when using Lotemax® Ointment as directed, these possible effects are not likely. See ACTION and CLINICAL PHARMACOLOGY. Immune Cortisol and the synthetic analogs of cortisol have the capacity to prevent or suppress the development of the local heat, redness, swelling, and tenderness by which inflammation is recognized.
At the microscopic level, they inhibit not only the early phenomena of the inflammatory process (edema, fibrin deposition, capillary dilation, migration of leukocytes into the inflamed area, and phagocytic activity) but also the later manifestations, such as capillary proliferation, fibroblast proliferation, deposition of collagen, and, still later, cicatrisation.
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 Lotemax® Ointment as directed, these possible effects are not likely.
See ACTION and CLINICAL PHARMACOLOGY. Ophthalmologic Lotemax® Ointment should be used as a short-term treatment. If Lotemax® Ointment is used for 10 days or longer, intraocular pressure should be closely monitored. The initial prescription and renewal of Lotemax® Ointment should be made by a doctor only after appropriate ophthalmologic examination is performed with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.
If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
Intraocular Pressure (IOP) Increase:
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Lotemax® Ointment 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.
Cataracts:
Use of corticosteroids may result in posterior subcapsular cataract formation.
Delayed Healing:
The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. If bleb formation occurs, decrease or discontinue corticosteroid therapy. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.
Bacterial infections:
Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. 5% Product Monograph Page 6 of 32 or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.
Viral infections:
Use of ocular steroids may prolong the course and may exacerbate the […]