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LOTEMAX (LOTEPREDNOL): PRESCRIBING INFORMATION
Lotemax (Loteprednol Etabonate ophthalmic suspension) contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use.
Loteprednol Etabonate is a white to off-white powder. Chemical Name: chloromethyl 17-alpha-[(ethoxycarbonyl)oxy]-11-beta-hydroxy-3-oxoandrosta-1,4-diene-17-beta-carboxylate
Each ml contains active ingredient: Loteprednol Etabonate 5 mg (0.5%); inactives: glycerin, edetate disodium, povidone, purified water and tyloxapol. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol / kg.
Preservative added: benzalkonium chloride 0.01%.
Lotemax clinical pharmacology
INDICATIONS AND USAGE
Loteprednol (Lotemax) eye drops 0.5% is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, herpes zoster keratitis, superficial punctate keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation.
Lotemax is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with Lotemax (Loteprednol) experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP ( >= 10 mmHg) was 1% with Lotemax (Loteprednol Etabonate) and 6% with prednisolone acetate 1%. Lotemax (Loteprednol Etabonate) eye drops should not be used in patients who require a more potent corticosteroid for this indication.
Lotemax (Loteprednol) ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.
Lotemax (Loteprednol) eye drops 0.5%, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Loteprednol (Lotemax) is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
WARNINGS AND PRECAUTIONS
Lotemax warnings and precautions
USE IN SPECIFIC POPULATIONS
Lotemax use in specific populations
Lotemax adverse reactions
DOSAGE AND ADMINISTRATION
Shake vigorously before using.
Steroid Responsive Disease Treatment:
Apply one to two drops of Lotemax into the conjunctival sac of the affected eye four times daily.
During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.
Apply one to two drops of Lotemax (Loteprednol) into the conjunctival sac of the operated eye four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.
Lotemax (Loteprednol Etabonate ophthalmic suspension) is supplied in a plastic bottle with a controlled drop tip in the following sizes: 5 ml, 10 ml, 15 ml.
Store upright between 15°-25°C (59°-77°F). Do not freeze Lotemax (Loteprednol Etabonate) eye drops.
Keep out of reach of children.
Manufactured and distributed by Bausch & Lomb, Valeant Pharmaceuticals companies and its divisions.
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