Lotemax

— THERAPEUTIC CATEGORIES —
  • Ocular allergy/inflammation
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Lotemax Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Loteprednol etabonate 0.5%; oph susp; contains benzalkonium chloride.

    Pharmacological Class

    Steroid.

    See Also

    How Supplied

    Susp—5mL, 10mL, 15mL, Oint—3.5g; Gel—5g

    How Supplied

    Lotemax suspension: is supplied in a plastic bottle with a controlled drop tip in the following sizes: 5mL, 10mL, and 15mL.

    Storage

    Lotemax Suspension: Store upright between 15° to 25°C (59° to 77°F). Do not freeze.

    Manufacturer

    Bausch & Lomb Inc.

    Lotemax Indications

    Indications

    Steroid-responsive ocular diseases. Post-op inflammation after ocular surgery.

    Indications

    Lotemax 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, superficial punctate keratitis, herpes zoster 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 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 and 6% with prednisolone acetate 1%. Lotemax should not be used in patients who require a more potent corticosteroid for this indication. 

    Lotemax is also indicated for the treatment of post-operative inflammation following ocular surgery. 

    Lotemax Dosage and Administration

    Adult

    Steroid-responsive diseases: 1–2 drops into affected eye(s) 4 times daily. May give up to 1 drop every 1hr within the 1st week of therapy. Post-op: 1–2 drops into operated eye(s) 4 times daily beginning 24hrs after surgery, continue for 2wks post-op.

    Adult

    Steroid-Responsive Disease Treatment

    • Apply one to two drops of Lotemax suspension 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.

    Post-Operative Inflammation

    • Apply one to two drops of Lotemax suspension 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.

    Children

    Not established.

    Lotemax Contraindications

    Contraindications

    Ocular fungal, viral, or mycobacterial infections.

    Contraindications

    Lotemax, 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.

    Lotemax Boxed Warnings

    Not Applicable

    Lotemax Warnings/Precautions

    Warnings/Precautions

    Reevaluate if no improvement after 2 days. Prescribe initially and renew only after appropriate exam. Corneal or scleral thinning. Glaucoma. History of herpes simplex. Monitor IOP and for secondary infections in prolonged therapy (>10 days). Avoid abrupt cessation. Contact lenses (remove during therapy and when eyes are inflamed). Pregnancy. Nursing mothers.

    Warnings/Precautions

    • For ophthalmic use only. 

    • The initial prescription and renewal of the medication order beyond 14 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. 

    • Re-evaluate patients if signs and symptoms fail to improve after 2 days. 

    • Monitor intraocular pressure even though it may be difficult in children and uncooperative patients if this product is used for 10 days or longer. 

    • 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 result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Use caution in the presence of glaucoma. 

    • 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. May mask infection or enhance existing infection in acute purulent conditions of the eye.

    • Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Must use great caution in the treatment of patients with a history of herpes simplex. 

    • May delay healing and increase the incidence of bleb formation when steroids are used after cataract surgery.

    Pregnancy Considerations

    Teratogenic effects

    • Loteprednol etabonate has been shown to be embryotoxic (delayed ossification) and teratogenic (increased incidence of meningocele, abnormal left common carotid artery, and limb flexures) when administered orally to rabbits during organogenesis at a dose of 3 mg/kg/day (35 times the maximum daily clinical dose), a dose which caused no maternal toxicity. 

    Nursing Mother Considerations

    It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Use caution when Lotemax is administered to a nursing woman.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Other Considerations for Specific Populations

    Carcinogenesis, Mutagenesis, Impairment of Fertility 

    • 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. 

    Lotemax Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Fecal.

    Lotemax Interactions

    Lotemax Adverse Reactions

    Adverse Reactions

    Local reactions (eg, blurred vision, burning, itching, dry eye), photophobia, headache, rhinitis, pharyngitis. May mask or exacerbate ocular infections. Prolonged use may increase: IOP, optic nerve damage, visual acuity and field defects, cataract formation, corneal perforation. May delay healing and increase bleb formation after cataract surgery; also, Oint/Gel: anterior chamber inflammation, conjunctival hyperemia, corneal edema, eye pain.

    Lotemax Clinical Trials

    Clinical Trials

    Post-Operative Inflammation

    • Placebo-controlled clinical studies demonstrated that Lotemax is effective for the treatment of anterior chamber inflammation as measured by cell and flare. 

    Giant Papillary Conjunctivitis

    • Placebo-controlled clinical studies demonstrated that Lotemax was effective in reducing the signs and symptoms of giant papillary conjunctivitis after 1 week of treatment and continuing for up to 6 weeks while on treatment. 

    Seasonal Allergic Conjunctivitis

    • A placebo-controlled clinical study demonstrated that Lotemax was effective in reducing the signs and symptoms of allergic conjunctivitis during peak periods of pollen exposure. 

    Uveitis

    • Controlled clinical studies of patients with uveitis demonstrated that Lotemax was less effective than prednisolone acetate 1%. Overall, 72% of patients treated with Lotemax experienced resolution of anterior chamber cell by day 28, compared to 87% of patients treated with 1% prednisolone acetate. The incidence of patients with clinically significant increases in IOP (≥10 mmHg) was 1% with Lotemax and 6% with prednisolone acetate 1%.

    Lotemax Note

    Not Applicable

    Lotemax Patient Counseling

    Patient Counseling

    This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the suspension. If pain develops, redness, itching or inflammation becomes aggravated, the patient should be advised to consult a physician. As with all ophthalmic preparations containing benzalkonium chloride, patients should be advised not to wear soft contact lenses when using Lotemax suspension.

    Cost Savings Program

    Lotemax SM Patient Support & Education: https://www.lotemaxsm.com/patient-access/

    Lotemax Gel Patient Support & Education: https://www.lotemaxgel.com/patient-savings/

     

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