Lotemax Oph Gel

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

    • Lotemax Oph Gel Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Loteprednol etabonate 0.5%; contains benzalkonium chloride.

    Pharmacological Class

    Steroid.

    See Also

    How Supplied

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

    How Supplied

    Lotemax Gel: is a sterile ophthalmic gel supplied in a white low density polyethylene plastic bottle with a white controlled drop tip and a pink polypropylene cap in the following size: 5g in a 10mL bottle.

    Storage

    Lotemax Gel: Store upright at 15º to 25º C (59º to 77º F).

    Manufacturer

    Bausch & Lomb Inc.

    Lotemax Oph Gel Indications

    Indications

    Post-op inflammation after ocular surgery.

    Lotemax Oph Gel Dosage and Administration

    Adult

    1–2 drops into operated eye(s) 4 times daily beginning day after surgery, continue for 2wks post-op.

    Children

    Not established.

    Lotemax Oph Gel 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 Oph Gel Boxed Warnings

    Not Applicable

    Lotemax Oph Gel 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

    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, and in posterior subcapsular cataract formation. Use caution in the presence of glaucoma. 

    • If this product is used for 10 days or longer, monitor IOP even though it may be difficult in children and uncooperative patients. 

    Cataracts

    • May result in posterior subcapsular cataract formation.

    Delayed Healing

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

    • The initial prescription and renewal of the medication order 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. 

    Bacterial Infections

    • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. May mask infection or enhance existing infection in acute purulent conditions of the eye.

    Viral Infections

    • 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. 

    Fungal Infections

    • Consider fungal infections in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

    Contact Lens Wear

    • Do not wear contact lenses during the course of therapy.

    Pregnancy Considerations

    Risk Summary

    • No adequate and well-controlled studies in pregnant women.

    • Loteprednol etabonate produced teratogenicity at clinically relevant doses in the rabbit and rate when administered orally during pregnancy.

    Nursing Mother Considerations

    • No data on the presence of loteprednol etabonate in human milk, the effects on the breastfed infant, or the effects on milk production.

    • Consider the developmental and health benefits of breastfeeding, along with the mother’s clinical need and any potential adverse effects on the breastfed infant.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Lotemax Oph Gel Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Fecal.

    Lotemax Oph Gel Interactions

    Not Applicable

    Lotemax Oph Gel 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 Oph Gel Clinical Trials

    Clinical Trials

    Adult Studies

    • The efficacy of Lotemax Gel was evaluated in 2 randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 813 patients with post-operative inflammation.

    • Lotemax was more effective in resolving anterior chamber inflammation and pain following cataract surgery compared with vehicle.

    • At post-operative Day 8, Lotemax achieved a statistically significant higher incidence of patients with complete clearing of anterior chamber cells and flare (31% vs 14-16%) and were pain-free (73-76% vs 42-46%). 

    Pediatric Study

    • The pediatric study included patients from birth to less than 11 years of age undergoing cataract surgery. Patients were randomly assigned to receive either Lotemax (n=54) or prednisolone acetate ophthalmic suspension 1% (n=53) four times daily for 14 days.

    • At Day 14, there was 57% of patients treated with Lotemax who achieved complete clearing of anterior chamber inflammation vs 63% of patients treated with prednisolone.

    Lotemax Oph Gel Note

    Not Applicable

    Lotemax Oph Gel Patient Counseling

    Patient Counseling

    Administration

    • Invert closed bottle and shake once before instilling drops.

    Risk of Contamination 

    • Do not touch the eyelid or surrounding areas with the tip of the tube.

    Contact Lens Wear

    • Do not wear contact lenses during the course of therapy.

    Risk of Secondary Infection

    • Consult a physician if pain, redness, itching, or inflammation becomes aggravated.

    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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