Lotemax Oph Oint

— 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 Oint Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Loteprednol etabonate 0.5%.

    Pharmacological Class

    Steroid.

    See Also

    How Supplied

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

    How Supplied

    Lotemax Ointment: is a sterile ointment supplied in a tin tube with a pink polypropylene cap in a 3.5g tube.

    Storage

    Lotemax Ointment: Store between 15°C to 25°C (59°F to 77°F). After opening, Lotemaxcan be used until the expiration date on the tube.

     

    Manufacturer

    Bausch & Lomb Inc.

    Lotemax Oph Oint Indications

    Indications

    Post-op inflammation after ocular surgery.

    Lotemax Oph Oint Dosage and Administration

    Adult

    Apply a small amount (approx. ½ inch ribbon) into the affected eye(s) 4 times daily beginning 24hrs after surgery, continue for 2wks post-op.

    Children

    Not established.

    Lotemax Oph Oint 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 Oint Boxed Warnings

    Not Applicable

    Lotemax Oph Oint 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

    Topical Ophthalmic Use

    • Not indicated for intraocular administration.

    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 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. 

    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.

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

    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 Oint Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Fecal.

    Lotemax Oph Oint Interactions

    Not Applicable

    Lotemax Oph Oint 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 Oint Clinical Trials

    Clinical Trials

    • The efficacy of Lotemax Ointment was evaluated in 2 independent, randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 805 patients who met a protocol-specified threshold amount of anterior chamber 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 complete clearing of anterior chamber cells and flare (24-32% vs 11-14%) and a statistically significant higher incidence of patients who were pain-free (73-78% vs 41-45%). 

    Lotemax Oph Oint Note

    Not Applicable

    Lotemax Oph Oint Patient Counseling

    Patient Counseling

    Risk of Contamination 

    • Wash hands prior to use.

    • 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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