Lotemax Sm

— 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 Sm Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Loteprednol etabonate 0.38%; oph gel; contains benzalkonium chloride.

    Pharmacological Class

    Steroid.

    See Also

    How Supplied

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

    How Supplied

    Lotemax SM: is a sterile ophthalmic submicron 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: 5 g in a 10 mL bottle.

    Storage

    Lotemax SM: Store upright at 15º to 25ºC (59º to 77ºF). After opening, Lotemax SM can be used until the expiration date on the bottle.

    Manufacturer

    Bausch & Lomb Inc.

    Lotemax Sm Indications

    Indications

    Post-op inflammation and pain after ocular surgery.

    Lotemax Sm Dosage and Administration

    Adult

    1 drop into operated eye(s) 3 times daily beginning 24hrs after surgery, continue for 2wks post-op.

    Children

    Not established.

    Lotemax Sm 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 Sm Boxed Warnings

    Not Applicable

    Lotemax Sm 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 Sm Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Fecal.

    Lotemax Sm Interactions

    Not Applicable

    Lotemax Sm 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 Sm Clinical Trials

    Clinical Trials

    • The efficacy of Lotemax SM was evaluated in 2 randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in patients who underwent cataract extraction with intraocular lens implantation. Patients were randomly assigned to receive either Lotemax SM or vehicle three times daily to the affected eye starting the day after cataract surgery.

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

    • At post-operative Day 8, Lotemax achieved a statistically significant higher rate of patients with complete clearing of anterior chamber cells and patients who were pain-free. 

    Lotemax Sm Note

    Not Applicable

    Lotemax Sm 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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