Ocular allergy/inflammation:

Indications for: LOTEMAX OPH GEL

Post-op inflammation after ocular surgery.

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.

Adult Dosage:

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

Children Dosage:

Not established.

LOTEMAX OPH GEL Contraindications:

Ocular fungal, viral, or mycobacterial infections.

LOTEMAX OPH GEL 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.

See Also:

LOTEMAX OPH GEL Classification:

Steroid.

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.

Metabolism:

Hepatic.

Drug Elimination:

Fecal.

How Supplied:

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