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LOTEMAX STERILE OPHTHALMIC SUSPENSION 0.5% [SIN12601P]

Active ingredients: LOTEMAX STERILE OPHTHALMIC SUSPENSION 0.5%

Last updated 26 October 2025

Product Info

LOTEMAX STERILE OPHTHALMIC SUSPENSION 0.5%

[SIN12601P]

Product information

Active Ingredient and Strength

LOTEPREDNOL ETABONATE - 5 MG/ML

Dosage Form

SOLUTION

Manufacturer and Country

BAUSCH & LOMB INC - UNITED STATES

Registration Number

SIN12601P

Licence Holder

BAUSCH & LOMB (SINGAPORE) PRIVATE LIMITED

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

S01BA14

INDICATIONS AND USAGE:
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, giant papillary conjunctivitis and seasonal allergic conjunctivitis.

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.

DOSAGE AND ADMINISTRATION:
SHAKE VIGOROUSLY BEFORE USING.

Steroid Responsive Disease Treatment: Apply one to two drops of Lotemax into the conjunctival sac of the affected eye(s) 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 (See PRECAUTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Post-Operative Inflammation: Apply one to two drops of Lotemax into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

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 is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.