Lotepred DS 1% Ophthalmic Suspension 5ml

1% ophthalmic suspension:

• For steroid-responsive ocular inflammation: Instill 1 drop of Loteprednol DS Ophthalmic Suspension into the conjunctival sac of the eye(s) 2 times a day.
• For inflammation after surgery: Instill 1 drop of Loteprednol DS Ophthalmic Suspension into the conjunctival sac of the operated eye(s) 2 times a day beginning 24 hours after surgery and continuing throughout the first two weeks after surgery

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Since Lotepred DS is not detected in plasma following the topical administration, it is not expected to affect the pharmacokinetics of systemically administered medicinal products.

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

Pregnancy Category C. For Loteprednol Etabonate, no clinical data on exposed pregnancies are available. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown, and it should not be used in pregnancy unless clearly necessary. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when Loteprednol is administered to a nursing woman.

Common Side Effects are Eye irritation, Watery eyes, and burning sensation

If signs and symptoms fail to improve after two days, the patient should be re-evaluated. If Lotepred DS is used for 10 days or longer, intraocular pressure should be monitored. Fungal invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. If redness or itching becomes aggravated, the patient should be advised to consult a physician. Patients should also be advised not to wear contact lenses during their course of therapy.

Store below 30 degree C in a dry place protected from light.