Ophthalmic corticosteroid potency

Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6 - 18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lotemax is used in dry eye syndrome to decrease and eliminate inflammation of the ocular surface caused by the hyperosmolarity of the tears.  The inflammation must first be brought under control before any other treatments can be optimally effective.  Lotemax would typically be prescribed for two weeks to three months initially and then may need to be used again on a 1-2 week regimen periodically if the inflammation occurs again.  Lotemax ointment has become a choice of many doctors to treat inflammation caused by dry eye (ocular surface disease) because it can be used at night with a long contact period to the eye's surfaces and provide some functional lubrication while the eyes are closed.

NDC 61314-637-10

Prednisolone Acetate Ophthalmic Suspension USP 1%

Rx only

STERILE
10 mL

SANDOZ

FOR TOPICAL OPHTHALMIC USE ONLY.

INGREDIENTS: Each mL contains:
Active: prednisolone acetate %.
Preservative: benzalkonium chloride %.
Vehicle: hypromellose.
Inactives: dibasic sodium phosphate, polysorbate 80, edetate disodium, glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified water.

USUAL DOSAGE: Two drops topically in the eye(s) four times daily.

WARNING: Do not touch dropper tip to any surface, as this may contaminate the suspension.

Read enclosed insert.

SHAKE WELL BEFORE USING.

STORAGE: STORE UPRIGHT at 8° - 24°C (46° - 75° F).

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Printed in USA

H13438-0214

LOT/EXP.:

Ophthalmic corticosteroid potency

ophthalmic corticosteroid potency

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