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Ilotycin Indications, Dosage, Storage, Stability - Erythromycin

Ilotycin Indications, Dosage, Storage, Stability - Erythromycin

INDICATIONS

AND USES

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to Ilotycin®.

For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis.

The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeae is not established.

For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.

DOSAGE AND ADMINISTRATION

In the treatment of superficial ocular infections, Ophthalmic Ointment ILOTYCIN® approximately 1 cm in length should be applied directly to the infected eye(s) up to six times daily, depending on the severity of the infection.

For prophylaxis of neonatal gonococcal or chlamydial ophthalmia, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.

Directions For Use for 1 Gram Plastic Tube:   DO NOT PULL CAP OFF. Twist cap to verify that a click is heard and/or resistance is felt. Either indicates that the plastic tip under cap was intact. The twisting motion breaks the seal and the tip remains in the cap. Dispense product and discard after use.

HOW SUPPLIED

ILOTYCIN® (Erythromycin Ophthalmic Ointment, USP, 0.5%) No. 52 is available in the following sizes:

1 / 8 oz. (3.5 g) tamper-resistant tube (NDC 0777-1863-17-Prod. No. FL09234

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

1 g plastic container (in cartons of 50) (NDC 0777-1863-55)-Prod. No. FL09232

DO NOT USE IF CLICK IS NOT HEARD AND/OR RESISTANCE IS NOT FELT.

Storage: Store between 15°-30°C (59°-86°F).

KEEP OUT OF REACH OF CHILDREN.

Caution: Federal law prohibits dispensing without prescription.

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