Ilotycin

ILOTYCIN™ Erythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*) -4-[(2,6-dideoxy-3-C-methyl-3-0-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7, 12,13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2, 10-dione) is an antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:

Molecular Formula: C37H67NO13

Molecular Weight: 733.94

Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum.

The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.

To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604 Monday-Friday 9am-5pm EST or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No information provided.

Ilotycin is part of the drug classes:

• Antiinfectives for treatment of acne

• Macrolides

Serious side effects have been reported with erythromycin. See the “Erythromycin Precautions” section.

Oral:

• Common side effects of oral erythromycin include the following:
• Upset stomach
• Diarrhea
• Vomiting
• Stomach cramps
• Mild skin rash
• Stomach pain

Topical:

Common side effects of topical erythromycin include the following:

• Irritation at the site of application, including dryness, redness, itching, and burning

Injectable:

Common side effects of oral injectable erythromycin include the following:

• Irritation at the injection site
• Skin rash

This is not a complete list of erythromycin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Other antibiotics
• Anticoagulants, such as warfarin (Coumadin)
• Astemizole (Hismanal)
• Carbamazepine (Tegretol)
• Cisapride (Propulsid)
• Clozapine (Clozaril)
• Colchicine
• Cyclosporine (Neoral, Sandimmune)
• Digoxin (Lanoxin)
• Disopyramide (Norpace)
• Ergotamine
• Felodipine (Plendil)
• Lovastatin (Mevacor)
• Phenytoin (Dilantin)
• Pimozide (Orap)
• Terfenadine (Seldane)
• Theophylline (Theo-Dur)
• Triazolam (Halcion)
• Verapamil (Calan, Verelan)

This is not a complete list of erythromycin drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of erythromycin, there are no specific foods that you must exclude from your diet when receiving this medication.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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

For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeaeor C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrhoeaeis 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.