Ilotycin® (Erythromycin Ophthalmic Ointment, USP) 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 is an antibiotic produced from a strain of Streptomyces erythraeus . The special sterile ophthalmic ointment base flows freely over the conjunctiva.

Chemical Name: (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3- O -methyl-(alpha)-L- ribo -hexopyranosyl)oxy]-14-ethyl-7, 12, 13-trihydroxy-3, 5, 7, 9, 11, 13-hexamethyl-6-[[3, 4, 6-trideoxy-3-(dimethylamino)-(beta)-D- xylo -hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione.

Each Gram Contains: ACTIVE: Erythromycin, USP, 5 mg (0.5%); INACTIVES: White Petrolatum, Mineral Oil.

Last updated on RxList: 12/8/2004

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.

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.

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.

Last updated on RxList: 12/8/2004

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

No Information Provided.

Last updated on RxList: 12/8/2004

No Information Provided.

General The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.

Information for Patients Avoid contaminating the tip of container with material from the eye, fingers, or other source.

Carcinogenesis, Mutagenesis, Impairment of Fertility Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted. No evidence of impaired fertility or harm to the fetus that appeared related to erythromycin was reported in these studies.

Pregnancy Pregnancy Category B Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.

Nursing Mothers Caution should be exercised when erythromycin is administered to a nursing woman.

Pediatric Use See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .

Last updated on RxList: 12/8/2004

No Information Provided.

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

Last updated on RxList: 12/8/2004

Microbiology Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections:

Streptococcus pyogenes (group A (beta)-hemolytic)

Alpha-hemolytic streptococci (viridans group)

Staphylococcus aureus , including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)

Streptococcus pneumoniae

Mycoplasma pneumoniae (Eaton Agent, PPLO)

Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)

Treponema pallidum

Corynebacterium diphtheriae

Neisseria gonorrhoeae

Chlamydia trachomatis

 

Last updated on RxList: 12/8/2004

Avoid contaminating the tip of container with material from the eye, fingers, or other source.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ERYTHROMYCIN - OPHTHALMIC

(eh-rith-row-MY-sin)

COMMON BRAND NAME(S): Romycin

USES: This medication is used to treat and prevent certain eye infections. It belongs to a class of drugs known as macrolide antibiotics. Erythromycin works by stopping the growth of bacteria.

This medication treats only bacterial eye infections. It will not work for other types of eye infections or for bacterial infections elsewhere in the body. Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: Apply this medication to the eye, usually up to 6 times a day or as directed by your doctor. Wash hands before applying. To avoid contamination, be careful not to touch the tip of the tube or let it touch your eye or any other surface.

Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to manufacturer's directions, and check with your doctor before you begin using them again.

To apply eye ointments, tilt your head back, look up, and gently pull down the lower eyelid to make a pouch. Place a1/2 inch (1.3 centimeters) strip of ointment into the pouch. Gently close the eye and roll the eyeball in all directions to spread the medication. Try not to blink and do not rub the eye. Repeat these steps for your other eye if so directed. Wipe the tip of the ointment tube with a clean tissue to remove extra medication before recapping it.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed. Stopping the medication too soon may allow the bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Eye stinging/burning/redness and temporary blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged or repeated periods may result in other types of eye infections, including fungal infections. Contact your doctor if you notice new eye symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using erythromycin, tell your doctor or pharmacist if you are allergic to it; or to other macrolide antibiotics (e.g., clarithromycin); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous eye problems, contact lens use.

After you apply this drug, your vision may become temporarily blurred. Use caution while driving, using machinery, or doing any other activity that requires clear vision. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether erythromycin passes into breast milk when given as an eye ointment. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Throw away the unused portion after treatment is completed. Do not use it later for another infection. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not expose this drug to high heat. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.