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    ERYTHROMYCIN Ophthalmic Ointment USP: Including Patient Medication Information

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    Rosnita Dewi R
    1. Erythromycin ophthalmic ointment is an antibiotic used to treat bacterial eye infections and prevent gonococcal and chlamydial conjunctivitis in newborns. 2. It works by inhibiting bacterial protein synthesis. Its spectrum of activity is similar to penicillin. Resistance has been shown in some strains of bacteria. 3. It comes as a 5mg/g ointment and is applied directly to the infected eye one or more times daily as directed by a doctor. Side effects can include allergic reactions like hives or rashes.

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    ERYTHROMYCIN Ophthalmic Ointment USP: Including Patient Medication Information

    Uploaded by

    Rosnita Dewi R
    246 views6 pages
    1. Erythromycin ophthalmic ointment is an antibiotic used to treat bacterial eye infections and prevent gonococcal and chlamydial conjunctivitis in newborns. 2. It works by inhibiting bacterial protein synthesis. Its spectrum of activity is similar to penicillin. Resistance has been shown in some strains of bacteria. 3. It comes as a 5mg/g ointment and is applied directly to the infected eye one or more times daily as directed by a doctor. Side effects can include allergic reactions like hives or rashes.

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    1. Erythromycin ophthalmic ointment is an antibiotic used to treat bacterial eye infections and prevent gonococcal and chlamydial conjunctivitis in newborns. 2. It works by inhibiting bacterial protein synthesis. Its spectrum of activity is similar to penicillin. Resistance has been shown in some strains of bacteria. 3. It comes as a 5mg/g ointment and is applied directly to the infected eye one or more times daily as directed by a doctor. Side effects can include allergic reactions like hives or rashes.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    246 views6 pages

    ERYTHROMYCIN Ophthalmic Ointment USP: Including Patient Medication Information

    Uploaded by

    Rosnita Dewi R
    1. Erythromycin ophthalmic ointment is an antibiotic used to treat bacterial eye infections and prevent gonococcal and chlamydial conjunctivitis in newborns. 2. It works by inhibiting bacterial protein synthesis. Its spectrum of activity is similar to penicillin. Resistance has been shown in some strains of bacteria. 3. It comes as a 5mg/g ointment and is applied directly to the infected eye one or more times daily as directed by a doctor. Side effects can include allergic reactions like hives or rashes.

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    You are on page 1of 6

    PRESCRIBING INFORMATION

    INCLUDING PATIENT MEDICATION INFORMATION

    Pr
    ERYTHROMYCIN Ophthalmic ointment USP

    Erythromycin ophthalmic ointment USP

    5mg / g

    ANTIBIOTIC

    Laboratoires Sterigen inc. Date of Revision:


    242 St-Cyrille Ouest October 16, 2018
    Upton, Quebec
    J0H 2E0

    Submission Control No: 211568

    ERYTHROMYCIN ophthalmic ointment USP


    Prescribing Information Page 1 of 6
    PRESCRIBING INFORMATION
    Pr
    ERYTHROMYCIN Ophthalmic ointment USP
    Erythromycin ophthalmic ointment USP 5mg / g

    THERAPEUTIC CLASSIFICATION
    Antibiotic

    ACTION AND CLINICAL PHARMACOLOGY


    Erythromycin inhibits protein synthesis by binding to the 50S ribosomal subunit within the
    microorganism. It is usually bacteriostatic but may be bactericidal depending on the sensitivity
    and number of organisms and the concentrations of the drug. Its spectrum of activity is similar
    to that of penicillin G. Resistance to erythromycin of some strains of H. influenza and
    Staphylococci has been demonstrated.

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

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


    Canadian Pediatric Society, the Centers for Diseases Control and the Committee on Drugs
    (US), the Committee of Fetus and Newborn and the Committee on Infectious Diseases of the
    American Academy of Pediatrics recommend 1% silver nitrate solution in single dose ampoules
    or single use tubes of an ophthalmic ointment containing 0.5% erythromycin or 1% tetracycline
    as effective and acceptable regimens for prophylaxis of gonococcal ophthalmia neonatorum.
    Erythromycin ophthalmic ointment has also been effective for prevention of neonatal
    conjunctivitis due to C. trachomatis, a condition that may develop one to several weeks after
    delivery in infants of mothers whose birth canal harbor the organism.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of


    ERYTHROMYCIN ophthalmic ointment and other antibacterial drugs, ERYTHROMYCIN
    ophthalmic ointment should be used only to treat infections that are proven or strongly
    suspected to be caused by susceptible bacteria. When culture and susceptibility information
    are available, they should be considered in selecting or modifying antibacterial therapy. In the
    absence of such data, local epidemiology and susceptibility patterns may contribute to the
    empiric selection of therapy.

    WARNINGS AND PRECAUTIONS


    Susceptibility/Resistance
    Prescribing ERYTHROMYCIN ophthalmic ointment in the absence of a proven or strongly
    suspected bacterial infection is unlikely to provide benefit to the patient and risks the
    development of drug-resistant bacteria.

    The rare possibility of superinfection caused by overgrowth of non-susceptible bacteria or fungi


    should be kept in mind during prolonged or repeated therapy, especially when other
    antibacterial agents are simultaneously employed. In such instances the drug should be
    withdrawn and appropriate treatment instituted if necessary.

    ERYTHROMYCIN ophthalmic ointment USP


    Prescribing Information Page 2 of 6
    CONTRAINDICATIONS
    Erythromycin and its derivatives should not be used in patients with known hypersensitivity to
    these drugs or any ingredient in the formulations or with infections that are resistant to the drug
    (primarily certain Staphylococci organisms).

    ADVERSE EFFECTS
    Serious allergic reactions to erythromycin have been extremely infrequent. Mild allergic
    reactions, such as urticaria and morbilliform skin rashes have occurred. Should a patient
    demonstrate signs of hypersensitivity, administer appropriate countermeasures such as
    epinephrine, corticosteroid and antihistamines, and withdraw the antibiotic.

    DOSAGE AND ADMINISTRATION


    In the treatment of external ocular infections, apply the ointment directly to the infected
    structure one or more times daily, depending on the severity of the infection.

    For prophylaxis neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment


    approximately 0.5 to 1 cm in length should be instilled into each conjunctival sac. The ointment
    should not be flushed from the eye following installation. A new tube should be used for each
    infant. Infants born by cesarean section as well as those delivered by vaginal route should
    receive prophylaxis.

    AVAILABILITY
    Each 1 g of sterile ophthalmic ointment contains: Erythromycin (base) 5 mg in a Mineral Oil and
    Petrolatum. Tubes of 3.5 g and unit dose tubes of 1 g in boxes of 50.

    STORAGE CONDITIONS
    Store at room temperature (15-30oC). Protect from freezing. Keep tightly closed.

    ERYTHROMYCIN ophthalmic ointment USP


    Prescribing Information Page 3 of 6
    READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE
    PATIENT MEDICATION INFORMATION
    Pr
    ERYTHROMYCIN Ophthalmic ointment USP
    Erythromycin ophthalmic ointment USP 5mg / g

    Read this carefully before you start taking ERYTHROMYCIN Ophthalmic ointment USP and
    each time you get a refill. This leaflet is a summary and will not tell you everything about this
    drug. Talk to your healthcare professional about your medical condition and treatment and ask
    if there is any new information about ERYTHROMYCIN Ophthalmic ointment USP.

    What is ERYTHROMYCIN Ophthalmic ointment USP used for?


    • ERYTHROMYCIN Ophthalmic ointment USP is used to treat bacterial eye infections.

    • Antibacterial drugs like ERYTHROMYCIN Ophthalmic ointment USP treat only bacterial
    infections. They do not treat viral infections. Although you may feel better early in the
    treatment, ERYTHROMYCIN Ophthalmic ointment USP should be used exactly as
    directed. Misuse or overuse of ERYTHROMYCIN Ophthalmic ointment USP could lead to
    the growth of bacteria that will not be killed by ERYTHROMYCIN Ophthalmic ointment
    USP (resistance). This means that ERYTHROMYCIN Ophthalmic ointment USP may not
    work for you in the future. Do not share your medicine.

    How does ERYTHROMYCIN Ophthalmic ointment USP work?


    ERYTHROMYCIN Ophthalmic ointment USP is an antibiotic. It works by killing or stopping
    the growth of the bacteria that cause your infection.

    What are the ingredients in ERYTHROMYCIN Ophthalmic ointment USP?


    Medicinal ingredients: Erythromycin
    Non-medicinal ingredients: Mineral oil, Petrolatum

    ERYTHROMYCIN Ophthalmic ointment USP comes in the following dosage forms:


    Ointment: 5mg / g

    Do not use ERYTHROMYCIN Ophthalmic ointment USP if you:


    • Are allergic to erythromycin or any other ingredients of ERYTHROMYCIN Ophthalmic
    ointment USP
    • Have infections that are resistant to this medication (bacteria will not be killed).

    To help avoid side effects and ensure proper use, talk to your healthcare professional
    before you take ERYTHROMYCIN Ophthalmic ointment USP. Talk about any health
    conditions or problems you may have.

    • If you wear contact lenses, remove them before applying ERYTHROMYCIN Ophthalmic
    ointment USP. These can be re-inserted 15 minutes after application of the ointment.

    Tell your healthcare professional about all the medicines you take, including any drugs,
    vitamins, minerals, natural supplements or alternative medicines.

    ERYTHROMYCIN ophthalmic ointment USP


    Patient Medication Information Page 4 of 6
    How to take ERYTHROMYCIN Ophthalmic ointment USP:
    Follow your doctor’s instruction carefully about how much ERYTHROMYCIN Ophthalmic
    ointment USP to apply and when to apply it.

    Usual dose:
    Apply the ointment directly into the affected eye(s) one or more times daily as directed by your
    doctor.

    Administration:
    1. Wash hands before use.
    2. Remove tube cap.
    3. Tilt head up when looking in a mirror.
    4. Gently pull down the lower eyelid until there is a “pocket” (see picture below).
    5. Apply a ribbon of ointment 0.5-1 cm along in this pocket (see picture below).
    6. Let go of the lower eyelid and close the eye for 30 seconds.
    7. If you use ointment in both eyes, repeat the steps for the other eye.
    8. To avoid contamination and injury, do not let the tip of the tube touch your eye.
    9. If you are using another eye medicine, wait at least 15 minutes before applying the
    other medicine.
    10. For the multiple-use 3.5 g tube, close and tighten the cap. If you are using a 1 g single-
    use tube, discard tube after use.

    Overdose:

    In case of drug overdose, including ingestion, contact your healthcare professional, hospital
    emergency department or regional poison control centre, even if there are no symptoms.

    Missed Dose:
    If you forget to apply the ointment, simply apply it as soon as you remember. Then go back to
    the original schedule as directed by your doctor. Do not apply 2 doses to make up for the
    missed dose.

    What are possible side effects from using ERYTHROMYCIN Ophthalmic ointment USP?

    These are not all the possible side effects you may feel when taking ERYTHROMYCIN
    Ophthalmic ointment USP. If you experience any side effects not listed here, contact your
    healthcare professional.

    ERYTHROMYCIN ophthalmic ointment USP


    Patient Medication Information Page 5 of 6
    Side effects may include:
    • Hives
    • Skin rashes

    Serious side effects and what to do about them


    Talk to your healthcare professional Stop taking drug
    Symptom / effect and get immediate
    Only if severe In all cases
    medical help
    RARE
    Severe allergic reaction with
    symptoms such as: swelling of
    the face, mouth, throat, lips,
    X
    eyes, difficulty breathing,
    burning and/or painful red eyes,
    tearing, skin reactions (rash,
    blisters, and hives).

    If you have a troublesome symptom or side effect that is not listed here or becomes bad
    enough to interfere with your daily activities, talk to your healthcare professional.

    Reporting Side Effects

    You can report any suspected side effects associated with the use of health products to
    Health Canada by:

    • Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-


    mps/medeff/report-declaration/index-eng.php) for information on how to report online,
    by mail or by fax; or
    • Calling toll-free at 1-866-234-2345.

    NOTE: Contact your health professional if you need information about how to manage your
    side effects. The Canada Vigilance Program does not provide medical advice.

    Storage:
    Store at room temperature (15-30oC). Protect from freezing. Keep tightly closed.

    Keep out of reach and sight of children.

    If you want more information about ERYTHROMYCIN Ophthalmic ointment USP:


    • Talk to your healthcare professional
    • Find the full prescribing information that is prepared for healthcare professionals and
    includes this Patient Medication Information by visiting the Health Canada website
    (http://hc-sc.gc.ca/index-eng.php).

    This leaflet was prepared by Laboratoires STERIGEN inc.

    Last Revised October 16, 2018

    ERYTHROMYCIN ophthalmic ointment USP


    Patient Medication Information Page 6 of 6

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