ODAN-ERYTHROMYCIN OINTMENT

Canada - English - Health Canada

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Active ingredient:
ERYTHROMYCIN
Available from:
ODAN LABORATORIES LTD
ATC code:
S01AA17
INN (International Name):
ERYTHROMYCIN
Dosage:
5MG
Pharmaceutical form:
OINTMENT
Composition:
ERYTHROMYCIN 5MG
Administration route:
OPHTHALMIC
Units in package:
1G/3.5G
Prescription type:
Prescription
Therapeutic area:
ANTIBACTERIALS
Product summary:
Active ingredient group (AIG) number: 0105708001; AHFS: 52:04.04
Authorization status:
APPROVED
Authorization number:
00641324
Authorization date:
2015-07-31

Documents in other languages

PRESCRIBING INFORMATION

Pr

ODAN-ERYTHROMYCIN

Erythromycin Ophthalmic Ointment, USP

5 mg / g

ANTIBIOTIC

ODAN LABORATORIES LTD.

325 Stillview Ave., Pointe Claire,

Québec H9R 2Y6

Submission Control No: 211571

Date of Revision:

January 5, 2018

www.odanlab.com

PRESCRIBING INFORMATION

Pr

ODAN-ERYTHROMYCIN

Erythromycin

O

phthalmic Ointment, USP

5 mg / g

THERAPEUTIC CLASSIFICATION

Antibiotic

ACTION AND CLINICAL PHARMACOLOGY

Erythromycin inhibits protein synthesis

binding to

the 50S ribosomal

subunit within

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,

Centers

Diseases

Control

Committee

Drugs

(US),

Committee

Fetus

Newborn

Committee

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

also

been

effective

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 ODAN-

ERYTHROMYCIN and other antibacterial drugs, ODAN-ERYTHROMYCIN 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

Susceptibility/Resistance

Prescribing ODAN-ERYTHROMYCIN 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.

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).

PRECAUTIONS

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

simultaneously

employed. In

such

instances

drug

should

withdrawn and

appropriate treatment instituted if necessary.

OVERDOSE

In case of drug overdose, including ingestion, contact a healthcare professional, hospital

emergency department or regional poison control centre, even if there are no symptom.

ADVERSE REACTIONS

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.

prophylaxis

neonatal

gonococcal

chlamydial

conjunctivitis,

ribbon

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 the vaginal

route should receive

prophylaxis.

AVAILABILITY

Each 1 g of sterile ophthalmic ointment contains: Erythromycin (base) 5 mg and the following non-

medicinal ingredients: Mineral Oil and

White Petrolatum. Single tubes of 3.5 g and unit dose tubes

of 1 g in boxes of 50.

STORAGE CONDITIONS

Store at room temperature (15°C to 30°C). Protect from freezing.

SCIENTIFIC INFORMATION

Drug Substance

Proper Name:

Erythromycin

Chemical Name:

(3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-Dideoxy-3-

C-methyl-3-O-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

Molecular Formula: C

Molecular Weight:

733.94

Structural Formula:

Erythromycin contains primarily erythromycin A but also contains erythromycin B and

C, with each having antibacterial activity.

Melting Point:

133-140°C

Physicochemical properties:

Physical description:

White or slightly yellow, odorless or almost odorless, slightly

hygroscopic crystals or powder with a bitter taste.

Solubility:

It is freely soluble in methanol, ethanol, acetone and chloroform. It is

soluble in water at 2 mg/mL.

SUPPORTING PRODUCT MONOGRAPHS

pdp-ERYTHROMYCIN (Erythromycin Ophthalmic Ointment, USP; 5 mg / g), submission

control. No. 200704, Prescribing Information, Pendopharm, Division of Pharmascience Inc.,

January 16, 2017.

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE

PATIENT MEDICATION INFORMATION

Pr

ODAN-ERYTHROMYCIN

Erythromycin Ophthalmic Ointment, USP

Read this carefully before you start taking ODAN-ERYTHROMYCIN 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 ODAN-ERYTHROMYCIN.

What is ODAN-ERYTHROMYCIN used for?

ODAN-ERYTHROMYCIN is used to treat bacterial eye infections.

Antibacterial drugs like ODAN-ERYTHROMYCIN treat only bacterial infections. They do not

treat viral

infections. Although you may feel better early in the treatment, ODAN- ERYTHROMYCIN should be used

exactly as directed. Misuse or overuse of ODAN- ERYTHROMYCIN could lead to the growth of bacteria that will

not be killed by ODAN- ERYTHROMYCIN (resistance). This means that ODAN-ERYTHROMYCIN may not

work for you in the future. Do not share your medicine.

How does ODAN-ERYTHROMYCIN work?

ODAN-ERYTHROMYCIN is an antibiotic. It works by killing or stopping the growth of the

bacteria that cause

your infection.

What are the ingredients in ODAN-ERYTHROMYCIN?

Active ingredient: Erythromycin

Inactive ingredients: Mineral Oil, Petrolatum.

ODAN-ERYTHROMYCIN comes in the following dosage forms:

Ointment: 5 mg / g

Do not use ODAN-ERYTHROMYCIN if you:

are allergic to erythromycin or any other ingredients of ODAN-ERYTHROMYCIN

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

ODAN-ERYTHROMYCIN. Talk about any health conditions or problems you may have.

If you wear contact lenses, remove them before applying ODAN-ERYTHROMYCIN. 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. How to take ODAN-ERYTHROMYCIN:

Follow your doctor’s instruction carefully about how much ODAN-ERYTHROMYCIN 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:

Wash hands before use.

Remove tube cap.

Tilt head up when looking in a mirror.

Gently pull down the lower eyelid until there is a “pocket” (see picture below).

Apply a ribbon of ointment 0.5- 1 cm along in this pocket (see picture below).

Let go of the lower eyelid and close the eye for 30 seconds.

If you use ointment in both eyes, repeat the steps for the other eye.

To avoid contamination and injury, do not let the tip of the tube touch your eye.

If you are using another eye medicine, wait at least 15 minutes before applying the other medicine.

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.

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.

Overdose:

In case of drug overdose, including ingestion, contact a healthcare professional, hospital

emergency department

or regional poison control centre, even if there are no symptom

What are possible side effects from using ODAN-ERYTHROMYCIN?

These are not all the possible side effects you may feel when taking ODAN-ERYTHROMYCIN. If you

experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

Hives

Skin rashes

Serious side effects and what to do about them

Symptom / effect

Talk to your healthcare professional

Stop taking drug

and get immediate

medical help

Only if severe

In all cases

RARE

Severe allergic reaction with

symptoms such

as: swelling of the face, mouth, throat, lips,

eyes,

difficulty

breathing,

burning

and/or

painful red eyes, tearing, skin reactions (rash,

blisters, 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 Suspected 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 (https://www.canada.ca/en/health-

canada/services/drugs-health-products/drugproducts/drug-product-database.html) 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°C to 30°C). Protect from freezing.

Keep out of reach and sight of children.

If you want more information about ODAN-ERYTHROMYCIN:

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); or by

calling 1-800-387-9342.

This leaflet was prepared by Odan Laboratories Ltd., Montreal, Canada, H9R 2Y6

Date of Revision:

January 5, 2018

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