Consumer medicine information

E-Mycin

Erythromycin

BRAND INFORMATION

Brand name

E-Mycin

Active ingredient

Erythromycin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using E-Mycin.

What is in this leaflet

This leaflet answers some common questions about E-Mycin tablets and mixtures.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking E-Mycin against the benefits expected for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What E-Mycin is used for

E-Mycin is used to:

  • treat certain bacterial infections
  • control acne, in addition to other acne treatments
  • prevent infections in people with a history of rheumatic disease, congenital heart disease or other acquired valvular heart disease and who are allergic to penicillin antibiotics.

E-Mycin is an antibiotic that belongs to a group of medicines called macrolides. These medicines work by killing or stopping the growth of bacteria, which cause infections or make acne worse.

E-Mycin will not work against infections caused by viruses, such as colds or flu.

Ask your doctor if you have any questions about why E-Mycin has been prescribed for you. Your doctor may have prescribed E-Mycin for another reason.

E-Mycin is available only with a doctor's prescription.

There is no evidence that E-Mycin is addictive.

Before you take E-Mycin

When you must not take it

Do not take E-Mycin if you are allergic to:

  • medicines containing erythromycin (e.g. EES) or any other antibiotic from the macrolide group (e.g. clarithromycin, roxithromycin)
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • Skin rash, itching or hives;
  • Swelling of the face, lips, tongue or other parts of the body;
  • Shortness of breath, wheezing or troubled breathing.

Do not take E-Mycin if you are taking any of the following medicines:

  • terfenadine or astemizole
  • cisapride, pimozide or domperidone
  • class IA and III antiarrhythmics e.g. quinidine, disopyramide, procainamide, amiodarone and sotalol
  • certain neuroleptics and tri- and tetracyclic antidepressants
  • arsenic trioxide, methadone, budipine, certain fluoroquinolones, imidazole anti-mycotics and anti-malarials e.g. petamidine i.v.
  • simvastatin, lovastatin or atorvastatin
  • ergotamine or dihydroergotamine

Taking E-Mycin with any of the above medicines may cause serious side effects.

Ask your doctor or pharmacist if you are not sure if you are taking one of the above medicines.

Do not take E-Mycin if you have:

  • severe liver disease
  • heart rhythm disorders from birth of have developed it
  • irregular heartbeat or severe chronic heart failure
  • deficiency of potassium and magnesium in blood

Do not take E-Mycin if the packaging shows signs of tampering or the tablets or mixtures do not look quite right.

Do not take E-Mycin if the expiry date (EXP) printed on the label has passed. If you take this medicine after the expiry date, it may not work as well.

Do not use any E-Mycin mixture left in the bottle after 10 days.

If you are not sure whether you should start taking E-Mycin, talk to your doctor.

Before you start to take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will discuss the risks and benefits of taking E-Mycin during pregnancy.

Tell your doctor if you are breastfeeding or wish to breastfeed. Your doctor will discuss the risks and benefits of taking E-Mycin when breastfeeding.

Tell your doctor if you have any medical conditions including:

  • liver problems
  • heart problems
  • myasthenia gravis, a condition in which the muscles become weak and tire easily
  • eye disorder
  • pneumonia

If you have not told your doctor about any of the above, tell them before you start taking E-Mycin.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with EES. These include:

  • medicines used to prevent blood clotting, such as warfarin, acenocoumarol
  • some medicines used for epilepsy such as phenytoin, carbamazepine, hexobarbital, phenobarbital (phenobarbitone) and valproate
  • theophylline, a medicine used to treat asthma
  • diltiazem, verapamil, felodipine and mibefradil, medicines used to treat high blood pressure and certain heart conditions
  • digoxin, a medicine used to treat heart failure
  • omeprazole and cimetidine, used to prevent ulcers by reducing amount of acid produced in stomach
  • ciclosporin, used to prevent organ transplant rejection or to treat certain problems with the immune system
  • tacrolimus, used as an adjunct to kidney transplantation
  • triazolam, zopiclone and midazolam, used to treat sleeplessness
  • nefazodone and St. John's wort, medicines used to treat depression
  • alprazolam used to treat anxiety disorders
  • methylprednisolone, a corticosteroid
  • vinblastine, a medicine used to treat Hodgkin's Disease
  • sildenafil, used to treat erectile dysfunction in adult males
  • mizolastine and ebastine medicines used to treat allergies such as hay fever
  • ritonavir, used to treat infections in patients with advanced HIV infection
  • medicines used to treat fungal infections such as ketoconazole, itraconazole, fluconazole
  • rifabutin, rifampicin, clindamycin, lincomycin, chloramphenicol, streptomycin, colistin and bactericidal betalactam antibiotics (e.g. penicillin, cephalosporin)
  • bromocriptine, used to treat various conditions including Parkinson's Disease
  • colchicine, used for pain relief in gout
  • alfentanil, a medicine used for pain relief during anaesthesia
  • cilostazol, a medicine used in the treatment of painful calves, due to poor blood flow to the muscles
  • diphenoxylate with atropine used to treat diarrhoea
  • opiates used as analgesics.

Your doctor can tell you what to do if you are taking any of these medicines. You may need different amounts of yours medicines, or you may need to take different medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking E-Mycin.

How to take E-Mycin

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

How much to take

The usual adult dose is one E-Mycin tablet (400 mg) every six hours but this may vary from person to person.

Your doctor will tell you how many tablets you will need to take. This depends on the infection being treated and how severe it is.

For children, their doctor will work out the dose according to their age, body weight and how severe the infection is.

Your doctor will adjust the amount or frequency of your doses according to the infection being treated and the severity of the condition.

How to take it

Tablets: Swallow whole with a glass of water.

Mixture: Always shake the bottle well before using a metric measure to measure the correct dose.

Shaking the bottle and using a medicine measure will make sure that you get the correct dose. You can buy a medicine measure from your pharmacist.

When to take it

Space the doses of E-Mycin evenly apart and take them at about the same time each day. This will allow E-Mycin to have its best effect and also help you to remember when to take it.

E-Mycin can be taken with or without food. However, taking E-Mycin with food may help reduce the chance of a stomach upset occurring.

How long to take it for

Keep taking E-Mycin until you finish the tablets or mixture, or for as long as your doctor recommends.

If you are being treated for an infection, E-Mycin is usually taken for one to two weeks. Your infection may not clear completely if you stop taking your medicine too soon.

For controlling acne, E-Mycin is normally taken for a few months.

Check with your doctor if you are not sure how long you should be taking E-Mycin.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

If you have any questions or are not sure what to do, ask your doctor or pharmacist.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much E-Mycin.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much E-Mycin, you may have nausea, vomiting or problems with your hearing.

While you are taking E-Mycin

Things you must do

If you are taking E-Mycin for an infection and your symptoms do not improve within a few days, or if they become worse, tell your doctor.

If your baby develops irritability with feeding or has severe vomiting during treatment with E-Mycin, tell your doctor immediately. This may be a sign of a stomach disorder in the infant.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking E-Mycin.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are being given this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking E-Mycin, tell your doctor.

If you get severe diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking E-Mycin.

Do not take any diarrhoea medicine without checking with your doctor. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care.

If you have to have any urine tests, tell your doctor you are taking E-Mycin. E-Mycin may affect the results of some tests.

If you develop itching with swelling or skin rash or difficulty breathing while you are taking E-Mycin, do not take any more and contact your doctor immediately.

If you get a sore, white mouth or tongue while taking or soon after stopping E-Mycin, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes, the use of E-Mycin allows fungi to grow and the above symptoms to occur. E-Mycin does not work against fungi.

Things you must not do

Do not use E-Mycin to treat any other conditions unless your doctor tells you to.

Do not give E-Mycin to anyone else, even if they have the same condition as you.

Do not stop taking E-Mycin, even if you feel better after a few days, unless advised by your doctor.

If you stop taking E-Mycin too soon, the infection may not clear completely or your symptoms may return.

If possible, your doctor will gradually reduce the amount you take each day before stopping the medicine completely.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking E-Mycin.

E-Mycin treats infections and controls acne in most people, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

If any of the following happen, stop taking E-Mycin and tell your doctor immediately or go to Accident and Emergency at the nearest hospital:

  • signs of an allergic reaction such as any type of skin rash, itching, or hives; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing, troubled breathing
  • watery and severe diarrhoea, which may also be bloody.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • yellowing of the eyes or skin (jaundice)
  • severe stomach cramps
  • feeling generally unwell and having poor appetite
  • loss of hearing
  • ringing or buzzing in the ears
  • fast, irregular or pounding heart beat, palpitations
  • chest pain
  • muscle pain, weakness and joint swelling
  • dizziness, drowsiness, confusion, hallucinations, fits
  • any type of skin rash, itching, hives, serious scaly red rash with bumps under skin and blisters
  • severe diarrhoea especially if bloody
  • any vision problems.
  • in infants, irritability with feeding or severe vomiting.

The above list includes serious side effects which may require medical attention.

Tell your doctor if you notice any of the following and they worry you:

  • stomach cramps and pains
  • feeling sick, vomiting, accumulation of gas and severe diarrhoea
  • oral thrush (white, furry sore tongue and mouth)
  • vaginal thrush (sore and itchy vagina, vaginal discharge).
  • Weight loss
  • Fever, headache

The above list includes the more common and mild side effects of E-Mycin.

Tell your doctor if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After you have finished taking E-Mycin

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with E-Mycin:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above.

You may have a serious condition affecting your bowel. These are rare but serious side effects. Therefore, you may need urgent medical attention.

Do not take any medicine for diarrhoea without first checking with your doctor.

After taking E-Mycin

Storage

Keep E-Mycin where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep E-Mycin tablets in a cool, dry place where the temperature stays below 30°C.

Keep E-Mycin mixture in the refrigerator but not in the freezer.

Do not use any mixture left in the bottle after 10 days.

Do not store E-Mycin or any other medicine in the bathroom or near a sink.

Do not leave E-Mycin in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking E-Mycin, or your medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

E-Mycin is available as a tablet and mixture.

  • Tablets are flesh pink in colour, oval-shaped, film-coated and marked "E-N" on one side and a Greek alpha symbol on the other. Each pack contains 25 tablets.
  • Mixtures are available as two strengths:
    - E-Mycin 200
    - E-Mycin 400.
    Both mixtures are pink, cherry flavoured and sugar-free. Each bottle contains 100 mL of mixture.

Ingredients

The active ingredient in E-Mycin tablets and mixtures is erythromycin (as erythromycin ethyl succinate).

E-Mycin tablets
E-Mycin tablets contain 400 mg of erythromycin (as erythromycin ethyl succinate).

The E-Mycin tablets also contain the following inactive ingredients:

  • calcium hydrogen phosphate anhydrous
  • maize starch
  • sorbic acid
  • povidone
  • purified talc
  • sodium starch glycollate
  • magnesium stearate
  • Opadry Pink OY-B-34901 (contains colours titanium dioxide CI 77891 [171]), iron oxide red CI 77491 [172]).

E-Mycin tablets do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

E-Mycin mixtures

  • E-Mycin 200 - each 5 mL contains 200 mg of erythromycin (as erythromycin ethyl succinate).
  • E-Mycin 400 - each 5 mL contains 400 mg of erythromycin (as erythromycin ethyl succinate).

The mixtures also contain the following inactive ingredients:

  • sorbitol
  • propylene glycol alginate
  • sodium citrate
  • colloidal anhydrous silica
  • aspartame (951)
  • sodium benzoate (211)
  • erythrosine CI45430 (127)
  • Trusil Nature Identical Cherry Flavour (contains preservative 320).

E-Mycin mixtures do not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Manufacturer

E-Mycin is made in Australia by:

Alphapharm Pty Limited
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au

Australian Registration Numbers:

Tablet:
E-Mycin - AUST R 71310

Mixtures:
E-Mycin 200 - AUST R 48286
E-Mycin 400 - AUST R 48287

This leaflet was prepared in February 2020.

e-mycin_cmi/Nov19

Published by MIMS April 2020

BRAND INFORMATION

Brand name

E-Mycin

Active ingredient

Erythromycin

Schedule

S4

 

1 Name of Medicine

Erythromycin (as ethyl succinate).

6.7 Physicochemical Properties

Erythromycin is produced by a strain of Streptomyces erythraeus and belongs to the macrolide group of antibiotics. It is a base and readily forms salts with acids. The base, the stearate salt and the esters are poorly soluble in water. Erythromycin ethyl succinate is an ester of erythromycin suitable for oral administration.

Chemical structure.


Chemical name: 4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}- 14-ethyl-7,12,13-trihydroxy-4- 5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}- 3,5,7,9,11,13-hexamethyl-1-oxacyclotetradecane-2,10-dione.
Molecular formula: C43H75NO16.
Molecular weight: 862.05.

CAS number.

1264-62-6.

2 Qualitative and Quantitative Composition

Each E-Mycin tablet contains 400 mg of erythromycin (as ethyl succinate) as the active ingredient.
Each 5 mL of E-Mycin granules when prepared contains either 200 mg or 400 mg of erythromycin (as ethyl succinate).

Excipients with known effect.

Tablets: contains sorbates.
Granules: contains benzoates and aspartame.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

E-Mycin.

Tablets, erythromycin 400 mg (as ethyl succinate): flesh-pink, oval-shaped, film coated, marked E-N on one side, α on reverse.

E-Mycin 200.

Granules, erythromycin 200 mg/5 mL (as ethyl succinate): pink free flowing granules. When reconstituted, pink suspension with a cherry odour and flavour.

E-Mycin 400.

Granules, erythromycin 400 mg/5 mL (as ethyl succinate): pink free flowing granules. When reconstituted, pink suspension with a cherry odour and flavour.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

The mode of action of erythromycin has been well characterised. Erythromycin binds to the 50S ribosomal sub-units of susceptible bacteria to inhibit protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active in vitro against the following Gram-positive and Gram-negative organisms:
Streptococcus pyogenes, α-haemolytic Streptococci (viridans group), Staphylococcus aureus, Streptococcus pneumoniae, Corynebacterium diphtheriae (as an adjunct to antitoxin), Corynebacterium minutissimum, Listeria monocytogenes, Neisseria gonorrhoeae, Haemophilus influenzae (some strains are resistant), Bordetella pertussis, Legionella pneumophila, Treponema pallidum, Mycoplasma pneumoniae, Clostridium tetani, Chlamydia trachomatis, Campylobacter jejuni (in severe or prolonged cases), Ureaplasma urealyticum.
Not all strains of the organisms listed above are sensitive, and culture and susceptibility testing should be done. Several strains of Haemophilus influenzae and Staphylococci have been found to be resistant to erythromycin. Some strains of Haemophilus influenzae are resistant to erythromycin alone, but are susceptible when erythromycin and sulfonamides are administered concurrently. Staphylococci resistant to erythromycin may emerge during a course of erythromycin therapy.
Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin and chloramphenicol.

Susceptibility testing.

Dilution or diffusion techniques - either quantitative (minimum inhibitory concentration [MIC]) or breakpoint, should be used following a regularly updated, recognised and standardised method (e.g. Clinical and Laboratory Standards Institute (CLSI)).
Standardised susceptibility test procedures require the use of laboratory control organisms to control the technical aspects of the laboratory procedures.
A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable.
A report of "Intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to the alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation.
A report of "Resistant" indicates that the pathogen is not likely to be inhabited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Note 1.

The prevalence of resistance may vary geographically for selected species and local information on resistance is desirable, particularly when treating severe infections.

Note 2.

Many strains of Haemophilus influenzae are resistant to erythromycin alone but are susceptible to erythromycin and sulfonamides together. Staphylococci resistant to erythromycin may emerge during a course of erythromycin therapy. Culture and susceptibility testing should be performed.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Erythromycin ethyl succinate is absorbed intact following oral administration, and undergoes hydrolysis to yield the active erythromycin base. Serum levels are comparable when administered to patients in either the fasting or non-fasting state. Individual peak serum levels are variable; the peak after each dose occurs in one to two hours.

Distribution.

The extent of plasma protein binding is variable but is probably of the order of 75%. After absorption, erythromycin diffuses readily into most body fluids, with the exception of cerebrospinal fluid, synovial fluid and vitreous humor.
Erythromycin appears in breast milk at levels which are approximately 50% of the plasma concentration. It crosses the placental barrier, and foetal plasma levels are usually 5 to 20% of the maternal plasma concentration.

Excretion.

In the presence of normal renal function, the plasma half-life is approximately 1.4 hours. In anuric patients, the half-life may increase to six hours but dosage adjustment is not usually required. Erythromycin is not removed by dialysis.
In the presence of normal hepatic function, erythromycin is concentrated in the liver and high concentrations appear in the bile. Approximately 1.5% of the absorbed erythromycin can be recovered unchanged in bile over a period of 8 hours. Substantial quantities appear in the faeces and probably represent the unabsorbed drug plus the drug excreted into the bile. After oral administration, approximately 5% appears in the urine. A large proportion of the absorbed drug remains unaccounted for and is presumably metabolised, probably in the liver.

5.3 Preclinical Safety Data

Genotoxicity.

Erythromycin was not genotoxic in assays for bacterial and mammalian mutagenicity and for clastogenicity in vitro. The clastogenic potential of erythromycin has not been investigated in vivo.

Carcinogenicity.

Long-term (2 year) oral studies conducted in rats up to about 400 mg/kg/day and in mice up to about 500 mg/kg/day with erythromycin stearate did not provide evidence of tumourigenicity.

4 Clinical Particulars

4.1 Therapeutic Indications

Streptococcus pyogenes (group A β-haemolytic Streptococcus).

Upper and lower respiratory tract, skin and skin structure infections of mild to moderate severity.
When oral medication is given, patient must comply with the prescribed regimen. Therapeutic dose should be administered for at least 10 days.

α-Haemolytic Streptococci (viridans group).

No controlled clinical efficacy trials have been conducted, however oral erythromycin has been suggested by the American Heart Association and the American Dental Association for use in bacterial endocarditis prophylaxis prior to dental/surgical procedures of the upper respiratory tract in penicillin-hypersensitive patients with a history of rheumatic, congenital or other acquired valvular heart disease. Erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.

Staphylococcus aureus.

Acute infections of skin and skin structure of mild to moderate severity. Bacterial resistance may emerge during treatment, hence cultures and sensitivity tests should be performed.

Streptococcus pneumoniae (Diplococcus pneumoniae).

Upper (e.g. otitis media, pharyngitis) and lower respiratory tract infections (e.g. pneumonia) of mild to moderate degree.

Mycoplasma pneumoniae (Eaton agent, PPLO).

For respiratory infections due to this organism.

Haemophilus influenzae.

For upper respiratory tract infections of mild to moderate severity. Not all strains of this organism are susceptible at the erythromycin concentrations normally achieved.

Chlamydia trachomatis and Ureaplasma urealyticum.

These organisms are sensitive to erythromycin; clinical studies have demonstrated erythromycin's efficacy in nongonococcal urethritis due to these organisms. A minimum of 10 days therapy is required.

Chlamydia trachomatis infection (excluding non-gonococcal urethritis).

Erythromycin has shown to be effective in treating trachoma or inclusion body conjunctivitis, acute inclusion conjunctivitis of the newborn (inclusion blennorrhoea) and pneumonia in infants caused by Chlamydia trachomatis.

Treponema pallidum.

Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to penicillins. Spinal fluid examinations should be done before treatment and as part of follow-up post therapy.

Neisseria gonorrhoeae.

Erythromycin lactobionate for injection in conjunction with oral erythromycin ethyl succinate, as an alternative treatment for acute uncomplicated gonorrhoea in female patients with penicillin hypersensitivity. Before treatment, patients who are suspected of also having syphilis should be evaluated including a microscopic examination for T. pallidum (by immunofluorescence or darkfield) before receiving erythromycin, and monthly serologic tests should be performed for a minimum of 4 months.

Corynebacterium diphtheriae, C. minutissimum and C. (propionibacterium) acnes.

As an adjunct to diphtheria antitoxin, to prevent establishment of carriers, and to eradicate the organism in carriers; in the treatment of erythrasma; adjunctive therapy of moderate to severe acne.

Bordetella pertussis.

For early elimination of the causative organism from the nasopharynx. Therapeutic doses should be continued for at least 10 days. The clinical course of the disease is not altered.

Clostridium tetani.

In vitro, Clostridium tetani is sensitive to erythromycin. Erythromycin may be used prophylactically in penicillin-hypersensitive persons for 5 days. As the value of antibiotic prophylaxis in tetanus is not unequivocally established, wounds should be regularly examined.

Legionnaires' disease.

Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' disease.

Campylobacter fetus (subspecies) jejuni, Listeria monocytogenes.

Infections due to these organisms when antibiotic therapy is indicated.

4.3 Contraindications

Erythromycin is contraindicated in the case of:
Hypersensitivity to erythromycin, or any of the excipients in the formulation.
Hypersensitivity to other antibiotics from the macrolide family.
Severely impaired hepatic function.
Congenital or acquired QT interval prolongation.
Concurrent treatment with ergotamine or dihydroergotamine (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Disturbances of the electrolyte balance (especially in the case of hypokalemia and hypomagnesaemia).
Clinically relevant cardiac arrhythmias (e.g. ventricular arrhythmias) or in severe congestive heart failure (NYHA IV).
Concomitant intake of medicinal products, which can lead to prolongation of the QT interval and under some circumstances to life-threatening ventricular arrhythmia (torsades de pointes) e.g. terfenadine, astemizole, domperidone, cisapride, pimozide, class IA and III antiarrhythmics (e.g. disopyramide), certain neuroleptics, tri- and tetracyclic antidepressants, arsenic trioxide, methadone, budipine, certain fluoroquinolones, imidazole anti-mycotics and anti-malarials (e.g. pentamidine i.v.) (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Concomitant use of simvastatin, lovastatin or atorvastatin. Treatment with these agents should be interrupted while taking erythromycin (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

QT prolongation.

Prolongation of the QT interval and development of ventricular arrhythmias (some of which have been fatal), including atypical ventricular tachycardia (torsades de pointes), have been reported with the administration of erythromycin. Therefore, use of erythromycin is contraindicated in patients with high risk factors for cardiac arrhythmia (see Section 4.3 Contraindications). Elderly patients may be more susceptible to drug associated effects on the QT interval.
If during therapy with erythromycin symptoms such as palpitations, dizziness or syncope occur which can be signs of arrhythmia, an investigation of the patient including Electrocardiogram and determination of the QT interval should be initiated immediately.
Electrolyte disturbances promote the probability of cardiac arrhythmia. In the case of risk factors for electrolyte disturbances (such as diuretic/laxative medication, vomiting, diarrhoea, use of insulin in emergency situations, renal diseases or anorectic conditions), adequate laboratory tests and if necessary an adequate electrolyte balance should be carried out.

Musculature and nervous system.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with simvastatin, lovastatin or atorvastatin (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). The concomitant use of these medicines with erythromycin is contraindicated (see Section 4.3 Contraindications).
Patients taking other statins and erythromycin concomitantly should be instructed by the physician to pay attention to signs of myopathy (e.g. inexplicable muscle pain or weakness or dark coloured urine). If myopathy occurs, the intake of the statin has to be stopped immediately.
There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.

Clostridium difficile-associated diseases.

The use of erythromycin can lead to the development of severe colitis as a result of colonisation with Clostridium difficile, a toxin-producing organism. Colitis, which may or may not be accompanied by the formation of a pseudomembrane in the colon, can range in severity from mild diarrhoea to fatal colitis. If significant diarrhoea occurs, erythromycin should be discontinued (diarrhoea may, however, begin up to several weeks to over two months after cessation of antibiotic therapy). This may be sufficient treatment in the early stages although colestyramine orally may help by binding the toxin in the colonic lumen. In moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against Clostridium difficile should be considered.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may prolong and/or worsen the condition and should not be used.

Allergic reactions.

With the administration of erythromycin, severe, life-threatening allergic reactions may occur, e.g. severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome or toxic epidermal necrolysis (especially in children of all ages), as well as angioneurotic oedema or anaphylaxis. A cross allergy in patients with hypersensitivity to macrolide antibiotics can exist, so in patients with known hypersensitivity to macrolides or related substances (e.g. ketolides), special caution is recommended. At first signs of hypersensitivity, erythromycin has to be stopped immediately and necessary symptomatic emergency measures initiated.
As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

Prolonged or repeated therapy.

Overgrowth of non-susceptible bacteria or fungi may occur during prolonged or repeated therapy. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.
In the case of a treatment duration longer than 3 weeks, it is recommended that whole blood count and hepatic and renal function tests be performed at regular intervals.

Eye disorder.

There is a risk for developing visual impairments after exposure to erythromycin. For some patients, a pre-existing dysfunction in mitochondrial metabolism from genetic causes such as Leber's hereditary optic neuropathy (LHON) and autosomal dominant optic atrophy (ADOA) might play a contributing role.

Pneumonia.

Due to very common resistance of Streptococcus pneumoniae against macrolides, erythromycin is not the first choice therapy in case of ambulant acquired pneumonia. In hospital acquired pneumonia, erythromycin should only be used in combination with other antibiotics.
Oral erythromycin is not considered to be the antibiotic of choice in critically ill patients.
When indicated, incision or drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

Vomiting and diarrhoea.

Use of erythromycin can cause vomiting and diarrhoea (see Section 4.8 Adverse Effects (Undesirable Effects)), impairing the efficacy of this and other concomitantly taken medicines.

Use in hepatic impairment.

There have been reports of hepatic dysfunction, including increased liver enzymes, hepatomegaly and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products (see Section 4.8 Adverse Effects (Undesirable Effects)). Patients should be informed to terminate the therapy and seek medical advice if signs and symptoms of liver disease such as loss of appetite, jaundice, dark colouring of the urine and itching or pressure sensitivity of the stomach develop.
Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin is administered to patients with impaired hepatic function. Erythromycin is contraindicated in severe hepatic impairment (see Section 4.3 Contraindications).
Patients with existing liver damage and allergies may be at higher risk of intrahepatic cholestasis and cholestatic jaundice due to sensitisation, resulting in colicky abdominal pain, nausea, vomiting, urticaria, eosinophilia and fever. Although these reactions can occur after initial administration, the risk increases with repeated administration and therapy lasting longer than 10 days (see Section 4.8 Adverse Effects (Undesirable Effects)).

Use in the elderly.

See Section 4.4 Special Warnings and Precautions for Use, QT prolongation.

Paediatric use.

To avoid liver damage due to overdose in infants and toddlers, dosing should be dependent on the clinical picture and the course of the disease.
There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible dose-response effect was described with an absolute risk of IHPS of 5.1% for infants who took erythromycin for 8 to 14 days and 10% for infants who took erythromycin for 15 to 21 days. Since erythromycin may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or Chlamydia trachomatis), the benefit of erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

Effects on laboratory tests.

Erythromycin interferes with the fluorimetric determination of urinary catecholamines.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Theophylline.

Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In cases of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.
There have been published reports suggesting that when oral erythromycin is given concurrently with theophylline, there is a significant decrease in erythromycin serum concentrations. This decrease could result in sub-therapeutic concentrations of erythromycin.

Digoxin.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated serum digoxin levels.

Oral anticoagulants.

There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants (e.g. warfarin) were used concomitantly.

Medicines that prolong the QTc interval.

Erythromycin has been shown to prolong the QTc interval and is associated with case reports of torsades de pointes in some patients. Patients with uncorrected electrolyte disorders particularly hypokalaemia; known prolongation of the QTc interval, or those concurrently receiving medicines that prolong the QTc interval, in particular Class IA (e.g. quinidine, procainamide) or Class III (amiodarone, sotalol) antiarrhythmics, certain neuroleptics, tri- and tetracyclic antidepressants, ebastine, arsenic trioxide, methadone, budipine, certain fluoroquinolones, imidazole anti-mycotics and anti-malarial medicines (e.g. pentamidine i.v.), are at increased risk of ventricular arrhythmias. As these predisposing conditions may increase the risk for ventricular arrhythmias, erythromycin should not be used in patients with ongoing proarrhythmic conditions (see Section 4.3 Contraindications).

Medicines metabolised by the cytochrome P450 system.

Erythromycin is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome P450 system (CYP3A) and P-glycoprotein. Co-administration of erythromycin and a drug primarily metabolised by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both the therapeutic or adverse effects of the concomitant medicine e.g. ciclosporin, phenytoin, felodipine, hexobarbital, carbamazepine, alfentanil, disopyramide, bromocriptine, valproate, methylprednisolone, vinblastine, sildenafil, cilostazol, quinidine, tacrolimus, rifabutin, verapamil, diltiazem, acenocoumarol, astemizole, digoxin, dihydroergotamine, ergotamine, midazolam, omeprazole, terfenadine, mizolastine, domperidone, theophylline, triazolam and antifungals (e.g. fluconazole, ketoconazole and itraconazole). Dosage adjustments may be considered, and when possible, serum concentrations of medicines primarily metabolised by CYP3A4 should be monitored closely in patients receiving erythromycin.
Erythromycin has been shown to prolong the QTc interval and is associated with case reports of torsades de pointes in some patients. In one published study patients who used both oral erythromycin and strong CYP3A inhibitors (azole antifungal medicines [ketoconazole, itraconazole and fluconazole, all administered systemically], diltiazem, verapamil, troleandomycin, mibefradil, nefazodone) had a risk of sudden death from cardiac causes that was five times as great as that among patients who had not used these medicines. Many of the medicines that are known to block CYP3A4 also have direct effects on repolarisation, which may cause a dramatic lengthening of the QT interval. Given that there are alternatives to erythromycin and these listed CYP3A inhibitors, the use of these combinations should be avoided.
Hypotension, bradyarrhythmia and lactic acidosis have been observed in patients receiving concurrent verapamil.
Medicines that induce CYP3A (such as rifampicin, phenytoin, carbamazepine, phenobarbital (phenobarbitone), St John's Wort) may induce the metabolism of erythromycin. This may lead to sub-therapeutic levels of erythromycin and a decreased effect. The induction decreases gradually after discontinuing treatment with CYP3A4 inducers. Erythromycin should not be used during, or for two weeks after stopping treatment, with CYP3A4 inducers.
The following are examples of some clinically significant CYP3A based drug interactions. Interactions with other medicines metabolised by the CYP3A isoform are also possible. The following CYP3A based drug interactions have been observed with erythromycin products in post-marketing experience.

Ergotamine/ dihydroergotamine.

Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterised by severe peripheral vasospasm and dysaesthesia (see Section 4.3 Contraindications).

Triazolobenzodiazepines (such as triazolam and alprazolam) and related benzodiazepines.

Triazolam plasma concentrations may approximately double when erythromycin is co-administered, due to a reduction in clearance and increase in elimination half-life but drug accumulation has not been observed with repeated dosing. Therefore consideration of dose reduction may be appropriate in patients treated concurrently with triazolam and erythromycin.

HMG-CoA reductase inhibitors.

Erythromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g. lovastatin, simvastatin or atorvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these medicines concomitantly (see Section 4.3 Contraindications).

Sildenafil (e.g. Viagra).

Erythromycin has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction of sildenafil dosage should be considered.

Carbamazepine.

Erythromycin administration in patients receiving carbamazepine has been reported to cause increased serum levels of carbamazepine with subsequent development of signs of carbamazepine toxicity.

Cisapride.

Elevated cisapride levels have been reported in patients receiving erythromycin and cisapride concomitantly. This may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes. Similar effects have been observed in patients taking pimozide and clarithromycin, another macrolide antibiotic. Concomitant administrations of erythromycin with cisapride or pimozide is contraindicated. (See Section 4.3 Contraindications.)

Zopiclone.

Erythromycin has been reported to decrease the clearance of zopiclone and thus may increase the pharmacodynamic effects of this medicine.

Colchicine.

There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin and colchicine.

Cimetidine.

It may inhibit the metabolism of erythromycin which may lead to an increased plasma concentration.

Protease inhibitors.

Protease inhibitors (e.g. ritonavir) has been reported to increase the level of effect of erythromycin by altering drug metabolism.

Anti-bacterial agents.

Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin and chloramphenicol. Same interaction is applicable with streptomycin, tetracyclines, colistin and bactericidal beta-lactam antibiotics (e.g. penicillin, cephalosporin).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There was no apparent effect on male or female fertility in rats treated with erythromycin base by oral gavage at 700 mg/kg/day (approximately 9 times the human dose).
(Category A)
Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by oral gavage to pregnant rats and mice at 700 mg/kg/day (approximately 9 times the maximum human dose), and to pregnant rabbits at 125 mg/kg/day (approximately 1.5 times the maximum human dose).
A slight reduction in birth weights was noted when female rats were treated prior to mating, during mating, gestation and lactation at an oral dosage of 700 mg/kg/day of erythromycin base; weights of the offspring were comparable to those of the controls by weaning. No evidence of teratogenicity or effects on reproduction was noted at this dosage. When administered during late gestation and lactation periods, this dosage of 700 mg/kg/day (approximately 9 times the maximum human dose) did not result in any adverse effects on birth weight, growth and survival of offspring.
There are no adequate and well-controlled studies in pregnant women. However, observational studies in humans have reported cardiovascular malformations after exposure to medicinal products containing erythromycin during early pregnancy.
Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low. Erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Newborns of mothers treated with oral erythromycin against early syphilis during pregnancy, will require treatment with an appropriate antibiotic, e.g. penicillin.
Erythromycin should be used by women during pregnancy only if clearly needed.
Erythromycin is concentrated in breast milk and adverse effects have been seen in breast-fed infants including gastrointestinal disturbances, pyloric stenosis (see Section 4.4 Special Warnings and Precautions for Use, Paediatric use), sensitisation or colonisation with fungi. Caution should therefore be exercised when erythromycin is administered to a breastfeeding woman.

4.8 Adverse Effects (Undesirable Effects)

The most frequent adverse effects encountered with erythromycin preparations are gastrointestinal, such as abdominal cramping and discomfort, and are dose related. Nausea, vomiting and diarrhoea occur infrequently with usual oral doses.
The following adverse effects have been reported for erythromycin. The adverse effects are listed according to the frequency defined as: very common (≥ 1/10); common (≥ 1/100 - < 1/10); uncommon (≥ 1/1000 - < 1/100); rare (> 1/10,000 - < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

Infections and infestations.

Uncommon: overgrowth of non-susceptible bacteria or fungi (e.g. oral and vaginal candidiasis).
Rare: pseudomembranous colitis.

Blood and lymphatic system disorders.

Not known: eosinophilia.

Immune system disorders.

Uncommon: hypersensitivity ranging from urticaria and mild rash.
Rare: anaphylactic reaction including anaphylactic shock.

Metabolism and nutritional disorders.

Very common: decreased appetite.

Psychiatric disorders.

Not known: hallucinations and confusional state.

Nervous system disorders.

Rare: seizures.
Not known: headache, somnolence and dizziness.

Eye disorders.

Not known: visual impairment including diplopia and blurred vision.

Ear and labyrinth disorders.

Very rare: tinnitus, reversible hearing loss and deafness*.
Not known: vertigo.
*These disorders are concentration-dependent and are more likely in patients with severe renal and/or hepatic impairment or in high doses or in cases of overdose.

Cardiac disorders.

Rare: QT interval prolongation, cardiac arrhythmias such as ventricular tachycardia (torsades de pointes) and palpitations.

Vascular disorders.

Not known: hypotension.

Respiratory, thoracic and mediastinal disorders.

Not known: dyspnoea (including asthmatic states).

Gastrointestinal disorders.

Very common: nausea, vomiting, abdominal pain, flatulence, soft defecation or diarrhoea.
Rare: pancreatitis.
Very rare: spastic hypertrophic pyloric stenosis in children.
Not known: abdominal discomfort.

Hepatobiliary disorders.

Uncommon: elevation of certain liver enzymes (GPT, GPT. LDH, AP, γ-GT).
Rare: cholestasis and cholestatic jaundice.
Very rare: hepatic dysfunction, with or without jaundice, hepatitis, and/or abnormal liver function test results, hepatomegaly and hepatic failure.

Skin and subcutaneous tissue disorders.

Uncommon: erythema, urticarial exanthema, pruritus.
Rare: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, allergic oedema/angioedema.
Not known: acute generalised exanthematous pustulosis (AGEP).

Musculoskeletal and connective tissue disorders.

Very common: muscle spasms.
Rare: joint swelling, rhabdomyolysis.
Very rare: unmasking and worsening of myasthenia gravis.

Renal and urinary disorders.

Very rare: tubulointerstitial nephritis.

General disorders and administration site conditions.

Rare: pyrexia.
Not known: chest pain, malaise, headache.

Infantile hypertrophic pyloric stenosis (IHPS).

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following erythromycin therapy. In one cohort of 157 newborns who were given oral erythromycin for pertussis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. The relative risk of IHPS was increased 6.8-fold (95% CI = 3-16) compared to a retrospective cohort of infants.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

E-Mycin tablets and granules may be given without regard to meals.
The tablets are intended primarily for adult use. The granules are intended for constitution with water. When constituted, they are cherry flavoured suspensions intended primarily for paediatric use but can also be used by adults.
Some clinicians believe that twice daily dosing is inadequate for all but minor infections caused by highly susceptible organisms. Twice daily dosing should not be employed when more than 1.6 g/day of erythromycin (as ethyl succinate) is required.

Adults.

400 mg erythromycin every six hours is the usual dose. Dosage may be increased up to 4 g/day according to the severity of the infection.
If a twice daily dosage is desired, one-half of the total daily dose may be given every twelve hours, provided the daily dose does not exceed 1.6 g.

Children.

Age, weight and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections, the usual dosage for children is 30 to 50 mg/kg/day in divided doses. For more severe infections this dosage may be doubled. The maximum calculated dose for children should not exceed the maximum dose as specified above for adults.
The following dosage schedule is suggested for mild to moderate infections, both for adults and children (see Table 1).
The total daily dosage must be administered in equally divided doses.

Granules.

The recommended dosage ranges from 30 to 50 mg/kg/day or more in divided doses. For mild to moderately severe infections caused by erythromycin sensitive organisms, the following dosage schedule is suggested. See Table 2.
The total daily oral dose may be given two, three or four times daily in equally divided portions.
The length of therapy will depend on the severity of the infection and other clinical factors.
For severe or life-threatening infections and infections of the lower respiratory tract, these doses may be doubled or increased even more. However, in such instances, it may be preferable to initiate treatment by the parenteral route with a suitable injectable preparation.

Special dosage recommendations.

In the treatment of streptococcal infections.

A therapeutic dosage of erythromycin ethyl succinate should be administered for at least 10 days. In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day.

When used prior to dental or upper respiratory tract surgery to prevent endocarditis in patients at risk (see Section 4.1 Therapeutic Indications, α-Haemolytic Streptococci (viridans group)).

A recommended schedule for adults is 1.6 g (20 mg/kg for children) 1.5 to 2 hours before the procedure and 800 mg every six hours for 6 doses after the procedure.

For the treatment of primary syphilis.

Adults.

A total of 48 to 64 g given in divided doses over a period of 15 days.

Mycoplasmal and chlamydial infections.

800 mg every six hours for a period of seven days, or alternatively 400 mg every six hours for 14 days.

Severe acne.

400 mg four times daily for two weeks and then adjust the dose every 4 to 6 weeks, depending on clinical response. Therapy should be continued for at least three months.

Legionnaires' disease.

Although optimal doses have not been established, doses utilised to date indicate a dosage of 0.8 to 1.6 g every six hours for 14 days.

4.7 Effects on Ability to Drive and Use Machines

Erythromycin has a negligible influence on the ability to concentrate and react. However the occurrence of undesirable effects can negatively influence the ability to drive and use machines.

4.9 Overdose

Symptoms.

The ingestion of large amounts of erythromycin can be expected to cause hearing problems, gastrointestinal distress and other adverse effects (see Section 4.8 Adverse Effects (Undesirable Effects)).

Treatment.

Allergic reactions accompanying overdosage should be treated by the prompt elimination of unabsorbed drug and supportive measures. Erythromycin serum levels are not appreciably altered by peritoneal dialysis or haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

E-Mycin tablets contain the following inactive ingredients: calcium hydrogen phosphate, maize starch, sorbic acid, povidone, purified talc, sodium starch glycollate, magnesium stearate, Opadry Pink OY-B-34901.
E-Mycin granules contain the following inactive ingredients: sorbitol, propylene glycol alginate, sodium citrate dihydrate, aspartame, sodium benzoate (preservative), colloidal anhydrous silica, erythrosine CI 45430, cherry flavour.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

E-Mycin.

Store tablets below 30°C.

E-Mycin 200 and E-Mycin 400.

Store granules below 25°C.
Reconstituted suspension should be refrigerated at 2°-8°C and used within 10 days; do not freeze.

6.5 Nature and Contents of Container

E-Mycin.

Pack type: HDPE bottle.
Pack size: 25 tablets.

E-Mycin 200 and E-Mycin 400.

Pack type: HDPE bottle.
Pack size: 100 mL.

Reconstitution.

Add 77 mL of water in small volumes and shake vigorously until no lumps are visible.
Refrigerate at 2° to 8°C.
Use within 10 days of date of preparation. Discard remaining portion thereafter. Shake well before use.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

Summary Table of Changes