Consumer medicine information

1. Why am I taking E-MYCIN?

E-MYCIN contains the active ingredient erythromycin. E-MYCIN is used to treat certain bacterial infections, control acne and prevent infections in people with a history of rheumatic, congenital or other acquired valvular heart disease who are allergic to penicillin antibiotics. For more information, see Section 1. Why am I taking E-MYCIN? in the full CMI.

2. What should I know before I take E-MYCIN?

Do not take if you have ever had an allergic reaction to erythromycin or any other antibiotic from the macrolide group (e.g. clarithromycin, roxithromycin), or any of the ingredients listed at the end of the CMI. Do not take if you have severe liver problems, an irregular heartbeat or heart rhythm disorder, or irregular electrolyte levels.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take E-MYCIN? In the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with E-MYCIN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? In the full CMI.

4. How do I take E-MYCIN?

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

5. What should I know while taking E-MYCIN?

6. Are there any side effects?

Less serious side effects: feeling sick (nausea), fever, headache, stomach cramps and pains, vomiting and oral or vaginal thrush. Serious side effects: yellowing of the eyes or skin (jaundice), poor appetite, hearing or visual disturbances, irregular heartbeat, muscle pain, dizziness, hallucinations, drowsiness and, in infants, irritability with feeding or severe vomiting. Very serious side effects: signs of an allergic reaction including skin rash, itching or hives; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing and troubled breathing, and watery, bloody or severe diarrhoea.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Erythromycin (as ethyl succinate).

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, aspartame, phenylalanine and sorbitol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

E-Mycin (tablet). 19 mm x 8.7 mm oval, normal convex, flesh pink film coated tablet marked "E-N" on one side, "alpha symbol" on the reverse.
E-Mycin 200. Pink free flowing granules. When reconstituted, pink suspension with a cherry odour and flavour.
E-Mycin 400. Pink free flowing granules. When reconstituted, pink suspension with a cherry odour and flavour.

4 Clinical Particulars

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).

5 Pharmacological Properties

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.

6 Pharmaceutical Particulars

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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSERETSU.gif 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.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/EMYCINST.gif