E-MYCIN 400 erythromycin 400mg/5mL powder for oral liquid

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

erythromycin ethyl succinate, Quantity: 468 mg (Equivalent: erythromycin, Qty 400 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

Erythromycin ethyl succinate

Pharmaceutical form:

Oral Liquid, powder for

Composition:

Excipient Ingredients: sorbitol; propylene glycol alginate; sodium citrate dihydrate; erythrosine; aspartame; sodium benzoate; colloidal anhydrous silica; Flavour

Administration route:

Oral

Units in package:

1 X 100mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Streptococcus pyogenes (group A beta-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. Alpha 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 unsuitable 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

Product summary:

Visual Identification: Pink free flowing granules. When reconstituted, pink suspension with a cherry odour and flavour; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1994-04-22

Patient Information leaflet

E-MYCIN
_erythromycin (as ethyl succinate)_
CONSUMER MEDICINE INFORMATION
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
�

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
E-MYCIN
E-MYCIN 200
E-MYCIN 400
_Erythromycin (as ethyl succinate) film coated tablets and powder for
oral liquid _
1
NAME OF THE 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
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
E-Mycin 400
Granules, erythromycin 200 mg/5 mL (as ethyl succinate): pink free
flowing
granules. When reconstituted, pink suspension with a cherry odour and
flavour.
Granules, erythromycin 400 mg/5 mL (as ethyl succinate): pink free
flowing
granules. When reconstituted, pink suspension with a cherry odour and
flavour.
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.
E-MYCIN