E-MYCIN 400mg tablet

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

erythromycin ethyl succinate, Quantity: 482.04 mg (Equivalent: erythromycin, Qty 400 mg)

Disponible des:

Alphapharm Pty Ltd

Designació comuna internacional (DCI):

Erythromycin ethyl succinate

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: sodium starch glycollate; povidone; maize starch; sorbic acid; calcium hydrogen phosphate; purified talc; magnesium stearate; titanium dioxide; iron oxide red; xanthan gum; polyvinyl alcohol; lecithin

Vía de administración:

Oral

Unidades en paquete:

25

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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 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 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 nongonococcal 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 alternative drug in treating 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 ethylsuccinate, 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 prophylatically 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 this organism when antibiotic therapy is indicated.

Resumen del producto:

Visual Identification: 19mm X 8.7mm oval, normal convex, flesh pink film coated tablet marked "E-N" on one side, "alpha symbol" on the reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

1999-10-07

Informació per a l'usuari

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
�

Fitxa tècnica

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