MAYNE PHARMA ERYTHROMYCIN erythromycin 250mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

erythromycin, Quantity: 250 mg

Available from:

Mayne Pharma International Pty Ltd

INN (International Name):

Erythromycin

Pharmaceutical form:

Capsule, enteric

Composition:

Excipient Ingredients: povidone; monobasic potassium phosphate; lactose monohydrate; Gelatin; carbon black; sunset yellow FCF; Shellac; indigo carmine; purified water; cellacefate; erythrosine; diethyl phthalate

Administration route:

Oral

Units in package:

25

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MAYNE PHARMA ERYTHROMYCIN is indicated in children and adults for the treatment of the following conditions: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes (group A beta haemolytic streptococci), Streptococcus pneumoniae (Diplococcus pneumoniae). Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes (group A beta hemolytic streptococci), Streptococcus pneumoniae (Diplococcus pneumoniae), acute and chronic bronchitis, pneumonia. Sinusitis caused by Streptococcus pneumoniae, Streptococcus pyogenes. Otitis media due to Streptococcus pneumoniae, Streptococcus pyogenes. Respiratory tract infections due to Mycoplasma pneumonia (Eaton's agent). Skin, and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes and Staphylococcus aureus (resistant staphylococci may emerge during treatment). Bordetella pertussis: Erythromycin produces early elimination of the causative organism from the nasopharynx although the clinical course of the disease is not altered; therapeutic doses should be continued for at least 10 days. Diphtheria: As an adjunct to antitoxin infections due to Corynebacterium diphtheriae, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Infections due to Listera monocytogenes. Non-gonococcal Urethritis: Chlamydia trachomatis and Ureaplasma urealyticum have been shown to be sensitive to erythromycin and clinical studies have demonstrated its efficacy in urethritis due to these organisms. A minimum of 10 days therapy appears to be required. Chlamydia trachomatis infection (excluding Non-gonococcal urethritis): Erythromycin has been shown to be effective in the treatment of trachoma or inclusion-body conjunctivitis and pneumonia in infants caused by Chlamydia trachomatis. Campylobacter fetus (subspecies) jejuni: Infections due to this organism when antibiotic therapy is indicated. Primary syphilis caused by Treponema pallidum: Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In the treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the followup after therapy. Legionnaires' disease caused by Legionella pneumophila: 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. Prevention of initial attacks of rheumatic fever: Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of group A beta - haemolytic streptococcal infections of the upper respiratory tract e.g. tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin allergic patients. A therapeutic dose should be administered for 10 days. Prevention of Recurrent Attacks of Rheumatic Fever: Penicillin or sulphonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulphonamides, oral erythromycin is recommended by the American Heart Association in the long term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever). Prevention of bacterial endocarditis: Although no controlled clinical efficacy trials have been conducted, oral erythromycin has been suggested by the American Heart Association and the American Dental Association in a regimen for prophylaxis against bacterial endocarditis in patients sensitive to penicillin who have congenital heart disease, or rheumatic or other acquired valvular heart disease when they undergo dental or surgical procedures of the upper respiratory tract. Erythromycin is not suitable prior to genitourinary or gastrointestinal tract surgery.

Product summary:

Visual Identification: a red/yellow gelatin capsule printed Eryc in black, filled with white spheroidal pellets; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-07-10

Patient Information leaflet

MAYNE PHARMA ERYTHROMYCIN CAPSULES
1
MAYNE PHARMA ERYTHROMYCIN CAPSULES
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MAYNE PHARMA ERYTHROMYCIN CAPSULES?
Mayne Pharma Erythromycin capsules contain the active ingredient
erythromycin. They are used to treat infections in different
parts of the body caused by bacteria and prevent infections in
patients with a history of rheumatic disease who may be allergic to
penicillin. For more information, see Section 1. Why am I using Mayne
Pharma Erythromycin capsules?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MAYNE PHARMA ERYTHROMYCIN CAPSULES?
Do not use if you have ever had an allergic reaction to erythromycin
or any of the ingredients listed at the end of the CMI.
Do not use if you have severe liver problems. Do not use if you have
ever had changes in the rhythm or rate of the heartbeat, or
disturbances in your 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 use Mayne Pharma Erythromycin capsules? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mayne Pharma Erythromycin capsules
and affect how they work. A list of these medicines is
in Section 3. What if I am taking other medicines? in the full CMI.
4.
HOW DO I USE MAYNE PHARMA ERYTHROMYCIN CAPSULES?
•
For treating most infections, the usual adult dose of Mayne Pharma
Erythromycin capsules is one 250 mg capsule four times
a day or two 250 mg capsules twice a day. For the long-term prevention
of streptococcal infections in persons with a history
of rheumatic heart disease and an allergy to penicillin, the usual
dose is one 250 mg capsule twice a day.
•
Swallow the capsules whole with a full glass of water. Do not chew or
crush the capsule

Summary of Product characteristics

v 4.0
1
AUSTRALIAN PRODUCT INFORMATON
MAYNE PHARMA ERYTHROMYCIN (ERYTHROMYCIN)
CAPSULES
1.
NAME OF THE MEDICINE
Erythromycin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin is produced by a strain of
_Streptomyces erythreus_
and belongs to the
macrolide group of antibiotics. It is basic and readily forms salts
with acids.
Each Mayne Pharma Erythromycin capsule contains 250 mg erythromycin,
comprising of
enteric coated pellets of erythromycin for oral administration. The
enteric coating on the
pellets covers the bitter tasting erythromycin as well as protects the
erythromycin from
gastric acid destruction during the passage through the stomach.
Mayne Pharma Erythromycin contains lactose. For the full list of
excipients, see
_section _
_6.1 List of Excipients_
.
3.
PHARMACEUTICAL FORM
Mayne Pharma Erythromycin capsules are transparent red/yellow capsules
imprinted
with ‘Eryc’, containing white enteric coated pellets.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Mayne Pharma Erythromycin capsules are indicated in children and
adults for the
treatment of the following conditions:
Upper respiratory tract infections of mild to moderate degree caused
by
_Streptococcus _
_pyogenes_
(group A beta haemolytic
_streptococci_
),
_Streptococcus pneumoniae _
_(Diplococcus pneumoniae)_
.
Lower respiratory tract infections of mild to moderate severity caused
by
_Streptococcus _
_pyogenes_
(group A beta haemolytic
_streptococci_
),
_Streptococcus pneumoniae _
_(Diplococcus pneumoniae)_
, acute and chronic bronchitis, pneumonia.
Sinusitis caused by
_Streptococcus pneumoniae, Streptococcus pyogenes_
.
Otitis media due to
_Streptococcus pneumoniae, Streptococcus pyogenes_
.
v 4.0
2
Respiratory tract infections due to
_Mycoplasma pneumonia_
(Eaton's agent).
Skin, and skin structure infections of mild to moderate severity
caused by
_Streptococcus _
_pyogenes_
and
_Staphylococcus aureus_
(resistant
_staphylococci_
may emerge during
treatment).
_Bordetella pertussis_
: Erythromycin produces early elimination of the c