Miocamen

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MIDECAMYCIN

Available from:

A. Menarini Industrie Farmaceutiche Riunite S.r.L. Via Sette Santi 3, 50131, Florence, Italy

ATC code:

J01FA03

INN (International Name):

MIDECAMYCIN 600 mg

Pharmaceutical form:

COATED TABLET

Composition:

MIDECAMYCIN 600 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2005-09-23

Patient Information leaflet

MIOCAMEN
® 
MIOCAMYCIN 

MIOCAMEN 600 MG TABLETS 
MIOCAMEN 250MG/5ML GRANULATE FOR ORAL SUSPENSION_ _

COMPOSITION 
_Miocamen 600 mg tablets _
Each film-coated tablet contains: 
Active ingredient: Diacetyl-midecamycin 600 mg 
Excipients: hydroxypropylmethyl cellulose, aluminum glycinate, sodium
starch 
glycollate, microcrystalline cellulose, magnesium stearate,
polyethylene glycol, 
talc, titanium dioxide, sunset yellow, erythrosin. 

_Miocamen granulate for oral suspension  _
Each 30 g bottle of granulate contains: 
Active ingredient: Diacetyl -midecamycin 6 g 
Excipients: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, citric
acid, 
anhydrous sodium phosphate, banana flavouring, sodium saccharinate,
sunset 
yellow, hydroxypropylmethyl cellulose, dimeticone, sorbitan palmitate,
glyceril 
stearate, sucrose palmitate, mannitol. 

FEATURES 
Miocamycin is a semisynthetic antibiotic of the macrolide family
which is active 
by oral route. 
The action of this antibiotic, which is based on bacterial protein
synthesis 
inhibition, is exerted on Gram-positive aerobic and anaerobic
micro-organism 
(Streptococci, Staphylococci, Pneumococci, Clostridia,
Corynebacteria, 
Peptococci, Peptostreptococci) and on some Gram-negative ones (B.
pertussis, 
H. influenzae, N. gonorrhoeae, Bacteroides, Chlamydias, Legionella 
pneumophila), even if beta-lactamase producers. 
Miocamycin is moreover active on Ureoplasma and on bacterial forms
which 
are wall-less like Mycoplasma pneumoniae and L forms. Miocamycin does
not 
induce crossed resistances towards other macrolide antibiotics and is
often 
active against erythromycin-resistant germs. 
Miocamycin, which is excellently absorbed orally and in the presence
of food, 
rapidly reaches high blood levels (blood peak after 30’). It binds
weakly to 
plasma proteins; even in the form of active metabolites it diffuses
rapidly into 
biological fluids and tissues where it reaches higher concentrations
than in the 
blood; it is excreted

Summary of Product characteristics

MIOCAMEN
®

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Miocamen 600- tablets 
Miocamen granulate 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Miocamen 600- tablets 
Each coated tablet contains: diacetyl-midecamycin 600 mg.  
Miocamen granulate 
Each 30 g bottle of granulate contains: 
diacetyl-midecamycin 6 g 

3. PHARMACEUTICAL FORM  

Tablets 
Granulate for oral suspension 

4. CLINICAL PARTICULARS.  
4.1 THERAPEUTIC INDICATIONS.  

Infections of the adult and of the child caused by germs susceptible
to miocamycin: bronchitis, 
pneumonia, tonsillitis, pharyngitis, rhinopharyngitis, sinusitis,
otitis, otitis media,  scarlet fever, 
furunculosis, pyodermatitis, abscess, phlegmon, etc. 
It is active also against odontostomatological, genitourinary and
biliary tract infections caused by 
susceptible germs.  
It is indicated also in patients allergic to penicillin.  

4.2 POSOLOGY AND METHOD OF ADMINISTRATION.  

Children: daily administration is 50 mg/kg/die divided in 2-3 intakes
according to the physician's 
judgment. 

Body weight 
Amount of miocamycin 
to 5 kg 
5 to 10 kg 
10 to 15 kg 
15 to 20 kg 
250 mg/die 
500 mg/die 
750 mg/die 
1000 mg/die 

Adults: daily posology ranges between 900 and 1800 mg divided into
2-3 oral administrations. 
Average daily administration is 1 tablet of 600 mg every 12 hours. 
In severe infections, daily dosage may be increased up to 1800 mg in
three intakes: 1 tablet of 
600 mg every 8 hours. 

Dosing cup is graduated at 1 to 10 mL corresponding to 50, 100 etc. mg
of miocamycin 
respectively. 
Preparation of the suspension: slowly add water into the bottle up to
the sign and then shake 
vigorously. 
The obtained suspension is ready for use and must be stored in
refrigerator. Use the 
suspension within 14 days. 
Vigorously shake the bottle before each use. 

4.3 CONTRA-INDICATIONS.  

Known hypersensitivity to miocamycin.  

4.4 SPECIAL