Pyostacine SPC (2012)
Pyostacine SPC (2012)
Pyostacine SPC (2012)
Revised: 12/07/2012
1. NAME OF THE MEDICINAL PRODUCT
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
PYOSTACINE 500 mg scored film-coated tablet is indicated in adults and children for treating the
following infections (see sections 4.4 and 5.1):
Official recommendations on the proper use of antibacterial agents should be taken into account.
Posology
Adults
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Children
The dose is 50 mg/kg body weight per day, divided into two or three takings.
No dosage adjustment is deemed necessary in patients with kidney failure because renal excretion of
pristinamycin is low.
Method of administration
ORAL ROUTE
This medication must be taken with meals.
The tablets are to be swallowed with a beverage. When administration to a young child is planned, the
tablets may be crushed in a little bit of milk or in a sweet excipient (jam) (see section 4.4).
4.3. Contraindications
Hypersensitivity to pristinamycin, to other streptogramins, or to one of the excipients
mentioned in section 6.1.
History of acute generalized exanthematous pustulosis occurring after taking pristinamycin (see
section 4.4).
Allergy to wheat (other than coeliac disease)
Concomitant administration of pristinamycin and colchicine (see section 4.5).
Lactation (see section 4.6).
E.N.T. infections
Sinusitis
The efficacy of pristinamycin has been demonstrated in the treatment of acute maxillary sinusitis,
whereas the efficacy against chronic sinusitis has not been documented by clinical trials.
Sore throat
Pristinamycin is not suitable for treating sore throats.
In a clinical study conducted on sore throats in adults and children comparing pristinamycin (2 g/d in
adults and 50 mg/kg/d in children, for 4 days) to amoxicillin (2 g/d in adults and 50 mg/kg/d in children,
for 6 days), the group A beta-haemolytic streptococcus eradication rates were generally more
favourable for amoxicillin than for pristinamycin (difference of 48% between the two arms).
Otitis
Very little data on the treatment of otitis (microbiological arguments, no clinical studies) are available.
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Hypersensitivity
Hypersensitivity reactions, including Quinckes oedema and anaphylactic shock, may occur when taking
pristinamycin (see section 4.8) and may be life-threatening. In these cases the pristinamycin treatment
must be stopped and an appropriate medical treatment administered.
If a generalized febrile erythema associated with blisters occurs at the induction of treatment, a
generalized acute exanthematous pustulosis (see section 4.8) must be suspected. In this case the
treatment must be stopped and re-administration of pristinamycin is contraindicated. A previous local
or systemic sensitization caused by virginiamycin is possible.
This medication may be administered to patients with coeliac disease. Wheat starch may contain gluten,
but only at trace levels and is therefore not considered dangerous to patients with coeliac disease.
Paediatric population
Children who are under 6 years old should not take tablets because it could lead to choking. There are
no other pristinamycin-based pharmaceutical forms suitable for young children.
4.5. Interactions with other medicinal products and other forms of interaction
Contraindicated combinations
. Colchicine
Increase of colchicine side effects with potentially fatal consequences.
. Immunosuppressants
Increase in blood concentrations of the immunosuppressant due to inhibition of the hepatic metabolism
thereof.
Assay of blood concentrations of the immunosuppressant. Monitoring of renal function and adaptation
of the immunosuppressant dosage during and after stopping concomitant use.
Numerous cases of increased activity of oral anticoagulants have been reported in patients receiving
antibiotics. The marked infectious or inflammatory context, the age and general state of the patient
appear to act as risk factors. In such circumstances it may be difficult to judge whether the infectious
disease or the treatment thereof is responsible for INR imbalance. However, certain classes of
antibiotics have been implicated more than others, notably: fluoroquinolones, macrolides, cyclines, co-
trimoxazole and certain cephalosporins.
Pregnancy
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Because of the anticipated benefit, when needed, the use of pristinamycin during pregnancy is
conceivable in spite of insufficient animal and clinical data.
Lactation
In view of the tolerance profile of this medication, breastfeeding is contraindicated during treatment
with this medication.
Not applicable.
Gastrointestinal disorders
vomiting, diarrhoea, sense of abdominal fullness.
pseudomembranous colitis, acute haemorrhagic colitis.
Skin reactions
Very rare cases of acute generalized exanthematous pustulosis (see sections 4.3 and 4.4).
The following have been reported very rarely:
o Cases of eczema with the possibility of aggravating pre-existing eczema.
o Cases of vascular purpura.
o Cases of bullous eruptions, including Stevens-Johnson and Lyells syndromes
Hypersensitivity
4.9. Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
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The prevalence of acquired resistance in certain species can vary geographically and temporally. It is
therefore useful to have information on the prevalence of local resistance, particularly for treating
severe infections. If necessary, it is desirable to obtain an expert opinion, mainly when the interest of
the medication for treating certain infections may be questionable due to the prevalence level of local
resistance.
Classes
HABITUALLY SENSITIVE SPECIES
Gram positive aerobes
Bacillus anthracis
Bacillus cereus
Corynebacterium
Enterococcus faecium ($)
methicillin-susceptible Staphylococcus
methicillin-resistant Staphylococcus
Streptococcus
Streptococcus pneumoniae
Gram negative aerobes
Bordetella pertussis
Haemophilus ($)
Legionella
Moraxella catarrhalis (Branhamella catarrhalis)
Neisseria
Anaerobes
Actinomyces
Clostridium perfringens
Eubacterium
Fusobacterium
Mobiluncus
Peptostreptococcus
Porphyromonas
Prevotella
Propionibacterium acnes
Other
Chlamydia trachomatis
Chlamydophila pneumoniae
Coxiella
Mycoplasma hominis
Mycoplasma pneumoniae
Ureaplasma urealyticum
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Enterobacteria
Pasteurella
Pseudomonas
Anaerobes
Clostridium difficile
Veillonella
($) Naturally intermediate species in the absence of a resistance mechanism
Absorption
The medication is readily and relatively rapidly absorbed (peak attained in 1 to 2 hr).
Distribution
The maximum serum concentration is 1 g/ml after ingestion of 500 mg. The plasma half-life is 6 hr.
Pristinamycin does not pass into the CSF. The binding to plasma proteins is 40 to 45% for constituent I
and 70 to 80% for constituent II.
Biotransformation
Unknown.
Excretion
The maximum concentration in urine is 10 to 15 g/ml. The biliary concentration is very high. The
presence in the faeces is more than negligible.
No toxicity has been reported after single and repeated administration, regardless of the animal species
tested and the route of administration. Pristinamycin studies in mice and rats gave no indication of
teratogenic potential or embryotoxicity.
6. PHARMACEUTICAL PARTICULARS
Hydrated colloidal silica, white dextrin, gelatine, magnesium stearate, wheat starch, hypromellose,
macrogol 20 000, titanium dioxide.
6.2. Incompatibilities
Not applicable.
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4 years.
No special requirements.
SANOFI-AVENTIS FRANCE
1-13, boulevard Romain Rolland
75014 Paris
11. DOSIMETRY
Not applicable.
Not applicable.
List I.
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Idis have obtained this translation either direct from the manufacturer or have used an established
external ISO 9001 accredited translation agency specialising in chemical, medical and pharmaceutical
translations. This information has been supplied under a CLA Licence as supporting information
following an order and Idis cannot be held responsible for any inaccuracies in or misuse of the
translation. It is protected by copyright and it may not (even for internal purposes) be further copied
stored or on-copied electronically without permission.
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1. DENOMINATION DU MEDICAMENT
3. FORME PHARMACEUTIQUE
4. DONNEES CLINIQUES
PYOSTACINE 500 mg comprim pellicul scable est indiqu chez ladulte et chez lenfant dans le
traitement des infections suivantes (voir rubriques 4.4 et 5.1) :
Il convient de tenir compte des recommandations officielles concernant l'utilisation approprie des
antibactriens.
Posologie
Adultes
Enfants
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Dans les infections svres, cette posologie peut tre porte 100 mg/kg/jour.
La posologie chez lenfant ne doit pas dpasser la posologie de ladulte.
La pristinamycine tant peu limine par le rein, aucun ajustement posologique nest jug ncessaire
chez les patients insuffisants rnaux.
Mode dadministration
VOIE ORALE
Ce mdicament est prendre au moment des repas.
Les comprims sont avaler avec une boisson. Lorsque ladministration chez un jeune enfant est
envisage, les comprims peuvent tre crass dans un peu de lait ou dans un excipient sucr
(confiture) (voir rubrique 4.4).
4.3. Contre-indications
Infections ORL
Sinusites
Angines
Otites
Les donnes sont trs limites dans le traitement des otites (arguments microbiologiques, absence
dtude clinique).
Hypersensibilit
Des ractions dhypersensibilit, y compris dme de Quincke et choc anaphylactique, peuvent survenir
avec la prise de pristinamycine (voir rubrique 4.8) et peuvent mettre en jeu le pronostic vital. Dans ces
cas, le traitement par pristinamycine doit tre interrompu et un traitement mdical adapt doit tre mis en
place.
La survenue, en dbut de traitement, d'un rythme gnralis fbrile associ des pustules doit faire
suspecter une pustulose exanthmatique aigu gnralise (voir rubrique 4.8) ; elle impose l'arrt du
traitement et contre-indique toute nouvelle administration de pristinamycine. Une sensibilisation
antrieure par la virginiamycine locale ou systmique est possible.
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Ce mdicament peut tre administr en cas de maladie coeliaque. Lamidon de bl peut contenir du
gluten, mais seulement ltat de trace, et est donc considr comme sans danger pour les sujets
atteints de maladie coeliaque.
Population pdiatrique
La prise de comprim est dconseille chez l'enfant g de moins de 6 ans, car elle peut entraner une
fausse route. Il nexiste pas dautres prsentations base de pristinamycine adapte au jeune enfant.
Associations contre-indiques
Colchicine
Augmentation des effets indsirables de la colchicine aux consquences potentiellement fatales.
Immunosuppresseurs
Augmentation des concentrations sanguines de limmunosuppresseur par inhibition de son mtabolisme
hpatique.
Dosage des concentrations sanguines de limmunosuppresseur. Contrle de la fonction rnale et
adaptation de sa posologie pendant lassociation et aprs son arrt.
De nombreux cas d'augmentation de l'activit des anticoagulants oraux ont t rapports chez des
patients recevant des antibiotiques. Le contexte infectieux ou inflammatoire marqu, l'ge et l'tat
gnral du patient apparaissent comme des facteurs de risque. Dans ces circonstances, il apparat
difficile de faire la part entre la pathologie infectieuse et son traitement dans la survenue du dsquilibre
de l'INR. Cependant, certaines classes d'antibiotiques sont davantage impliques: il s'agit notamment
des fluoroquinolones, des macrolides, des cyclines, du cotrimoxazole et de certaines cphalosporines.
Grossesse
Allaitement
4.7. Effets sur l'aptitude conduire des vhicules et utiliser des machines
Sans objet.
Troubles gastro-intestinaux
Atteintes cutanes
xTrs rares cas de pustulose exanthmatique aigu gnralise (voir rubriques 4.3 et 4.4).
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Hypersensibilit
4.9. Surdosage
Sans objet.
5. PROPRIETES PHARMACOLOGIQUES
Classes
ESPCES HABITUELLEMENT SENSIBLES
Arobies Gram positif
Bacillus anthracis
Bacillus cereus
Corynebacterium
Enterococcus faecium ($)
Staphylococcus mticilline-sensible
Staphylococcus mticilline-rsistant
Streptococcus
Streptococcus pneumoniae
Arobies Gram ngatif
Bordetella pertussis
Haemophilus ($)
Legionella
Moraxella catarrhalis (Branhamella catarrhalis)
Neisseria
Anarobies
Actinomyces
Clostridium perfringens
Eubacterium
Fusobacterium
Mobiluncus
Peptostreptococcus
Porphyromonas
Prevotella
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Propionibacterium acnes
Autres
Chlamydia trachomatis
Chlamydophila pneumoniae
Coxiella
Mycoplasma hominis
Mycoplasma pneumoniae
Ureaplasma urealyticum
Absorption
Distribution
Aprs ingestion de 500 mg la concentration srique maximale est de 1 g/ml. La demi-vie plasmatique
est de 6 h. La pristinamycine ne passe pas dans le LCR. La liaison aux protines plasmatiques est de 40
45 % pour le constituant I et de 70 80 % pour le constituant II.
Biotransformation
Excrtion
Dans les urines, la concentration maximale est de 10 15 g/ml. Il existe une trs forte concentration
biliaire. Elle est prsente en quantit non ngligeable dans les fcs.
Aprs administration unique et rpte, aucune toxicit n'a t rapporte quelle que soit l'espce
animale considre et la voie d'administration. L'tude de la pristinamycine chez la souris et la ratte n'a
pas rvl de potentiel tratogne ni d'embryotoxicit.
6. DONNEES PHARMACEUTIQUES
Silice collodale hydrate, dextrine blanche, glatine, starate de magnsium, amidon de bl,
hypromellose, macrogol 20 000, dioxyde de titane.
6.2. Incompatibilits
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Sans objet.
4 ans.
SANOFI-AVENTIS FRANCE
1-13, boulevard Romain Rolland
75014 Paris
11. DOSIMETRIE
Sans objet.
Sans objet.
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