Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Pefloxacin
laboratory: Sanofi-Aventis France
Divisible coated tablet
Box of 50
PEFLACINE 400 mg scored film-coated tablets are indicated in adults for the treatment of the following infections (see sections Warnings and Precautions and Pharmacodynamic Properties ). Special attention should be paid to the available information on bacterial resistance to pefloxacin before initiating treatment.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.
In the adult
· Acute and chronic prostatitis, including severe forms;
· As a relay treatment for osteoarticular infections;
· Severe infections caused by gram-negative bacilli and susceptible staphylococci, in their manifestations:
o septicemic and endocardial
o the genital tract,
o abdominal and hepatobiliary,
During the treatment of Pseudomonas aeruginosa and Staphylococcus aureus infections, the emergence of resistant mutants has been described and may warrant the combination of another antibiotic. Microbiological monitoring in search of such resistance should be considered, particularly in case of suspicion of failure.
Dosage PEFLACINE 400 mg Film-coated tablet scored box of 50
In the subject with normal liver functions
800 mg per day on average, in two daily doses, one taken in the morning and one taken in the evening.
To achieve effective blood levels faster, a loading dose of 800 mg can be indicated at the first dose.
In patients with hepatic insufficiency
In subjects with severe hepatic impairment or decreased hepatic blood flow, the daily dosage should be adjusted by decreasing the rate of administration (see Warnings and Precautions section ).
In the elderly
In subjects over 65 years of age: 400 mg daily in two doses of 200 mg (ie 2 ½ tablet) at 12-hour intervals (see Warnings and Precautions ).
PEFLACINE 400 mg scored film-coated tablet is contraindicated in children and adolescents until the end of the growth period (see section 4.3 ).
The tablets should be swallowed with a large glass of water.
The tablets should be taken in the middle of meals to avoid digestive disorders
This medicine should never be used:
· In children or adolescents during growth (because of the risk of severe arthropathies affecting electively large joints),
· In patients with hypersensitivity to pefloxacin, other quinolones or to any of the components of this drug (see section Composition ),
· In patients with a history of quinolone-related tendinopathy (see sections Warnings and Precautions and Adverse Reactions ),
· In breastfeeding women (see section on Pregnancy and breastfeeding ),
· In patients with wheat allergy (other than celiac disease).
Adverse effects Peflacine
Data on the frequency of adverse events are from clinical trials (including literature). The most common side effects with pefloxacin are insomnia, gastralgia, nausea, vomiting, urticaria, arthralgia and myalgia. The most serious side effects include: pancytopenia, anaphylactic shock, seizures, Stevens-Johnson syndrome, Lyell's syndrome, aggravation of myasthenia gravis, tendon ruptures and acute renal failure.
Class of organ systems
(≥ 1/100 to
(≥ 1/1 000 to
(≥ 1/10 000 to
(<1 / 10, 000)
Not known (can not be estimated from the available data)
Blood and lymphatic system disorders
Immune system disorders
Anaphylactic shock (see section Warnings and precautions for use )
Nervous system disorders
Seizures (see section Warnings and Precautions for Use ),
Intracranial hypertension (particularly in young subjects, after prolonged treatment with pefloxacin, the evolution being favorable in most cases after stopping treatment with pefloxacin and setting up appropriate treatment),
sensitive or sensitivomotor (see section Warnings and Precautions for Use ),
Aggravation of myasthenia gravis (see section Warnings and precautions for use )
membranous (see section Warnings and precautions for use )
Elevation of transaminases,
Increased blood bilirubin
Skin and subcutaneous tissue disorders
sensitivity (see section Warnings and precautions for use )
Musculoskeletal and connective tissue disorders and bone disorders
Tendon rupture (possibility of slow healing or sequelae for tendon disorders) (see sections Contraindications and Warnings and precautions for use ),
Renal and urinary disorders
Acute renal failure