Medicinal Products

PEFLACINE 400 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Pefloxacin
laboratory: Sanofi-Aventis France

Divisible coated tablet
Box of 50
All forms

Indication

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 meningeal,

o respiratory,

o otolaryngology,

o urinary,

o the genital tract,

o abdominal and hepatobiliary,

o osteo-articular,

o cutaneous.

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

Dosage

adults

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 ).

Pediatric population

PEFLACINE 400 mg scored film-coated tablet is contraindicated in children and adolescents until the end of the growth period (see section 4.3 ).

Administration mode

Oral way.

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

Against indications

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

Frequent

(≥ 1/100 to

<1/10)

Rare

(≥ 1/1 000 to

<1/100)

Rare

(≥ 1/10 000 to

<1/1000)

Very rare

(<1 / 10, 000)

Not known (can not be estimated from the available data)

Blood and lymphatic system disorders

eosinophilia

thrombocytopenia

Anemia,

leukopenia,

pancytopenia

Immune system disorders

angioedema

Anaphylactic shock (see section Warnings and precautions for use )

Nervous system disorders

Insomnia

sensations

vertiginous,

headaches

hallucinations,

Irritability

Confusion,

Seizures (see section Warnings and Precautions for Use ),

disorientation,

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),

myoclonus,

nightmares,

paresthesia

Peripheral neuropathies

sensitive or sensitivomotor (see section Warnings and Precautions for Use ),

Aggravation of myasthenia gravis (see section Warnings and precautions for use )

Gastrointestinal disorders

Gastralgias,

nausea,

vomiting

Diarrhea

Colity pseudo

membranous (see section Warnings and precautions for use )

Hepatobiliary disorders

Elevation of transaminases,

alkaline phosphatases,

Increased blood bilirubin

Skin and subcutaneous tissue disorders

Urticaria

Photo

sensitivity (see section Warnings and precautions for use )

Erythema,

itching

Vascular purpura,

Erythema

polymorph,

Stevens-Johnson Syndrome,

Lyell Syndrome

Musculoskeletal and connective tissue disorders and bone disorders

arthralgia,

myalgia

tendonitis,

Tendon rupture (possibility of slow healing or sequelae for tendon disorders) (see sections Contraindications and Warnings and precautions for use ),

Joint effusion

Renal and urinary disorders

Acute renal failure

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