Prixina, the newest fluoroquinolone of wide spectrum

10/01/2007

PATIENT INFORMATION LEAFLET

1. DETERMINATION OF MEDICINAL PRODUCT 

1.1.Product name:PRIXINA 

1.2.Composition: Active substance:Prulifloxacin 

Excipients: Nucleus: Lactose monohydrate, microcrystalline cellulose, sodium croscarse, povidone, silica colloidal anhydrous, magnesium stearate. 

Coating: Hypromellose, propylene glycol, Titanium dioxide (E171), Talc, Ferric oxide (E172) 

1.3. Pharmaceutical form

Film coated tablet 

1.4. Content in active substance

1 film coated tablet contains 600 mg Prulifloxacin 

1.5 Description – Packaging:

Box, containing 1 blister with 1 or 2 or 5 film coated tablets. Box, containing 2 blisters with 5 film coated tablets each. 

1.6 Pharmaceutical category:

Antibiotic, belonging to the fluoroquinolones group 

1.7 Responsible for marketing:

Aziende chimiche Riunite Angelini Francesco-ACRAF S.p.A. 

Viale Amelia 70-00181 Rome ITALY 

1.8 Manufacturer:

A.C.R.A.F. S.p.A. Via Vecchia del Pinocchio 22 60131 Ancona - Italy 

2. WHAT YOU SHOULD KNOW ABOUT THE DRUG PRESCRIBED TO YOU BY YOUR PHYSICIAN 

2.1 General information

Prulifloxacin is a highly effective, wide spectrum antibacterial agent, belonging to the fluoroquinolones group. Following the oral administration of Prulifloxacin, it is absorbed in the gastrointestinal tract and is immediately transformed to ulifloxacin, its active metabolite. 

2.2. Indications: 

Prixina is indicated for the treatment of infections, due to drug sensitive strains, in the below mentioned conditions: 

  • Acute, uncomplicated lower urinary tract infections (simple cystitis) 
  • Complicated lower urinary tract infections 
  • Acute exacerbation of chronic bronchitis. 

During the treatment of patients with infectious diseases, the history of local susceptibility to antibiotics must be taken into consideration. 

2.3 Contraindications: 

  • Hypersensitivity to prulifloxacin, to other antibiotic agents of the quinolone type or any of the product excipients. 
  • Pre-pubertal children or teenagers aged below 18 years, with an incomplete skeletal development. 
  • Patients with a history of Tendonopathies, associated with the administration of quinolones. 
  • Pregnancy and lactation 

2.4. Special precautions and warnings during use 

2.4.1. As with other quinolones, Prixina must be taken with caution by patients with CNS disorders that may predispose for convulsions or lower the seizure threshold. 

2.4.2. Treatment with antibiotic substances, including quinolones, may provoke the occurrence of pseudomembranous colitis. For this reason, it is important to consider the likelihood of diarrhea after the administration of antibiotics. 

2.4.3. As with other quinolones, in patients under treatment with prulifloxacin exposure to the sun or ultraviolet radiation may provoke phototoxicity reactions. 

Excessive sun exposure or exposure to ultraviolet radiation must be avoided during treatment with Prixina. In case of phototoxicity reactions, treatment must be discontinued. 

2.4.4. Patients with latent or established G-6PD deficiency (glucose – 6- dihydrogenase phosphate) are predisposed to hemolytic reactions when under treatment with antibiotic substances of the quinolone group and for this reason Prixina must be given with caution. 

2.4.5. As mentioned for other quinolones, rhabdomyolysis events may be rarely observed, characterized by myalgia, asthenia, increased CPK and plasma myoglobulin levels and rapid kidney function aggravation. In these cases, the patient must be carefully monitored and appropriate measures must be taken, considering the likelihood of treatment discontinuation. 

2.4.6. The use of quinolones is occasionally associated with the onset of crystalluria. In patients under treatment with these medicinal products, belonging to this therapeutic category, a sufficient fluid balance must be preserved, in order to prevent excessive urine concentration. 

2.4.7. There is no clinical data regarding the exposure of pregnant women to prulifloxacin. As with other quinolones, prulifloxacin was proved to provoke arthropathy in young test animals and for this reason its use during pregnancy and lactation is contraindicated. 

2.5. Interactions with other drugs or substances: 

The co-administration of prulifloxacin with cimetidine, antacids containing A1 and Mg or products containing iron and calcium, reduces the absorption of Prixina. For this reason, Prixina must be given 2 hours before or at least 4 hours after the administration of the above mentioned preparations – substances. 

The concomitant taking of prulifloxacin and milk leads to the reduction of the area under the concentration – time curve (AUC) and the reduction of the prulifloxacin recovery from the urine, while food taking delays the achievement of maximum levels and reduces the maximum drug levels. The prulifloxacin excretion in the urine is reduced when given concomitantly with probenecid. The concomitant administration of fenbufen with some quinolones may provoke increased risk of seizures. Therefore, the administration of Prixina and fenbufen must be evaluated carefully. Quinolones may provoke hypoglycemia in diabetic patients, receiving the drug for the treatment of hypoglycemia. 

The co-administration of Prixina and theophyllin may provoke slight decrease of theophyllin clearance that should not have any clinical implications. However, as with all quinolones, in patients with metabolic disorders or risk factors for these disorders, plasma theophyllin levels must be monitored. 

Quinolones may potentiate the activities of orally taken anticoagulants, e.g. warfarin and its derivatives. When these medicinal products are given concomitantly with Prixina, the close monitoring of the prothrombin test,= or the conduct of appropriate coagulability tests are recommended. 

Preclinical data have shown that nicardipin may potentiate the prulifloxacin phototoxicity.. 

2.6. Dosage: 

The proposed dosage regimen for adults only is the following: 

  • Patients with acute, uncomplicated lower urinary tract infections (simple cystitis): a single 600 mg tablet is sufficient. 
  • Patients with complicated lower urinary tract infections: one 600 mg tablet once a day, for a maximum treatment duration of 10 days. 
  • Patients with acute exacerbation of chronic bronchitis: one 600 mg tablet once a day, for a maximum treatment duration of 10 days. 

Treatment duration in complicated lower urinary tract infections and acute exacerbation of chronic bronchitis depends on the severity of the disease and the clinical outcome of the patient and treatment must be continued for at least 48-72 hours after symptoms withdrawal / healing. 

Prixina tablets must be swallowed whole with water and must be taken considering food taking (see Section 2.5). Since there are no particular studies, it is impossible to determine the dosage in patients with severe kidney impairment (patients with creatinine clearance < 60 ml/min) and in patients with severe liver impairment. For this reason, in these patients the most valid method of dose adjustment is to monitor plasma levels of the drug. 

2.7. Overdose taking: 

There is no information regarding overdose taking in humans. Prixina has been tested in healthy volunteers at a dose of up to 1200 mg/day for 12 days, with a good tolerability. 

In acute overdose taking, gastric emptying is recommended, with provocation of vomiting or gastric lavage and the patient must be monitored carefully and supportive treatment must be administered. Poisons Center Telephone number: 2.8 What you should know if you miss a dose: If you must take the drug continuously and missed a dose, take it as soon as possible. If, however, the time for your next dose is close, do not take the missed dose and continue with your regular treatment. Do not double doses. 

2.9. Undesirable effects:

The above mentioned undesirable effects have been observed in clinical trials performed with Prixina and in pharmacovigilance reports. Most of these undesirable effects were mild or moderate. 

The following percentages have been used for their classification: very frequent ( 10%), frequent (from 1% to 10%), infrequent (from 0.1% to 1%), rare (from 0.01% to 0.1%) and very rare (<0.01% including isolated reports). 

General disorders and conditions at the administration site – Rare:fever. 

Nervous System Disorder – Infrequent: headache, dizziness. Rare: taste alteration. 

Phychiatric disorders – Rare: sleep disorder, somnolence, confusion. 

Ear and labyrinth disorders – Rare: hearing impairment. 

Ophalmic disorders – Rare: eye hyperemia. 

Gastrointestinal disorders – Frequent (only for long term treatment) epigastralgia, nausea. Infrequent: diarrhea, epigastralgia, nausea, gastritis and vomiting. Rare: abdominal pain, gastrointestinal disorders, perleche, dyspepsia, flatulence, indigestion, oral cavity discomfort, oral candida, glossitis, gastric dilatation. The frequency of epigastralgia and nausea may increase in case of long term treatment. 

Musculoskeletal and connective tissue disorders – Rare: muscle spasms, rhabdomyolysis. 

Dermatological disorders and subcutaneous tissue disorders - Infrequent: pruritus, skin rash. Rare: facial edema, phototoxicity and urticaria. 

Vascular disorders – Rare: hot flashes. 

Tests – Rare: increase of γ GT levels, increase of bilirubin levels. 

Metabolic Disorders and Nutrition Disorders – Infrequent: Anorexia. 

The below mentioned adverse reactions have been reported very rarely (<0.01%): anaphylactic / anaphylactoid reaction, Stevens Johnson syndrome, hypoglycemia, hypoesthesia, drug-induced dermatitis. 

Treatment with Prixina may be associated with asymptomatic crystalluria with no change of the creatinine levels, with liver function parameter variations and with eosinophilia. In the patients monitored, these changes were asymptomatic and transient. 

During treatment with Prixina, the likelihood of undesirable effects or changes in laboratory parameters occurring not mentioned above may not be excluded, but these changes are reported with quinolones. 

2.10 Expiration date of the product: 

Printed on the outer and inner packaging. If this date has expired do not use the drug. 

2.11 Special precautions for product storage:

The product is stored at room temperature (T< 30οC). 

  • This drug was prescribed by your physician only for your specific medical problem. You should not use it for any other disease or give it to any other person without consulting your physician. 
  • If, during therapy, you experience any problems, please inform your physician or pharmacist immediately. 
  • For any questions regarding the drug or your medical problem, do not hesitate to ask your physician or pharmacist 
  • In order for the drug to be effective and safe, you should always take it according to the instructions provided to you. 
  • For your safety and welfare, please read carefully any information regarding the drug prescribed to you. 
  • Do not store the drug in bathroom closets, since humidity and heat may cause the drugs to deteriorate and thus make them dangerous for your health. 
  • Do not store drugs you do not use any more as well as drugs that have expired 
  • For greater safety keep all drugs in a safe place, away from children’s reach 

4. DISTRIBUTION METHOD 

This drug is only distributed with a physician’s prescription.

 

Angelini Pharma Hellas S.A.
Achaias & Trizinias str.
145 64, N. Kifissia
Athens - Greece
Tel: +30 210 6269200
Fax: +30 210 8071688
e-mail: info@angelinipharma.gr