Parvens Solution

Composition

Each 100 ml contains: ciprofloxacin USP – 200 mg, sodium chloride BP – 900 mg.

Indications for use

The Parvens is indicated for the treatment of the following infections. Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.
Adults:
Lower respiratory tract infections due to Gram-negative bacteria:

• Exacerbations of chronic obstructive pulmonary disease
• Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis, pneumonia
• Chronic suppurative otitis media

Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria:

• Urinary and genital tract infections
• Gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae
• Epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
• Pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
• Infections of the gastro-intestinal tract (e.g. travellers’ diarrhoea)
• Intra-abdominal infections
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Malignant external otitis
• Infections of the bones and joints
• Prophylaxis of invasive infections due to Neisseria meningitidis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment).

Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
Children and adolescents:

• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
• Complicated urinary tract infections and pyelonephritis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
• Parvens may also be used to treat severe infections in children and adolescents when this is considered to be necessary.

Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.

Parvens is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues.

Mode of application

Adults:
Infections of the lower respiratory tract: 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Infections of the upper respiratory tract:
Acute exacerbation of chronic sinusitis – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Chronic suppurative otitis media – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Malignant external otitis – 400 mg three times a day. Total duration of treatment – 28 days up to 3 months.
Urinary tract infections:
Complicated and uncomplicated pyelonephritis – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses).
Prostatitis – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 2 to 4 weeks (acute).
Genital tract infections:
Epididymo-orchitis and pelvic inflammatory diseases – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – at least 14 days.
Infections of the gastro-intestinal tract and intra-abdominal infections:
Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhea – 400 mg twice daily. Total duration of treatment – 1 day.
Diarrhoea caused byShigella dysenteriae type 1 – 400 mg twice daily. Total duration of treatment – 5 days.
Diarrhoea caused byVibrio cholera – 400 mg twice daily. Total duration of treatment – 3 days.
Typhoid fever – 400 mg twice daily. Total duration of treatment – 7 days.
Intra-abdominal infections due to Gram-negative bacteria – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 5 to 14 days.
Infections of the skin and soft tissue: 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Bone and joint infections: 400 mg twice daily to 400 mg three times a day. Total duration of treatment – max. of 3 months.
Neutropenic patients with fever that is suspected to be due to a bacterial infection: 400 mg twice daily to 400 mg three times a day. Total duration of treatment -Therapy should be continued over the entire period of neutropenia.
Parvens should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons requiring parenteral treatment: 400 mg twice daily. Total duration of treatment – 60 days from the confirmation of Bacillus anthracis exposure.
Drug administration should begin as soon as possible after suspected or confirmed exposure.
Paediatric population:
Cystic fibrosis: 10 mg/kg body weight three times a day with a maximum of 400 mg per dose. Total duration of treatment – 10 to 14 days.
Complicated urinary tract infections and pyelonephritis: 6 mg/kg body weight three times a day to 10 mg/kg body weight three times a day with a maximum of 400 mg per dose. Total duration of treatment – 10 to 21 days.
Inhalation anthrax post-exposure curative treatment for persons requiring parenteral treatment: 10 mg/kg body weight twice daily to 15 mg/kg body weight twice daily with a maximum of 400 mg per dose. Total duration of treatment – 60 days from the confirmation of Bacillus anthracis exposure.
Drug administration should begin as soon as possible after suspected or confirmed exposure.
Other severe infections: 10 mg/kg body weight three times a day with a maximum of 400 mg per dose. Total duration of treatment – According to the type of infections.
Elderly patients:
Elderly patients should receive a dose selected according to the severity of the infection and the patient`s creatinine clearance.
Patients with renal and hepatic impairment:
Recommended starting and maintenance doses for patients with impaired renal function:
Creatinine Clearance [mL/min/1.73 m²] – > 60, Serum Creatinine [µmol/L] – <124, Intravenous Dose [mg] -See usual Dose.
Creatinine Clearance [mL/min/1.73 m²] – 30- 60, Serum Creatinine [µmol/L] – 124 to 168, Intravenous Dose [mg] -200-400 mg every 12 h.
Creatinine Clearance [mL/min/1.73 m²] – <30, Serum Creatinine [µmol/L] – >169, Intravenous Dose [mg] -200-400 mg every 24 h.
Creatinine Clearance [mL/min/1.73 m²] – Patients on haemodialysis, Serum Creatinine [µmol/L] – >169, Intravenous Dose [mg] -200-400 mg every 24 h (after dialysis).
Creatinine Clearance [mL/min/1.73 m²] – Patients on peritoneal dialysis, Serum Creatinine [µmol/L] – >169, Intravenous Dose [mg] -200-400 mg every 24 h.
Parvens should be checked visually prior to use. It must not be used if cloudy.
Parvens should be administered by intravenous infusion. For children, the infusion duration is 60 minutes.
In adult patients, infusion time is 60 minutes for 400 mg Parvens and 30 minutes for 200 mg Parvens. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.