Ciprofloxacine SHAHBA 750
Composition :
Each Film coated Tablets of Ciprofloxacine SHAHBA contains 750 mg Ciprofloxacine as (Ciprofloxacine hydrochloride Monohydrate)
Indications:
Ciprofloxacin Tablets is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below.
DOSAGE :
Adult dosage: Generally Ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax
Infection Dose Frequency Usual Durations
Urinary Tract 250 to 500 mg every 12 hours 7 to 14 days
Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days
Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days
Lower Respiratory Tract 500 to 750 mg every 12 hours 7 to 14 days
Acute Sinusitis 500 mg every 12 hours 10 days
Skin and Skin Structure 500 to 750 mg every 12 hours 7 to 14 days
Bone and Joint 500 to 750 mg every 12 hours 4 to 8 weeks
Complicated Intra–Abdominal (Used in conjunction with metronidazole) 500 mg every 12 hours 7 to 14 days
Infectious Diarrhea 500 mg every 12 hours 5 to 7 days
Typhoid Fever 500 mg every 12 hours 10 days
Uncomplicated Urethral and Cervical Gonococcal Infections 250 mg single dose single dose
Inhalational anthrax (post-exposure 500 mg every 12 hours 60 days
Plague 500 to 750 mg every 12 hours 14 days
Inhalational anthrax (post-exposure) and Plague (Begin drug administration as soon as possible after suspected or confirmed exposure)
Conversion of IV to Oral Dosing in Adults:
Patients whose therapy is started with Ciprofloxacin IV may be switched to Ciprofloxacin tablets when the physician prescribe it
Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours 200 mg intravenous every 12 hours
500 mg Tablet every 12 hours 400 mg intravenous every 12 hours
750 mg Tablet every 12 hours 400 mg intravenous every 8 hours
Dosage in Pediatric Patients:
Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection.
Infection Dose Frequency Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing more than 51 kg) Every 12 Hrs 10 to 21 days
Inhalational Anthrax (Post-Exposure) 15 mg/kg (maximum 500 mg per dose) Every 12 Hrs 60 days
Plague 15 mg/kg (maximum 500 mg per dose) Every 12 to 8 Hrs 10 to 21 days
The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days
Inhalational anthrax (post-exposure) and Plague (Begin drug administration as soon as possible after suspected or confirmed exposure)
Dosage Modifications in Patients with Renal Impairment:
Ciprofloxacin is eliminated primarily by renal excretion, some modification of dosage is recommended, particularly for patients with severe renal dysfunction.
Creatinine Clearance (mL/min) Dose
> 50 See Usual Dosage.
30 to 50 250 to 500 mg every12 hours
5 to 29 250 to 500 mg every 18 hours
Patients on hemodialysis or Peritoneal dialysis 250 to 500 mg every 24 hours (after dialysis)
– In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
– No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency
Hepatic Impairment:
In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in Ciprofloxacin pharmacokinetics have been observed. The pharmacokinetics of Ciprofloxacin in patients with acute hepatic insufficiency, have not been studied.
Packing:
3 Blister, each contains 10 film-coated tablets of ciprofloxacin SHAHBA 750 mg /box.
