CIPRO A
Ciprofloxacin HCl
ANTI-INFECTIVE » QUINOLONES
INDICATION
General: Urinary tract infections, Skin and soft tissue infections, Typhoid fever, Gonorrhea and other sexually transmitted diseases, Bacterial gastrointestinal infections, Bone and joint infections, Osteomyelitis, Infectious diarrhea, Surgical prophylaxis, Gynecological infection, Other infections.
Eye : For the treatment of corneal ulcers and conjunctivitis caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Pseudomonous aeruginosa etc.
Ear : Otitis externa, acute otitis media, chronic suppurative otitis media. Prophylaxis in otic surgeries such as mastoid surgery.
DOSAGE AND ADMINISTRATION
Infection | Type of Severity | Unit Dose | Frequency | Usual Durations |
Urinary tract | Acute Uncomplicated | 100 mg or 250 mg | b.i.d | 3 Days |
Mild/Moderate | 250 mg | b.i.d | 7-14 days | |
Severe/Complicated | 500 mg | b.i.d | 7-14 days | |
Chronic Bacterial Prostatitis | Mild/Moderate | 500 mg | b.i.d | 28 days |
Lower Respiratory Tract | Mild/Moderate | 500 mg | b.i.d | 7-14 days |
Severe/Complicated | 750 mg | b.i.d | 7-14 days | |
Acute Sinusitis | Mild/Moderate | 500 mg | b.i.d | 10 days |
Skin & Skin Structure | Mild/Moderate | 500 mg | b.i.d | 7-14 days |
Severe/Complicated | 750 mg | b.i.d | 7-14 days | |
Bone and Joint | Mild/Moderate | 500 mg | b.i.d | ³ 4-6 Weeks |
Severe/Complicated | 750 mg | b.i.d | ³ 4-6 Weeks | |
Intra-Abdominal | Complicated | 500 mg | b.i.d | 7-14 days |
Infectious Diarrhea | Mild/Moderate/Severe | 500 mg | b.i.d | 5-7 days |
Typhoid Fever | Mild/Moderate | 500 mg | b.i.d | 10 days |
Urethral and Cervical Gonococcal Infections | Uncomplicated | 250 mg | Single dose | Single dose |
Inhalational anthrax (Post-exposure) | Adult | 500 mg | b.i.d | 60 days |
Pediatric | 15 mg/kg per dose, not to exceed 500 mg per dose | b.i.d | 60 days |
Patients whose therapy is started with Ciprofloxacin I.V. may be switched to Ciprofloxacin Tablets or Suspension when clinically indicated at the discretion of the physician.
Pediatric patients & adolescents (1- 17 years of age): Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli.
Pediatric Dosage Guideline
Infection
Route of Administration
Dose (mg/kg)
Frequency
Total Duration
Complicated Urinary Tract or Pyelonephritis (Pyelonephritis (Patients from 1 to 17 years of age)
Oral
10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing >51 kg)
b.i.d
10-21 days
Inhalational Anthrax (Post-Exposure
Oral
15 mg/kg (maximum 500 mg per dose)
b.i.d
60 days
The dosage of Cipro-A IV Infusion is determined by the severity and type of infection, the sensitivity of the causative organisms and the age, weight, and renal function of the patient. The usual intravenous dose is 100 mg to 400 mg twice daily.
Indications
Dosage
Infusion Rate
Duration
Upper and Lower UTI
100 mg (50 ml) b.d.
Should be administ-ered by slow intraven-ous infusion over periods of 30-60 minutes
The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. The usual duration of therapy for acute infections is 7-14 days.
Upper and lower respiratory tract infections (depending on severity and sensitivity of causative organism)
200 mg–400 mg b.d.
Cystic fibrosis patients with pseudomonal lower RTI
400 mg b.d.
Other infections
200 mg – 400 mg b.d.
Gonorrhoea
100 mg single dose
Inhalation Anthrax
400 mg b.d.
Impaired renal function
Dosage adjustments are not usually required, except in patients with severe renal impairment (serum creatinine >265 micromole/l or creatinine clearance <20 ml/minute). If adjustment is necessary, this may be achieved by reducing the total daily dose by half, although monitoring of drug serum levels provides the most reliable basis for dose adjustment.
Children : Child not recommended but where benefit outweighs risk, by intravenous infusion, 8-16 mg/kg body weight daily in 2 divided doses.
Or as directed by the physician.
Eye : Corneal ulcer – 2 drops to be instilled into the affected eye every 15 minutes for the first six hours and then every 30 minutes for the rest of the day when the patient is awake. On the second day 2 drops every hour; from the third day every 4 hours. Bacterial conjunctivitis – 1 to 2 drops to be instilled to the affected eye every two hours for 2 days, and every 4 hours for the next five days.
Ear: For all infections 2 – 3 drops every 2 – 3 hours initially while reducing the frequency of the instillation with control of infection.
COMPOSITION
Cipro-A 250 mg Tablet : Each film-coated tablet contains Ciprofloxacin (as hydrochloride) USP 250 mg.
Cipro-A 500 mg Tablet : Each film-coated tablet contains Ciprofloxacin (as hydrochloride) USP 500 mg.
Cipro-A 750 mg Tablet: Each film-coated tablet contains Ciprofloxacin (as hydrochloride) USP 750 mg.
Cipro-A pellets for Suspension : After reconstitution each 5 ml contains Ciprofloxacin (as hydrochloride) USP 250 mg.
Cipro-A IV Infusion : Each 100 ml contains Ciprofloxacin USP 200 mg (as Ciprofloxacin Lactate INN).
Cipro-A Eye & Ear Drops : Each ml contains Ciprofloxacin USP 3 mg