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Product Prescribing Information
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CIPROCIN


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  • Prescription Information
  • Composition


    Each dosage unit contains
    Film coated Tablets
    Vials (20 ml)
    Ciprofloxacin
    250 mg, 500 mg or 750 mg (as hydrochloride)
    10 mg/1 ml (as lactate)


    Therapeutic Indications


    Treatment of infections due to susceptible micro-organisms: 

    Urinary tract infections.

    Acute sinusitis, and malignant otitis externa.

    Lower respiratory tract infections.

    Exacerbations of cystic fibrosis.

    Bone and joint infections.

    Skin and soft tissue infections.

    Gastrointestinal tract infections including biliary tract infections, infectious diarrhoea, typhoid and paratyphoid fevers.

    Genital tract infections: prostatitis, gonorrhea and chancroid.

    Septicemia and peritonitis.

    Surgical infection prophylaxis.

    Meningococcal meningitis prophylaxis.

    Infections in immunocompromised patients (neutropenia).

    Inhalation anthrax.


    Dosage and Administration


    Oral Route. CIPROCIN can be taken without regard to meals.

    CIPROCIN Tablets should be given every 12 hours.

    The Usual Adult Dose: 

    Location of infection
    Type of Severity
    Unit Dose
    Frequency
    Usual Duration
    Urinary tract
    Acute uncomplicated
    250 mg
    q 12 hrs
    3 days
    Mild/Moderate
    250 mg
    (200 mg IV)
    q 12 hrs
    7-14 days
    Severe/Complicated
    500 mg
    (400 mg IV)
    q 12 hrs
    7-14 days
    Lower Respiratory tract Bone and Joint Skin and Skin Structure
    Mild/Moderate
    500 mg
    (400 mg IV)
    q 12 hrs
    7-14 days
    ( ≥ 4 – 6 weeks for
    Bone and Joint only
    Severe/Complicated
    750 mg
    (400 mg IV)
    q 12 hrs
    q 8 hours
    Nosocomial pneumonia
    Mild/Moderate/Severe
    (400 mg IV)
    q 8 hours
    10 – 14 days
    Acute sinusitis
    Mild/Moderate
    500 mg
    (400 mg IV)
    q 12 hrs
    10 days
    Infectious diarrhoea
    Mild/Moderate/Severe
    500 mg
    q 12 hrs
    5 – 7 days
    Typhoid fever
    Mild/Moderate
    500 mg
    q 12 hrs
    10 days
    Intra-abdominal (+ metronidazole)
    Complicated
    500 mg
    q 12 hrs
    7-14 days
    Empirical therapy in febrile neutropenic patients
    Severe: CIPROCIN + Piperacillin
    400 mg IV
    50 mg/kg IV
    (not to exceed 24 g/day)
    q 8 hrs
    q 4 hrs
    7-14 days
    Empirical therapy in febrile neutropenic patients
    Severe: CIPROCIN + Piperacillin
    400 mg IV
    50 mg/kg IV
    (not to exceed 24 g/day)
    q 8 hrs
    q 4 hrs
    7-14 days
    Chronic bacterial prostatitis
    Mild/Moderate
    500 mg
    (400 mg IV)
    q 12 hrs
    28 Days
    Chancroid (H. ducreyi)
    -------
    500 mg
    q 12 hrs
    3 days
    Urethral/Cervical gonococcal infections
    Uncomplicated
    250 mg
    single dose
    single dose
    Disseminated gonococcal
    Ceftriaxone 1 gm I.M./I.V./24 hrs or Cefotaxime 1 gm/8 hrs;
    then 24 – 48 hrs after improvement with parenteral therapy, CIPROCIN 500 mg/12 hrs
    Second line anti-tuberculous
    500 – 750 mg
    q 12 hrs

    Cystic Fibrosis
    Adult
    500 – 750 mg
    q 12 hrs
    10 – 20 days
    Pediatric
    12 mg/kg
    q 12 hrs
    Inhalational Anthrax (Postexposure)
    Adult
    500 mg (400 mg IV)
    q 12 hrs
    60 days
    Pediatric
    15 mg/kg/dose, not to exceed 500 mg/dose (10 mg/kg/IV dose, not to exceed 500 mg/dose)
    q 12 hrs
    Malignant otitis externa

    750 mg
    q 12 hrs
    6-12 weeks
    Surgical infection prophylaxis
    750 mg as a single dose, 60-90 minutes before the procedure
    Meningococcal meningitis Prophylaxis
    500-750 mg as a single dose

    Duration of Therapy:

    Depends upon the severity of infection.

    Generally, CIPROCIN should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (postexposure).

    Doses in Renal Function Impairment: 

    Creatinine Clearance (mL/min.)
    Dose
    > 50 (Oral); > 30 (IV)
    See usual dose.
    30-50
    250-500 mg/12 hrs
    5-29
    250-500 mg/18 hrs (Oral);
    200-400 mg/18 -24 hrs (IV)
    Haemodialysis or Peritoneal dialysis
    250-500 mg/24 hours (after dialysis)


    Dosage In Hepatic Function Impairment: 

    No dosage adjustment except in severe impairment.

    IV Route: 

    CIPROCIN Vials should be diluted prior to administration and given by intravenous (IV) infusion over 60 minutes.

    Preparation of IV Dose: 

    Prepare the IV dose by aseptically withdrawing the appropriate volume of concentrate from the vial. Dilute before use with a suitable IV infusion to a final concentration of 1-2 mg/mL.

    Admixture Compatibility/Stability: 

    Stable up to 14 days under refrigeration or at room temperature (5ºC-25ºC) when diluted with 0.9% sodium chloride injection or 5% dextrose injection, sterile water for injection, 10% dextrose for injection, 5% dextrose and 0.225% sodium chloride for injection, 5% dextrose and 0.45% sodium chloride for injection. 

    If a Y – type IV infusion set or a piggyback method is used, temporarily discontinue the administration of any other solution during the CIPROCIN infusion.

    CIPROCIN is incompatible with amoxicillin, mezlocillin, flucloxacillin, pefloxacin, heparin sodium, frusemide, aminophylline and lecicoplanin.


    Contraindications


    As with other quinolones, CIPROCIN is contraindicated in hypersensitivity to quinolones, tendinitis or tendon rupture associated with quinolone use, pregnant women or breast-feeding mothers, children and adolescents less than 18 years of age.


    Warnings and Precautions


    CIPROCIN should be cautiously used in patients with known or suspected central nervous system disorders, or other factors predisposing to seizures; impaired renal or hepatic function; G6PD deficiency; myasthenia gravis; elderly.

    Exposure to strong sunlight or sunlamps should be avoided.

    An adequate fluid intake should be maintained during treatment with CIPROCIN and excessive alkalinity of the urine avoided because of risk of crystalluria.

    Tendon damage may occur rarely with fluoroquinones and treatment should be discontinued if patients experience tendon pain, inflammation, or rupture; subsequent use of fluoroquinolones is contraindicated.

    The ability to drive or operate machinery may be impaired by CIPROCIN, especially when alcohol is also taken.

    Hyper- or hypoglycemia, usually in diabetic patients receiving concomitant oral hypoglycemic agents or insulin, may occur with quinolones.


    Drug Interactions


    As with other fluoroquinolones, concurrent use of aluminium, magnesium hydroxide antacids, iron and zinc salts or sucralfate is better avoided.

    (Aluminium, magnesium, or iron preparations are not given within 4 hours).

    (Sucralfate can be given 6 hours before CIPROCIN).

    Concurrent administration of ciprofloxacin with caffeine, theophylline, dairy products or enteral feedings is better avoided.

    CIPROCIN may increase cyclosporine toxicity.

    Opioid premedication should not be used if CIPROCIN is given for surgical infection prophylaxis.


    Undesirable Effects


    CIPROCIN is generally well-tolerated.

    Most reactions are mild to moderate. As with other quinolones, gastrointestinal disturbances e.g. nausea, vomiting, diarrhea, abdominal pain, dyspepsia, pseudomembraneous colitis (rarely) ; central nervous system disturbances e.g. headache, dizziness, restlessness, tremor, drowsiness, insomnia, visual disturbances; skin reactions e.g. photosensitivity, rash, pruritus; vaginitis; transient increases in serum creatinine, blood urea nitrogen, crystalluria; elevated liver enzymes; eosinophilia, leucopenia, thrombocytopenia; myalgia, tendinitis or tendon rupture; tachycardia, edema may occasionally occur. Pain and irritation may occur at the site of injection accompanied rarely by phlebitis or thrombophlebitis.


    Pharmacological Properties


    CIPROCIN is one of the most potent of the fluoroquinolone antibacterial group. It is bactericidal acting by inhibition of the A subunit of DNA gyrase enzyme essential for bacterial DNA reproduction.

    CIPROCIN has a broad spectrum of activity against most Gram-negative bacteria and many Gram-positive bacteria including:

    Enterobacteriaceae, including E. coli, Proteus, Klebsiella, Salmonella, Shigella, Serratia, Citrobacter, Enterobacter, Providentia, Yersinia; Pseudomonas aeruginosa; Moraxella catarrhalis and Haemophilus influenzae (including beta-lactamase producing strains), Haemophilus parainfluenzae and ducreyi, Neisseria gonorrhoeae (including beta-lactamase producing strains), Neisseria meningitidis, Campylobacter spp., and Vibrio spp.; Staphylococci (including penicillinase-producing and penicillinase-nonproducing strains and some methicillin-resistant strains), Streptococci (including pyogenes, faecalis and pneumoniae).

    CIPROCIN has some activity against mycobacteria, and mycoplasmas.

    Pharmacokinetics: 

    Ciprofloxacin is rapidly and well absorbed from the gastrointestinal tract. Oral bioavailability is about 70% and a peak plasma concentration is achieved 1-2 hours after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food but is not substantially affected overall.

    Plasma half-life is about 3.5-4.5 hours. Protein binding ranges from 20-40%. It is widely distributed in the body and tissue penetration is generally good. High concentrations are achieved in bile. Ciprofloxacin is eliminated primarily by urinary excretion, but non-renal clearance may account for about a third of elimination and includes hepatic metabolism, biliary excretion , and possible transluminal secretion across the intestinal mucosa. About 40-50% of the oral dose is excreted unchanged in urine and about 15% as metabolites which have antimicrobial activity, but are less active than unchanged ciprofloxacin. Up to 70% of the parenteral dose may be excreted unchanged and within 24 hours and 10% as metabolites. Fecal excretion over 5 days has accounted for 20-30% of an oral dose and 15% of an intravenous dose.


    Storage


    CIPROCIN Tablets: Stored at a temperature not exceeding 30ºC.

    CIPROCIN Vials: Stored at a temperature 15ºC - 30ºC.


    Packaging


    CIPROCIN 250 mg Film coated Tablets: Box containing 1 blister of 10 film coated tablets.

    CIPROCIN 500 mg Film coated Tablets: Box containing 1 blister of 10 film coated tablets.

    CIPROCIN 750 mg Film coated Tablets: Box containing 2 blisters of 5 film coated tablets each.

    CIPROCIN 200 mg Vials: Box containing 1 vial of 20 ml.




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