Bactin - Ciprofloxacin-Antibacterial Film Coated Tablet

Description:
Bactin® is a film coated tablet which is a broad spectrum synthetic Quinolone antiinfective agent. It is active against most of the gram negative aerobic bacteria like Enterobacteriaceae & Pseudomonas aeruginosa and gram positive aerobic bacteria including penicillinase producing, penicillinase nonproducing and Methicillin-resistant Staphylococci. The bactericidal action of Ciprofloxacin results from interfering with the enzyme DNA gyrase.

Composition:
Bactin®Tablet : Each tablet contains Ciprofloxacin USP 250 mg.
Bactin® 500 Tablet : Each tablet contains Ciprofloxacin USP 500 mg.
Bactin® 750 Tablet : Each tablet contains Ciprofloxacin USP 750 mg.

Indication:
Bactin®is indicated for the management of single or mixed infections caused by two or more susceptible microorganisms. It can also be used against infections caused by organisms resistant to other antibiotics. Bactin®is indicated for the treatment of the following infections.
Gastrointestinal tract infection : Enteric fever and infected diarrhoea.
Respiratory tract infection : Pneumonia, acute and chronic bronchitis, cystic fibrosis, bronchiectasis and empyema.
Urinary tract infection : Complicated and uncomplicated urethritis, cystitis, pyelonephritis, prostatitis and epididymitis.
Severe systemic infection : Septicemia, bacteremia, infection in
immunosuppressive patient with hematological or solid tumors.
Skin and soft tissue infection : Wound infection, abscess, infected ulcer, cellulitis, infected burn, erysipelas and otitis externa.
Biliary tract infection : Cholangitis, cholecystitis, empyema of the gall bladder.

Bone and joint infection : Osteomyelitis and arthritis.
Eye, ear, nose and throat infection : Otitis media, sinusitis, mastoiditis and tonsillitis.
Pelvic infection : Salpingitis, endometritis and pelvic inflammatory diseases.
Abdominal infection : Peritonitis & intra-abdominal abscess.
Gonorrhoea : Urethral, rectal and pharyngeal gonorrhoea caused by beta-lactamase producing organisms or organisms moderately sensitive to penicillin.

Dosage and administration:
Adult : The usual adult dose is 250-750 mg twelve hourly.
Adolescent and Children : Generally not recommended but where the benefit is more than potential risk, the dose should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses.

Dosage Schedule:

Infection	Dose	Duration
1. Enteric Fever	500 mg	12 hourly 7 -14 days
2. Infected Diarrhoea	500 mg	12 hourly 5 -7 days
3. Chronic Salmonella carriers	500 - 750 mg	12 hourly 28 days
4. Complicated UTI	500 mg	12 hourly 5-7 days
5. Uncomplicated UTI	250 mg	12 hourly 3 -5 days
6. Respiratory Tract Infection	500 - 750 mg	12 hourly 7 -14 days
7. Skin & Soft Tissue Infection	500 - 750 mg	12 hourly 7 -14 days
8. Uncomplicated Gonorrhoea	250 mg	Single dose.
9. Wound Infection	250 mg	12 hourly 7 -14 days
10. Bone & Joint Infection	500 - 750 mg	12 hourly 7 -14 days but may need to continue for 4-6 weeks or longer.
11. Other Infections	500 - 750 mg	12 hourly 7 -14 days

Side effect:
Gastrointestinal disturbances like nausea, vomiting, diarrhoea, dyspepsia and abdominal pain; Disturbances of the CNS eg. dizziness, drowsiness, headache, tiredness, confusion, convulsion, skin rashes, pruritus and possible systemic reactions may occur. It has also been reported that joint pain, mild photosensitivity may occur and liver enzyme, serum bilirubin, creatinine levels may increase slightly.

Contraindication:

Ciprofloxacin is contraindicated in patients with a history of hypersensitivity to it any of its components and to other Quinolones.

Precaution:
Ciprofloxacin should be used with great caution in patient with a known history of epilepsy or other factors which predispose to seizure and convulsion. Patients should be advised to take Ciprofloxacin two hours after meal. Patients should be advised not to take Antacid containing aluminium or magnesium

Bactin® concomitantly or within two hours after dosing and also requested to drink plenty of water.

Pregnancy and lactation:
Ciprofloxacin has been shown to cause arthropathy in immature animals and therefore its use during pregnancy is not yet recommended. It has been reported that Ciprofloxacin is secreted in milk during administration to nursing mother and is thus not recommended yet.

Children & growing adolescents:
The use of quinolones can be considered if it is felt to be necessary by a registered physician, with no suitable alternatives, for a particular clinical situation.

Drug interaction:
Concurrent administration of Ciprofloxacin with theophylline and caffeine may potentiate the adverse effects of theophyline and caffeine. Antacid containing aluminium or magnesium may decrease the bioavailabiltiy of Ciprofloxacin. Quinolones, including Ciprofloxacin, have been reported to enhance the effects of the oral anticoagulantl ike Warfarin or its derivatives.

How supplied:
Bactin®Tablet : Box contains 2 x 10's film coated tablets in blister pack.
Bactin®500 Tablet : Box contains 2 x 10's film coated tablets in blister pack.
Bactin®750 Tablet : Box contains 2 x 10's film coated tablets in blister pack.

Manufacturer’s Source: IBN SINA