ciproven tablets

COMPOSITION Each Sugar coated tablet contains
  • Ciprofloxacin B.P 500 mg.
  • As Ciprofloxacin Hcl
PROPERTIES
Antibacterial, Fluoro quinolone antimicrobial.
PHARMACOLOGY
Nimesulide is a non-steroidal anti-inflammatory drug of the sulphonanilide class. The anti-inflammatory, analgesic and antipyretic activities of the Nimesulide have been demonstrated in a number of experimental models and in numerous clinical trials. The anti-inflammatory potency of Nimesulide is similar or greater than that if Indomethacin, Diclofenac, Piroxicam and Ibuprofen as shown in standard animal models of inflammation such as carrageenin-induced rat paw edema and inflammation, UV light induced erythema in guinea pigs and adjuvant arthritis in rats. Nimesulide has an analgesic potency similar to that of Ibuprofen and less than that of Indomethacin in an acetic acid writhing test in rats, and acetic acid and acetylcholine writhing tests in mice. The antipyretic potency of Nimesulide is superior to that of Indomethacin, Ibuprofen, Asprin and paracetamol in rats with yeast-induced fever.
On oral adminstration of Nimesulide 50-200 mg tablets to healthy volunteers, peak serum concentration of 1.98 to 9.85 mg/L are achieved within 1.22 to 3.17 hours. Oral absorption of Nimesulide is nearly complete. Concomitant adminstration of food may decrease the rate but not the extent of absorption of Nimesulide. Plasma binding was high (99%) and the apparent volume of distribution ranged from 0.19 to 0.35 L/kg. Nimesulide is extensively metabolized to several metaboloties which are excreted mainly in the urine (70% and in faeces (20%).
In patients with moderately impaired renal function (creatinine clearance 1.8 to 4.8 L/h, (30 to 80 ml/min), also in children and elderly volunteers, the pharmacokinetic profile of Nimesulide is not significantly altered. In patients which moderate renal impairment, slight accumulation of 4-Hydroxy Nimesulide was noted, however, the clinical significance of this finding is unknown.
In children, compared with values of adult healthy volunteers, tmax and t1/2 values were similar for the granule for formulation and lower for the suppository formulation in children suggesting a faster absorption and elimination of this formulation in children.
However, additional well-designed studies are needed for further comments on this matter.
INDICATION & USAGE
Tablets : Respiratory tract, urinary tract, E.N.T., skin and soft tissue, GI tract, Intra-abdominal, gynaecological Bone and joint severe systemic infections, Gonorrhoea. Prostatitis, throat infection, enteric fever eye infection.
Infusion : UTI, respiratory, ENT, skin & soft tissue, bone & joint, GI infections. Gonorrhoea, severe systemic infections. Surgical prophylaxis, septicaemia.
Dosage: Adults: 100-200 mg twice daily by i.v. inf. over 30-60 mins. Gonorrhoea: 100 mg.
Children: Not recommended.
Antimicrobial action : Ciprofloxacin is bactericidal and acts by inhibiting the A subunit of DNA gyrase (topoisomerase) which is essential in the reproduction of bacterial DNA. It has a broader spectrum of activity and is more potent in vitro than the non-fluorinated quinolone nalidixic acid. Activity may be reduced in acid media.
Onset of action: within 1 hour.
Duration of action : 8-12 hours.
DOSAGE
Adults : The dosage of ciprofloxacin is determined on die basis of severity of infection, type of infecting organism and age, weight and renal function of the patient. The recommended dosage schedule of oral ciprofloxacin is as follows :
  • (i)   Uncomplicated UTI : 250 mg every 12 hours.
  • (ii)   Prostatitis and complicated UTI in patients with severe underlying structural abnormalities:500 mg every 12 hours.
  • (iii)   Lower respiratory tract infections : mild-250 mg; moderate to severe-500 mg;all every 12 hrs. Dosage of 750 mg every 12 hrs should preferably be used in cases of infection with resistant gram-positive bacteria.
  • (iv)   ENT infections : 500 to 750 mg every 12 hrs.
  • (v)   Bone and joint infections 500 to 750 mg every 12 hrs.
  • (vi)   Gastroenteritis: 500 mg every 12 hrs.
  • (vii)   Enteric fever: 500-750 mg every 12 hrs.
  • (viii)   Gynaecological infections : 500 mg every 12 hrs.
  • (ix)   Gonorrhoea : 250 mg single dose.
  • (x)   Septicemia, bacteremia and intra-abdommal infections: Initial IV ciprofloxacin therapy may be followed by oral 500 to 750 mg every 12 hrs.
Children: Not recommended.
Drug interaction :
  • (i)   Antacids (aluminium/magnesium hydroxide), iron salts, zinc salts : Absorption of ciprofloxacin is decreased.
  • (ii)   Antineoplastic drugs : Decrease serum levels of ciprofloxacin.
  • (iii)   Caffeine : Enhanced efficacy of caffeine.
  • (iv)   Oral anti-coagulants : Enhanced efficacy of anti-coagulants.
  • (v)   Cyclosporine : Nephrotoxicity increased by ciprofloxacin.
  • (vi)   Theophylline : Increased plasma levels of theophylline resulting in toxicity.
  • (vii)   Theophylline : Increased plasma levels of theophylline resulting in toxicity.
  • (viii)   Rifampicin : Decreases serum concentration of ciprofloxacin.
  • (ix)   Chloramphenicol : Antagonises effects of ciprofloxacin.
SIDE EFFECTS
Nausea, epigastric distress, headache, vomiting, diarrhoea, restlessness, abdominal pain, skin rash, insomnia, confusion, dizziness aid arthralgia.
PRECAUTIONS :
Renal dysfunction, epilepsy. Prolonged use, children.
CONTRA-INDICATION
Hypersensitivity.
PHARMACEUTICAL PRECAUTION
Ciprofloxacin tablets should be stored in a cool, dry and dark place.
PRESENTATION
Blister pack of 1 x 10 tablets.