Ciprofloxacin 500 mg tablet
(i)
ROUTE OF ADMINISTRATION
Oral
DOSAGE AND ADMINISTRATION
Health
2000 Ciprofloxacin 500mg tablets should be swallowed whole with adequate
amount of liquid. Ciprofloxacin tablets can be taken without regard to meals.
Fluids should be taken liberally. Antacids should not be taken concomitantly
or within two hours of dosing.
Adults
Respiratory tract, bone and joint infections
Mild/moderate 500 mg twice daily
Severe/complicated 750 mg twice daily
Urinary
tract infections
Mild/moderate 250 mg twice daily
Severe/complicated 500 mg twice daily
Infectious diarrhoea
Mild/moderate/severe 500 mg twice daily
Gonorrhoea 250 mg single dose
Non-gonococcal urethritis 750 mg twice daily
Chancroid 500 mg twice daily
Other infections 500-750 mg twice daily
(ii) THERAPEUTIC / DIAGNOSTIC CLAIMS
Health 2000 Ciprofloxacin 500 mg tablet is indicated for the treatment of a wide variety of infections caused by susceptible gram-positive and gram-negative organisms including mixed infections caused by two or more organisms. It may also be used for infections caused by multi-drug resistant bacteria. Health 2000 Ciprofloxacin 500 mg tablet is indicated for the treatment of the following infections caused by susceptible bacteria:
Respiratory Tract Infections: Acute and chronic bronchitis, obstructive airways disease (COPD), empyema, lung abscess, bronchiectasis, lobar and bronchopneumonia, acute exacerbation of cystic fibrosis, otitis media, sinusitis and mastoiditis especially due to gram-negative bacteria (including Pseudomonas sp.)
Urinary
Tract Infections:
Acute and chronic pyelonephritis, cystitis, urethritis, prostatitis, epididymitis
and chronic complicated or recurrent UTI caused by multi-drug resistant organisms
and/or Pseudomonas aeruginosa.
Skin and Soft Tissue Infections: In surgical
and post-operative wound infections due to gram-negative organisms such as
Pseudomonas aeruginosa, also useful in infections caused by resistant Staphylococci
including infected ulcers, wound infections, abscesses, cellulitis, erysipelas,
infected burns.
Surgical Infections: Peritonitis, intra-abdominal abscess, cholecystitis, empyema of gall bladder. cholangitis,
Bone
And Joint Infections: Acute
and chronic osteomyelitis, septic arthritis.
Pelvic Infections: Salpingitis, endometritis, pelvic inflammatory disease.
Sexually Transmitted Diseases: Gonorrhoea including that caused by beta-lactamase producing strains and chancroid caused by H.ducreyi.
Gastrointestinal
Infections: Enteric
fever, infective diarrhoea.
Severe Systemic Infections: Septicaemia, bacteraemia, infections in immunocompromised
patients.
.
(iii) DESCRIPTION OF DOSAGE FORM
Ciprofloxacin,
a fluoroquinolone is a synthetic broadspectrum antibacterial agent for oral
and intravenous administration. The bactericidal action of ciprofloxacin results
from interference with the enzyme DNA gyrase which is needed for the replication
of bacterial DNA
.
(iv) CONTRAINDICATIONS
Hypersensitivity
to fluoroquinolones or the quinolone group of
antibacterialagents.
WARNING
AND PRECAUTIONS
INTERACTION
Theophylline: Serum concentrations and elimination
halflife of theophylline may be increased when it is used concurrently with
ciprofloxacin. Theophylline doses should be reduced and plasma levels monitored.
Antacids: Antacids containing magnesium hydroxide and/or aluminium hydroxide
may interfere with the absorption of ciprofloxacin, resulting in lower serum
and urine levels; concurrent administration of antacids with ciprofloxacin
should be avoided.
Anticoagulants: Prolongation of bleeding time has been reported during concomitant
administration of ciprofloxacin and anticoagulants.
Cyclosporin: Transient increases in serum creatinine
have been seen following concomitant administration of cyclosporin and ciprofloxacin.
Caffeine: Ciprofloxacin may interfere with the
metabolism of caffeine, resulting in reduced clearance of caffeine.
Pregnancy: No adequate and well controlled studies are available on the use of ciprofloxacin in pregnant women. Should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Nursing
mothers
Ciprofloxacin is secreted in breast milk, however, the amount ingested by
the infant appears to be low. Because of the potential for serious adverse
reactions in nursing infants, the drug should be used only after taking into
account the benefits offered and the potential risks involved.
Pediatric
use
As with other drugs of this class, ciprofloxacin has been shown to cause arthropathy
in weight-bearing joints of immature animals. Hence ciprofloxacin is usually
not recommended for use in children. However, if benefits are considered to
outweigh the potential risk, it may be administered.
In
impaired renal damage :
Dosage adjustments will be required in patients with moderate to severe impairment
of renal function. Monitoring of serum drug levels is the most reliable basis
for dosage adjustment. If creatinine clearance is less than 20 ml/min, half
the recommended dosage may be administered.
Others:
CNS stimulation: As ciprofloxacin may cause CNS stimulation, it should be
used with caution in patients with CNS disorders such as severe cerebral arteriosclerosis
or epilepsy.
Crystalluria: Inadequate intake of water, when on ciprofloxacin, can cause
crystalluria.
Phototoxicity: Moderate to severe phototoxicity manifested by an exaggerated
sunburn reaction has been observed in patients who are exposed to direct sunlight
with some members of the quinolone class of drugs. Therapy should be discontinued
if phototoxicity occurs.
(v)
SIDE EFFECTS
Ciprofloxacin is generally well tolerated. Diarrhoea, vomiting, abdominal
pain, headache, restlessness and rash, have been reported. Other side effects
which have been reported very rarely include myalgia, tendinitis/rupture,
exacerbation of myasthenia gravis and increases in serum transaminase levels
Potentially
life-threatening effects
A series of 15 cases of anaphylactoid reactions has been reported associated
with ciprofloxacin. Stevens-Johnson syndrome, toxic epidermal necrolysis,
fulminant hepatic failure have been reported rarely.
Severe
or irreversible effects
As with all quinolones, seizures may occur and this effect may be potentiated
by concurrent use of non-steroidal anti-inflammatory drugs. Pseudomembranous
colitis has occurred with ciprofloxacin therapy. Transient disturbance of
hearing has been reported, particularly during high-dose therapy.
Symtomatic
adverse effects
Probable or possible drug-related reactions were reported in 93% of 9473 patients
treated with ciprofloxacin worldwide. The incidence of severe reactions was
0.6%. The most frequent reactions were from the gastrointestinal system (nausea,
diarrhea, vomiting, dyspepsia), central nervous system (dizziness, headache,
nervousness, tremors, seizures, confusion) and skin (rash, pruritus, urticaria,
photosensitivity).
Other effects
Elevation of AST (SGOT) and ALT (SGPT), blood creatinine, and blood urea have
been observed. Eosinophilia, leucopenia and thrombocytopenia have also been
related to ciprofloxacin use.
Interference with clinical pathology tests
No technical interferences of this kind have been reported.
(vi) TOXIC EFFECTS
Mutagenicity, Carcinogenicity and Teratogenicity
Teratogenecity:
There are no adequate and controlled studies to date using ciprofloxacin in
pregnant women. Since the drug, like most other quinolones, causes arthropathy
in immature animals, ciprofloxacin should not be used in pregnant women.
Reproduction studies in rats and mice using ciprofloxacin dosages up to 6
times the usual human dosage have not revealed evidence of impaired fertility
or harm to the fetus.In rabbits, ciprofloxacin dosages of 30 and 100mg/kg
caused adverse GI effects resulting in maternal weight loss and an increased
incidence of abortion, but there was no evidence of teratogenecity. IV ciprofloxacin
given to rabbits at doses up to 20 mg/kg has not resulted in maternal toxicity,
embryocity or teratogenicity. Administration of high dosages (100 mg/kg daily
) of some quinolones(e.g norfloxacin, pefloxacin, pipemidic ) has been associated
with impaired spermatogenesis and/or testicular damage (atrophy in rats and
dogs ) in chronic (for 3 months or longer) toxicity studies.
Ciprofloxacin and other quinolones (e.g nalidixic acid, ofloxacin) have been
shown to distribute into milk. Because of the potential for serious adverse
effects of ciprofloxacin in nursing infants, a decision should be made whether
to discontinue nursing or the drug, taking into account the importance of
the drug to the women.
Ciprofloxacin does not show any carcinogenic and mutagenic effects.