Ciprofloxacin Hydrochloride USP
Description: Ciprom containing Ciprofloxacin
is a synthetic quinolone anti-infective agent. Ciprofloxacin
has broad spectrum of activity. It is active against most
gram-negative aerobic bacteria including Enterobacteriacae
and Pseudomonas aeruginosa. Ciprofloxacin is also active against
gram-positive aerobic bacteria including penicillinase producing,
non-penicillinase producing, and methicillin resistant staphylococci,
although many strains of streptococci are relatively resistant
to the drug. The bactericidal action of Ciprofloxacin results
from interference with the enzyme DNA gyrase needed for the
synthesis of bacterial DNA.
Following oral administration it is rapidly and well absorbed
from the G.l. tract, It is widely distributed into body tissues
and fluids. The half-life is about 3.5 to 4.5 hours. About
30 to 50 % of an oral dose of Ciprofloxacin is excreted in
the urine within 24 hours as unchanged drug and biologically
Powder: Each 5 ml.
Suspension contains Ciprofloxacin Hydrochloride USP equivalent
to 250 mg Ciprofloxacin.
250: Each film coated tablet
contains Ciprofloxacin USP 250 mg as Ciprofloxacin Hydrochloride.
Ciprom 500:Each film coated tablet contains Ciprofloxacin
USP 500 mg as Ciprofloxacin Hydrochloride. Ciprom-DS dry
Syrup : After reconstitution each 5 ml contains Ciprofloxacin
Hcl USP equivalent to 250 mg ciprofloxacin.
used in adults for the treatment of urinary tract infections,
lower respiratory tract infections, skin and soft tissue-infections
bone and joint Infections and GI infections caused by susceptible
gram-negative and gram-positive aerobic bacteria. It is also
used for the treatment of uncomplicated gonorrhoea caused
by penicillinase producing and non-penicillinase producing
DOSAGE AND ADMINISTRATION :
be given orally without regard to meals. Patients receiving
Ciprofloxacin should be well hydrated and should be instructed
to drink fluids liberally. Because of the risk of crystaluria,
it is recommended that the usual dosage of the drug should
not be exceeded.
For the treatment of urinary tract infections, the usual adult
oral dosage of Ciprom for mild to moderate infections is 250
mg every 12 hours and the usual adult dosage for complicated
infections, caused by organisms not highly susceptible to
drug is 500 mg every 12 hours. A dosage of 750 mg every 12
hours may be needed, especially in bone and joint infections
or when infections are severe or complicated. The usual adult
oral dosage of Ciprom for infectious diarrhoea is 500 mg every
12 hours. For the treatment of uncomplicated urethral, endocervical
or rectal gonorrhoea, caused by penicillinase producing strains
of Neisseria gonorrhoeae (PPNG) or non-penicillinase producing
strains of the organisms, adults should receive a single 500
mg oral dose of Ciprom followed by oral doxycycline therapy
for possible co-existing Chlamydial infection. In the treatment
of chancroid, 500 mg orally twice daily for 3 days is required.
The duration of Ciprom therapy depends on the type and severity
of infection and should be determined by the clinical and
bacteriological response of the patients. For most infections
one may require more prolonged therapy. Ciprofloxacin therapy
may need to be continued for 4-6 weeks or longer for the treatment
of bone and joint infections. Infectious diarrhoea generally
is treated for 3-7 days, although less prolonged therapy.
may be adequate. Modification of the usual dosages of Ciprofloxacin
generally is unnecessary in patients with creatinine clearances
greater than 30-50ml/minute or less, doses and/or frequency
of administration of ciprofloxacin should be modified in response
to the degree of renal impairment and the site and severity
Adults with creatinine clearances of 30-50 ml/minute
can receive 250-500 mg of Ciprofloxacin every 12 or 18 hours.
However these patients should be monitored carefully and serum
ciprofloxacin concentrations determined periodically.
Precaution & Warning:
It should be used with caution in patients
with suspected or known CNS disorders such as arteriosclerosis
or epilepsy or other factors which predispose to seizures
Pregnancy, Lactation & Children:
Not to be used in pregnancy and nursing
stage. Though not recommended for the children where benefit
out -weighs risk a dosage of 7.5-15 mg/kg/day in two divided
dose can be given.
Patients with a history to hypersensitivity
to ciprofloxacin and to other quinolones and in children and
in pregnant women.
Adverse effects include nausea and other
gastrointestinal disturbances, drowsiness, headache, dizziness
and skin rashes. Crystalluria has occurred with high doses.
Ciprom 250 :
Box containing 3 x 10 tablets in blister pack.
Ciprom 500 : Box containing 2 x 10 tablets in blister
Ciprom-DS dry Syrup:In
60 ml. amber glass bottle.