Cipocil Ciprofloxacin Hydrochloride Tablets

Cipocil®
Ciprofloxacin Hydrochloride tablets U.S.P. 500 mg

 

COMPOSITION

Each film coated tablet contains

Ciprofloxacin Hydrochloride U S.P.

Equivalent to Ciprofloxacin 500mg

 

PHARMACOLOGY

Cipocil is a fluroquinolone anti-microbial agent with potent activity against a broad spectrum of gram positive and gram negative bacteria including P.aeruginosa, Enterobacteriaceae and S.aureus.

 

ANTIMICROBIAL ACTIVITY

Cipocil kills bacteria rapidly at a concentration 1 to 2 folds higher than its MIC. Cipocil eliminates bacteria in just 19 minutes.

The rapid bactericidal action of Cipocil is attributed to its unique mode of action. Cipocil hire other fluroquinolones, blocks DNA gyrase and disrupts the DNA functions leading to death of bacteria in addition Cipocil damages bacterial cell wall membrane leading to extrusion of cell contents CipociI is effective against both replicating strains and bacteria in stationary phase it is also effective against intracellular bacteria. It has significant post- antibiotic effect up to 6 hours and thus prevents regrowth of bacteria.

Cipocil does not disturb the normal intestinal or vaginal flora and has no significant effect against anaerobes.

Bacterial resistance with CipociI is extremely rare. There is no plasmid mediated resistance and it does not show any cross resistance with other antibiotics or antibacterial agents except fluoroquinolones.

Cipocil is active against a wide range of gram positive and gram negative pathogens including strains resistant to penicillins, cephalosporins and/or aminoglycosides Cipocil’s spectrum includes the following:

Aerobic Gram negative bacteria

Enterobacteriaceae Enteropathogens
E.coli
Klebsielia species
Proteus species
lndole (+) or (-)
Enterobacter species
Morganella morganii
Providencia species
Citrobacter species
Serratia species
Enteropathogenic E.coli
Salmonella species
Shigella species
Y.enterocolitic
A. hydrophilia
Arizona species
V cholerae
V. parahaemolyticus
Campylobacter jejuni

 

Pseudomonadaceae Miscellaneous
Ps. Aeruginosa
Ps. cepacia
N.gonocrhoeae
N.meningitidis
H.influenzae
Acinetobacter anitratus
Branhamella catarrhalis
Gardnerella vaginalis
Moraxella
Pasteurella

 

Aerobic Gram positive bacteria

Staph aureus including penicillinase producing and methicillin resistant strains
Staph. epidermidis, Strep. pneumoniae
Strep pyrogenes Sterp viridans
Strep agalactiae, Listeria monocytogenes

Intra-cellular Bacteria Resistant Strains

Chlamydia trachomatis Anaerobes including
Mycoplasma hominis most species of Bacteroides
Legionella species Clostridium and Fusobacterium
Brucella species Actinomyces

The absolute bioavailability of Cipocil tablets is between 60-85% with no substantial loss by first pass metabolism. Half life is about 3-4 hours About 40-50% of an oral dose is recovered unchanged in urine.

Approximately 20-35 % of an oral dose is recovered from faeces within 5 days after dosing. Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Serum concentrations increase proportionately with the dose as shown:

DOSE
(mg)
MAXIMUM SERUM CONCENTRATIONS
(mcg/ml)
250
500
750
1000
1.2
2.4
4.3
5.4

 

INDICATIONS

Cipocil 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. lt may also be used for infections caused by multi-drug resistant bacteria.

The potent broad- spectrum antibacterial activity of Cipocil (including activity against Pseudomonas) combined with its excellent tissue penetration enables Cipocil to be used alone effectively pending sensitivity results. However, to provide an effective coverage against anaerobes, it may be combined with metronidazole, whereof anaerobes is suspected.

Cipocil is indicated for the treatment of the following infections caused by susceptible bacteria.

Respiratory Tract Infections e.g. Pneumonia, bronchopneumonia, infected pleurisy, empyema, lung abscess, infected bronchiectasis, acute excerbation of chronic bronchitis and lung infections in patients with cystic fibrosis.

Urinary Tract Infections e.g. acute and chronic pyelonephritis, prostatitis, cystitis, epididymitis and chronic complicated or recurrent UTI.

E.N.T infections e.g. Otitis Media, sinusitis, mastoiditis

Gonorrhoea including urethral rectal and pharyngeal gonococcal infections even those caused by resistant gonococci.

Skin and Soft Tissue Infections e.g. infected ulcers, wound infections, abscesses, cellulitis, otitis extrema, infected burns.

Gastrointestinal Tract infections e.g. enteric fever, bacterial diarrheas.

Intra-Abdominal infections e.g. peritonitis, intra abdominal abscess, cholangitis, cholecystitis, ampyema of gall bladder.

Gynaecological infections e.g. Salpingitis, endometritis, pelvic inflammatory disease.

Bone and joint infections e.g. Acute and chronic Osteomyelitis, Septic arthritis.

Severe Systemic infections e.g. Septicemia, bacteremia and infections in immunocompromised patients.

 

CONTRAINDICATIONS

Cipocil is contraindicated in individuals with a history of hypersensitivity to Ciprofloxacin or any other quinolone derivative.

Cipocil has been shown to cause arthropathy in weight bearing joints of immature animals. Though the relevance of this to man is unknown, its use in children and adolescents is not recommended.

 

Precautions

As Cipocil may cause CNS stimulation, it should be used with caution in patients with CNS disorders such as severe cerebra, arteriosclerosis or epilepsy.

Patients receiving this drug should be well hydrated to prevent crystalluria.

Excessive alkalinisation of urine should be avoided.

The dosage should be reduced in patients with renal impairment.

Reproduction studies in animals at doses up to 6 times the usual daily human dose did not revealed any evidence of impaired fertility or teratogenicity due to Cipocil.

However information from well controlled studies in pregnant women is not available.
Since Cipocil causes arthropathy in immature animals it should not be used in pregnant and nursing women.

 

Side Effects

Cipocil is generally well tolerated. Owing clinical trials in a large number of patients adverse effects related to drug occurred infrequently and were commonly reported as diarhea, vomiting, abdominal pain, headache, restlessness and rash.

Other side effects which have been reported very rarely include local irritation at the site of infection, thrombophlebitis, convulsions, arthralgia and increase in serum transaminase levels.

 

DRUG INTERACTIONS

(1) Xanthine Derivatives

When Xanthine derivatives like theophylline were coadministrated with Cipocil, the plasma concentrations of theophylline were raised to toxic range. The total body clearance of theophylline was also decreased. When concurrent administration of theophylline with Cipocil is considered necessary the patient must be monitored for signs of theophylline toxicity and suitable dose reduction of theophylline may be considered.

(2) Probenecid

As Probenecid delays the excretion of Cipocil, it may elevate and prolong the concentrations of the drug in the serum this should be kept in mind when both drugs are given simultaneously.

(3) Antacids

Antacids like aluminium Hydroxide and Magnesium reduce the bioavailability of Cipocil. Cipocil should not, therefore, be administered simultaneously with alumunium and Magnesium antacids.

 

Dosage and Administration

Cipocil is generally administered in oral doses of 250mg or 500 mg twice daily for 5-7 days in most cases.

LOCATION OF INFECTION TOTAL DAILY DOSE (mg)
Urinary Tract
Mild/moderate
Severe/complicated
 

500
1000

Respiratory Tract, Bone and Joint, Skin and Skin Structures
Mild/moderate
Severe/Complicated
 

1000
1500

Infectious Diarrhea
Mild/Moderate/Severe
 

1000

In gonorrhea 250mg or 500mg is given as single dose.

The dose may be taken with or without meals, the preferred time is 2 hours after meal.

Children

Cipocil is usually not recommended for use in children. However if the benefits of Cipocil therapy are considered to outweigh the potential risk, the dosage should be 5-10 mg/kg/day in 2 divided doses, depending on severity of infection.

 

Storage

Store in cool & dry place. Protect from light.

Keep all medicine away from children.

 

Presentation

Blister of 10 tablets.

 

Manufactured by

GREENFIELD PHARMACEUTICAL (JIANG SU) CO., LTD.

NO.38, TAI JIU ROAD, TAI ZHOU, JIANG SU PROVINCE, P.R. CHINA

 

Distributed by

JUSTEEN PHARMACEUTICALS LTD.

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