Ciprozera Ciprofloxacin Hydrochloride Tablets

CIPROZERA®

Ciprofloxacin tablets U .S. P. 500 mg

 

COMPOSITION

Each film coated tablet contains

Ciprofloxacin Hydrochloride U.S.P

Equivalent to Ciprofloxacin 500mg

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

 

ANTIMICROBIAL ACTIVITY

Ciprozera kills bacteria rapidly. At a concentration 1 to 2 folds higher than its MIC, Ciprozera eliminates bacteria in just 19 minutes.

The rapid bactericidal action of Ciprozera is attributed to its unique mode of action Ciprozera like other fluroquinolones, blocks DNA gyrase and disrupts the DNA functions leading to death of bacteria. In addition Ciprozera damages bacterial cell wall membrane leading to extrusion of cell contents. Ciprozera 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 preventing regrowth of bacteria.

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

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

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

Enterobacteriaceae Enteropathogens
E. coli

Klebsiella species

Proteus species

Indole (+) 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. cholera

V. parahaemolyticus

Campylobacter jejuni

 

Pseudomonadaceae Miscellaneous
Ps. Aeruginosa

Ps. cepacia

N. gonorrhoeae

N. meningitidis

H. influenzae

Acinetobacter anitratus

Branhamella catarrhatis

Gardnerella vaginalis

Moraxella

Pasteurelia

 

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 Ciprozera 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

Ciprozera 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.

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

Ciprozera 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, mastoditis.

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

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

Gastro-intestinal Tract Infections e.g. enteric fever, bacterial diarrheas.

Intra-Abdominal Infections e.g. peritonitis, intra abdominal abcess, 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. Septicema, bacteremia and infections in immunocompromised patients.

 

CONTRAINDICATIONS

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

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

 

Precautions

As Ciprozera 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 not revealed any evidence of impaired fertility or teratogenicity due to Ciprozera.

However, information from well controlled studies in pregnant women is not available.

Since Ciprozera causes arthropathy in immature animals, it should not be used in pregnant and nursing women.

 

Side Effects

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

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

 

DRUG INTERACTIONS

Xanthine Derivatives

When Xanthine derivatives like theophylline were coadministered with Ciprozera, 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 Ciprozera is considered necessary, the patient must be monitored for signs of theophylline toxicity and suitable dose reduction of theophylline may be considered.

Probenecid

As Probenecid delays the excretion of Ciprozera, 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.

Antacids

Antacids like aluminium hydroxide and magnesium reduce the bioavilability of Ciprozera. Ciprozera should not, therefore, be administered simultaneously with aluminium and magnesium antacids.

 

Dosage and Administration

Ciprozera is generally administered in oral doses of 250 mg 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

Respiratory Tract, Bone and Joint, Skin and Skin Structures

Mild/Moderate

Severe/Complicated

Infections Diarrhea

Mild/Moderate/Severe

 

500

1000

 

 

1000

1500

 

1000

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

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

 

Children

Ciprozera is usually not recommended for use in children. However if the benefits of Ciprozera 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 and dry place. Protect from light.

Keep all medicines away from children.

 

Presentation

Blister of 10 tablets.

2 Alu packs of 7 tablets.

 

Manufactured by

Greenfield Pharmaceutical (Jiang Su) Ltd.

No. 38, Tai Jiu Road, Tai Zhou, Jiang Su Province,

P.R. China.

 

Marketed by

Kuka Consumer Healthcare Ltd.

7, Sawyer Crescent, Phase 1,

Gbagada Estate, Lagos.

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