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Ciprofloxacin

DESCRIPTION
Pharmaniaga Ciprofloxacin tablet 250 mg.
White, round film-coated tablet, plain on one side and scored on the other.
Pharmaniaga Ciprofloxacin tablet 500 mg.
White, oblong film-coated tablet (8 x 17 mm in dimension) plain on one side and scored on the other.
Pharmaniaga Ciprofloxacin tablet 750 mg.
White, oblong film-coated tablet (21.5 x 10 mm in dimension) plain on one side and scored on the other.

COMPOSITION
Pharmaniaga Ciprofloxacin tablet 250 mg. Each film-coated tablet contains: Ciprofloxacin (as Hydrochloride) 250 mg.

Pharmaniaga Ciprofloxacin tablet 500 mg. Each film-coated tablet contains: Ciprofloxacin (as Hydrochloride) 500 mg.

Pharmaniaga Ciprofloxacin tablet 750 mg. Each film-coated tablet contains: Ciprofloxacin (as Hydrochloride) 750 mg.

ACTIONS
Ciprofloxacin is a fluoroquinolone antibacterial agent with a strong antibacterial activity against a broad spectrum of bacteria. These substances are also known as gyrase inhibitors. It prevents transcription by the chromosome (genetic material) of the information needed for the normal metabolism of bacteria. This leads to a rapid decrease in the ability of bacteria to reproduce. Ciprofloxacin is also characterised by the fact that, as a result of its particular mode of action, it does not generally exhibit parallel resistance to any other antibiotic outside the gyrase inhibitor group. Therefore, Ciprofloxacin is highly effective against bacteria which are resistant, eg to aminoglycosides, penicillins, cephalosporins, tetracyclines and other antibiotics.

Ciprofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections.

Aerobic Gram-positive microorganisms

Enterococcus faecalis
(Many strains are only moderately susceptible)

Staphylococcus aureus (methicillin susceptible)

Staphylococcus epidermidis

Staphylococcus saprophyticus

Streptococcus pneumoniae

Streptococcus pyogenes

Aerobic Gram-negative microorganisms

Campylobacter jejuni

Citrobacter diversus
Citrobacter freundii

Enterobacter cloacae

Escherichia coli

Haemophilus influenzae

Haemophilus parainfluenzae

Klebsiella pneumoniae

Moraxella catarrhalis

Morganella morganli

Neisseria gonorrhoeae

Proteus mirabilis
Proteus vulgaris

Providencia rettgeri

Providencia stuartii

Pseudomonas aeruginosa

Salmonella typhi

Serratia marcescens

Shigella boydii

Shigella dysenteriae

Shigella flexneri

Shigella sonnei

Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the gastro-intestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500 or 750 mg are 0.1, 0.2 and 0.4 g/ mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug. After a 250 mg oral dose, urine concentrations of ciprofloxacin usually exceed 200 mg/ mL during the first 2 hours and are approximately 30 mg/ mL, at 8 to 12 hours after dosing. The urinary excretion of ciprofloxacin is virtually complete within 24 hours after dosing. The renal clearance of ciprofloxacin which is approximately 300 mL/ minutes, exceeds the normal glomerular filtration rate of 120 mL/ minute. Thus, active tubular secretion would seem to play a significant role in its elimination. Although bile concentrations of ciprofloxacin are several fold higher than serum concentrations after oral dosing, only a small amount of the dose administered is recovered from the bile as unchanged drug.

An additional 1 to 2 % of the dose is recovered from the bile in the form of metabolites. Approximately 20 to 35% of an oral dose is recovered from the faeces within 5 days after dosing. This may arise from either biliary clearance or trans-intestinal elimination. Four metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin. When ciprofloxacin tablet is given concomitantly with food there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing.

The binding of ciprofloxacin to serum proteins is 20 to 40 which is not likely to be high enough to cause significant protein binding interactions with other drugs. After oral administration, ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate. Ciprofloxacin is present in active form in the saliva, nasal and bronchial secretions, mucosa of the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile and prostatic secretions. Ciprofloxacin has also been detected in lung, skin, fat muscle, cartilage and bone. The drug diffuses into the cerebrospinal fluid (CSF): however, CSF concentrations are generally less than 10% of peak serum concentrations. Low levels of the drug have been detected in the aqueous and vitreous humor of the eye.

INDICATIONS
Uncomplicated and complicated infections caused by ciprofloxacin-sensitive pathogens:
Infections of the
- respiratory tract. Ciprofloxacin can be regarded as an advisable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, Pseudomonas, Haemophilus, Branhamella, Legionella, and Staphylococcus.
- Middle ear (otitis media), of the paranasal sinuses (sinusitis), especially if these are caused by Gram-negative organisms including Pseudomonas or by Staphylococcus.

- Eyes
- Kidneys and / or urinary tract.
- Genital organs, including adnexitis, gonorrhoea and prostatitis.
- Abdominal cavity (e.g. bacterial infections of the gastrointestinal tract, biliary tract, peritonitis).

- Skin and soft tissue
- Bones and joints

Septicaemia
Ciprofloxacin is also indicated for prophylaxis against infection in elective upper gastro-intestinal surgery and endoscopic procedures where there is an increased risk of infection. Infections or imminent risk of infection (prophylaxis) in patients whose immune system has been weakened (e.g. patients on immunosuppressants or in state of neutropenia). Selective intestinal decontamination in immunosuppressed patients.

CONTRAINDICATIONS
Ciprofloxacin must not be used in cases of hypersensitivity to ciprofloxacin or other quinolone chemotherapeutics. Ciprofloxacin must not be prescribed for children, adolescents, pregnant women, or nursing mothers, since there is no experience on the drug's safety in these patient groups and since on the basis of animal studies, it is not entirely improbable that the drug could cause damage to articular cartilage in the immature organism.


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