Brucipro

Brucipro

ciprofloxacin

Manufacturer:

Brawn Labs

Distributor:

Ambica
Full Prescribing Info
Contents
Ciprofloxacin hydrochloride.
Description
Each film-coated tablet contains: Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg.
Ciprofloxacin is a synthetic 4-quinolone derivative, with bactericidal activity against wide range of Gram negative and Gram-positive organisms.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Ciprofloxacin is bactericidal and kill bacteria rapidly. It acts via inhibition of bacterial DNA gyrase, ultimately resulting in interference with DNA function. Ciprofloxacin is highly active against a wide range of Gram-positive and Gram-negative organisms and has shown activity against some anaerobes, Chlamydia spp. and Mycoplasma spp.. Killing curves demonstrate the rapid bactericidal effect against sensitive organisms and it is often found that minimum bactericidal concentrations are in the range of minimum inhibitory concentrations. Ciprofloxacin has been shown to have no activity against Treponema pallidum and Ureaplasma urealyticum. Nocardia asteroids and Enterococcus faecium are resistant.
Pharmacokinetics: Ciprofloxacin is rapidly and well absorbed from the gastro-intestinal tract. Oral bioavailability is approximately 80% and a peak plasma concentration of about 2.5 ug per mL is achieved 1 to 2 hours after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food, but it is not substantially affected overall. The plasma half-life is about 3.5 to 4.5 hours and there is evidence of modest accumulation. Half-life maybe prolonged in severe renal failure - a value of 8 hours has been reported in end stage renal disease - and to some extent in the elderly. There is limited information on the effect of liver dysfunction.
In one study the half-life of ciprofloxacin was slightly prolonged in patients with severe cirrhosis of the liver. With one or two exceptions, most studies have shown the pharmacokinetics of ciprofloxacin to be not markedly affected by cystic fibrosis.
Plasma protein binding ranges from 20 to 40%. Ciprofloxacin is widely distributed in the body and tissue penetration is generally good. It appears in the CSF, but concentrations are only about 10% of those in plasma when the meninges are not inflamed.
Ciprofloxacin is eliminated principally by urinary excretion, but non-renal clearance may account for about a third elimination and includes hepatic metabolism, biliary excretion, and possibly transluminal secretion across the intestinal mucosa. At least 4 active metabolites have been identified. Oxociprofloxacin appears to be the major urinary metabolite and sulphociprofloxacin the primary faecal metabolite. Urinary excretion is by active tubular secretion as well as glomerular filtration and is reduced by probenecid; it is virtually complete within 24 hours. About 40-50% of an oral dose is excreted unchanged in the urine and about 15% as metabolites. Up to 70% of a parenteral dose may be excreted unchanged within 24 hours and 10% as metabolites. Faecal excretion over 5 days has accounted for 20-35% of an oral dose and 15% of an intravenous dose.
Indications/Uses
It has been used in the treatment of wide range of infections including anthrax, biliary-tract infections, infected bites and stings (animal bites), bone and joint infections, cat scratch disease, chancroid, exacerbations of cystic fibrosis, gastroenteritis (including travellers diarrhoea and campylobacter enteritis, cholera, salmonella enteritis, and shigellosis), gonorrhoea, infections in immunocompromised patients (neutropenia), legionnaires' disease, otitis externa, otitis media, peritonitis, Q fever, lower respiratory-tract infections (including Pseudomonas infections in cystic fibrosis, but excluding infections due to Streptococcus pneumoniae such as pneumococcal pneumonia), septicaemia, skin infections (including soft-tissue infections) spotted fevers, typhoid and paratyphoid fever, typhus and urinary-tract infections. Ciprofloxacin is also used for meningococcal meningitis prophylaxis. It is also used for surgical infection prophylaxis.
Dosage/Direction for Use
The usual adult dose of ciprofloxacin ranges from 250 mg-750 mg twice daily usually depending on the severity and nature of the infection. A dose of 100 mg twice daily by mouth for 3 days is recommended in women with acute uncomplicated cystitis. Single oral doses of 250 or 500 mg are used for the treatment of gonorrhea, depending upon patterns of resistance. A single oral dose of 500 mg is suggested for meningococcal meningitis prophylaxis. A single oral dose of 750 mg is suggested for surgical infection prophylaxis, given 60 to 90 minutes before the procedure.
Ciprofloxacin is not generally recommended for other uses in children and adolescents but, if considered essential, doses of 5 to 15 mg per kg body-weight twice daily by mouth or 4 to 8 mg per kg twice daily intravenously have been suggested.
Or as prescribed by the physician.
Contraindications
Ciprofloxacin is contraindicated in patients who have shown hypersensitivity to ciprofloxacin or any of the excipients, or other quinolone anti-infectives.
Studies have indicated that ciprofloxacin is secreted in breast milk. Administration to nursing mothers is thus, not recommended.
Special Precautions
In the event of hypersensitivity, which in some instances can occur after the first administration, therapy should be discontinued.
Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweigh the risk of possible CNS side-effects. CNS side-effects have been reported after first administration of ciprofloxacin in some patients. Treatment should be discontinued if the side-effects, depression or psychoses lead to self-endangering behavior.
Crystalluria related to the use of ciprofloxacin has been reported. Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Use In Pregnancy & Lactation
Studies have indicated that ciprofloxacin is secreted in breast milk. Administration to nursing mothers is thus, not recommended.
Adverse Reactions
Gastrointestinal disturbances include nausea, vomiting, diarrhoea, abdominal pain, and dyspepsia are the most frequent adverse effects. Pseudomembranous colitis, pancreatitis, and dysphagia have been reported rarely.
Headache, dizziness, and restlessness are among the commonest effects on the CNS. Others include tremor, drowsiness, nightmares, visual and other sensory disturbances, hallucinations, psychotic reactions, depression, convulsions, and intracranial hypertension. Paresthesia and peripheral neuropathy have been reported.
In addition to rash and pruritus, hypersensitivity type reactions affecting the skin have included, rarely, vasculitis, erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis. Photosensitivity has occurred, and may be more frequent with some newer fluoroquinolones such as lomefloxacin and sparfloxacin. Anaphylaxis has been reported. As with other quinolone antibacterials reversible arthralgia has sometimes occurred and joint erosions have been documented in immature animals. Tendon damage has been reported.
Other adverse effects reported with ciprofloxacin include crystalluria, transient increases in serum creatinine or blood urea nitrogen and, rarely, acute renal failure secondary to interstitial nephritis. Elevated liver enzyme values, jaundice, and hepatitis; haematological disturbances including eosinophilia, leucopenia, thrombocytopenia and very rarely, haemolytic anemia or agranulocytosis. Cardiovascular adverse effects include tachycardia, hypotension, oedema, syncope, hot flushes, and sweating. Some fluoroquinolones may rarely cause prolongation of the QT interval and ventricular arrhythmias, including torsade de pointes. As with other antibacterials, superinfection with organisms not very susceptible to ciprofloxacin is possible. Such organisms include Candida, Clostridium difficile, and Streptococcus pneumoniae. There is some evidence that fluoroquinolones use may be associated with an increased risk of colonisation by MRSA.
Pain and irritation also occur at the site of infusion accompanied rarely by phlebitis or thrombophlebitis. Adverse effects reported after ocular use of ciprofloxacin include local burning or discomfort, keratopathy, corneal staining, corneal precipitates or infiltrates and photophobia.
Drug Interactions
Ciprofloxacin is known to inhibit the cytochrome P450 isoenzyme CYP1A2 and may increase plasma concentrations of drugs, such as clozapine, ropinirole, theophylline, and tizanidine, that are metabolised by isoenzyme. Use of ciprofloxacin with tizanidine is contraindicated, although theophylline may be used providing its dose is reduced and concentrations monitored. Clozapine or ropinirole may also be used, providing appropriate clinical surveillance occurs with subsequent dose adjustment where necessary.
Ciprofloxacin is reported to enhance the effect of oral anticoagulants such as warfarin and the oral antidiabetic glibenclamide. Severe hypoglycemia, sometimes fatal, has occurred in patients also taking glibenclamide. Renal tubular secretion of methotrexate may be inhibited by ciprofloxacin, potentially increasing its toxicity.
The excretion of ciprofloxacin or related drugs is reduced and plasma concentrations may be increased by probenecid. Cations such as aluminium, calcium, magnesium, or iron reduce the absorption of oral ciprofloxacin or related drugs when given together. Changes in the pharmacokinetics of fluoroquinolones have been reported when given with histamine H2 antagonists, possible due to changes in gastric pH, but do not seem to be of much clinical significance. Transient increases in serum creatinine have occurred when ciprofloxacin is given with ciclosporin; monitoring of serum creatinine concentrations is recommended. Altered serum concentrations of phenytoin have been reported in patients also receiving ciprofloxacin.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 500 mg x 100's.
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