Pharproxin

Pharproxin

ciprofloxacin

Manufacturer:

Community Pharm PCL

Distributor:

Community Pharm PCL
Full Prescribing Info
Contents
Ciprofloxacin hydrochloride.
Description
1 film coated tablet contains Ciprofloxacin hydrochloride eq. to Ciprofloxacin 250 mg or 500 mg.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Ciprofloxacin usually is bactericidal in action. Ciprofloxacin inhibits DNA synthesis in susceptible organisms via inhibition of enzymatic activities of 2 members of the DNA topoisomerase class of enzymes, DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacteria DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
Pharmacokinetics: The bioavailability of ciprofloxacin is approximately 71-79%. Ciprofloxacin is rapidly and well absorbed from the GI tract after oral administration with no substantial loss by first-pass metabolism. The protein binding of ciprofloxacin is 20-40%. Ciprofloxacin is widely distributed into the body tissues and fluids following oral administration. The apparent volume of distribution is 2-3.5 L/kg. The elimination half-life of ciprofloxacin is 3-7 hours. Ciprofloxacin is eliminated by the renal and nonrenal mechanisms. The drug is partially metabolized in the liver by the modification of the piperazinyl group to at least 4 metabolites. Ciprofloxacin and its metabolites are excreted in urine and feces. Unchanged ciprofloxacin is excreted in urine by both glomerular filtration and tubular secretion. Renal clearance of ciprofloxacin averages 300-479 mL/min in adults with normal renal function.
Indications/Uses
250 mg: Infections of the respiratory tract, skin and soft tissue, bones and joints.
500 mg: Acute sinusitis: Caused by Haemophilus influenza, Streptococcus pneumonia (penicillin-susceptible), or Moraxella catarrhalis.
Acute uncomplicated cystitis (in women): Cause by Escherichia coli or Staphylococcus saprophyticus.
Bone and joint infections: Caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
Chronic bacterial prostatitis: Caused by E. coli or Proteus mirabilis.
Complicated intra-abdominal infections: Used in combination with metronidazole, caused by E. coli, P. aeruginosa, P. mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
Infection diarrhea: Caused by E. coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydii, Shigella dysenteriae, Shigella flexneri, or Shigella sonnei.
Lower respiratory tract infections: Caused by E. coli, K. pneumoniae, E. cloacae, P. mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, P. aeruginosa, Staphylococcus aureus (methicillin-susceptible), Staphylococcus epidermidis (methicillin-susceptible), or Streptococcus pyogenes.
Typhoid fever (enteric fever): Caused by Salmonella typhi.
Uncomplicated cervical and urethral gonorrhea: Caused by Neisseria gonorrhoeae.
Urinary tract infections: Caused by E. coli, K. pneumoniae, E. cloacae, S. marcescens, P. mirabilis, Providencia rettgeri, M. morganii, Citrobacter diversus, C. freundii, P. aeruginosa, S. epidermidis (methicillin-suscepticle), S.saprophyticus, or Enterococcus faecalis.
Complicated urinary tract infections and pyelonephritis: Caused by E. coli in children 1 to 17 years of age.
Inhalational anthrax (postexposure) in adults and in children: To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Dosage/Direction for Use
250 mg: 1-2 tablets twice daily, in the morning and evening for 7-14 days, or as directed by the physician.
500 mg: Recommended Dose: Adults: See Table 1.

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Children: See Table 2.

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Mode of Administration: Ciprofloxacin is administered orally. The drug may be given without regard to meals. Ciprofloxacin should not be administered concurrently with dairy products (e.g., milk, yogurt) or calcium-fortified products (e.g., juices) alone (without a meal) since absorption of the drug may be substantially reduced. Doses should preferably be taken 2 hours before or after these calcium-fortified products or substantial calcium intake (greater than 800 mg).
Overdosage
Reversible renal toxicity has been reported in some case of acute overdose of ciprofloxacin. If acute overdosage of the drug occurs, the stomach should be emptied by inducing emesis or by gastric lavage. Administration of antacids containing magnesium, aluminum, or calcium may reduce oral absorption of ciprofloxacin.
Contraindications
Ciprofloxacin is contraindicated in patients with a history of hypersensitivity to the drug or to other quinolones.
Ciprofloxacin is contraindicated in patients receiving tizanidine since ciprofloxacin increases plasma concentration of tizanidine and could lead to clinically important adverse effects.
Special Precautions
Because fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture in all age groups, patients receiving ciprofloxacin should be informed of this potential adverse effect and the drug should be discontinued if pain, swelling, inflammation, or rupture of  tendon occurs.
Ciprofloxacin may cause CNS stimulation that potentially could result in tremor, restlessness, lightheadedness, mental confusion, toxic psychosis, and/or seizures, the drug should be used with caution in patients with known or suspected CNS disorders that predispose to seizures or lower the seizure threshold and should be used with caution in the presence of other factors that predispose to seizures or lower the seizure threshold.
Ciprofloxacin inhibits the cytochrome P-450 (CYP) isoenzyme 1A2, concomitant use with drugs metabolized by this enzyme (e.g., theopylline, methylxanthines, tizanidine) results in increased plasma concentration of the other drug and could lead to clinically important adverse effects.
Patients receiving ciprofloxacin should be advised to avoid excessive exposure to sunlight or artificial ultraviolet light and to discontinue therapy if phototoxicity occurs.
Ciprofloxacin should be used with caution in those receiving concurrent therapy with drugs that can prolong QT interval (e.g., class IA or III antiarrhythmic agent) or those with risk factors for Torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).
Use In Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Ciprofloxacin is distributed into milk. Because of the potential for serious adverse effects of ciprofloxacin in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Adverse Reactions
Cardiovascular: Arrhythmia, cardiac murmur, cardiovascular collapse, hypotension, tachycardia (1% or less); angina pectoris, atrial flutter, cardiopulmonary arrest, cerebral thrombosis, myocardial infarction (MI), ventricular ectopy (less than 1%); postural hypotension.
Central nervous system: Restlessness (1.1%); anxiety, depersonalization, dysphasia, lightheadedness, manic reaction, paranoia, phobia, toxic psychosis, unresponsiveness, weakness (1% or less); anorexia, ataxia, irritability, nightmares, tremor (less than 1%).
Dermatologic: Anaphylactic reactions, angioedema, cutaneous candidiasis, edema of the lips, face, neck, conjunctivae, hands, or lower extremities, erythema multiforme, increased perspiration, purpura, vasculitis, vesicles; erythema nodosum, flushing, hyperpigmentation, urticaria (less than 1%).
Gastrointestinal: Anorexia, C.difficile-associated diarrhea, hepatic necrosis, ileus, jaundice, oral ulceration, pancreatitis (1% or less); painful oral mucosa (less than 1%).
Genitourinary: Albuminuria, candiduria, crystalluria, cylindruria, frequent urination, gynecomastia, hematuria, hemorrhagic cystitis, renal calculi (1% or less); acidosis, interstitial nephritis, polyuria, renal failure, urethral bleeding, urinary retention (less than 1%); vaginal candidiasis.
Hypersensitivity: Hyperpigmentation (less than 1%).
Musculoskeletal: Achiness, arthralgia, flare-up of gout, jaw, arm, or back pain, joint stiffness neck and chest pain (1% or less).
Respiratory: Pleural effusion, respiratory arrest, respiratory distress (1% or less); bronchospasm, dyspnea, epistaxis, hemoptysis, hiccups, laryngeal/pulmonary edema, pulmonary embolism (less than 1%).
Special senses: Anosmia, blurred vision, decreased visual acuity, nystagmus (1% or less); bad taste in mouth, diplopia, eye pain, tinnitus (less than 1%).
Miscellaneous: Erythema, injection-site burning, pain, paresthesia, pruritus, swelling, thrombophlebitis (1% or less); exacerbation of myasthenia gravis, dysphasia, agranulocytosis; cholestatic jaundice.
Drug Interactions
Concomitant administration of ciprofloxacin and antacids (magnesium, aluminum or calcium-containing) decrease absorption of oral ciprofloxacin, resulting in decreased serum and urine concentrations of the anti-infective agent. Ciprofloxacin should be administered at least 2 hours before or 6 hours after antacids containing magnesium or aluminum.
Precaution should be taken when using ciprofloxacin together with class IA or III antiarrhythmic as ciprofloxacin may prolong QT interval.
Coadministration of ciprofloxacin and corticosteroids may increase the risk of severe tendon disorders (e.g., tendinitis, tendon rupture), especially geriatric patients older than 60 years of age.
Coadministration of ciprofloxacin and metoclopramide may accelerate the rate of GI absorption ciprofloxacin resulting in a shorter time to peak plasma concentration.
Concomitant use of ciprofloxacin and a nonsteroidal anti-inflammatory agent (NSAID) could increase the risk of CNS stimulation (e.g., seizures).
Concomitant administration of ciprofloxacin and probenecid interferes with renal tubular secretion of ciprofloxacin.
Concomitant use of ciprofloxacin and tizanidine may increase serum concentrations and AUC of tizanidine and potentiated the hypotensive and sedative effects of the drug.
Concomitant use of ciprofloxacin and theophylline derivative may result in higher and prolonged serum therophylline concentrations and may increase the risk of theophylline-related adverse effects.
Storage
Store in tight containers at a temperature below 30°C and protect from light.
MIMS Class
ATC Classification
J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 250 mg x 10 x 10's. 500 mg x 10 x 10's.
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