Ziprox

Ziprox

ciprofloxacin

Manufacturer:

Myungmoon

Distributor:

Zyre Pharma
Full Prescribing Info
Contents
Ciprofloxacin.
Description
Each 100 mL solution contains: Ciprofloxacin 200 mg.
Indications/Uses
Ciprofloxacin is indicated for the treatment of the following infections: Susceptible strain: Escherichia coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia spp, Hafnia proteus (Indole positive and negative), Pseudomonas, Neisseria, Acinetobacter, Streptococcus, Chlamydia, Staphylococcus, Corynebacterium, Bacteroides, Clostridium.
Infections: Respiratory infections, ear-nose-laryngopharyngeal infection, oral cavity-tooth-jaw infection, renal or urinary tract infections, genital infections including gonorrhea, gastrointestinal tract infections, biliary secretion, infection and wound of soft tissue, bone and joint infections, gynaecological and obstetric infection, sepsis, meningitis, peritonitis, ophthalmic infections.
Dosage/Direction for Use
Dosage: Usual adult dosage is 100-400 mg I.V., every 12 hours.
The recommended adult dosage for urinary tract infections of mild to moderate severity is 200 mg I.V. every 12 hours. For severe or complicated urinary tract infections, the recommended dosage is 400 mg I.V. every 12 hours.
The recommended adult dosage for lower respiratory tract infections, skin and skin structure infections, and bone and joint infections of mild to moderate severity is 400 mg I.V. every 12 hours.
Duration of therapy: Duration of ciprofloxacin injection therapy is usually 7-14 day, for infections of bone and joint it is administered over 4-6 weeks or more. Also, it is administered 2 more days after symptom is disappeared.
Ciprofloxacin is administered by intravenous injection over 60 minutes. The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient's host-defense mechanisms and the status of renal and hepatic function. Parenteral therapy may be changed to oral ciprofloxacin when the condition warrants, at the discretion of the physician.
Renal impairment: The following provides dosage guidelines for use in patients with renal impairment; however, monitoring of serum drug levels provides the most reliable basis for dosage adjustment.
Creatinine Clearance (mL/min) >30 mL/min: See usual dosage.
Creatinine Clearance (mL/min) 5-29 mL/min: 200-400 mg q 18-24 hr.
When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance: See formula.

Click on icon to see table/diagram/image
Overdosage
In the event of acute, excessive oral overdosage, reversible renal toxicity has been reported in some cases. Therefore, apart from routine emergency measures, it is recommended to monitor renal function and to administer Mg or Ca containing antacids which reduce the absorption of ciprofloxacin. Only a small amount of ciprofloxacin (<10%) is removed from the body after haemodialysis or peritoneal dialysis.
Contraindications
Persons with a history of hypersensitivity to ciprofloxacin or any member of the quinolones class of antibacterial agents.
Pregnant women and nursing mothers.
Children in growing adolescents.
Patients with epilepsy.
Person with a history of hypersensitivity to ciprofloxacin tenontitis or tendon rupture related to member of the quinolones class of antibacterial agents.
Patients receiving Tizanidine.
Patients receiving ketoprofen.
Warnings
Ruptures of the shoulder, hand, or Achilles tendons that required surgical repair or resulted in prolonged disability have been reported. Ciprofloxacin should be discontinued if the patient experiences pain, inflammation, rupture of a tendon or symptom of tendonitis or tendon rupture has been a confidently excluded. Tendon rupture can occur during or after therapy with this drug.
Special Precautions
General cautions: To prevent resistant strain, susceptibility should be confirmed. It is recommended to use this drug during the only minimum period for therapeutic benefit.
Ciprofloxacin should be used with caution in patients with epilepsy or CNS disorder (such as decrease of seizure threshold, case history of convulsion, decrease of cerebral blood flow, cerebral change or cerebral apoplexy). Ciprofloxacin is used in these patients only when the therapeutic benefit overweighs the risk. In some patients those CNS reactions occurred at the first dose, and rarely depression or psychosis was aggravated to cause suicidal thoughts or acts. If these reactions occur in patients receiving ciprofloxacin, the drug is discontinued and patients consult physician.
If during or after therapy severe diarrhea or continuous diarrhea occur, severe intestinal disease (life-threatening Pseudomembranous colitis) could be masked. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Ciprofloxacin has been shown to be phototoxic. Patients taking ciprofloxacin should avoid direct exposure to sunlight. Therapy should be discontinued if photosensitisation occurs.
Even when the drug is taken exactly as prescribed, it can affect the speed of reaction to such an extent that the ability to drive or to operate machinery is impaired. This applies particularly in combination with alcohol.
Sodium chloride administration due to intravenous injection: In patients who are concerned with natrium supplement (with renal failure, cardiac failure, nephrotic syndrome), additional natrium administration should be carefully considered.
Careful administration: Patients with severe renal disorder; Patients with a history of convulsions; The elderly; Patients who have CNS disorder including severe cerebral arteriosclerosis or suspected; Patients with venous system damage; Patients with severe myasthenia (Symptoms may be aggravated); Patients receiving theophylline; Patients with glucose-6-phosphate dehydrogenase deficiency; Patients receiving phenyl acetates or propionate NSAID such as fenbufen, Flurbiprofen (There is a risk of convulsion).
Use in children: Toxicological studies have shown that this drug can produce erosions of cartilage of weight bearing joints and other signs of arthropathy in immature animals of various species.
For children, safety has not been established. Therefore, it is contraindicated to children below 18 years of age.
Use in elderly: This drug is mainly excreted into kidney. Generally, renal function is decreased in elderly and there is at risk of high serum concentration and adverse reactions. Therefore, this drug should be used with caution in the elderly.
Use In Pregnancy & Lactation
Ciprofloxacin must not be prescribed for 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 possible that the drug could cause damage to articular cartilage in the fetus or infant.
Ciprofloxacin is excreted in human milk. Therefore, a decision should be made to discontinue nursing or to avoid using the drug.
Adverse Reactions
Shock: Rarely shock may occur. Therefore careful observation is required. In the event of symptoms such as dropping of blood pressure, dyspnea and thoracic compression, administration is discontinued and appropriate measures are taken.
Hypersensitivity: In the event of hypersensitivity such as eruption, flare, pruritus, edema, fever, serum sickness-like syndrome, photosensitivity reaction with vesicle or erythema, therapy should be discontinued.
Skin: Rarely petechia, erythema multiforme, erythema nodosum, fixed drug eruption, life threatening mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome) or fixed eruption may occur. Therefore careful observation is required. In the event of symptoms administration is discontinued.
Urogenital system: Occasionally elevation of BUN and serum creatinine, rarely acute renal failure, renal dysfunction, vaginal candidiasis, hematuria, crystalluria, interstitial nephritis may occur.
Hepatic: Occasionally abnormal hepatic function value (increase of ALT, AST and ALP, bilirubinemia) rarely jaundice, cholestatic jaundice, hepatitis, hepatic necrosis (very rarely progressed to hepatic failure life threatening hepatic failure) may occur. Therefore careful observation is required. In the event of symptoms administration is discontinued and appropriate measures are taken.
Blood: Agranulocytosis, pancytopenia (very rarely life threatening) may occur. Occasionally leukopenia, thrombocytopenia, eosinophilia, rarely leukocytosis, erythrocytopenia, decrease of hemoglobin, decrease of hematocrit value, anemia, granulocytopenia, leukocytolysis, change of prothrombin value, thrombocytopenia, thrombocythemia, hemolytic anemia, petechia or myelosuppression (life threatening) may occur. Therefore careful observation is required. In the event of symptoms administration is discontinued.
Gastrointestinal: Colitis accompanying hemafecia including pseudomembranous colitis (rarely life threatening) may occur. In the event of abdominal pain and frequent diarrhea, administration is discontinued and appropriate measures are taken. Occasionally anorexia, diarrhea, abdominal discomfort, nausea, vomiting, abdominal pain, abdominal distension and rarely stomatitis, oral candidiasis, GI candidiasis or pancreatitis may occur.
Nervous system: Occasionally headache, dizziness, insomnia, agitation, alienation rarely sensory paralysis of tongue, drowsiness, tremolo, visual disturbance, hallucination, sweating, paresthesia (peripheral paraplegia), anxiety, nightmares, depression, tremor, convulsion, hypoesthesia, convulsive seizure, gait disturbance, psychosis, intracranial hypertension, ataxia, hyperesthesia, hypertonia or single twitch may occur. Attack or sleep disorder may occur.
Muscle: Muscle pain, muscular weakness, elevated CPK, rhabdomyolysis accompanying aggravation of renal function with elevation of myoglobin in urine or blood may occur. Therefore careful administration is required. Occasionally joint pain, rarely arthredema, myasthenia, tenontitis (Achilles tenontitis), tendon rupture (Achilles tendon rupture) may occur. Severe myasthenia may be aggravated.
Respiratory: Interstitial pneumonia accompanying with fever, cough, dyspnea disorder of chest X-ray, eosinophilia may occur. In occurrences of these symptoms, appropriate treatment including adrenocorticosteroid are taken.
Body as a whole: Occasionally candidiasis, anergia (weakness fatigue), rarely pain, melalgia, back pain, chest pain or joint pain may occur.
Sensory: Occasionally dysgeusia, rarely tinnitus, transient hearing loss, visual disturbance, double vision, chromatopsia, dysgeusia, olfactory disorders, anosmia (reversibly after drug discontinuation).
Metabolism disorder: Rarely edema (peripheral, vessel, facial, Pharyngeal), hyperglycemia, increase of amylase. Increase of lipase may occur. Hypoglycemia has rarely reported in other new quinolone antibiotics (elderly person, particularly with renal failure).
Cardiovascular system: Occasionally (thrombotic) phlebitis, rarely frequent pulse, migraine, syncope, angiectasia (flushing), hypotension, vasculitis, petechia, bleeding blister, acne, crust formation may occur.
Local I.V. site reactions have been reported with the intravenous administration of ciprofloxacin. These reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions which resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
Drug Interactions
Because this drug suppresses the action of cytochrome P450 enzyme, serum concentration of the drugs metabolized with cytochrome P450 (Theophylline, Methylxanthine, Caffeine, Duloxetine, Clozapine) is elevated and its toxicity could be increased. Therefore, caution is taken in the concurrent use. Concurrent administration of ciprofloxacin with theophylline may lead to elevated plasma concentrations of theophylline. The concurrent administration of ciprofloxacin and theophylline induce adverse reactions such as cardiac arrest nerve seizure, epilepsy, respiratory failure, and very rarely serious and fatal reactions. If concomitant use cannot be avoided, plasma levels of theophylline should be monitored and dosage adjustments made as appropriate.
Concurrent administration of ketoprofen with quinolones has resulted convulsion. Concurrent administration of some quinolone anti-infectives in patients receiving phenyl acetate group, such as fenbufen or flurbiprofen, nonsteroidal analgesic of propionate group has resulted convulsion. Animal studies have shown that the combination of very high doses of quinolones (gyrase inhibitors) and certain non-steroidal anti inflammatory agents (but not acetylsalicylic acid) can provoke convulsions.
Concurrent use with antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, calcium, and multivitamins preparations with zinc or iron may substantially interfere with the gastrointestinal absorption, resulting in systemic levels considerably lower than desired. These agents should be taken at least two hours before or two hours after administration.
Concurrent administration of omeprazole with ciprofloxacin may cause lower Cmax and AUC of ciprofloxacin.
Concurrent administration of warfarin and ciprofloxacin may strengthen the action of warfarin.
In special case if ciprofloxacin is used concurrently with glibenclamide, the action of glibenclamide could be strengthened to cause glycopenia.
Monitoring of serum creatinine concentrations is advised in patients on concurrent cyclosporin therapy. In these patients, serum creatinine adjustment is required 2 time per week.
Probenecid interferes with renal tubular secretion of ciprofloxacin and produces an increase in the level of ciprofloxacin in the serum.
Concurrent use of methotrexate with ciprofloxacin inhibit transferring of methotrexate, serum concentration of methotrexate may be increased. It may increase the risk of toxic reaction due to methotrexate. Therefore ciprofloxacin should be used with caution in patients who are receiving methotrexate.
In clinical trial with healthy volunteers, the concurrent use of this drug with tizanidine increased serum tizanidine (Cmax: 7 times increased, Range: 4-21 times, AUC: 10 times increased, Range: 6-24 times). It may induce dropping of blood pressure and sedation effect. Therefore, this drug should not be concurrently used with tizanidine.
Elevation of serum phenytoin has been reported in patients receiving phenytoin concomitantly.
Quinolones have also been shown to interfere with the metabolism of caffeine. It may reduce the clearance of caffeine and prolong its plasma half life.
In the concurrent use of this drug with metronidazole, serum concentration of two drug has not been changed.
Ropinirole: In the concurrent use of this drug with ropinirole, that is CYP450 1A2 enzyme inhibitor (medium inhibitor), Cmax and AUC have been increased to 60% and 84%. Tolerance for ropinirole administration was good. However, adverse reaction can be reported in concurrent use of ciprofloxacin with ropinirole.
Lidocaine: In the concurrent use of this drug with lidocaine, that is CYP450 1A2 enzyme inhibitor (medium inhibitor), lidocaine clearance has been decreased to 22% and 84%. Tolerance for lidocaine administration was good. However, adverse reaction can be reported in concurrent use of ciprofloxacin with lidocaine.
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
Soln for inj (vial) 2 mg/mL (colourless type 2 glass bottle containing transparent colorless or faint yellow liquid) x 100 mL.
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