Zalvos

Each ml contains Ciprofloxacin (as lactate), EP 2 mg.
Ciprofloxacin lactate is a synthetic broad-spectrum antimicrobial for intravenous administration. The active ingredient (Ciprofloxacin is a fluoroquinolone (C₁₇H₁₈FN₃O₃, molecular weight 331.4).

Ciprofloxacin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed as follows:
Urinary Tract Infections: Caused by Escherichia coli, Klebsiella pneumoniae, subspecies pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus epidermis and Enterococcus faecalis.
The treatment of mild to moderate lower respiratory tract infections, skin and skin structure infections and bone and joint infections due to the organisms listed in each section as follows. In severe and complicated lower respiratory tract infections, safety and effectiveness of the IV formulation have not been established.
Lower Respiratory Infections: Caused by Eschericia coli, Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, and Streptococcus pneumoniae.
Skin and Skin Structural Infections: Mild to moderate infections caused by Eschericia coli, Klebsiella pneumoniae subspecies pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermis, and Streptococcus pyogenes.
Bone and Joint Infections: Mild to moderate infections caused by Enterobacter cloacae, Serratia marcescens, and Pseudomonas aeruginosa.
Gastrointestinal Infections: Caused by resistant gram-negative organisms with appropriate therapy for anaerobic organisms.
Septicemia, Endocarditis: From gram negative-resistant pathogen members; endocarditis from Q fever (Coxiella burnetii).

Ciprofloxacin is given by intravenous infusion over 30 to 60 minutes as a solution of the lactate in a concentration of 1 to 2 mg per mL. The usual adult intravenous dose is 100 to 400 mg twice daily. For acute exacerbations of cystic fibrosis associated with Pseudomonas aeruginosa infection, ciprofloxacin may be given to adolescents and children ages 5 years or more in a dose of 10 mg per kg may be given intravenous infusion over 60 minutes three times daily, to a maximum of 400 mg three times daily. Or as prescribed by a physician.
Ciprofloxacin is not generally recommended for other uses in children and adolescents but if considered essential, doses of 4 to 8 mg per kg twice daily intravenously have been suggested. Doses should be reduced in patients with severe renal impairment. Halving the dose has been suggested when the creatinine clearance is less than 20 mL per minute or alternatively the dosage interval may be increased; ideally plasma concentrations of ciprofloxacin should be monitored.
Compatibility with common injection liquids: Ciprofloxacin is compatible with natural NaCl solution, Ringer solution, 5% Dextrose solution and 10% Dextrose solution and 10% Dextrose/NaCl solution and 10% Fructose.
Duration of treatment: The duration of treatment depends upon the severity of infection. For acute infections, the usual duration is 5-7 days. Generally, the administration should be continued for at least 3 days, after the signs and symptoms of infection have disappeared.
Parental therapy may be changed to oral Ciprofloxacin tablets.

No data concerning human overdosage is available. Adequate hydration must be maintained. In the event of serious toxic adverse reactions, hemodialysis or peritoneal dialysis may help for the removal of Ciprofloxacin from the organism specially if the renal activity is in danger.

Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to any member of the quinolone class.

The safety and effectiveness of Ciprofloxacin in children, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established. Ciprofloxacin causes lameness in immature dogs. Histopathological examination of the weight-bearing of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage weight-bearing joints and other signs of arthropathy in immature animals of various species.

Convulsions have been reported in patients receiving Ciprofloxacin. Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving Ciprofloxacin and other drugs of this class. Quinolones may also cause central nervous system (CNS) stimulation which may lead to tremors, restlessness, lightheadedness, confusion and hallucinations. As with all quinolones, Ciprofloxacin should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, and other factors that predispose to seizures.
Crystalluria related to Ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Alkalinity of the urine should be avoided in patients receiving Ciprofloxacin. Patients should be well hydrated to prevent the formation of highly concentrated urine. Alteration of the dosage regimen is necessary for patients with impairment of renal function.
Use in pregnancy: Pregnancy Category C: Reproduction studies have been performed in rats and mice at doses up to 16 times the usual daily human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Ciprofloxacin. In rabbits, Ciprofloxacin produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced, and no embryotoxicity or teratogenicity was observed.
Use in lactation: Ciprofloxacin is excreted in human milk. Because of the potential for serious adverse reactions in infants nursing from mothers taking Ciprofloxacin, a decision should be made either to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children: Safety and effectivity in children and adolescents less than 18 years of age have not been established. Ciprofloxacin causes arthropathy in juvenile animals.

Pregnancy: Pregnancy Category C: Reproduction studies have been performed in rats and mice at doses up to 16 times the usual daily human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Ciprofloxacin. In rabbits, Ciprofloxacin produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion. No teratogenicity was observed. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced, and no embryo-toxicity or teratogenicity was observed.
Nursing Mothers: Ciprofloxacin is excreted in human milk. Because of the potential for serious adverse reactions in infants nursing from mothers taking Ciprofloxacin, a decision should be made either to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Local IV reactions have been reported, followed in a few cases by phlebitis and thrombophlebitis.
Ciprofloxacin is generally well tolerated. During clinical research, 2,799 patients were treated with 2,868 series of the drug. Adverse reactions, eventually related to the drug appeared in 7.3% of the series, and non-related in 3.0%. Ciprofloxacin administration was interrupted in 3.5% because of adverse reactions. These concerned the gastrointestinal system (1.5%), the skin (0.6%) and CNS (0.4%). The reported events were: nausea (5.2%), diarrhea (2.3%), vomiting (2.0%), abdominal pain (1.7%), headache (1.2%), anxiety (1.1%), and anaphylactic reactions (1.1 %).
Additional events, without regard to drug relationship or route of administration, that occurred in 1% or less of Ciprofloxacin courses are listed as follows.
Gastrointestinal: Ileus; jaundice; gastrointestinal bleeding; C. difficile associated diarrhea; pseudomembranous colitis; pancreatitis; hepatic necrosis; intestinal perforation; dyspepsia; epigastric or abdominal pain; vomiting, constipation; oral ulceration; oral candidiasis; mouth dryness; anorexia; dysphagia; flatulence.
Central Nervous System: Convulsive seizures, paranoia, toxic psychosis, depression, dysphasia, phobia, depersonalization, manic reaction, unresponsiveness, ataxia, confusion, hallucinations, dizziness, lightheadedness, paresthesia, anxiety, tremor, insomnia, weakness, drowsiness, irritability, malaise, lethargy.
Skin/Hypersensitivity: Anaphylactic reactions; erythema multiforme/Stevens-Johnson syndrome; exfoliative dermatitis; toxic epidermal necrolysis; vasculitis; angioedema; edema of the lips face, neck, conjunctivae, hands or lower extremities; purpura; fever; chills; flushing; pruritus; urticaria; cutaneous candidiasis; vesicles; increased perspiration; hyperpigmentation; erythema nodosum; photosensitivity.
Allergic reactions ranging from urticaria to anaphylactic reactions have been reported.
Special Senses: Decreased visual acuity, blurred vision, disturbed vision (flashing lights, change in color perception, overbrightness of lights, diplopia), eye pain, anosmia, hearing loss, tinnitus, nystagmus, a bad taste.
Musculoskeletal: Joint pain, jaw, arm or back pain; joint stiffness neck and chest pain; achiness; flare up of gout.
Renal/Urogenital: Renal failure, interstitial nephritis, hemorrhagic cystitis, renal calculi, frequent urination, acidosis, urethral bleeding, polyuria, urinary retention, gynecomastia, candiduria, vaginitis. Crystalluria, cylinduria, hematuria and albuminuria have also been reported.
Cardiovascular: Cardiovascular collapse, cardiopulmonary arrest, myocardial infarction, arrhythmia, tachycardia, palpitation, cerebral thrombosis, syncope, cardiac murmur, hypertension, hypotension, angina pectoris.
Respiratory: Respiratory arrest, pulmonary embolism, dyspnea, pulmonary edema, respiratory distress, pleural effusion, hemoptysis, epistaxis, hiccup. Many of these events were described as only mild or moderate in severity, abated soon after the drug was discontinued and required no treatment. In several instances, nausea, vomiting, tremor, irritability or palpitation were judged by investigators to be related to elevated serum levels of Theophylline possibly as a result of drug interaction with Ciprofloxacin.

As with other quinolones concurrent administration of Ciprofloxacin with Theophylline may lead to elevated serum concentrations of Theophylline and prolongation of its elimination half-life. This may result in increased risk Theophylline­-related adverse reactions. If concomitant use of Ciprofloxacin and Theophylline cannot be avoided, serum levels of Theophylline should be monitored and dosage adjustments made as appropriate.
Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in the serum.
This should be considered if patients are receiving both drugs concomitantly. As with other broad-spectrum antimicrobial agents, prolonged use of Ciprofloxacin may result in overgrowth of nonsusceptible organisms. Repeated evaluation of the patient's condition and microbial susceptibility testing are essential. If superinfection occurs during therapy, appropriate measures should be taken.

Store at a temperature not exceeding 30°C.

Quinolones

J01MA02 - ciprofloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

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