SILAFOX [Ciprofloxacin] 200 mg IV solution
SILAFOX
instructions for medical use of the medicinal product
Tradename
Silafox, Силафокс
International non-proprietary name
Ciprofloxacin,
Composition
Each vial (100 ml solution) contains:
active ingredient: ciprofloxacin (as ciprofloxacin lactate) USP 200 mg
excipients: sodium chloride, lactic acid, water for injection
Dosage form
Solution for infusion.
Pharmacotherapeutic group
The antimicrobial agent is a fluoroquinolone .
Pharmacological properties
Silafox is a broad-spectrum antimicrobial agent, a fluoroquinolone derivative. The active substance is ciprofloxacin.
Pharmacodynamics
Ciprofloxacin inhibits bacterial DNA gyrase, disrupts DNA synthesis, growth and division of bacteria, causes pronounced morphological changes and rapid death of the bacterial cell. It acts bactericidal on gram-negative organisms during the period of rest and division (because it affects not only DNA gyrase, but also causes lysis of the cell wall), on gram-positive microorganisms - only during the period of division. Low toxicity to macroorganism cells is explained by the absence of DNA gyrase in them. While taking ciprofloxacin, there is no parallel development of resistance to other antibiotics that do not belong to the group of gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and many other antibiotics.
To ciprofloxacin sensitive gram-negative aerobic bacteria: enterobacteria
( Escherichia coli , Salmonella spp ., Shigella spp ., Citrobacter spp ., Klebsiella spp ., Enterobacter spp ., Proteus mirabilis , Proteus vulgaris , Serratia marcescens , Hafnia alvei , Edwardsiella tarda , Providencia spp ., Morganella morganii , Vibrio spp ., Yersinia spp .), other gram-negative bacteria ( Haemophilus spp ., Pseudomonas aeruginosa , Moraxella catarrhalis , Aeromonas spp ., Pasteurella multocida , Plesiomonas shigelloides , Campylobacter jejuni , Neisseria spp .), some intracellular pathogens ( Legionella pneumophila , Brucella spp ., Chlamydia trachomatis , Listeria monocytogenes , Mycobacterium tuberculosis , Mycobacterium kansasii , Corynebacterium diphtheriae ), Gram-positive aerobic bacteria: Staphylococcus spp . (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae).
Most methicillin-resistant staphylococci are also resistant to ciprofloxacin. Streptococcus susceptibility pneumoniae , Enterococcus faecalis , Mycobacterium avium (located intracellularly) - moderate (high concentrations are required to suppress them).
Resistant to the drug: Bacteroides fragilis , Pseudomonas cepacia , Pseudomonas maltophilia , Ureaplasma urealyticum , Clostridium difficile , Nocardia asteroides .
Not effective against Treponema pallidum .
Pharmacokinetics
With the on / in the introduction of 200 mg or 400 mg of ciprofloxacin 60 minutes after the start of the infusion, the concentration of the active substance in serum is 2.1 μg / ml or 4.6 μg / ml.
V d in the equilibrium state is 2-3 l / kg. There is a high concentration of ciprofloxacin in bile, several times higher than its concentration in plasma.
After intravenous administration, the concentration in the urine during the first 2 hours is almost 100 times greater than in serum.
In patients with unchanged renal function, T 1/2 is usually 3-5 hours. In case of impaired renal function, T 1/2 increases.
The main route of excretion of ciprofloxacin from the body is the kidneys. 50-70% is excreted in the urine. From 15 to 30% is excreted with feces.
Indications for use
Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin:
·
respiratory tract;
·
ear, throat and nose;
·
kidneys and urinary tract;
·
genital organs;
·
digestive system (including mouth, teeth, jaws);
·
gallbladder and biliary tract;
·
skin, mucous membranes and soft tissues;
·
musculoskeletal system.
Silafox is indicated for the treatment of sepsis and peritonitis, as well as for the prevention and treatment of infections in immunocompromised patients (during immunosuppressant therapy).
Contraindications
·
pregnancy;
·
lactation period;
·
childhood and adolescence;
· hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones.
Dosage and administration
The drug is administered intravenously.
Therapy begins with intravenous drip (within 30 minutes) administration of the drug at a dose of 200-400 mg 1-2 times / day. The treatment regimen depends on the indications and the clinical situation.
With a positive dynamics of the patient's clinical condition, after a few days of treatment, it is possible to switch from intravenous drip to oral administration of the drug.
The duration of treatment, depending on the course of the disease, is no more than 14 days.
Patients with severe renal insufficiency (creatinine clearance below 20 ml / min / 1.73 m 2 ) should be given half the daily dose of the drug.
Special instructions and precautions
It is prescribed with caution to patients with epilepsy, a history of seizures, vascular diseases and organic brain damage due to the threat of adverse reactions from the central nervous system.
If severe and prolonged diarrhea occurs during or after treatment with the drug, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.
If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued due to the fact that isolated cases of inflammation and even rupture of the tendons during treatment with fluoroquinolones have been described.
During the period of treatment with Silafox, it is necessary to provide a sufficient amount of fluid while maintaining normal diuresis.
During the period of drug treatment, contact with direct sunlight should be avoided.
Influence on the ability to drive vehicles and mechanisms
Patients taking Silafox should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially with the simultaneous use of alcohol).
Use during pregnancy and during breastfeeding
Use during pregnancy and during breastfeeding is contraindicated.
Interaction with other drugs
If you are taking any other medicines, be sure to inform your doctor, and if you are self-treating, consult your doctor about the possibility of using the drug.
With the simultaneous use of ciprofloxacin with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with the aluminum and magnesium salts contained in didanosine.
With simultaneous use with warfarin, the risk of bleeding increases.
Simultaneous administration of ciprofloxacin and theophylline can lead to an increase in the concentration of theophylline in the blood plasma, due to competitive inhibition in the binding sites of cytochrome P450, which leads to an increase in T 1/2 of theophylline and an increase in the risk of developing toxic effects associated with theophylline.
Simultaneous administration of antacids, as well as preparations containing aluminum, zinc, iron or magnesium ions, can cause a decrease in the absorption of ciprofloxacin, so the interval between the appointment of these drugs should be at least 4 hours.
With the simultaneous use of ciprofloxacin and anticoagulants, the bleeding time is prolonged.
With the simultaneous use of ciprofoxacin and cyclosporine, the nephrotoxic effect of the latter is enhanced.
Pharmaceutical interaction
Ciprofloxacin solution is incompatible with solutions or medicinal products with a pH of 3-4 that are physically or chemically unstable.
Side effect
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, increased activity of hepatic transaminases, alkaline phosphatase, LDH, bilirubin, pseudomembranous colitis.
From the side of the central nervous system: headache, dizziness, fatigue, sleep disorders, nightmares, hallucinations, fainting, visual disturbances.
From the urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase in serum creatinine.
From the hematopoietic system: eosinophilia, leukopenia, neutropenia, changes in platelet count.
From the side of the cardiovascular system: tachycardia, cardiac arrhythmias, arterial hypotension.
Allergic reactions: pruritus, urticaria, angioedema, Stevens-Johnson syndrome, arthralgia.
Adverse reactions associated with chemotherapeutic action: candidiasis.
On the part of laboratory indicators: an increase in the concentration of urea, creatinine.
Other: arthralgia; rarely - photosensitivity.
Overdose
Symptoms: there are no specific symptoms.
Treatment: it is necessary to carry out a gastric lavage, carry out the usual measures of emergency care, ensure sufficient fluid intake. The specific antidote is unknown.
Storage conditions
Store in a cool and dry place, at a temperature not exceeding 30 0 C.
Keep out of the reach of children.
Best before date
3 years. Do not use after the expiry date stated on the packaging.
Holiday conditions
Released by prescription.
Release form
1 bottle of 100 ml with instructions for use in a cardboard box.