Ciprolet solution for infusion bottle 100ml
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Release form
Solution
Composition
1 ml of 1 fl. ciprofloxacin 2 mg 200 mg. Excipients: sodium chloride - 900 mg, disodium edetate - 10 mg, lactic acid - 75 mg, citric acid monohydrate - 12 mg, sodium hydroxide - 8 mg, hydrochloric acid - 0.
Pharmacological effect
A broad-spectrum antibacterial drug from the group of fluoroquinolones. Bactericidal effect. The drug inhibits the enzyme DNA gyrase of bacteria, as a result of which DNA replication and synthesis of cellular proteins of bacteria are violated. Ciprofloxacin acts both on the breeding microorganisms and on those in the resting phase. Gram-negative aerobic bacteria are sensitive to ciprofloxacin: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafhia and I-family and I-year-olds. 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 pneumila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare. Gram-positive aerobic bacteria are also sensitive to ciprofloxacin: Staphylococcus spp. (S.aureus, S.haemolyticus, S.hominis, S.saprophyticus), Streptococcus spp. (St. pyogenes, St.agalactiae). Most methicillin-resistant staphylococci are also resistant to ciprofloxacin. The sensitivity of the bacteria Streptococcus pneumoniae, Enterococcus faecalis is moderate. Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to the drug. The effect of the drug on Treponema pallidum is not well understood.
Pharmacokinetics
After intravenous infusion of 200 mg or 400 mg TCmax - 60 min, Cmax - 2.1 mcg / ml and 4.6 mcg / ml, respectively. Vd - 2-3 l / kg, the bond with plasma proteins - 20-40%. It is well distributed in body tissues (excluding tissue rich in fats, for example, nervous tissue). Content in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are reached in saliva, tonsils, liver, gallbladder, bile, intestines, abdominal organs and small pelvis, uterus, seminal fluid, prostate tissue, endometrium, fallopian tubes and ovaries, kidneys and urinary organs, lung tissue, bronchial secretions, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. In CSF penetrates in a small amount, where its concentration in non-inflamed cerebral membranes is 6-10% of that in serum, and in inflamed - 14-37%. Ciprofloxacin also penetrates well into eye fluid, bronchial secretions, pleura, peritoneum, lymph, through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum. Activity decreases slightly at acidic pH values.Metabolized in the liver (15-30%) with the formation of inactive metabolites (diethylciploxacin, sulfocyrofloxacin, oxoicrofloxacin, formylcyrofloxacin). With intravenous injection of TT1 / 2 - 5-6 hours, with chronic renal failure - up to 12 hours. Mainly excreted by the kidneys by tubular filtration and tubular secretion in unchanged form (with intravenous administration - 50-70%) and in the form of metabolites (with the on / in the introduction - 10%), the rest - through the digestive tract. A small amount is excreted in breast milk. After intravenous administration, the concentration in the urine during the first 2 hours after administration is almost 100 times greater than in serum, which is significantly superior to BMD for most urinary tract pathogens. Renal clearance - 3-5 ml / min / kg; total clearance - 8-10 ml / min / kg. With CRF (CK above 20 ml / min), the percentage of the drug excreted through the kidneys is reduced, but cumulation in the body does not occur due to a compensatory increase in the metabolism of the drug and excretion with feces. Patients with severe renal insufficiency (CC below 20 ml / min / 1.73 m2) should be given half the daily dose.
Indications
Infectious and inflammatory diseases caused by microorganisms susceptible to ciprofloxacin, including: - respiratory tract infections - ENT-organ infections - infections of the kidneys and urinary tract - genital infections (gonorrhea, prostatitis, adnexitis) and postpartum infections - gastrointestinal infections ( including mouth, teeth, jaws) - infections of the gallbladder and biliary tract - infections of the skin, mucous membranes and soft tissues - infections of the musculoskeletal system - sepsis - peritonitis. Prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy).
Contraindications
- pseudomembranous colitis - glucose-6-phosphate dehydrogenase deficiency - pregnancy - lactation period (breastfeeding) - children and adolescents under 18 years of age (before completion of the skeleton formation process) - hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group. Precautions should be prescribed the drug in patients with severe atherosclerosis of the cerebral vessels, impaired cerebral circulation, mental illness, convulsive syndrome, epilepsy, severe renal and / or hepatic insufficiency, as well as elderly patients.
Use during pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation.
Dosage and administration
The drug should be administered in / in the drip for 30 min (200 mg) and 60 min (400 mg). The solution for infusion is compatible with 0.9% sodium chloride solution, Ringer's solution, 5% and 10% dextrose solution, 10% fructose solution, as well as a solution containing 5% dextrose solution with 0.225% or 0.45% sodium chloride solution. The dose of Ciprolet depends on the severity of the disease, the type of infection, the condition of the body, age, body weight and kidney function in the patient. A single dose, on average, is 200 mg (for severe infections, 400 mg), the frequency of administration is 2 times / day. The duration of treatment depends on the severity of the disease and is 1-2 weeks, if necessary, a longer administration of the drug. In acute gonorrhea, the drug is prescribed in / in a single dose of 100 mg. For the prevention of postoperative infections, it is administered intravenously in 30–60 minutes before surgery at a dose of 200–400 mg.
Side effects
On the part of the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with past liver diseases), hepatitis, hepatonecrosis, increased activity of hepatic transaminases and alkaline membrane cells. Nervous system disorders: dizziness, headache, fatigue, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (abnormal perception of pain), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, and other manifestations psychotic reactions (occasionally progressing to conditions in which the patient may harm himself), migraine, syncope, cerebral artery thrombosis. On the part of the senses: impaired taste and smell, impaired vision (diplopia, change in color perception), noise in the ears, hearing loss. Since the cardiovascular system: tachycardia, cardiac arrhythmias, lower blood pressure, rush of blood to the skin of the face. On the part of the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia. On the part of laboratory parameters: hypoprothrombinemia, hypercreatininemia, hyperbilirubinemia, hyperglycemia.On the part of the urinary system: hematuria, crystalluria (especially with alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, reduced nitrogen-excreting kidney function, interstitial nephritis. Allergic reactions: pruritus, urticaria, blistering, accompanied by bleeding, and small nodules that form scabs, drug fever, point hemorrhages (petechiae), swelling of the face or larynx, dyspnea, eosinophilia, increased sensitivity to light, vasculitis, nodular erythema, erythema, heart pattern, heart failure, nodular erythema. , Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome). On the part of the musculoskeletal system: arthralgia, arthritis, tendovaginitis, tendon ruptures, myalgia. Others: general weakness, superinfection (candidiasis, pseudomembranous colitis). Local reactions: pain and burning at the injection site, phlebitis.
Overdose
Treatment: The specific antidote is unknown. It is necessary to carefully monitor the condition of the patient, make a gastric lavage, carry out the usual emergency measures, to ensure adequate intake of fluid. With the help of hemo- or peritoneal dialysis, only an insignificant amount (less than 10%) of the drug can be derived.
Interaction with other drugs
Due to a decrease in the activity of microsomal oxidation processes in hepatocytes, it increases the concentration and lengthens the T1 / 2 of theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs, and indirect anticoagulants, reduces the prothrombin index. NSAIDs (excluding acetylsalicylic acid) increase the risk of seizures. Metoclopramide accelerates the absorption of ciprofloxacin, which leads to a decrease in the time to reach its Cmax. Co-administration of uricosuric drugs leads to a slower elimination (up to 50%) and an increase in the plasma concentration of ciprofloxacin. When combined with other antimicrobial agents (beta-lactams, aminoglycosides, clindamycin, metronidazole), synergism is usually observed; it can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin, azlocillin and other beta-lactam antibiotics - for streptococcal infections; with isoxazolylpenicillins and vancomycin - for staphylococcal infections; with metronidazole and clindamycin - for anaerobic infections.Enhances the nephrotoxic effect of cyclosporine, there is an increase in serum creatinine, so these patients need to control this indicator 2 times a week. At the same time, it enhances the effect of indirect anticoagulants. The infusion solution is pharmaceutically incompatible with all infusion solutions and drugs that are physically and chemically unstable in an acidic environment (pH of the ciprofloxacin infusion solution is 3.5-4.6). You cannot mix the solution for intravenous administration with solutions having a pH greater than 7.
special instructions
If severe or prolonged diarrhea occurs during or after treatment with Ciprolet, the diagnosis of pseudomembranous colitis should be excluded, which requires immediate discontinuation of the drug and appropriate treatment. If you experience pain in the tendons or the first signs of tendovaginitis appear, treatment should be stopped. During the treatment period with Ciprolet, it is necessary to provide a sufficient amount of fluid while observing normal diuresis. During treatment with Ciprolet, contact with direct sunlight should be avoided. Influence on the ability to drive vehicles and control mechanisms Patients taking Ciprolet, should be careful when driving a car and doing other potentially dangerous activities that require increased attention and speed of psychomotor reactions (especially with simultaneous use of alcohol).